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May 31, 2007

Caps on Medical Malpractice Cut Doctors’ Insurance Costs

According to a new review from two Alabama universities Caps on medical malpractice damages mean lower insurance premiums for doctors. How these caps affect patient care or cost is less certain. “There’s been substantial controversy over whether caps do what they’re supposed to; reduce malpractice insurance premiums,” said lead author Leonard J. Nelson III, of the Cumberland School of Law at Samford University in Birmingham. “The rates of increase in malpractice insurance premiums are lower in states that have caps.” The study appears in the latest issue of The Milbank Quarterly. More than half of the states have damages caps. Thirteen states and the District of Columbia never passed laws instituting caps and they were ruled unconstitutional in nine others states.

In their analysis of 10 studies conducted since 1990, Nelson and co-authors from the Lister Hill Center for Health Policy at the University of Alabama found no evidence that caps affect consumers’ health insurance costs. However, they did say there is evidence of “small-to-modest effects” of damages caps on so-called defensive medicine and some evidence that more physicians will practice in areas where there are caps. Doctors practice defensive medicine when they avoid high-risk patients or procedures to reduce their exposure to malpractice suits. In one study that examined 12 years of data, researchers found that damages caps reduced premiums for general practitioners, general surgeons and OB/GYNs by 13.4 percent, 14.3 percent and 16.9 percent, respectively, in the short term and by 40 percent to 58 percent longer term.

Lower malpractice insurance premiums for physicians indirectly help patients, said David Studdert, adjunct professor at the Harvard School of Public Health. “If doctors’ fear of litigation, stimulated in part by pricey premiums, prompts them to deliver treatments and order tests designed to cover them, not improve the patient’s care, then the patient may suffer,” Studdert said. “Lower premiums may, and probably do, reduce the incidence of such defensiveness.” Nelson said that caps might have “some good effects,” but that “they can be unfair because people who are severely injured don’t get adequately compensated.” One effect of caps, he said, is that they discourage lawsuits.


Journalistic Malpractice views from a Doctor

Doctor Scott Gottlieb M.D. shares his views on Medical Journal behaviors.

“As medical information is exploding and becoming more accessible, all of us, particularly physicians need objective sources to interpret data and present a balanced view. Unfortunately, major medical journals that should be filling this role often put more weight on pushing political agendas. Their editorial prejudice has left a troubling void for rigorous and unbiased arbiters of medical evidence who can guide sound medical practice decisions.

The behavior of the New England Journal of Medicine (NEJM) is a case in point, when it rushed onto its Web site a limited and flawed analysis of safety concerns around the diabetes drug Avandia. The publication was timed to get ahead of the Food and Drug Administration's more careful evaluation of the same issues. The journal seemed bent on beating the FDA to the punch. The goal? Painting the FDA as impotent, in order to argue for legislation winding through Congress that would increase regulatory hurdles for drug approvals. The journal's motives were made bare by its own editorial on the matter.

At what cost do political machinations of the medical journals come? When editors pursue a political agenda, it is public health that pays a price. NEJM said it rushed to post the study on the Web because of its medical importance, but the FDA, which would need to act on any safety issues, wasn't even given a heads up about the study's publication or its findings. Rep. Henry Waxman (D., Calif.), however, seems to have known in advance that it was coming because he issued a substantive press release immediately after the study was posted online. He was even ready with the date and location of oversight hearings aimed at probing the FDA's "handling" of the drug safety issues. Mr. Waxman is trying to add new restrictions to the FDA's drug approvals. The study's primary author, Cleveland Clinic cardiologist Steve Nissen, admitted to the Wall Street Journal that he was in touch with Congress while preparing his analysis. Three days after the study was submitted to NEJM, and before it was published, the FDA commissioner received a letter about Avandia from members of the House Energy and Commerce Committee that seemed to reference the NEJM study.”


May 30, 2007

BlueCross BlueShield of South Carolina Launches Subsidiary to Facilitate Medical Tourism

BlueCross BlueShield of South Carolina recently launched a subsidiary, Companion Global Healthcare, to help U.S. patients plan trips to Thailand for lower-cost medical procedures, the Charleston Post and Courier reports. BCBS will cover patients' procedures organized through Companion Global if their BCBS plan allows the travel, according to spokesperson Elizabeth Hammond. Additionally she said the insurer also will cover two follow-up visits with physicians at Doctors Care centers in the state. The company is "one of the first efforts of its kind" in the nation and "reflects several trends," such as an increase in medical tourism, increasing health care costs and rising health standards in Asian countries, according to the Post and Courier.

However, "some question whether American patients really want to travel halfway around the world for a hospital visit," and some critics contend Companion Global is "a ploy by insurers to squeeze domestic health care providers already suffering from hefty malpractice premiums and tight Medicare and Medicaid reimbursements." David Boucher, assistant vice president of health care services at BCBS, denied the charge, adding that the company is responding to health care trends. Patti Smoake, a spokesperson for the South Carolina Hospital Association, said the program is an indication of the nation's frustration with the health care system but that medical tourism is "not the answer to the problem of rising health care costs"


Many hurt in boat collision Memorial Day weekend

A speed boat collided with a pontoon boat on Sunday night of Memorial Day weekend on Lake Holcombe in Wisconsin. Nearly a dozen people were injured, several seriously. The driver of the speed boat was arrested for drunk driving. The crash happened when a runabout-type boat carrying eight people collided head-on with a pontoon boat carrying 11 people, according to Department of Natural Resources Conservation Warden Scott Bowe. The runabout, a 19-ft. fiberglass craft with an inboard engine, rode up on the top of the pontoon, then came down on the left side. The out drive became entangled in a railing on the pontoon. The preliminary results of the investigation into the crash indicate that no one on board the runabout was injured, but perhaps everyone on the pontoon suffered some form of injury. Several of the injuries were quite serious, involving head trauma and broken bones. One person was reportedly pinned under the runabout while another one who was seriously injured was in the water. The operator of the runabout was given a field sobriety test and a preliminary breathalyzer and then taken to a hospital for a blood draw. Derek Lee Brost, 22, was booked into the Chippewa County Jail by the DNR for reckless operation of a motor boat and operating a boat while intoxicated. Bowe said the boats were so entangled that a wrecker had to be brought in to lift the runabout off of the pontoon. He said the fact that the runabout rode up so far onto the pontoon is an indication that the boat must have been moving fast.


Coping with a TBI using a game

Rachel Weisbarth's was dramatically affected when her dad received a traumatic brain injury in a car accident. The 9-year-old suddenly got less attention from both parents and had a dad who behaved differently than before the January 2005 accident. Rachel didn't understand why her dad would get upset for no apparent reason. Her mom, Christina, wanted to find a way to teach her daughter more about brain injuries and how to handle the new emotions that were flooding into her life. Working with Judy McAtee, a social worker with Special Tree Neuro Skills Center in Midland, Michigan Rachel created "The Brain Game." It features Action, Facts, Bonus and Feelings cards that are given out based on what color square a player ends up on after rolling dice. The squares are arranged in the shape of a brain, and the cards teach facts about traumatic brain injuries or ways to handle feelings that Rachel learned through research and experience. One thing Rachel learned is that her dad no longer can control his mood and he doesn't mean to hurt her feelings when his mood shifts. Knowing that, she can process her own feelings and know that he still loves her instead of being hurt. Another thing she has learned is to think of "can" statements instead of "can't" statements. Rachel said her dad can't do a lot of the everyday things they used to do together. "He can't talk. He can't walk. He can't take me to the park," she said. McAtee then pointed out there are things they can do together. "Dad can't take me to the park, but dad can go to the park with me," McAtee said to her as an example. Making "The Brain Game" helped Rachel so much that she wanted to share it with others going through the same experience she went through. She presented Special Tree CEO Joe Richert with the game last week to bring to a neurological skills center.

With support from his wife and sister, Rich also has seen improvements in his life. He now can eat regular food on his own and can speak a few words. He also can enjoy watching NASCAR races and hockey games he used to enjoy, and occasionally gets out to see a movie. He lives at home and goes to the Special Tree center for physical, occupational and recreational therapy. Rachel's mom said having the whole family's support, including Rachel's, means a lot to Rich. "I think without family support, the patient doesn't do well," she said. "If you don't have somebody pushing you, there's no response."


May 29, 2007

Operation Helmet

Dennis Smith of Illinois has good reason for launching the McHenry County arm of Operation Helmet, a project to ensure that Marines are equipped with proper helmets. His granddaughter’s husband is serving his second term in Iraq and still does not have the proper helmet protection, Smith said. Operation Helmet takes donations to buy upgrade kits for helmets to protect soldiers from traumatic brain injury. Since starting in November, McHenry Operation Helmet has raised about $3,000 in donations. Each new helmet upgrade kit costs $77. Operation Helmet is not just a local project. Bob Meaders of Texas started Operation Helmet in 2004 because he, like Smith, has a connection to a person serving in Iraq.

Smith is the former executive director of the Mental Health Board and serves as the treasurer for the McHenry County Behavior Health Foundation. Head injury is a subject that is very close to Smith’s heart. When Smith’s daughter was 15, she sustained serious head injuries in a car accident. “I became aware over the next several years how inadequate the resources were for people with head injuries,” Smith said. “Head injuries require a really specific approach to rehabilitation and many times people with head injuries end up in the mental-health system because they exhibit symptoms that are similar to mental illnesses. ... And because they are misdiagnosed, they receive the wrong treatment.” Bipolar disorder, post traumatic stress disorder and borderline personality disorder are just a few examples of misdiagnosing brain injuries. Sixty percent of soldiers treated for head injuries at Walter Reed Hospital have been diagnosed with traumatic brain injury, according to the New England Journal of Medicine.

Smith also has run into snags along the way when it comes to fitting Marines with the helmet inserts. For example, Smith’s grandson said he would not use the inserts unless his entire fire team was fitted with them as well, saying that he didn’t want to have better protection than his friends. The problem is, now they need to figure out the type of helmet and the size for everyone, but the Marines will not disclose that information for security reasons. The Marines are in the process of upgrading their helmets to include the inserts, but the helmet upgrade kits that are being provided right now are not being used by most soldiers because of discomfort, Meaders said.


Bicycle Helmet Safety Institute promotes: Helmet Safety for Skateboarders

SKATEBOARDERS
* You always need a helmet when you board. You will crash eventually.
* Even a low-speed fall can scramble your brains.
* Buy a skateboard helmet for skateboarding, not a bicycle helmet. You will get better coverage and protection built for skateboarding.
* Skateboard helmets should meet the ASTM F1492 skateboard helmet standard.
* You don't know how hard pavement is until your head really hits it. If you fracture a wrist, arm or collarbone, it heals, but the brain is different.

WHAT TO LOOK FOR
* A skateboard helmet softens the impact when the foam inside crushes or slowly deforms. The hard shell on board helmets holds up under multiple impacts. Bike helmets use thin plastic that breaks immediately the first time you hit hard.
* The best interior foam for skateboarding is probably Expanded PolyPropylene (EPP). It looks like bike helmet foam, but feels a little bit rubbery. Unlike bike helmet EPS foam, EPP recovers and is good for the next hit.
* The helmet must stay on your head. It's not a hat, just sitting there, otherwise it will fly off while you are flying through the air. It needs a strong strap and an equally strong buckle. And you need to remember to fasten it.

STANDARDS
A sticker inside the helmet tells what standard it meets. True skateboard helmets meet ASTM F1492. Some "skate-style" helmets only meet the CPSC bicycle helmet standard. Those are bike helmets, not skateboard helmets, even if there is a skateboard on the box.

WHAT TO BUY
* Some of the best skateboard helmets are "dual-certified" to both ASTM and CPSC standards.
* Check out the Dual Certified Helmets page at www.helmets.org/dualcert.htm for the latest list.
* Those helmets are designed for skateboarding and bicycling.


After serious accident, teen promotes helmet use

A scar remains after Nick Perez, 14, fell off his long board and required emergency brain surgery to remove a blod clot. He was not wearing his helmet when he fell. In late April, Nick, a 14-year-old eighth-grader, was skating home from a friend's house on his long board (an extra long, extra wide skate board) he used for transportation. He was moving fast, listening to his iPod, and the board went out from under him and Nick's head hit the pavement. At most, Nick would have suffered a pounding headache and a lecture from his parents about being late for dinner. Paramedics came and when they put Nick on the stretcher he could not lay his head down because it hurt too badly, he said. A CAT scan taken at San Antonio Community Hospital revealed a blood clot that was pinching his brain. During the ambulance ride from San Antonio to Children's Hospital of Orange County, the clot had almost doubled in size. "It was 2 a.m. and I had to make this snap decision for my son to have brain surgery," Perez said. "At first I said no, not unless they could guarantee me 100 percent that he wouldn't die." Nick's neurosurgeon couldn't make that promise, but she was certain that Nick was getting worse with every second. Perez and wife Mary agreed to the surgery. They waited anxiously as doctors cut a "U"- shaped flap through their son's scalp, removed a piece of his skull, drained the clot, replaced the skull then joined the scalp flap back together with 39 staples. Nick was lucky. He didn't suffer any of the possible side effects associated with the surgery and was back in school just weeks after surgery. "I didn't think anything like this would ever happen to me," he said. "I've taken falls a lot worse and never really got hurt."

After his release from CHOC, Nick was eager to share his experience in hopes to protect other children from head injuries. He had a dozen T-shirts printed sporting a photo of his stapled-together head with the slogan: Protect It - It's The Only One You Got! He's handed the shirts out to his friends, neighbors and classmates. Even to skaters he sees not wearing helmets. "I'll just start talking to them asking how long they've been skating," he said. "Then I'll show them my head and I tell them, `No matter how good you are it can happen to anyone."' Some will listen; some won't. Nick understands both attitudes. Before his accident, he was a student of the "It-will-never-happen-to-me" school of thought. "I didn't want to mess up my hair," he said sheepishly. "It would take me 30 minutes in the morning to spike it. Everyone who knew me knows: `Don't mess with Nick's hair."' After surgery, Nick didn't have to worry about styling his hair - it was all gone. At first it bothered him, but not for long. Nick learned the hard way that no matter how athletic a person is, how close to home or how careful one is, accidents happen. "If it could happen to me, it can happen to anyone," Nick said, then offered a word of advice to parents everywhere. "Make your kids wear their helmets. Don't let them talk you out of it."


MRI test immobilizes woman

Debbie Bochanski has struggled with chronic kidney disease for 15 years. Even receiving and then rejecting a transplant during that time. The 46-year-old mother of two is dependent on dialysis. She is now confined to a wheelchair, immobilized by a rare disease that has been linked to the dye that was injected into her veins as part of an MRI test in 2002. The disease, which seems to only afflict people with kidney disease, has just recently been identified and linked to the contrast agent. When she suffered a seizure in August 2002, she had two MRIs done. Within a month, the first signs appeared of what would eventually be diagnosed as NFD. The skin on her legs became tight and red and patchy. "When it was first diagnosed they thought it was scleroderma," Joe Bochanski recalled. "At first she could walk across the room," said Lisa Bellopede, 39, Debbie's sister. "Then she needed a walker. Then she needed a wheelchair." In 2003, doctors at the University of Pennsylvania diagnosed the problem as NFD, a rare and little known illness first identified in 1997, for which there was no known cause. "Until then, we didn't know what we were dealing with," Joe Bochanski said. It wouldn't be until late 2006 that the medical community finally settled on the dye used in MRI testing as the likely cause.

As of December 2006, the U.S. Food and Drug Administration had received reports of 90 kidney patients who developed NFD after having an MRI or MRA with a gadolinium-based contrast agent. According to the FDA, worldwide about 215 cases of NFD have been reported. The medical histories of 75 of these patients were reviewed in detail, and all were found to have received a gadolinium-based dye. The FDA is accordingly advising that renal patients avoid getting these tests with the dye whenever possible, and if they are necessary, to do dialysis after the procedure. "While there is no consistently successful treatment for NFD, improving renal function seems to slow or arrest NFD and in many cases allow for gradual reversal of the process, reports Dr. Shawn Cowper, an assistant professor of dermatology at the Yale Medical School and the head of the International Center for NFD Research there.


May 28, 2007

CDC warns about contact lens solution Moisture Plus Multi-Purpose Solution

Government officials are warning people to throw away a contact lens solution after an investigation linked it to a rare eye infection. The warning concerns AMO Complete Moisture Plus Multi-Purpose Solution, used for cleaning and storing soft contact lenses, said a spokeswoman for the U.S. Centers for Disease Control and Prevention. The solution seems to be a factor in cases of Acanthamoeba keratitis, a painful eye infection that can lead to permanent vision loss or blindness. The CDC and the U.S. Food and Drug Administration are investigating 138 confirmed cases. The solution is made by Advanced Medical Optics Inc. The confirmed infections have been reported since January 2005. The amoeba that causes the infection is naturally present in soil and water. Wearing contact lenses while swimming or in the hot tub appears to increase the risk of infection. The cases were reported to the Illinois state health department, which notified the CDC. A CDC investigation in about 35 states led to the announcement. The solution is not marketed to protect against the amoeba, but "it's supposed to be free of any type of microorganisms. It's not supposed to result in anyone getting an infection," said Julie Zawisza, an FDA spokeswoman.

Health officials have interviewed 46 patients so far. Of those, 36 wore contact lenses and used some form of solution, and 21 used the Advanced Medical Optics solution within a month of onset of symptoms, Beach said. It was a strong enough association to cause health officials to issue Friday's warning, Beach said. An estimated 85 percent of U.S. cases of Acanthamoeba keratitis occur in contact lens users, but it's extremely unusual, the estimated prevalence is one to two cases per 1 million contact lens wearers. It's hard to diagnose and treat and some of the drugs used to fight the infection are available only overseas or from compounding pharmacies.

Doctors first suspected a problem in 2004, when a University of Illinois-Chicago ophthalmologist, Dr. Elmer Tu, noticed more than a dozen cases of the infection. Normally, he might see only one or two in a year, Tu said. UIC doctors saw 35 patients with the condition from May 2003 through September 2006. About 55 percent used the Advanced Medical Optics product exclusively, Tu said. UIC investigators think the infection is not originating in the manufacturing process, but that the cleaning solution is not protecting people from the infection, which they get in their eyes through showering or swimming, Tu said. The investigation is the second into eye infections associated with contact lens solution undertaken by the CDC and FDA in the past year. In 2006, a Bausch & Lomb multipurpose contact lens solution was linked to a fungal eye infection called Fusarium.


Bill seeks ideas on medical malpractice

States would be able to use federal money to experiment with new ways to avoid medical tort suits under a bill unveiled in the U.S. Senate May 24th. The Bill would allow the Department of Health and Human Services to award up to 10 demonstration grants to states for the development, implementation and evaluation of alternatives to the litigation based system. The measure seeks to use the promise of grants from Washington to urge states to come up with novel dispute resolution programs designed to keep some malpractice suits out of court. The bipartisan bill, sponsored by Montana Democratic Sen. Max Baucus and Wyoming Republican Sen. Mike Enzi, could be promising to supporters of "health courts," which advocates say could resolve medical error lawsuits more quickly and fairly than traditional courts do.

"We need a system that restores a sense of order and proportion," Enzi said in a statement. Congress for years has stalled on efforts by Republicans to place caps on malpractice awards against doctors and hospitals. Insurers and physician groups strongly back the caps, while trial lawyers and many patient groups oppose them. Baucus said Thursday May 24th that the bill could rekindle efforts, bypassing Congress and allowing states to experiment with alternative ways of adjudicating lawsuits. "This is legislation that takes a frontal assault at our medical malpractice system," he said in an interview.


Glaxo’s Avandia study in jeopardy

Drug maker GlaxoSmithKline's medical director said the company's study of the heart risk associated with its Avandia diabetes treatment may be in jeopardy because patients have dropped out following reports of the drug's risks, The New York Times reported on Saturday. Dr. Ronald Krall said he did not know how many of the 4,450 patients in the drug trial had withdrawn but said Glaxo diabetes was worried it may not be able to complete the trial, which is scheduled to run through 2008. Independent research committees overseeing the study, which is designed to gauge any increased risk of heart attack or stroke for people taking it, "are concerned about the ability of the study to continue" and are "considering what to do to prevent people from dropping out of the trial," the Times quoted Krall as saying.


Avandia Study Panics diabetes patients

New research suggesting the diabetes drug Avandia may trigger heart problems has set off a major finger-pointing battle. The Food and Drug Administration is saying more analysis is needed. Caught in the crossfire are panicked patients who don't know what to believe or what to do. Organizations like the American Heart and Diabetes Associations have issued statements acknowledging that the findings are serious and deserve follow-up, but they note that the overall risk to patients seemed relatively small. The statement does not recommend stopping treatment and advises patients to be patient. But not every patient is willing to wait for that answer and they are probably going to switch drugs. It's estimated that more than 2 million people worldwide take the drug Avandia for Type 2 diabetes. The drug was first approved in 1999.


House votes to extend benefits for veterans

The House on Wednesday May 23rd marked the Memorial Day holiday by approving a number of bills to benefit veterans, including one aimed at improving screening and treatment of veterans with traumatic brain injuries. The bills "keep our contract with our nation's veterans and there's no better time than just before Memorial Day to say thank you," said Veterans' Affairs Committee Chairman Bob Filner, D-Calif. Tuesday May 22nd, a House Appropriations subcommittee approved a record budget for Veterans Affairs Administration programs for the fiscal year beginning in October, including the largest single increase in veterans health care funding in history.

The bills passed Wednesday included:

H.R. 2199, which sets up care facilities at four geographically placed locations to deal with traumatic brain injury. The bill also orders mandatory screening of veterans for traumatic brain injury, sets up a registry of those who show symptoms, authorizes $70 million over four years for research into TBI and forms a committee on the care of veterans with brain injuries.

H.R. 612, which ensures that those who served in combat in the Persian Gulf War or later hostilities are eligible for health care for five years after their service ends, instead of the current two years. Supporters said the legislation was needed because some returning veterans, particularly those with brain injuries or post-traumatic stress disorder, may not experience problems until years after they are discharged or released. It would cost $115 million through 2012.

H.R. 1470, which requires chiropractic care be available at 75 VA medical centers by the end of 2009 and all medical centers by the end of 2011.

H.R. 67, which sets up a grant program for state and local veterans' outreach programs to ensure that veterans are receiving the benefits they are entitled to. Veterans are losing out on $22 billion in benefits a year because they are unaware of benefits or have difficulty filing claims.

H.R. 2239, which expands eligibility for vocational rehabilitation benefits for severely injured service members and allows the VA to extend vocational rehabilitation and employment benefits to injured service members before they are discharged from active duty.


May 25, 2007

Does 2004 Tort Reform Legislation Violate Plaintiffs’ Right To Have Juries Decide Damage Awards?

Melisa Arbino v. Johnson & Johnson et al., Case no. 2006-1212
U.S. District Court, Northern District

ISSUES: Do provisions of S.B. 80, a “tort reform” bill enacted by the Ohio General Assembly in 2004, unconstitutionally limit the rights of plaintiffs in personal injury lawsuits to obtain a complete remedy for their injuries and to have a jury determine the amounts of noneconomic and punitive damages to which they are entitled?

BACKGROUND: S.B. 80, legislation enacted by the General Assembly in 2004 which took effect in April 2005, imposes caps on certain types of money damages that Ohio courts may award to successful plaintiffs in civil lawsuits.

One provision of the bill limits the amount of “noneconomic damages” that may be awarded to a plaintiff in a personal injury suit (i.e. damages for intangible injuries such as pain and suffering, loss of consortium, disfigurement, mental anguish, etc.) to the greater of $250,000 or three times the amount of “economic damages” awarded to the same plaintiff based on the same injuries, up to an absolute maximum of $350,000. The bill makes an exception to these limits for plaintiffs who suffer permanent disability or the loss of a limb or bodily organ system. Other provisions of the bill prohibit Ohio courts from awarding a plaintiff punitive damages that exceed two times the amount of his or her compensatory damages from the same defendant, and further reduce the maximum punitive damages that may be awarded to a current plaintiff by the amounts of any punitive damages previously awarded against the defendant in other lawsuits based on the same tortious conduct.

In this case, an Ohio woman, Melisa Arbino, filed a product liability lawsuit against the Johnson & Johnson Pharmaceutical Co. in federal district court to recover damages for a series of blood clots and other continuing medical problems Arbino suffered in 2005 after using a hormonal birth control product known as the Ortho Evra Birth Control Patch. During pretrial proceedings in federal district court, Arbino filed a motion for summary judgment asking the court to declare that provisions of S.B. 80 imposing caps on the potential amounts of noneconomic and punitive damages she could recover from Johnson & Johnson were unconstitutional and therefore unenforceable. While that motion was pending, Arbino's case was consolidated with those of dozens of other plaintiffs asserting claims against Johnson & Johnson based on medical problems allegedly caused by the Evra birth control patch.

After initially scheduling oral argument on Arbino's summary judgment motion, the U.S. District Court for the Northern District of Ohio postponed argument and submitted four “certified questions of state law” to the Supreme Court of Ohio. The Justices have agreed to answer three of the certified questions, which ask whether three specific Revised Code sections adopted or amended as part of S.B. 80 are unconstitutional because they violate plaintiffs' rights to trial by jury, to a remedy at law for their injuries and to due process and equal protection of the laws. The certified questions also cover claims by the plaintiffs that S.B. 80 violates the constitutional separation of powers between the legislative and judicial branches of state government, and violates the provision of the Ohio Constitution that limits the content of a legislative enactment to a “single subject.”

Attorneys for Arbino point to 1991 and 1999 decisions in which the Supreme Court of Ohio struck down as unconstitutional caps on noneconomic damages and other limitations on personal injury awards that were included in previous “tort reform” bills enacted by the General Assembly. They argue that there is no material difference between the damage caps imposed by S.B. 80 and the caps that were held unconstitutional in the Court's earlier decisions, and assert that the current Court is obliged to affirm its previous rulings under the doctrine of stare decisis (to “let stand” rulings on legal issues that a court has previously decided).

The plaintiffs argue that the fundamental constitutional right to trial by jury has historically been held to encompass not only having a jury decide which side has prevailed in a trial, but also allowing jurors to determine how much the prevailing party is entitled to recover in damages. They contend that the caps imposed on noneconomic and punitive damages by H.B. 80 are arbitrary numbers imposed by the legislature with no connection to the injuries suffered by individual plaintiffs. As such, they assert, the caps deprive Arbino and other personal injury claimants of their right to have a jury determine the types and amounts of compensation that are appropriate under the specific facts of their individual cases. They also argue that the H.B. 80 caps violate the constitutional right of citizens to equal protection of the law because they allow plaintiffs whose injuries are relatively small to collect 100 percent of the damages they have suffered, while restricting the recovery of those who have suffered much more severe injuries to a lesser percentage of their noneconomic damages.

Their position is supported by amicus curiae (friend of the court) briefs submitted to the Court by the Ohio Academy of Trial Lawyers and multiple state and national consumer and plaintiff-oriented interest groups.

Attorneys for Johnson & Johnson, supported by amicus briefs submitted by the State of Ohio, the Ohio Association of Civil Trial Attorneys and multiple business and industry associations, urge the Court to uphold the constitutionality of S.B. 80. They note that courts analyzing enactments of the legislature are required to begin with a strong presumption that statutes are constitutional, and to place a heavy burden of proof on parties seeking to invalidate an act of the legislature. With regard to the 1991 and 1999 Supreme Court decisions that held previous tort reform measures unconstitutional, they argue that H.B. 80 was specifically designed to address concerns expressed by the Court in earlier decisions regarding unequal treatment of those plaintiffs with the most severe injuries. They point to specific language in the current statute that was not included in prior tort reform bills that exempts plaintiffs who have suffered loss of a limb or permanent disability from the cap on noneconomic damages.

They argue that the legislative purpose underlying S.B. 80 was to rein in the high costs of civil lawsuit awards in order to protect the state's economy and the financial and employment security of all Ohioans. Because the bill's caps on noneconomic and punitive damage awards allow reasonable recovery for all but the most severely injured plaintiffs, and exempt victims of catastrophic injuries from the caps, they argue that the statutory scheme must be upheld as constitutional because there is a clear “rational basis” for its limitations on personal injury damage awards.


Workers' comp rules leave amputee tough choice

Four months after William D. "Billy" Parker lost both his arms in a drywall shredder at a Jeffersontown machine manufacturing company, he says the thing he misses most is his sense of touch, the ability to feel his son Cody when he gives him a hug. Parker, 39, has learned to use a prosthetic left arm to feed himself and put on his clothes. He uses his feet to open doors and to change channels on an oversized remote control he keeps on his living room floor. However he must depend on his son Cody, 15, to help him cook his meals. His stoicism hides nagging concerns about how he as a single parent will provide for his son, whom he's had custody of since Cody was 9. Parker also faces a vexing dilemma in deciding what path to pursue for compensation for his catastrophic injuries, money he says he needs to raise Cody and pay for a house adapted to his needs. Should he take the meager benefits available from workers' compensation, as little as $546 a week, or two-thirds of his pay? Those payments would never rise with inflation and would be cut off when he is eligible for Social Security. Or should he risk getting nothing at all by rejecting workers' comp and suing his employer, Six Sigma Inc.? Under Kentucky workers' comp law, an employee can only successfully sue his employer for a workplace injury if he can prove his company deliberately intended for him to be harmed. Experts on workers' compensation say no employee has ever been able to meet that burden, which has been described as harder than proving intentional murder.

Parker and the company blame each other and offer completely different accounts of what occurred. Parker says an engineer handed him a screwdriver and told him to clean the machine while it was running, in direct violation of OSHA rules. He says he believes the company knew it was sending him to do something that was unsafe. Don Cox, the company's lawyer, said Parker was never told to clean the machine with the screwdriver and did that strictly on his own. "He did something he shouldn't have done … and something he was specifically told not to do," Cox said. Parker and his lawyer, John Talbott, contend that the company was rushing to repair the machine, which had repeatedly malfunctioned, so it could be delivered to a customer.

About 1.7 million employees and 80,000 employers are covered under Kentucky's workers' comp law, which is designed to quickly provide injured employees with lost wages and medical care, even if they were at fault. In exchange for modest benefits, employees give up their right to sue. Employers are shielded from litigation that might drive them out of business. A dozen states allow injured workers to sue their employer if there is a "substantial certainty" or similar evidence that the employer required them to do a task knowing it would harm them, according to the authoritative book on the subject, Larson's Workers' Compensation. In Kentucky, the law is so strict, the Kentucky Supreme Court held in 2004, that knowingly putting an employee in harm's way isn't enough to win a lawsuit, even if the employer knew it might kill the worker.


Neuro-psychotherapist talks to students at Central Washington Univ about TBIs

Dr. Tedd Judd talked to an audience about traumatic brain injuries May 22nd inside the Central Washington University Student Union Theater. “You’re this new person,” said psychologist Tedd Judd about traumatic brain injury. “How do you find out who this new person is?” That’s the goal of neuropsychotherapy, the field Judd practices in. He spoke about the consequences of such injuries as part of the college’s Disabilities Awareness Week. Judd treats people suffering from traumatic brain injury through his psychology practice. He is also author of “Neuropsychotherapy and Community Integration: Brain Illness, Emotions and Behavior.”


There are some myths that exist around ailments caused by brain injuries. You don’t have to hit your head or lose consciousness to have a traumatic brain injury, according to Judd. Loss of consciousness depends on which area of the brain is affected. It can also be difficult to even see the injury to the brain itself. Much of the damage caused by a traumatic brain injury occurs at the microscopic level, and is invisible on common brain scans, such as an MRI or CT scan, but the symptoms of the injuries are plentiful and can affect a person’s cognitive, emotional and behavioral abilities. “The brain is the organ of emotion,” he said. Due to a traumatic brain injury, a person’s physical ability to communicate can be affected because of voice problems, but the emotional changes that can occur also cause problems, according to Judd. The injured can become indifferent, depressed or angry. “It’s the anger that tends to be the biggest problem,” Judd said.

For people who have a traumatic brain injury, 1/3 get better within a week, 1/3 get better within three months and 1/3 still have problems after a year. Among doctors, these patients are known as the “miserable minority,” according to Judd. Ultimately, dealing with such issues is about compensation and accommodation. “You’ve got to learn how to live with this new brain,” Judd said. Ian Campbell, who coordinates adaptive services for CWU Disability Support Services, said brain injuries can be one of the most difficult disabilities to accommodate for. But social awareness around the needs of people with brain injuries is also increasing, he said. “It’s a social movement that’s unfolding as we speak,” Campbell said.


FDA scrutinized for lack of power amid new warnings on diabetes drug

Troubling questions about the safety of a widely used diabetes medication have given more ammunition to Democrats seeking tougher drug-safety legislation. Key House Democrats and their staff were still digesting the disclosure on Monday that GlaxoSmithKline’s Avandia may be associated with a significantly increased likelihood of heart attacks and other fatal cardiovascular side effects. The news plays into the hands of lawmakers and consumer advocates who contend that the FDA lacks the authority to ensure that drugs already on the market are safe. Some of these critics say the pending bill does not go far enough to address the agency’s shortcomings. Closed-door negotiations among the Democratic members of the House Energy and Commerce Committee on the FDA bill have been taking place for months. The panel already has convened a series of hearings on the FDA and the safety of prescription drugs and medical devices, and it is expected to begin marking up the bill soon after the House returns from Memorial Day recess.

On Monday, Energy and Commerce Committee Chairman John Dingell (D-Mich.) issued a written statement strongly criticizing the FDA and vowing action. “Regrettably, it is incidents like this that demand legislative changes in the way FDA deals with drug safety. The committee will address these dangerous shortcomings while writing legislation to reauthorize the Prescription Drug User Fee Act,” Dingell said. The underlying bill, considered to be passed by the Democratic leadership, the administration and the pharmaceutical industry, would reauthorize two programs through which prescription drug makers and medical device manufacturers would pay user fees to the FDA for reviews of their new products. The Energy and Commerce Committee is expected to add language increasing the FDA’s authority to monitor drugs already on the market and force corrective actions when safety concerns arise. It has not determined the extent of that authority.


NYC adds post 9/11 death to victims toll

A woman who died of lung disease five months after Sept. 11 was added to the medical examiner's list of attack victims, marking the first time the city has officially linked a death to the toxic dust caused by the World Trade Center's collapse. Felicia Dunn-Jones, a 42-year-old attorney who was caught in the dust cloud while fleeing the collapsing towers on Sept. 11, 2001, died of sarcoidosis, a disease that causes inflammation and scarring in the lungs, on Feb. 10, 2002. "Mrs. Dunn-Jones' exposure to World Trade Center dust on 9/11/01 contributed to her death, and it has been ruled a homicide," Chief Medical Examiner Charles Hirsch wrote. The city said the Sept. 11 death toll at the trade center now stands at 2,750. Dunn-Jones will be listed on the Sept. 11 memorial when it opens in 2009, a spokeswoman for the World Trade Center Memorial Foundation said. Dunn-Jones' family had asked last year that the medical examiner add her name to the death toll, but Hirsch wrote at the time that his office could not link her death to the exposure with certainty beyond a reasonable doubt. Since then, a doctor for the Fire Department of New York published a study that found firefighters who worked at ground zero contracted sarcoidosis at a much higher rate after the Sept. 11 attacks than before, linking the disease firmly to the dust exposure.

A class action lawsuit has claimed dozens of deaths have been caused by exposure to toxic trade center dust. A New Jersey medical examiner last year ruled that the January 2006 death of a retired police detective, 34-year-old James Zadroga, was directly related to his work at ground zero on and after Sept. 11. Zadroga's father, Joseph Zadroga, said that his son also suffered from sarcoidosis and that he and many others should be added to the list of victims with Dunn-Jones. "I think that anybody that passes as a result of 9/11 should be listed on the wall," said Zadroga. "They're going to be adding to that wall for the next 20 years." Dunn-Jones was not one of the plaintiffs suing the city. But David Worby, the attorney who filed the lawsuit, said he hopes listing her as a Sept. 11 victim bolsters arguments that people exposed to the toxic plume of pulverized concrete, jet fuel, asbestos and other toxins can contract rare diseases very quickly. Worby said more than 100 of his clients have died, and said at least five of those people had sarcoidosis.

New York lawmakers, some of whom urged the city to add Dunn-Jones to the death toll last year, said more people should be added in the future. "Sadly, we have known that Felicia is not alone and that others have died from ailments caused by 9/11," said U.S. Rep. Carolyn Maloney (news, bio, voting record), D-N.Y. "I hope that the medical examiner is no longer in denial about the trade center dust. Dr. Hirsch must review the cases of other 9/11 heroes who, like Felicia, died in the prime of their lives."


Congress to Weigh Health Courts

The medical tort reform debate has not been ideal for compromise, but the sponsors of a bipartisan bill introduced say they may have found a way out of the impasse. The Fair and Reliable Medical Justice Act would give 10 states grants to establish special health courts devoted specifically to resolving medical malpractice claims. Instead of jury trials in regular court, malpractice cases would be heard by medical experts in a setting similar to small-claims court. Courts would encourage the disclosure of medical errors, and these data would be collected and analyzed by states with pilot projects. Medical malpractice law "has always been a state responsibility," bill co-sponsor Rep. Jim Cooper, D-Tenn., says “Hopefully, this bill will give states the confidence to embrace a new approach," said Cooper, who is co-sponsoring the bill with Republicans and Democrats in the House and Senate.

For the last decade, Congress has been in a stalemate over the issue of medical malpractice legal reform, with powerful lobbies for and against change. Those in favor of health courts, a coalition that includes doctor, patient and insurer groups, say the current system is broken. Injured patients must wait months or years to place their fate in the hands of juries that render arbitrary decisions. Since the outcomes of trials are so unpredictable, they say, doctors design their treatment to avoid lawsuits instead of patients' needs, driving up the cost of medical care for everyone. Opponents of health courts, a constituency that includes the powerful attorney lobby, say patients hurt by doctors should not be deprived of their right to be heard by a jury. The face-off between those two groups has meant little federal progress in medical tort reform has materialized, but supporters of the bill say they think it can make it into law.


New Report Shows Malpractice Insurers Price Gouging Doctors and Driving Up Cost of Care

The American Association for Justice (AAJ) released a report revealing the medical malpractice insurance industry has been price-gouging doctors through excessive premiums and needlessly contributing to the growing cost of healthcare. Written by former Missouri Insurance Commissioner Jay Angoff, the study is based on recent annual reports from the top 15 medical malpractice insurers as rated by A.M. Best. The report shows that these insurers artificially raised doctors' premiums and misled the public about the nature of malpractice claims, asserting that a so-called "malpractice crisis" exists. The report has exposed it as a lie to that claim.

According to the study: The medical malpractice insurers saw losses and projected losses drop by 48% over the period 2003-2006. These incurred losses have declined every year for the past five years. These insurers' 2006 surplus is 43% greater than their surplus in 2003, five times the state-minimum surplus for insurer stability. Only three of the 15 leading insurers issued dividends to doctors in 2006. "Medical malpractice insurance companies have been price-gouging doctors, padding their pockets with excessive premiums and driving up the cost of healthcare," said Jon Haber, AAJ Chief Executive Officer. "Cynically, these same insurance companies have been blaming high premiums on a so-called 'malpractice crisis' that doesn't exist. We have an insurance crisis, not a medical malpractice crisis."

The new report also demonstrates the difference between two types of losses in the insurance industry, incurred losses and paid losses. The industry evaluates its performance based on incurred losses (which include projections of future payments) and not paid losses (which are actual claims payments). This report takes into account both paid and incurred losses, and shows that although both have decreased, malpractice rates for doctors continue to increase. "No matter how you look at it, doctors and patients are getting ripped off by the insurance industry," said Haber. AAJ calls for a thorough and immediate review of the insurance industry's unscrupulous price gouging and its effect on Americans' access to a safe, affordable healthcare system.


Hospital celebrates soldier's miraculous rehabilitation

Less than five months ago, Sgt. Michael Boothby was starting life over at Warm Springs Rehabilitation Hospital. With the work of therapists, family support and the grit of a soldier, he learned to walk, dress and feed himself again, after a severe brain injury in Iraq. A large part of Boothby's skull had to be removed to save his life. Boothby became a symbol of the signature injury of the war after appearing in nationally televised news reports on traumatic brain injury.

Boothby began 2007 at Warm Springs, with several weeks of inpatient physical, occupational and speech therapy, then a few months of outpatient therapy. He learned to dress and feed himself and walk again, often with his wife guiding him. When doctors at Brooke Army Medical Center pulled back his scalp last month to reseal his skull with a titanium prosthesis, a cyst on his brain burst, relieving pressure that had hindered his left hand. Boothby, who remains on active duty, now has better balance and full use of his hand. "I can hold my daughters now," without worrying about falling and seriously hurting himself, he said. He's blind in the left side of each eye, but can read children's books to his 5-year-old and her younger sisters. He now gets therapy, including jump-roping and balancing exercises, four days a week at another private facility in San Antonio. "The hardest part for me is watching him go through it all," Megan Boothby said.

He was in a Stryker vehicle in Baghdad when shrapnel from a bomb planted in the road pierced the back of his skull last Sept. 17. In Balad, doctors removed nearly half his skull to keep pressure buildup from causing permanent damage. He then was treated at National Naval Medical Center in Bethesda, Md. At Bethesda, Boothby and his wife, Megan, befriended ABC News anchor Bob Woodruff, who sustained a similar injury in Iraq. They agreed to be interviewed for segments that aired in February. Boothby returned home in December. Less than a week later, he was at BAMeC, unable to keep his balance or move his left hand. Doctors' use of a shunt to relieve pressure on the brain may have saved his life, his wife said.


May 24, 2007

Stronger Warnings for Gadolinium-Based Contrast Agents

The Food and Drug Administration has requested that makers of all gadolinium-based contrast agents (GBCAs) add new warnings, including a "black box" warning about the risk of nephrogenic systemic fibrosis (NSF). Brand names affected by the new warnings include: Magnevist, MultiHance, Omniscan, OptiMARK, and ProHance. A black box warning is the strongest warning the FDA can mandate.

GBCA is used as a contrast agent to provide an improved image of body organs and tissues during an MRI or MRA. Although GBCAs are approved by the FDA for use in MRIs (Magnetic Resonance Imaging), they are not approved for use in MRAs (magnetic resonance angiography), an imaging procedure that evaluates blood vessels to detect heart disorders, stroke, and vascular diseases.

The FDA's alert to healthcare professionals highlights the risk for NSF following exposure to a GBCA in patients with acute or chronic severe renal (kidney) insufficiency. Warnings also describe other risk factors, such as repeated or higher than recommended doses.

NSF is a debilitating and potentially fatal disease that involves the skin, muscle and internal organs. Signs and symptoms include:

* For the skin--burning or itching, reddened or darkened patches;and/or skin swelling, hardening and/or tightening

* For the eyes--yellow raised spots on the whites of the eyes

* For the bones, joints and muscles--joint stiffness; limited range of motion in the arms, hands, legs, or feet; pain deep in the hip bone or ribs; and/or muscle weakness.

For patients receiving hemodialysis, the FDA recommends prompt hemodialysis immediately after administering a GBCA because it hastens its elimination. However, it is unknown whether hemodialysis prevents or reduces the risk of NSF.

Patients should be screened for kidney problems before receiving one of these imaging agents. The recommended dose should not be exceeded and enough time should elapse to ensure that a dose has been eliminated from the body before the agent is used again. To date, the FDA says there have been no reports of NSF among patients with normal kidney function or those with mild-to-moderate kidney insufficiency.


May 23, 2007

Doctors and Lawyers Find Themselves in Rare Agreement on Med-Mal Bill

Both doctors and lawyers in North Carolina are supporting a bill that would cap monetary damages at $1 million in some medical malpractice cases. Both the North Carolina Medical Society and the N.C. Academy of Trial Lawyers support a bill, approved in the House by a wide margin that caps monetary damages in negligence cases at $1 million, but only for those who agree to go to binding arbitration. The agreement is a marked change from previous years, when physicians have blamed rising malpractice insurance premiums on multimillion-dollar awards by runaway juries, of which lawyers usually receive a percentage. Trial attorneys wouldn't agree to award limits sought by doctors and hospitals, saying patients need financial protection for mistakes by the truly worst physicians. Lawmakers and both sides were hopeful that the current bill, finalized after weeks of negotiations and modeled on a Washington state law passed last year, will signal a new era of cooperation.

Under the bill, plaintiffs and defendants in a patient negligence lawsuit against a doctor or hospital could agree to settle their case under binding arbitration. The two sides could agree on an arbitrator or ask a court to select one. The measure lays out how the arbitration would occur, with legislators seeking hearings to begin no later than 10 months after agreeing to enter the procedure. The arbitrator would have to issue a decision within two weeks of the hearing's close, with all monetary damages limited to $1 million. Appeals would be very limited. The bill now heads to the Senate. A final edition also would have to go to the Governor’s desk to become law.


Dealing with medical malpractice in court

About 80,000 people die in the United States each year due partly to medical malpractice, according to a study entitled "Patients, Doctors and Lawyers: Medical Injury, Malpractice Litigation, and Patient Compensation in New York," published by the Harvard Medical Practice Study in 1990 and cited by the Consumer Action and Information Center of Hawaii. Only about 2 percent of those injured by physicians' negligence seek compensation through a lawsuit, according to a 1991 article in the New England Journal of Medicine also cited by the group.

The first thing you should do if you think you have experienced medical malpractice is retain a lawyer to help you sort through the complexities of the case and to determine if you have a case worth pursuing in court. You do not have to come to the lawyer's office armed with sheaves of evidence in order to have a successful case. Sometimes people will come to a lawyer’s office with nothing more than benefit statements, their story or their loved one’s story. In warning, there is not an unlimited timeframe to file suit if you think you have been injured by medical negligence, the statute of limitations is usually two years from the time you reasonably should have discovered the malpractice, and no more than three years from the date of the actual alleged negligence. Another concern is how long a case takes, from the time you go to a lawyer until the case has come to a conclusion in court. A case can take anywhere from one year in an area with less crowded courts, to up to two or three years in a large city or other area with very busy courts.

Medical malpractice also has another side, however. A February 2006 study, prepared by PricewaterhouseCoopers for America's Health Insurance Plans and cited by the Insurance Information Institute, found that medical liability costs and defensive medicine account for 10 percent of medical care costs. Defensive medical practice is when doctors order tests and medicine, or makes referrals to specialists that they do not really feel are necessary, in order to protect themselves from being accused of negligence. If you are injured through negligence by a doctor who has no malpractice insurance (which is not actually required to practice), you can go after their assets, but doctors who are doing so will typically be employing a number of protections, such as having all their accounts in their wife's name or putting assets overseas.


FDA Requests Boxed Warning for Contrast Agents Used to Improve MRI Images

The U.S. Food and Drug Administration (FDA) has asked manufacturers of Magnevist (gadopentetate dimeglumine), Omniscan (gadodiamide); OptiMARK (gadoversetamide); MultiHance; (gadobenate dimeglumine); and Prohance (gadoteridol) to include a new boxed warning on the product labeling of all gadolinium-based contrast agents which are used to enhance the quality of magnetic resonance imaging (MRI). The requested warning would state that patients with severe kidney insufficiency who receive gadolinium-based agents are at risk for developing a debilitating, and a potentially fatal disease known as nephrogenic systemic fibrosis (NSF). In addition, it would state that patients just before or just after liver transplantation, or those with chronic liver disease, are also at risk for developing NSF if they are experiencing kidney insufficiency of any severity.

Patients with NSF develop thickening of the skin and connective tissues that inhibits their ability to move and may result in broken bones. Other organs are at risk of thickening as well. The cause of NSF is not known and there is no consistently effective treatment of this condition. Reports have identified the development of NSF following single and multiple administrations of the gadolinium-based contrast agents. The reports have not always identified a specific agent. Omniscan was the most commonly reported agent, when a specific agent was identified, followed by Magnevist and OptiMARK. NSF also has developed after the sequential administration of Omniscan and MultiHance and Omniscan and ProHance. Because reports incompletely describe exposure to gadolinium-based contrast agents, it is not possible to know if the extent of risks for developing NSF is the same for all agents. Patients should be screened for kidney problems prior to receiving one of these imaging agents. The recommended dose should not be exceeded and enough time should elapse to ensure that a dose has been eliminated from the body before the agent is used again. There have been no reports of NSF among patients with normal kidney function or those with mild-to-moderate kidney insufficiency.

FDA first notified health care professionals and the public about the gadolinium-related risks for NSF in June 2006. Information on the risks was updated in December. Bayer Schering Pharma, Berlin, Germany, manufactures Magnevist; GE Healthcare, Chalfont St. Giles, U.K., is the maker of Omniscan; OptiMARK is manufactured by Mallinckrodt, Inc., Hazelwood, Mo.; and ProHance and Multihance are made by Bracco Diagnostics Inc., Princeton, N.J.


FDA Issues Safety Alert on Avandia

The U.S. Food and Drug Administration (FDA) has become aware of a potential safety issue related to Avandia (rosiglitazone), a drug approved to treat type 2 diabetes. Avandia is manufactured by GlaxoSmithKline. Data from controlled clinical trials have shown that there is a potentially significant increase in the risk of heart attack and heart-related deaths in patients taking Avandia. However, other published and unpublished data from long-term clinical trials provide contradictory evidence about the risks in patients treated with Avandia.

Avandia was approved in 1999 for treatment of type 2 diabetes. Diabetes is a leading cause of coronary heart disease, blindness, kidney failure and limb amputation. Since the drug was approved, FDA has been monitoring several heart-related adverse events (e.g., fluid retention, edema and congestive heart failure) based on signals seen in previous controlled clinical trials of Avandia alone and in combination with other drugs, and from postmarketing reports. FDA has updated the product's labeling on several occasions to reflect these new data, most recently in 2006. The most recent labeling change for Avandia also included a new warning about a potential increase in heart attacks and heart-related chest pain in some individuals using Avandia. This new warning was based on the result of a controlled clinical trial in patients with existing congestive heart failure.

The FDA is continuing to analyze all available data and has not confirmed the clinical significance of the reported increased risk in relation to the other studies. Questions to be answered include whether the other approved treatment from the same class of drugs, pioglitazone, has the same risks. There is inherent risk associated with switching patients with diabetes from one treatment to another even in the absence of specific risks associated with particular treatments. For these reasons, FDA is not asking GlaxoSmithKline, the drug's sponsor, to take any specific action at this time. FDA is providing this emerging information to prescribers so that they, and their patients, can make individualized treatment decisions.


Is the Diabetes Drug Avandia a Heart Risk?

The diabetes drug Avandia may increase a person's risk of heart attack and death due to heart disease, a new study warns. Maker GlaxoSmithKline says the study is flawed and that better data from an ongoing clinical trial show Avandia poses no significant risk to patients' heart health.

The FDA says that based on this "contradictory evidence about the risks in patients treated with Avandia," patients taking the drug, especially those who have had heart attacks or who have underlying heart disease, should talk with their doctors about whether to continue taking the drug. "In susceptible patients, [Avandia] therapy may be capable of provoking myocardial infarction [heart attack] or death from cardiovascular causes after relatively short-term exposure," suggest study investigators Steven Nissen, MD, and Kathy Wolski, MPH. The Nissen/Wolski report will be published in The New England Journal of Medicine. The journal made the report public under its early-release policy. The new warning comes from an analysis of publicly available, short-term clinical studies comparing Avandia to other diabetes treatments. It shows that Avandia increases heart attack risk by 43%, and increases risk of death from heart disease by 64%. However, the overall risk was small. Among the 15,560 Avandia patients there were 86 heart attacks and 39 deaths, compared with 72 heart attacks and 22 deaths among the 12,283 patients not taking Avandia. However, none of the trials on which Avandia was approved showed that the drug actually prevented the greatest threats to people with diabetes: microvascular problems, heart disease, or heart death. In a strongly worded editorial accompanying the study, University of Washington researcher Bruce M. Psaty, MD, PhD, says the Nissen study means there's no good reason for most patients to take Avandia. Psaty warns patients taking Avandia not to just stop using it. They should continue taking the drug until they can discuss the matter with their doctor. "This is not an immediate risk. It is the absence of an expected benefit and the possibility of harm over the years," he says. "Patients should talk with their doctors and see if they are getting the benefit they expected. Doctors can look at the data and say whether there is a compelling reason for them to prescribe this drug. I don't think there is."

GlaxoSmithKline has done its own analysis of Avandia's heart safety data. Using techniques similar to those used in the Nissen study, the GSK study showed about a 30% increase in heart risk to patients taking Avandia. A study of 33,000 patients in a managed-care database showed no increased heart risk in patients taking Avandia. Both this study and the GSK analysis were given to the FDA in August 2006. Ongoing, long-term studies also support Avandia safety, says GSK chief medical officer Ronald Krall, MD. "I want to be very clear that we are confident in the benefit/risk profile for Avandia. We believe that if it is used according to the directions incorporated into U.S. and European labels, it is an important treatment for patients with type 2 diabetes," Krall says in a news release. "We believe that important evidence coming from long-term studies supports the safety of Avandia."


NFL sets guidelines for head injuries

The NFL announced new guidelines for addressing the chronic problem of head injuries in the sport. The new standards, which Commissioner Roger Goodell reviewed with club officials at a one-day owners meeting in Nashville, Tenn., are based on “extensive medical research and discussion by the NFL's independent committee on mild-traumatic brain injury,” the league said. “The overriding principle governing management of concussions in the NFL is that medical considerations must always have priority over competitive situations,” Goodell said in a statement. Further, Goodell said the league will work with the players' union, the NFL Retired Players Association, NFL Alumni Association, NFL Charities and the Pro Football Hall of Fame in an alliance to coordinate medical support for former players. ESPN's magazine reported in October that several of the nation's top sports-concussion authorities were critical of the NFL's committee on mild-traumatic brain injury committee and its then-chairman, Elliot Pellman. Three neurosurgeons joined the committee in January and Pellman, the league's medical adviser, stepped down the next month, ESPN said.

The new standards are medical decisions must always override competitive considerations. Neurological baseline tests will be administered annually to all players in training camp beginning this year. The league will establish a “whistle-blower” system so that anyone may anonymously report incidents in which a doctor or medical person pressures a player to return to the field before he's ready after sustaining a concussion. The league will conduct a conference June 19 in Chicago for all team physicians and athletic trainers to share the latest information on caring for and managing players who have sustained concussions.

“I think it's good, especially for some of those quarterbacks and the Wayne Chrebets that have had issues with concussions,” said Roman Oben, the Chargers' player representative, mentioning the former Jets receiver who suffered nine concussions during his NFL career. “Doing things that will help prevent these things from happening in the future is important. I don't think people understand the magnitude of the physical trauma that we go through, and some of it doesn't affect you until you're five years out. People think about knees and shoulders, but the brain is the most important part of your body. Look at what has happened to some of the former boxers.” “The league has to do its part in protecting the players, because we're going to be men a lot longer than we're football players. We have to be able to function when we're done playing.”


May 22, 2007

Diabetes Drug Avandia Suspected of Increasing Heart Attack and Death Risk

A new study to be published next month in the New England Journal of Medicine shows that patients taking Avandia (generic: rosiglitazone) for type 2 diabetes have a 43 percent higher risk of having a heart attack than those on other diabetes medications. Even worse was the finding that patients taking Avandia had a 64 percent higher chance of dying from cardiovascular causes than their counterparts not taking Avandia. The new study was an evaluation of 42 older studies which compared patients taking Avandia with others not using the drug. Of the almost 28,000 patients studied, 15,560 were taking Avandia.

An editorial accompanying the study's conclusions noted, however, that the findings are not conclusive. Editors included Dr. Bruce M. Psaty of the University of Washington and Curt D. Furberg of Wake Forest University, both diabetes experts, who said, "A few events either way might have changed the findings for myocardial infarction [heart attack] or for death from cardiovascular causes. In this setting, the possibility that the findings were due to chance cannot be excluded. In their discussion, the authors properly emphasize the fragility of their findings." Still, the editors concluded, "In view of the potential cardiovascular risks and in the absence of evidence of other health advantages, except for laboratory measures of glycemic [blood sugar] control, the rationale for prescribing rosiglitazone at this time is unclear."

Avandia's maker, GlaxoSmithKline, was quick to issue an aggressive defense of Avandia, saying that it "strongly disagrees" with the findings of the new study, and asserting that Avandia's safety profile is similar to other oral anti-diabetic drugs.

More than 2 million patients worldwide take Avandia for type 2 diabetes, resulting in $3.2 billion in annual sales for GlaxoSmithKline, according to the New York Times. Avandia was first approved by the FDA in 1999.

The Food and Drug Administration issued a MedWatch alert yesterday, alerting healthcare professionals to a "potential safety issue" with Avandia. The FDA suggests that, "Prescribers should continue to carefully make individualized treatment decisions for patients with diabetes mellitus."


May 21, 2007

Academy of Managed Care Pharmacy Congratulates Senate on Passage of the FDA Revitalization Act

The Academy of Managed Care Pharmacy congratulates the Senate on passage of the Food and Drug Administration Revitalization Act (S. 1082). Judith A. Cahill, executive director of the Academy, said, "This action strengthens the FDA's ability to conduct post-market surveillance of prescription drug products, which will result in improved safety and outcomes for patients." Since 2001, the Academy has advocated for the FDA to have expanded authority in critical areas for prescription drug safety. The legislation provides expanded authority to require post-market effectiveness and safety studies by drug manufacturers, grants new authority to FDA to require manufacturers to adopt risk management plans and make labeling changes and imposes additional limits on direct-to-consumer advertising. Also included in the bill is a reauthorization of the Prescription Drug User Fee Act (PDUFA), which authorizes the collection of fees from drug manufacturers to help defray the cost of the drug approval process by providing additional resources to the agency.

The Academy believes post-market surveillance studies are essential to protect the public health because once a drug is available to the general population; many more patients are put at risk. Often, problems associated with drugs are identified only after a drug has been in use by a broader population than during clinical trials, or after longer periods of time.


Arizona Bill to Raise Burden of Proof on ER Suits Fails in House

The Arizona House has narrowly rejected a medical malpractice bill (SB1032) that would have made it harder to successfully sue emergency medical providers for alleged malpractice. The bill was the only major piece of malpractice legislation considered during the current session. The Senate narrowly approved the bill on Jan. 29, but it then lingered in the House for more than two months as supporters worked to get more votes. Gov. Janet Napolitano vetoed an identical bill last year, but Republican Sen. Carolyn Allen of Scottsdale reintroduced the measure this year after a Napolitano-appointed task force recommended adoption of the change.

"This bill helps create a climate that will help keep them here," said Rep. John Kavanagh, a Fountain Hills Republican who noted that the state is spending millions of dollars to train new physicians. The bill was backed by hospitals, health insurance companies, business organizations and groups representing doctors and nurses. It was opposed by groups representing and supported by plaintiffs' lawyers who argue that the change would deprive many Arizonans of the chance to recover damages for medical negligence. Napolitano's 2006 veto letter said raising the burden of proof alone wouldn't remedy shortages of on-call specialists needed by emergency rooms and that changing the evidence standard could violate the Arizona Constitution's guarantee of the right to sue to recover damages. In conjunction with that veto, Napolitano created the task force which later included a higher standard of proof among numerous recommendations.


An Everyday Operation Goes Wrong

Alan Cronin checked into a Valley hospital for an out patient hernia surgery. The routine surgery quickly forced doctors to make a critical choice, either save his life or limbs. Mr. Cronin, father and husband, woke up from a five-week coma victim of a post operation catastrophic injury; quadruple amputation. “I woke up missing my legs just above the knee and my hands on both sides below the elbow. It's as if your mind has a defense mechanism that kicks in to prevent you from going crazy.” At his post-surgery check-up, he complained to doctors about feeling sick. Without taking his blood pressure or drawing blood, his surgeon and primary care physician diagnosed him with the flu and sent him home. Days later he slips in to a coma. As his wife rushes him to the E.R., doctors find his body poisoned with a rampant staph infection. “The staph infection infected me in a way that just shut down my circulation and gangrene set in,” Cronin says. As gangrene sets in, he's given a five percent chance of life. Doctors decide quadruple amputation is his only chance of survival.

“My daughter plays softball and I can’t help her out with that. When your body is deformed you don't feel as good about yourself.” Today he still suffers from severe phantom pain. “I still can feel my fingers today. The pain is so bad that you can't live. It’s a frost bite pain, crushing, stabbing.” With hooks for hands and bound to a motorized wheelchair for life, Alan sets out to sue for his pain and suffering. “I blame my primary care physician for being negligent, I blame my surgeon for being negligent.” However, because of the 1975 medical injury compensation act, his pain and suffering is limited to $250,000. “Medical mistakes, misjudgment, lapses of reasoning…they unfortunately occur and it's not a nice thing and there is reimbursement thought MICRA.” The president of the Los Angeles County Medical Association insists the cap keeps malpractice premiums down for doctors. Consumer advocates insist MICRA only preys on those already vulnerable and urge the public to change the law. “It's no good for patients. MICRA has been a complete disaster for the people of California. It’s been great for insurance companies who only pay to put a few cents on premium claims and it’s been great for negligent doctors who want to escape responsibility.”


Shielded by medical malpractice cap

Kathy Blankenship went to Oregon Health & Science University thinking she would receive the best medical care, but now believes mistakes were made and she is stuck without a way to hold the hospital accountable. She recorded a video for her kids the day before her vocal chords were removed so they would remember the sound of her voice. She now speaks through an artificial larynx device. "I go to my children's sporting events and I'm the silent parent on the sidelines," she said. While other parents are able to cheer on their kids, Blankenship has to find other ways to support her boys. She also misses the taste of a good meal because she lost her ability to swallow. She developed esophagal cancer, but not from smoking, from a virus. She claims a misdiagnosis and delayed treatment at OHSU resulted in these devastating consequences. "I'm a teacher and the loss of your voice pretty much means the loss of your career, so it was traumatic," she said.

Blankenship learned that OHSU has a tort liability cap, limiting damages in all malpractice cases to $200,000. Blakenship has not filed a lawsuit because she would have to deplete her retirement fund to pay for legal expenses, with no guarantee she would get any of it back. "It is very, very difficult if you can find any lawyer anywhere who is willing to take on that kind of a case because the costs just don't pencil out," said Larry Wobbrock, a malpractice attorney. Wobbrock further added he would not be able to prosecute a case of medical malpractice without spending at least $100,000 of his own money. Blankenship is at a steep disadvantage now. "I think patients strongly need to be advised before they are treated about that because I had no idea until there was a problem and then it's too late," she said.

"As long as humans are treating humans, there will be mistakes," said Dr. Joe Robertson, OHSU President. Dr. Robertson recently testified in Salem about a bill that would raise the tort liability cap. The proposed increases range from $500,000 to $875,000. Dr. Robertson acknowledged that $200,000 is too low, but said removing the cap altogether would hurt the patients most in need. "At the end of the day, the tort cap is what allows OHSU to say yes when others say no and without it, it is our society's most disadvantaged that would be most affected," he said.


Construction worker speaks about East Valley Arizona site conditions

There was a second construction accident within 24-hours at a construction site in East Valley of Arizona. One construction worker knew the site was dangerous, but no one would listen. After three months on the job with S.J. Lewis construction, Carlos Acosta said he was fired for speaking up about unsafe working conditions. “I never thought it was a safe condition and I'm still saying it's not a safe condition,” Acosta said. Acosta, a former S.J. Lewis employee, was brought to tears one day after his firing when his friend and co-worker was buried alive by 100 tons of dirt. Acosta said it's the second such accident in just two days, where a thin wall wipe caved under pressure. A photo taken by Acosta, showed that while operating the heavy track ho he said he was swallowed by a shallow trench then fired on the spot. “No one ever cared one second if I was safe or not, it was the machine, or the pipe,” he said. Fearing for his co-workers safety, Acosta tried confronting his superiors like he'd done several times before. “And they just said, hey you don't know what you're talking about, kind of shined me off,” he said. Authorities confirm that incident was never reported until now, when 25-year-old Marcos Garcia from Mesa, a husband a father of 3 became trapped. “He loved his family, loved his wife,” Acosta said. “Maybe I feel like if I would have ran my mouth some more I could have prevented this today, ya know.” For wrecking the tractor, Acosta said his boss threatened to garnish $500 bucks from his paycheck to pay the deductible.


Experts find concussion is hidden injury

Characterized by the medical community as a "hidden epidemic," concussions, formally known as mild traumatic brain injuries, are sometimes hard to diagnose in professional and college athletes. They are even more difficult to detect at the high school level. "It's a hidden injury," said Dr. Kevin Guskiewicz, a certified athletic trainer who does concussion research at the University of North Carolina. "We are calling it a hidden epidemic. It's not like a knee sprain, where you can see swelling, bleeding or deformation of a joint. It's hidden because it's in the cranial cavity. You don't know how the brain is responding to this insult." Getting knocked out is no longer the best indicator for diagnosing a concussion the loss of memory is a better predictor. In fact, recognition and treatment of concussions have changed significantly over the past decade. New discoveries have made old practices outdated. "In our primary medical community, there is pretty significant need in getting updated," said Dr. Gerard A. Gioia, director of the Pediatric Neuropsychology Program at Children's National Medical Center in Washington. "The information out in the last five to eight years has revolutionized how we understand these injuries, from elementary-aged kids, or even 4-year-olds, on up through high school. When someone gets injured and goes to a pediatrician or the emergency room, the information they get is wildly variable and the symptoms may not be recognized as a concussion." With funding from CDC, Gioia has run a five-year research study that involves baseline neurological testing for more than 1,000 kids, ages 5 through 18, from Maryland, the District of Columbia, Pennsylvania, Vermont and New Hampshire.

The National Federation of State High School Associations made concussions a point of emphasis in all rulebooks for the school year. Available to all 18,500 national high schools this year was a tool kit produced by the CDC, including basic concussion information and a DVD. Bob Colgate, the assistant director of the NFHS and liaison on its sports medicine advisory committee, said the organization is attempting to establish a national injury surveillance system at the high school level, similar to one used by the NCAA.

It's not just coaches and emergency medical technicians who must be informed on the most recent studies into concussions. General practitioners and emergency room personnel need the updates as well. "We do a much better job rehabbing knees and shoulders and ankles," said Diane Triplett, executive director of the Brain Injury Association of Maryland. "We go out and find the best orthopedics. But we don't come close to that when we hurt our brain." The accepted guideline is that once an athlete has suffered a concussion, he or she should remain out of action for at least seven days. In most sports, a player who has had a concussion must have a doctor's release to return to play. But even that is not foolproof. "In most cases it takes seven to 10 days to heal. But it could be three weeks or longer," Guskiewicz said.


Accommodating an employee with a traumatic brain injury

The U.S. Office of Disability Employment Policy cites an estimate of the Brain Injury Association of America of about 1.4 million occurrences a year. Accommodating an employee with a TBI depends on the area of limitation resulting from the injury. The Job Accommodation Network is a service of the U.S. Department of Labor. Its fact sheet, "Employees with Brain Injuries," covers many ways to accommodate these employees. Those with visual problems may be accommodated with better lighting, or vision aids for the computer, or even by providing information written in large print. Concentration can be maintained or improved by reducing distractions in the work area, or by providing space enclosures, or even reducing clutter. Memory deficits can be met by allowing an employee to tape-record meetings, or by posting instructions near equipment used frequently, or maybe utilizing color codes in the office. Other problem areas resulting from a TBI could include problem-solving deficits, maintaining stamina, difficulty with handling stress, or even simple attendance issues.


Children's Hospital of Pittsburgh leading study on kids with brain injuries

A national clinical trial to examine the effects of induced hypothermia on children suffering traumatic brain injury will be led by a Children's Hospital of Pittsburgh neurosurgeon. The 5-year, $11.5 million trial, led by Dr. P. David Adelson, director of pediatric neurotrauma at Children's and a professor of neurosurgery at the University of Pittsburgh, seeks to enroll 340 children. Adelson will direct researchers at 12 hospitals and universities nationwide. The clinical trial is paid for by the National Institutes of Health. "We've proven this therapy is safe," Adelson said in a news release. "Now if we can determine that it is effective, it would be a major breakthrough because currently there are very limited treatments that improve outcome following traumatic brain injury in children."

By cooling a child who has hit their head to about 90 degrees - almost nine degrees below normal body temperature - doctors believe they reduce subsequent brain swelling, preventing further injury. Children are cooled with special cooling blankets and intravenous injection of cooled saline. To be effective, hypothermia must be induced within six hours of injury. Because of the time-sensitive nature, federally mandated parental consent will be waived for this trial if the parents cannot be reached on time.


May 18, 2007

Surgery that Sterilized Girl Suffering from Severe Brain Injury Violated State Law

In 2004, a 6-year-old girl’s uterus and breast buds were removed, leaving her sterile and frozen forever in a child-like state. The young girl, known as Ashley, suffers from static encephalopathy. The condition is an unchanging brain injury that causes permanent brain damage and disabilities such as motor skill problems and mental retardation.

Ashley’s parents decided to go forth with the controversial surgery to keep Ashley at a size that would enable them to include her in family activities more easily. “Ashley’s smaller and lighter size makes it more possible to include her in the typical family life and activities that provide her with needed comfort, closeness, security, and love . . .” said Ashley’s parents.

No matter what Ashley’s parents’ motives were, an investigative report found that the procedure was in violation of Washington state law. The Washington Protection and Advocacy System (WPAS) found that Seattle Children’s Hospital and Regional Medical Center violated the constitutional and common law rights of Ashley by performing the surgery without a court order.

“Washington law specifically prohibits the sterilization of minors with developmental disabilities without zealous advocacy on their behalf and court approval,” said WPAS’ executive director.

Seattle Children’s Hospital regrets their decision to not obtain a court order and plans to take full responsibility for their actions. WPAS have no plans to take legal action against the Seattle hospital. The advocates would just like to make others aware of the rights that disabled individuals have as human beings.


Brain Injury Advocacy Group Sues State of Massachusetts

The Center for Public Representation and the Brain Injury Association of Massachusetts has filed a class action suit against the state of Massachusetts. The lawsuit claims that state administration officials are violating the Americans with Disabilities Act by failing to provide community support care options.

According to the Brain Injury Association of Massachusetts, over 1,000 brain injury victims have been left to suffer in inappropriate institutions, such as nursing homes, after sustaining a traumatic brain injury (TBI). With no other alternatives, brain injury sufferers are forced to seek rehabilitative services from nursing homes - stripping individuals of their independence and self-dignity.

“Sometimes I feel I am in prison for a crime I did not commit,” said one of the plaintiffs.

The lawsuit was filed as a last resort; after the advocates have been urging state officials to provide community care options for decades.

“I’ve heard from many people with brain injuries who live in nursing homes . . . who are depressed and distraught about the isolation and segregation of living in a nursing home,” said Arlene Korab, executive director of the Brain Injury Association of Massachusetts.


May 17, 2007

Georgia HIV appeal at high court

The family of a boy who contracted HIV from a blood transfusion at the Medical College of Georgia in 1985 and whose condition went undiagnosed for many years should not be allowed to proceed with a malpractice lawsuit, attorneys argued this week. The statute of limitations has long since expired, argued Bryan Dorsey, who represented MCG Health Inc. and two physicians before the Georgia Supreme Court. Derek was born with a rare heart defect. He received blood transfusions at MCG while undergoing heart surgery as an infant. In 1985 when Derek received the blood, hospitals had not started screening for HIV. Sharon Kaminer, a pediatric cardiologist at MCG, and Ayman Al-Jabi, another pediatrician, both saw Derek routinely as he was growing up and attributed most of his ailments to childhood colds and his heart condition.

The state's high court is being asked to overturn a Georgia Court of Appeals decision that would allow Derek Canas, now 22, and his family to sue because he continued to show new pediatric AIDS symptoms as he grew older and the continuing misdiagnosis amounted to negligence. State law gives patients five years after a negligent or wrongful act, such as a misdiagnosis, to file a lawsuit, whether they knew anything was wrong at the time. In the case of an injury, there is a two-year statute of limitation. The test determining Derek was HIV positive came seven years after both sides agreed doctors first should have realized Derek's numerous respiratory and infection problems could be serious enough to warrant more tests. That was clearly past the allowed time limit to file a claim, Dorsey said. In previous decisions, the Georgia Supreme Court has ruled against similar efforts to extend the time period for malpractice suits to be filed, citing the statute of limitations rules the General Assembly set up. Dorsey said the appeals court's opinion would be difficult to apply to cases. "What new symptoms are new enough to create a jury question," he said. "It seems to me that nearly every misdiagnosis case is going to have new symptoms over time. This situation will arise in other cases because most diseases if not treated are going to get worse."

Robert Persons, who represents the Canas family, said the Court of Appeals was right to rule that as Derek's symptoms changed and became worse over the years, the physicians' negligence continued beyond just the first time they misdiagnosed his condition. "You cannot abide the notion that a doctor over an eight- to 10-year period is negligent one time," Persons argued Tuesday. Persons said the clock should have restarted in 2000, when after a lengthy break of not seeing Derek, Kaminer examined him as a 15-year-old boy who had not grown in the 3 years since she last saw him. Derek was 4-foot-2 inches tall, barely weighed 60 pounds and had more respiratory problems. Canas' family filed their lawsuit in 2001.


Concussions Need to Be Taken More Seriously

As the weather gets warmer, more and more people are outside playing some sort of recreational sport. More than 300,000 individuals fall victim to a sports related TBI and warm weather sports players need to be more cautious. Most sports related TBI's are mild to moderate concussions that are often ignored by athletes. Common concussion signs include headache, blurred vision, confusion, and nausea. The immediate symptoms of a concussion are often mild and go away quickly - prompting many sports players to go back to the game too soon.

"People say, you got a concussion, you know, suck it up," said one student athlete.

It is important for individuals to understand the dangers of ignoring a concussion. Former professional sports players, such as ex-Patriots player Ted Johnson, have revealed the devastating consequences of sustaining multiple concussions - including severe memory loss and depression. In a recent study of retired athletes, it was found that players who suffered 3 or more concussions were at a higher risk for developing severe memory loss, early onset Alzheimer's, and severe depression.

When an individual suffers a blow to the head, the brain hits the front of the skull and bounces back to hit the backside of the skull. This bouncing of the brain affects parts of the brain responsible for short-term memory, organization, and mood. The damage is not always detectable in MRI's; which makes it even more important for individuals to be more cautious after sustaining a blow to the head.

"It's the secondary hit, it's not so much even the first hit, and it's the second one and possibly even the third one that can really make the athlete even worse," said Paul Roberti, President of the Rhode Island Athletic Trainers Association.

Medical experts recommend athletes to play it safe after a blow to the head to give the brain time to heal and recover.


Woman survives internal decapitation

Shannon Malloy’s surgeon calls here a miracle. She was critically injured Jan. 25 when a car crash slammed her into the dashboard. Her skull separated from her spine, although her skin, spinal cord and other internal organs remained intact. The rare condition is known clinically as internal decapitation, and it left her with no control over her head. Her injuries left Malloy with nerve damage that made her eyes cross, and she has difficulty swallowing. She was not paralyzed. She told her story to Denver station KMGH-TV.

Dr. Gary Ghiselli, an orthopedic spine surgeon at the Denver Spine Center, said he and his colleagues had never seen such an injury in someone still living. "I've seen it once before," Ghiselli said, "and, unfortunately, the patient didn't make it." Even after the crash, physicians in Nebraska, where Malloy lives, told relatives they should prepare to say their goodbyes. Ghiselli said a will to survive kept Malloy, 30, alive long enough for surgeons to insert screws in her head and neck and attach a halo to minimize movement.

"My skull slipped off my neck about five times," Malloy said. "Every time they tried to screw this to my head, I would slip." Doctors eventually stabilized her head and strengthened her neck. The halo has since been removed. "It's a miracle that she was able to survive from the actual accident," Ghiselli said. "It's a miracle that she's made the progress that she's made."


Patients with brain injuries sue MA claiming inadequate care

A class action suit filed May 17th by a pair of advocacy groups claims 2,000 people with brain injuries are being discriminated against due to a lack of community-based care, leaving many in nursing homes and other inappropriate institutional settings. The suit, filed by the Center for Public Representation and the Brain Injury Association of Massachusetts, alleges Governor Deval Patrick, JudyAnn Bigby Secretary of the Office of Health and Human Services and other administration officials are violating federal law by failing to provide community support services, which can improve independence and promote rehabilitation.

With no alternatives, many patients are forced to seek services like speech, occupational and physical therapy in nursing homes, where services are severely limited and expensive. The lack of such services means hundreds of people who would prefer to live independently cannot, the suit alleges. "I've heard from many people with brain injuries who live in nursing facilities who are depressed and distraught about the isolation and segregation of living in a nursing home," said Arlene Korab, executive director of the Brain Injury Association of Massachusetts "They talk about how it physically, socially and emotionally debilitates them, how easy it is for them to give up hope and turn to us for help." For decades, the association has urged state officials to create programs to reach out to individuals with brain injuries, to no avail. With no other alternative, she said, they decided to go to court. "We have patiently urged six governors and their executive officials to create community programs as alternatives to institutions," Korab said. "We take this dramatic step because the Commonwealth of Massachusetts has refused to create adequate community services for people with brain injuries."


Brain Injury Association of Utah 13th annual 5K event

The Brain Injury Association of Utah will be holding its 13th annual 5K Run, Walk and Roll to raise awareness for brain injury victims. The event takes place May 19th at 8.00 a.m. at Liberty Park, 600 East 1300 South, Salt Lake City. It will begin at the entrance of Liberty Park and end at the Bowery on the eastside of the park. Nearly 40,000 Utah residents are living with a disability caused by Traumatic Brain Injury. The risk is highest among adolescents, young adults and seniors over 75. The Brain Injury Association of Utah’s mission is to create a better future through brain injury prevention, research, education and advocacy.


May 16, 2007

Ob-gyn group stops prescribing Ortho Evra

The serious health risks associated with the Ortho Evra patch is enough to compel one Knoxville, TN ob-gyn group to stop prescribing it to patients. Hundreds of women are receiving letters, citing an American College of Gynecology study exposing the greater risk of deep vein thrombosis in women using the Ortho Evra birth control patch. Parkwest Women's Specialists have decided to change their patients to another form of birth control. Obstetrician/Gynecologist Rosalind Cadigan says “With the Ortho Evra patch, at the end of the month, you end up getting more estrogen in your body than a pack of birth control pills.” Doctor Cadigan will prescribe the Ortho Evra patch to her patients, with informed consent, but she does recommend other options, due to the risks. “FDA has not taken the Ortho Evra patch off the market, but several people, several clinicians have been worried about the possibility. The bottom line is that pregnancy is going to be a higher risk situation than the Ortho Evra patch. So, your risk of having a blood clot in your leg or a pulmonary embolism due to pregnancy is higher than the risk of having that with an Ortho Evra patch,” Dr. Cadigan says


More Doctors are Sharing Their Experiences Using Blogs

Doctors are increasingly telling all through blogs, sometimes anonymously and with altered facts. About 1 percent of all blogs deal with health, according to a 2006 study by the Pew Internet & American Life Project. Many are by consumers writing about their own health issues, but the numbers of health care providers who are blogging is steadily growing. Some doctor blogs are intended for the broader public. However, many, especially those by anonymous writers, feature doctors venting about patients, hospitals, insurers and malpractice lawyers to each other. Others dissect health news or health policy debates.

The blogs often make interesting reading. Val Jones, senior medical director of the new Revolution Health site (www.revolutionhealth.com), recently blogged about a woman who stayed for weeks, 24/7, by the bedside of her comatose, severely brain-damaged mother. One day, the daughter decided to go out for lunch. A new attending physician, a "bit of a cowboy," came in, pronounced the mother hopeless and "turned off the machine." The daughter returned, learned what had happened and "fell to the ground and screamed," Jones wrote. "That scream still haunts me." Such stories, of course, raise the question should we all worry that our doctors are blogging about us and potentially violating our privacy? "The details are always, always, obscured," said Nicholas Genes, a New York City emergency room physician who organizes a weekly sampling of medical blogs, called Grand Rounds, hosted by a different blogger each week. "If someone is coming in with a bleeding finger, it's going to become a toe." Patient genders, ages, locations and timing whether an incident happened last week or last year also are commonly obscured, medical bloggers said. "No personal information about any patient whatsoever" is revealed, says Jones.

Concerns have been raised. Len Lichtenfeld, deputy chief medical officer for the American Cancer Society, says he avoids discussing patients at "Doctor Len's Cancer Blog" (www.cancer.org/drlen) and worries a bit about storytelling bloggers: “There will be a problem eventually with some violation of patient privacy,” he predicted. Many carry disclaimers, saying that they should not be considered a source of medical advice. Pew researcher Susannah Fox said the blogs can be informative as long as readers keep in mind that “there's a difference between a conversation in a clinical setting and a conversation at a cocktail party.” Genes says there may be better places for patients to get information, but "patients can certainly benefit from knowing more about doctors' mind-sets."


Death and Disability from Brain injury Reduced

A study by Emory University researchers that found giving progesterone to trauma victims shortly following brain injury may reduce the risk of death and the degree of disability was recently highlighted in the April 2007 Annals of Emergency Medicine. No new medical therapies have been developed for traumatic brain injuries in over 30 years. David Wright, MD, assistant professor in the Department of Emergency Medicine at Emory and lead author of the study says the study gives hope of finally identifying an agent for the treatment of traumatic brain injury and possibly other neurological injuries such as stroke, spinal cord injury and multiple sclerosis. "This is the first therapy exists that improves the outcome of brain injury patients," says Dr. Wright.

Emory's researchers designed a clinical trial to assess the promise of progesterone for treatment of TBI. Their three-year pilot study, called ProTECT (Progesterone for Traumatic brain injury-Experimental Clinical Treatment), enrolled 100 participants. The phase II study was primarily designed to evaluate whether progesterone can be administered intravenously in a reliable way, and whether the treatment is safe to use in humans with TBI. The researchers also hoped to find preliminary evidence that the treatment might be effective. Progesterone is a neurosteroid that exerts protective effects on human tissue. It is naturally present in small but measurable amounts in the brains of males and females. Laboratory studies suggest that progesterone is critical for the normal development of neurons in the brain and exerts protective effects on damaged brain tissue.

The research team is now planning a large, multi-center, phase III clinical trial designed to test the effectiveness of progesterone in 1,000 patients with TBI. They also hope to study the effects of progesterone treatment in animal models of blast-related brain injury, a major cause of death among combat personnel. Additionally, they plan to implement a study of progesterone to treat pediatric brain injury, which is a leading cause of death and disability in children.


Medical Malpractice against Phospho Soda Bowel Prep solution

A Norfolk, Virginia law firm has filed a $10 million lawsuit against Lynchburg-based C.B. Fleet Company on behalf of a Texas woman who suffered acute renal failure and other side effects after the use of Fleet Phospho-soda prior to a medical procedure. While there have been hundreds of reports of patients damaged by the product, this legal action is believed to be the first filed against the large manufacturer of health, medical and pharmaceutical products. According to the complaint, the plaintiff in the case, Lora Joyce Goza, went for a routine cancer screening colonoscopy in May of 2005. As part of the procedure she was given a Fleets Phospho-Soda Bowel Prep solution. A common administration designed to clean a patient's bowels to facilitate accurate viewing of the intestines. According to the suit, the Phospho-Soda combined with Goza's blood pressure medication creates a negative response, causing permanent kidney damage and eventually kidney failure. It further alleges that the damage to Goza was avoidable because the C.B. Fleet Company had known for at least 12 years of the potential of the product to produce dehydration, renal failure and other complications when combined with certain blood pressure medications and diuretics. Furthermore, the C.B. Fleet Company did not issue special warnings to gastrointestinal physicians or radiologists who were the likely users of the bowel purgative even though C.B. Fleet knew of the dangers. Neither the product package nor the accompanying instructions carried any warnings about the dangerous side effects of the product, in spite of frequent reports of problems from patients and physicians.

Fleet Phospho-Soda is one of the best-selling bowel cleansing products in the world, with millions consumed annually by patients undergoing medical examinations. After several years of reported side effects, the FDA issued a notice to healthcare professionals in 2005 of reported "acute renal failure, a serious event associated with the use of oral sodium phosphates for bowel cleansing." The notice listed other complications of the solution when combined with a number of different drugs.


May 15, 2007

Man awarded $3M in malpractice suit

A Lake County Superior Court jury deliberated nearly nine hours before awarding Steven Sangster $3 million in a medical malpractice suit. Sangster, 30, filed against orthopedic surgeon Dr. Richard Oni and anesthesiologist Dr. James Kim whose medical actions left Sangster with brain damage. After Judge Diane Kavadias Schneider read the verdict, Sangster's sister and legal guardian, broke down into tears and hugged the family's attorney, John Kopack, of Kopack & Associates in Merrillville. "Steven ... was in court and smiled at me after the verdict was read," Kopack said in a release. "He didn't fully understand what had happened, but I hope he knows that for once in his life, he got a fair shake from fate and that it was a good jury that did it for him." After four days of testimony and a day of deliberations, the seven-member jury found the physicians negligent.

On July 12, 1996, Sangster, then 19, underwent spinal surgery by Oni at Methodist Hospitals Northlake Campus in Gary, for the correction of congenital scoliosis or curvature of his spine, the release stated. About three hours into the surgery, the anesthesiologist informed Oni that some of the patient's monitoring equipment had malfunctioned, but Oni chose to continue the surgery. An hour later, Sangster went into cardiac arrest and a coma. Later, he was diagnosed with permanent brain damage due to lack of oxygen during the surgery. In 2001, a medical review panel of three doctors ruled that Oni and Kim had breached the standard of care during surgery and caused Sangster to suffer injuries. It is believed that the panel included one doctor that was appointed by both Dr. Oni and Dr. Kim. Their own panel expert ruled against them.


A silent ride of support

Roger Bartley sustained a traumatic brain injury 16 years ago from a car accident in Colorado, yet his disability is invisible. He is remarkably fit and more than six feet tall. Bartley, a bicyclist of 40 years and a member of the Napa Valley Eagle Cycle Club, is coordinator of Wednesday evening's local version of the Ride of Silence in a show of support for those who lost their lives or were injured while sharing the road with motor vehicles. The event is intended to encourage mindfulness, road safety and awareness among both cyclists and motorists. Throughout the Ride of Silence, cyclists will wear black arm bands to represent those hurt or killed in biking accidents; those injured in an accident will wear red arm bands. Cyclists will stop halfway through the ride for a recitation of the names of Napa County bicyclists killed or injured on the road.

Chris Phelan kicked off the first Ride of Silence four years ago in Dallas after he learned of the death of Larry Schwartz, an accomplished cyclist who died after being hit by the side mirror of a bus. Bartley is riding in honor of Ross Dillon, a Sonoma County resident who suffered a traumatic brain injury in June of 2002 when a vehicle stuck him from behind. Like Dillon, Bartley was also the victim of a traumatic brain injury. During a skiing trip, he was in a car crash on a Colorado access road and remained in a coma for 42 days. He said doctors told him he'd never walk or talk again. "I wrote down on a piece of paper, 'Doc, I'm gonna walk out of here.'" Today, Bartley skis, plays basketball, and rides his road bike. Bartley said one of the most important messages of the Ride of Silence is for cyclists to make their presence known.

Sandy Houck, 60, a certified instructor for the League of American Bicyclists, echoed his message. "It's important to recognize the potential impact to bicyclists from conflicts with motorists. As cyclists, we like to think that we can amicably share the road, but of course we're a lot smaller." Houck said bicyclists should be predictable and follow the rules of the road, while motorists should drive courteously. Bicycles should also travel in the same direction as traffic and wear a helmet. Bob Hillhouse attended last year's Ride of Silence. He said the event is important because it honors the memory of those who lost their lives in bicycle accidents. "We need to work on safe bike routes to schools and more awareness that bicyclists have the right to be on the road. Bicycles also need to follow the vehicle code to be safe out there." Accidents, he said, are "easily avoidable if people are respectful."


Positive Analysis from Synthetic Blood Oxycyte use in TBI

Synthetic Blood International, Inc. announced positive data from a statistical analysis of its Phase IIa study with Oxycyte™ in patients with traumatic brain injury. In agreement with preliminary study results announced in December 2006, statistical results confirmed that the primary endpoint of increasing patients’ oxygen tension levels compared with baseline was met. Patients in this trial were stabilized with either 50% or 100% oxygen. “This analysis further validates our initial study findings that Oxycyte is more effective in increasing brain oxygen tension levels and impacting other brain chemistries that contribute to more favorable clinical outcomes in patients with traumatic brain injury, than breathing either 100% or 50% oxygen alone,” said Robert Nicora, president and CEO. “Based on these positive results, we are working with Virginia Commonwealth University (VCU) to develop a protocol for a multicenter, controlled Phase IIb trial that could enroll up to 100 patients with traumatic brain injury.”

In the Phase II eight-patient study conducted at Virginia Commonwealth University, Oxycyte was administered to patients with severe traumatic brain injury. The study protocol includes two groups. The first four study patients were stabilized with 50% oxygen for four hours before and 12 hours following Oxycyte administration. The remaining four study patients breathed 100% oxygen on the same schedule. The primary purpose of this study is to demonstrate Oxycyte’s ability to increase brain oxygen tension and favorably affect other brain chemistries that impact the outcome of patients suffering severe head injury. Additionally, the study will further assess the safety of Oxycyte when given by intravenous infusion.

Due to a technical malfunction whereby a complete measurement of oxygen levels in the brain of one treated patient was not made, nine patients were treated to meet the eight-patient goal. While survival was not a trial endpoint, seven patients in the trial survived their brain trauma. Neither of the two mortality cases was related to the safety of Oxycyte. One patient suffered massive injury and was not expected to survive. Another patient was withdrawn from the trial upon the voluntary decision to remove life-support.


Brain Injury Verdict among Virginia’s Largest

A woman was recently awarded 12 million dollars for a brain injury from a 2003 fall. The Hampton, Virginia jury gave this large award in a slip and fall accident case. The large multi-million dollar jury award is probably among the highest in the slip and fall premises liability category in Virginia history. The defendant was a gas station convenience store operator. The store had allowed slippery algae to continue to grow unchecked on its sidewalk just outside the store creating a danger for customers.

Brain injury cases are among the most high stakes types of injuries that injury lawyers handle. In an appropriate case a Virginia jury will be very generous in compensating someone who has suffered a closed head injury also called a traumatic brain injury. Proving the injury, which is often hard to diagnose and demonstrate, requires a very skilled trial lawyer. The combination of a slip and fall with a brain injury is a very volatile combination. Sometimes a jury will be hesitant to hold a store owner responsible for their negligence, if there is a strong argument that the person who got hurt was partially at fault for their own injury. For this reason insurance companies are often stingier about resolving a slip and fall case fairly. Insurance companies are also quite stingy in traumatic brain injury cases, especially mild or moderate traumatic brain injuries. Part of the reason is they may not be willing to voluntarily pay a fair amount of compensation to a brain injury victim because they often look fairly normal. To see them across the court room in a first impression you may not be able to realize a person has suffered post-concussive syndrome, closed head injury, or brain injury. The insurance companies hope that they can avoid paying significant compensation to brain injury victims because they hope that a jury's first impression may be that the person looks fine. For this reason they may be more willing to let a case like the Hampton, Virginia one go to verdict. Luckily for the particular client in question, the jury was convinced that the store was at fault, that she was free from fault, and that the brain injury was real and devastating. As a result of this big verdict, hopefully the next time an insurance company is evaluating a slip and fall case with a brain injury they may be more reasonable knowing that a Hampton, Virginia jury was willing to put a large number on such a case.


TBI Victim Urges Governor to Implement Tougher Pesticide Control

Over the past 14 months, 3 schools in Hawaii have been forced to close due to toxic pesticide fumes. In light of the recent closings, Hawaii's governor, Gov. Linda Lingle, has been faced with a barrage of complaints regarding the state's current pesticide control methods.

Citizens and lawmakers alike are urging the governor to consider implementing tougher pesticide control measures. "We've had children who had to go through the whole hazmat process and get cleaned off with water because of improper use of pesticides," said one Hawaii lawmaker. In one of the most serious events, one Hawaiian citizen's life was completely turned upside-down because of a TBI caused by the inhalation of pesticide fumes. Clare Apana lost her home, her business, and her well-being. "Everyday I have to worry about am I going to come into contact with a little bit of this pesticide?" said Apana.

With the help of Apana, 2 new bills have been introduced calling for improved pesticide control methods. House Bill 1646 requires all pesticide retailers to post warning signs that must include directions for the proper handling, storage, and disposal of all pesticides. In addition, House Bill 1641 calls for the prohibition of the sale, solicitation, and receipt of orders for restricted pesticide to unlicenced pest controllers.

Many Hawaii farmers and gardeners say they are already doing what the bills call for; however, Apana still believes more precautions should be made and be required by law. "When you think about getting rid of these little pests, you could be getting rid of people," said Apana.


Differing Opinions on TBI's in Children May Hinder Child Abuse Detection and Prevention

Researchers at Indiana University School of Medicine found that pediatricians and pathologists were unable to agree whether certain traumatic brain injury cases were caused by child abuse in 50% of the incidents. Antoinette Laskey, forensic pediatrician and assistant professor at Indiana University School of Medicine, says that the study's results illustrate the dire need to develop uniform definitions to detect and prevent child abuse.

"We have to understand abusive head trauma. Research in the field is in its infancy compared to what we know about other pediatric conditions. We need to increase both the volume and the quality of what we know. We need to know more and we can't until we have pediatricians and pathologists, the doctors who see these children, speaking the same language," stated Dr. Laskey.

Each year more than 1 million American children sustain a TBI. Over 1,500 American children die after sustaining a TBI and over 30,000 are left severely injured and brain damaged annually. TBI's are the leading cause of abusive death in children and is most commonly found in children under the age of 4. These statistics are alarming and are what prompted Dr. Laskey to launch her comprehensive study.

In the study, 570 pediatricians and pathologists were shown 16 hypothetical TBI scenarios. The pediatricians and pathologists were asked to categorize each injury as inflicted, unintentional, or undetermined. It was found that agreement between the two medical provider groups could not be made in 50% of the cases. Additionally, the pediatricians were more likely to view each scenario as an inflicted TBI than the pathologists.

"Our study results will help facilitate the development of more uniform research definitions for future comparative studies of unintentional versus inflicted pediatric traumatic brain injury." said Dr. Laskey, Dr. Laskey and her colleagues are currently in the process of creating a follow-up evaluation to further investigate the study's results.


May 14, 2007

Mental "Workout" Could Reverse Effects of Dementia

As aging baby boomers look for more and more ways to stay youthful, the importance of keeping the body and mind young is becoming a hot topic. "People are saying 'I want to live long, but I want to do it on my terms.' They're saying 'I could live with a little bit of physical decline, but I don't want any decline in my cognitive abilities. So what can I do about it?' " said Michael Patterson, director of the brain fitness program, Staying Sharp.

It is well known that physical exercise is important to keep the body healthy, and now research has shown mentally stimulating exercises can help with the effects of a declining brain. This is a momentous finding in light of the increasing number of individuals with neurodegenerative disorders such as Alzheimer's and traumatic brain injuries. Neurodegenerative disorders commonly cause dementia - a negative effect previously thought to be irreversible.

There is now new hope for individuals with declining cognitive abilities as brain studies show that the brain may have more plasticity and can respond positively to certain stimulation. Posit Science's Brain Fitness Program is currently the only program available that is based on scientific findings. The program has shown great success in individuals over the age of 60 - on average those individuals experienced a 10-year improvement in cognitive abilities. The program takes advantage of the brain's plasticity and engages individuals in programs that focus on the brain's ability to listen, see, and process information. As individuals progress through the program, the exercises become increasingly difficult to retrain the brain.

Other mental workout programs available include Nintendo's Brain Age, CogniFit, and Sharp Brains. Experts advise researching the legitimacy of a mental workout program before starting one. Things to look for are scientific research that supports the program's exercises, specifics on how the activities affect the brain, and the presence of neuroscientists or other health professionals on staff.


$17 million in death benefits wasn't paid to Texas families

Donald Coit Smith believes that Texas insurance companies profited after his 22-year-old son was electrocuted in an industrial accident, all because of state laws that regulate the payment of death benefits through workers' compensation. For his loss, Smith got $6,000 to bury his son. Additionally, Smith was told that the workers' compensation death benefit, $100,500 would not be paid to grieving family members because his oldest child, Donald W. Smith had no wife or children. Instead, the money, paid by his employer's insurance company, went to a state workers' comp fund. More than $17 million in workers' compensation benefits bypassed the relatives of as many as 140 dead workers from 2003 to 2006. All of that money ended up in a workers' comp fund where $10 million was then funneled back to insurance companies, according to a Houston Chronicle analysis of state data. Coit Smith, who has 20 years of experience as an industrial safety specialist, calls the payments "blood money." "I feel it's immoral, what they did with that money," Smith said.

About 450 people are killed in workplace accidents in Texas each year. Yet many families of dead workers collect nothing because historically, workers' compensation benefits have been reserved only for those who depended on those wages to live. Death benefits are typically paid only to spouses and children younger than 18. Spouses who remarry and children who come of age lose the benefits. Parents and older children also are denied unless they were financially dependent on the worker killed, according to state law. When no family members qualify, the lump-sum death benefit, often more than $100,000 per worker, goes to the state Division of Workers' Compensation and into the so-called "Subsequent Injury Fund."

The fund was meant to provide a safety net for workers who needed extra help after suffering multiple injuries on the job, but because of changes in the law in 1991, most of that money now goes back to insurance companies who underwrite workers' compensation. Workers' compensation, an optional employer-funded insurance plan administered by the state of Texas, is designed to assist injured workers and the families of those killed on the job. More than 250 companies collected from the fund, one company got more than $400,000 in a single payment, the Chronicle analysis showed. The insurance companies are reimbursed as a way to recover money from unrelated cases in which injured workers were paid benefits that later were successfully challenged by the insurers.


Veterans for America stands up for sick GIs

An Army general said that a "Wounded Warrior Transition Brigade" would come soon to Fort Carson. It will help soldiers with post-traumatic stress and brain injuries. As Brig. Gen. Michael Tucker spoke at Colorado's Mountain Post, no one from Veterans for America stood beside him. They should have. VFA played as big a role in Tucker's announcement as any of Fort Carson's brass. Veterans for America, a group run by ex-military personnel, has forced the Army's hand across the country by exposing bad treatment of soldiers who return from war with psychological wounds. Before whistle-blowers attracted media attention, sick soldiers were being ignored or even forced from the military without the support they needed. Fort Carson conveniently announced formation of the Wounded Warrior Transition Brigade the week before nine senators send staff members to Carson. The senatorial staffers will investigate claims of inadequate health treatment of soldiers. Tucker spoke of Fort Carson as "a great example of what right looks like." In fact, Robinson and other advocates say, Fort Carson has made positive changes in health care for soldiers. Unfortunately too often, it had to be embarrassed into action. "Leaders at the unit level still don't understand how to deal with post-traumatic stress disorder and traumatic brain injury," said VFA's director of veterans affairs, Steve Robinson. "Without help, people with PTSD turn to drinking and drugs. People with traumatic brain injury have discipline and anger issues. And yet they still say that PTSD and brain injury are not an excuse for bad behavior."

Veterans for America's latest charge is that the Army is forcing out some soldiers with war-related post-traumatic stress by claiming they have pre-existing personality disorders. It is just one more thing in a years-long pattern. "Without VFA, more people would have killed themselves," said an ex-Special Forces soldier who spent months in "medical hold" at Fort Carson in 2004 awaiting treatment. The man didn't want his name published. He feared the military would try to take away his disability benefits. Problems treating post-traumatic stress or brain injury "were not going to go away without pressure and oversight" from outside the military, the ex-soldier said. "When I was (at Fort Carson), they just wanted to get soldiers with problems out of the service without giving them adequate care. In my case, if I didn't have a medical background, I wouldn't have gotten the treatment I needed." That's a searing indictment. Veterans for America has surely been a thorn in the military's side, but if the Walter Reed scandal and the establishment of a Wounded Warrior Transition Brigade prove anything, it is this: Without groups like Veterans for America, this country's war casualties would be victims of tunnel vision as deadly as friendly fire.


House Panel OKs Bill to Improve Treatment of Veterans with Brain Injuries

The House Veterans’ Affairs Subcommittee approved a bill May 10th aimed at improving the treatment of veterans with traumatic brain injuries, putting the measure on track for House passage by the end of the month. The bill (HR 2199) would authorize new traumatic brain-injury research centers and mandate a comprehensive program for treating traumatic brain injuries at health centers operated by the Veterans Affairs Department. A committee aide said he expects the full Veterans’ Affairs Committee to mark up the bill next week, with a House floor vote to follow before the Memorial Day recess. The bill, sponsored by Health Subcommittee Chairman Michael H. Michaud, D-Maine, would require the department to establish a comprehensive long-term care program for traumatic brain injury, to be carried out at four special polytrauma care centers, which focus on treatment of veterans with multiple injuries. It also would mandate screening of veterans for traumatic brain injury.


Risky sports get even riskier under some insurance plans

Outdoor recreation groups are alarmed because some carriers refuse to pay medical bills for injuries suffered in high-risk activities. Health insurance coverage may be denied if you’re injured while participating in horseback riding, snowmobiling, motorcycle and all-terrain-vehicle riding, skiing and other outdoor pursuits. A very large loophole in the Health Insurance Portability and Accountability Act, or HIPAA, remains open. It’s being called health care discrimination. HIPAA was enacted to protect those involved in legal transportation and recreational activities, but according to outdoor recreation groups, its language can deny coverage because the way an injury occurred. For instance, if you break a bone tripping over a little boy’s scooter, the medical bills are covered. If the same bone is broken in a skiing accident, coverage may be denied. “I’m sure there are lots of horseback riders and snowmobilers who have no clue this is out there,” says Pam Gluck, executive director of American Trails, a Redding, Calif. based national, nonprofit organization. “If people who pay premium dollars are being denied coverage, it defeats the intent of HIPAA,” says Carla Varriale, a partner in the New York law firm Havkins Rosenfeld Ritzert & Varriale. “From a policy point of view, you could debate both sides, but it’s definitely something worth watching.” Varriale, who has done extensive insurance coverage litigation, enjoys horseback riding and motorcycling during leisure hours. “It flies in the face of the intent of the act,” she said. “These are otherwise legal activities and it seems heavy-handed in our private lives. And I’m a bit uncomfortable about who defines ‘risky.’ ” Outdoor-recreation groups have found sympathetic supporters in Congress. Bipartisan legislation to close the so-called HIPAA loophole is in committee while the Senate and House address the war in Iraq and other issues. While understandable, the delay is unsettling to outdoor enthusiasts.


Infant died of catastrophic injuries

A baby who initially was said to have been dropped on a linoleum floor suffered skull fractures, two wrist fractures, broken ribs on both sides and a broken ankle, prosecutors said Friday. Leonardo Gonzalez's massive injuries were detailed as his mother, Joanna Michelle Vasquez, 22, made her first court appearance to face a capital murder charge. The 2½-month-old boy died April 27 of "catastrophic injuries," prosecutors said. He had been placed on life support shortly after being taken to a hospital on April 24 by Vasquez and her common-law husband, said Assistant District Attorney John Jocher.

Vasquez at first told medical personnel and police she had shaken the baby and dropped him on the "soft tile kitchen floor" in her north Houston apartment, Jocher said. After being confronted with the autopsy findings, however, she admitted punching her baby four times in the head, prosecutors said in state District Judge Michael McSpadden's court. Estella Olguin, spokeswoman for Harris County Child Protective Services, said recently that Vasquez admitted hitting and shaking her baby because he would not stop crying. No decision has been made on whether prosecutors will seek the death penalty, Jocher said.


Bike helmet crushed, but head fine

A white paneled delivery truck ran over a UW-Madison graduate student's head, except for a concussion, he wasn't hurt. He saw the large delivery truck preparing to make a right turn onto another Street. Ryan Lipscomb, 26, said he was riding his bicycle pretty fast down a bike path and had a green light, so the crosswalk for the bike path showed a white walk sign. Lipscomb said he could tell the truck wasn't going to stop. So Lipscomb slammed on his brakes, flipping his bike and throwing himself into the street. He landed right at the intersection and the truck ran over his head. "I didn't see it coming, but I sure felt it roll over my head. It feels really strange to have a truck run over your head." His helmet, a Giro, was crushed, but Lipscomb's head was fine.

Madison Police Department Sgt. Chris Boyd said the officer at the scene urged Lipscomb to keep the helmet. He did. It is all flattened and mangled and broken, unlike his head. Even though the truck did not stop, Boyd initially refused to call the incident a hit-and-run. She said the police were not sure that the truck driver knew that someone had been hit. But Sgt. Bernie Gonzalez said later in the evening that the accident report calls it a hit-and-run. Lipscomb agrees with Gonzalez. "The truck driver definitely would have known. You know when you run over a curb and my head was definitely higher than a curb." Moreover, Lipscomb said, he was already in the street as the truck was turning. "He had to have seen me." He was taken to University Hospital, but was released by about 6 p.m. "I'm OK except for a concussion," he said Friday night about 10 p.m.


WCC graduate overcame brain injury

Tiffany Mills almost died several times while in a coma. Doctors didn't know if she would survive. They said she would never walk again. Tiffany, now 22, is not only walking. She will graduate from Wayne Community College with a diploma in business administration. If all goes as expected, she will receive her associate degree in December.

Tiffany doesn't remember being thrown onto the highway from the back seat of a four-wheeler in 2003 or the helicopter that took her to the hospital with a severe brain injury. She doesn't remember anything from that summer. She was in a coma for nearly a month and after two-months in the hospital, she went to 24 hour care for another four months at Renu Life. Her oldest sister, Glenda Bass worked at Renu Life, and her mother, Debbie Mills, worked the second shift. After the accident, her twin brother, Bill, went to work there, too. "Thank God we knew how to work with traumatic brain injury," Debbie said. If they didn't, she said, the family would not have known to push her. When the family would bring Tiffany home on weekends from the hospital, all she wanted to do was go to her room and close the door. The family would have none of that. They knew if you push a victim of traumatic brain injury, you always see results. "A lot of parents don't push them. If you don't know how to work with (TBI), it can be bad," he mother said. Tiffany has always pushed herself, too. When the accident happened, she was working two jobs and attending Wayne Community College. She was working toward her associate degree to transfer to a university and realize her lifelong dream to become an elementary school teacher. She is now a substitute teacher. "Who knows? It might lead to something," she said.

At first when she returned to Wayne Community, she figured she would only be able to earn a one-year diploma, but her advisor told her there was no need to stop there and that she should pursue her associate degree. The doctors had told her to start out with just one course. She started with three. "She's just a miracle," her mother said.


Bike Safety Month Reminds Us All to Wear Helmets to Prevent Brain Injury

May is Bike Safety Month - the perfect time to stress the importance of precautions to take to reduce the risk of brain injury while on a bicycle.
Over 85 million Americans ride a bike each year and wearing a protective helmet is of utmost importance. Individuals who ride without a helmet are 14 times more likely to sustain a brain injury than riders who wear a helmet. Experts believe this estimate is actually on the low side since it does not take individuals who do not seek medical help into account. The use of bicycle helmets reduce the risk of brain injury while on a bicycle by 88%.

If those statistics alone are not enough to get you to wear a helmet - and to urge others to do so - here are a few more alarming facts:
- Chilren are 74% more likely to die from motor-vehicle related bicycle crashes than adults.
- Children are 81% more likely to be injured in bicycle related incidents from the months of April through October.
- 75% of all bicycle related brain injuries occur in children 14 and under.
- Children 14 and under are 5 times more likely to be injured in a bicycle related accident than all other age groups.
- Over 40% of all bicycle related deaths are caused by brain injuries.

When getting ready to ride a bike remember to follow the following guidelines to reduce the risk of all injuries:

1) Put on a helmet before getting a bike.
2) Always stop to scan your surroundings before riding a bike into the street.
3) Obey stop signs and other traffic signals and rules.
4) Check behind you before swerving, turning, or changing lanes.
5) Always be aware of your surroundings and other moving objects around you.


Marine's TBI Detected 10 Years Later

Mark Palmquist was in Panama 10 years ago when the helicopter he was traveling in was shot down. A decade after the accident, Mark began to notice he was having difficulty with simple math problems, and he was experiencing severe memory loss. "It's very frustrating," said Mr. Palmquist. "I can't remember nursery rhymes to save my life." Worried by the symptoms, Mark went to the doctor and he was diagnosed with traumatic brain injury (TBI).


Early detection of TBI's is becoming an eminent concern as record numbers of veterans are returning form Afghanistan and Iraq with TBI's. A recent Army study found that 18% of Iraq vets were diagnosed with a brain injury. Experts speculate that this number does not even take into account those who have yet to be formally diagnosed with a TBI.

"Traumatic brain injury is one of the signature injuries of this conflict. May of them would not have survived in other wars. They're coming back to us though with serious brain injuries," said VA Secretary Jim Nicholson.

In response to the increasing number of vets returning with TBI's, the Pentagon and Congress have been working on measures to improve in detection of TBI's. Detection of TBI's is difficult; however, in the cases of vets with closed brain-injury and mild TBI. Both types of TBI often elude current detection technologies and the effects become more and more devastating as more time passes.

"If they don't kill them, they may look absolutely perfect and whole, but they may have soft-tissue brain damage that is tough to detect unless you really knew that person extremely well and knew how they would think and react," said Lt. Gen. Steven Blum of the National Guard.

A $95 billion emergency spending bill pending in Congress includes $50 million for trauma centers, $100 million for mental-health care and $870 million to improve veterans facilities across the country.


May 12, 2007

FDA Announces Results of Investigation into Illegal Promotion of OxyContin

The U.S. Food and Drug Administration's Office of Criminal Investigations (OCI) announced today that The Purdue Frederick Company, Inc. has agreed to pay more than $700 million to resolve criminal charges and civil liabilities in connection with several illegal schemes to promote, market and sell OxyContin, a powerful prescription pain reliever that the company produces. An investigation by OCI uncovered an extensive, long-term conspiracy by The Purdue Frederick Company, Inc. to generate the maximum amount of revenues possible from the sale of OxyContin through various illegal schemes. Purdue trained its sales representatives to make false representations to health care providers about the difficulty of extracting oxycodone, the active ingredient, from the OxyContin tablet; trained its sales force to represent to health care providers that OxyContin did not cause euphoria and was less addictive than immediate-release opiates; and allowed health care providers to entertain the erroneous belief that OxyContin was less addictive than morphine. In addition, Purdue falsely labeled OxyContin as providing "fewer peaks and valleys than with immediate-release oxycodone," and by representing that "…delayed absorption as provided by OxyContin Tablets is believed to reduce the abuse liability of the drug."

"FDA will not tolerate practices that falsely promote drug products and place consumers at health risk," said Margaret O.K. Glavin, Associate Commissioner for Regulatory Affairs. "We will continue to do all we can to protect the public against drug companies and their representatives who are not truthful and bilk consumers of precious health care dollars." To resolve the criminal charges, Purdue pled guilty to a felony count of misbranding a drug with intent to defraud and mislead. As part of the plea, Purdue will pay a $600 million settlement. That amount includes a criminal fine, restitution to government agencies, and over $276 million in forfeiture. In a separate civil settlement, Purdue will pay $100.6 million to the United States.

This case was prosecuted by the U. S. Attorney's Office for the Western District of Virginia and investigated by FDA's Office of Criminal Investigations; the Internal Revenue Service's Criminal Investigations Division; the U.S. Department of Health and Human Services' Office of Inspector General; and the State Police Departments of Virginia and West Virginia.


Family Sues Over Fatal Hair Transplant

A Southern California man who wanted a hair transplant died during the procedure. Now his family is suing the cosmetic surgery firm. Walter Riley, 52, went to Crown Cosmetic Surgery in Los Angeles a year ago for what he was told was a routine $4,000 hair transplant procedure. He died an hour into the transplant. His family filed a medical malpractice lawsuit against Crown Cosmetic and several of the doctors who work there. The suit says an overdose of the anesthetic lidocaine is to blame. According to the family's lawyers, the medical firm's own records show Riley received three times the normal amount of lidocaine. The defense counters that Riley failed to disclose an allergy to the anesthetic before the procedure.


Former Fort Collins Nurse Sues GE Healthcare for complications with Omniscan

Through the law firm of Burg Simpson, Eldredge, Hersh & Jardine, P.C. in Denver, Greta Carolus a former nurse and resident of Loveland, Colorado, recently filed a lawsuit in U.S. District Court for the District of Colorado against General Electric Company, GE Healthcare, Inc. and GE Healthcare Bio-Sciences Corporation claiming that their drug caused her a debilitating skin and joint disease known as Nephrogenic Systemic Fibrosis (NSF). The suit seeks damages for fifteen separate causes of action stemming from the effects of Omniscan(TM) also known as gadodiamide. “Within days after being administered Omniscan(TM), Ms. Carolus developed symptoms associated with NSF/NFD, which was formally diagnosed in November 2005, and which has progressed to widespread fibrosis and edema in areas including, but not limited to, her arms, legs, and associated joints," says Peter W. Burg, a partner in the Denver litigation law firm of Burg Simpson Eldredge Hersh & Jardine, who filed the suit. “This disease has caused Ms. Carolus to suffer this condition and has caused permanent effects affecting her throughout her lifetime and could lead to death," said Burg. Ms. Carolus is now wheelchair bound with limited use of her legs, several fingers and elbows. She was forced to leave her employment as a nurse as a result of these injuries. Burg Simpson is currently involved in the representation of more than 20 individuals with Nephrogenic Systemic Fibrosis (NSF).

The suit also notes that in 2006 the FDA issued Public Health Advisory alerts about the development of serious, sometimes fatal, NSF/NFD following patient exposure to several contrast agents, including Omniscan(TM). The suit claims that GE was aware or should have been aware of the risks of Omniscan(TM) and that “during the years that the defendants have manufactured, marketed and sold Omniscan(TM), there have been numerous reports, studies, assessments, papers and other clinical data describing or demonstrating NSF/NFD in connection with the use of gadodiamide contrast agents, including Omniscan(TM). Despite this, defendants have repeatedly failed to take prompt, reasonable, and effective measures to alert the appropriate members of the health care community and its patients, including but not limited to, renal patients, nephrologists and other physicians, radiologists, administrations, technicians, and hospital/radiology supply personnel, to the serious adverse health risks presented by Omniscan(TM) (gadodiamide) administration.” The suit claims that in the course of being evaluated for a renal transplant at Poudre Valley Hospital in Fort Collins, Colorado, Carolus was given Omniscan(TM) in preparation for a magnetic resonance angiogram (MRA). She was formally diagnosed with NSF/NFD in November 2005. “Neither Greta Carolus nor her prescribing physician, nor the performing radiologists or technicians were warned or cautioned by defendants about the serious health risks presented by the administration of Omniscan(TM),” states the suit.

The relationship between gadodiamide contrast agents and NSF has been made public recently. In its Public Health Advisory last December, the FDA said it was notifying health care providers that patients with moderate to end-stage kidney disease that receive an MRI with a gadodiamide contrast agent may get NSF. The Clinical Journal of the American Society of Nephrology reported in its February issue that NSF is a fibrosing disorder that involves predominantly the skin but also affects systemic organs, such as the liver, heart, lungs, diaphragm, and skeletal muscles. The CDC concluded in its late February Morbidity and Mortality Weekly Report that it has also been investigating illnesses related to metallic dyes containing gadodiamide used in MRI scans concluding that when possible, use of gadodiamide contrast agents should be avoided in patients with advanced renal failure, particularly in patients who are undergoing peritoneal dialysis. The American College of Radiology, in a Guidance Document for Safe Practices, recently recommended that gadodiamide contrast agents not be administered to patients with advanced kidney disease unless the benefits clearly outweigh the risks. Even more strongly, the European Agency for the Evaluation of Medicinal Products issued a recent advisory against the use of Omniscan(TM) and one other gadodiamide contrast agent for patients with severe renal disease.


Crash Test Study

According to a new study released, about 60% of car models in a recent crash test did not adequately protect your head and neck in simulated accidents. Most people probably don't consider a car's headrest as part of its safety features. According to The Insurance Institute for Highway Safety, it's the one you're most likely to use in a crash. “Neck injury is the most common type of injury in automobile crashes. There are about two million insurance claims for neck injury each year, and they cost at least eight and a half billion dollars,” says Russ Rader says Insurance Institute for Highway Safety. The institute recently tested 75 vehicles for head and neck protection in a simulation of a rear-end crash at 20 miles per hour. 22 of the vehicles got 'good' or 'acceptable' ratings. 53 others received ratings of 'marginal' or 'poor'. "They may have a head restraint that is good or acceptable when we measure it, but if it doesn't have a seat that works along with that head restraint to keep your head and body moving together, it's not going to earn a good rating," says Rader.

The institute also says it tests headrests at the height most motorists select, not at the best height for neck protection. That means motorists and passengers can help improve their own odds in the case of a rear end collision. The institute and automakers say a headrest should reach at least as high as the top of ears, and be placed as close to the back of the head as possible. Spokespersons for some auto makers say the tests also don't take into consideration the vehicles' other safety measures such as its structure, rear bumpers or crumple zones.


Therapeutic Riding of Tucson, TROT

A new program at Therapeutic Riding of Tucson, or TROT, provides therapeutic equine programs to people with special needs, like those with Down Syndrome, Traumatic Brain Injury and Autism. Organizers say improvements in balance, strength and coordination result in increased mobility, independence and overall function.

In September 2006, TROT teamed up with the Southern Arizona VA Health Care System, creating a new therapy program for disabled military veterans. The goal is to help veterans gain the riding skills and confidence they need to become independent riders. TBI is the most common injury treated at the Polytrauma Network Site of Tucson, which is located at the Southern Arizona VA Health Care System. The Polytrauma Network Program started in June of 2005. There are now 21 Polytrauma Network Sites in the U.S., allowing veterans with multiple injuries to be treated closer to their homes. Kent Wilson, Ph.D, the co-director of the Polytrauma Network Site of Tucson says the VA is involved in a new initiative to do TBI screenings on all troops who return from Iraq and Afghanistan.


May 11, 2007

House kills proposal to raise barriers to suits claiming medical malpractice

A bill that would have made it harder for patients to sue for medical malpractice was killed in the House on Monday, May 7th. It's part of a continued effort by lawmakers to raise the legal barriers to sue doctors and hospital personnel. An identical bill passed the Legislature last year, only to be vetoed by Gov. Janet Napolitano. The legislation would have required "clear and convincing" evidence that a doctor or other medical personnel performed work poorly. The current standard is the "preponderance of evidence," an easier legal threshold. It would have pertained to staffers in emergency rooms and on-call doctors. However, it would not have stopped people from suing if they felt they had been wronged, argued Rep. Bob Stump, R-Peoria, who also is chairman of the House Health Committee.

Proponents have argued that frivolous lawsuits have scared doctors away from Arizona and raised medical-malpractice-insurance rates. Opponents, such as House Minority Leader Phil Lopes, D-Tucson, have argued that the bill would curtail people's constitutional rights to sue. Stump's arguments failed to win enough votes, with the measure failing on a 29-27 vote. Stump then changed his voted to a "no" so he could bring the bill back up for reconsideration. The measure passed the Senate on a 16-12 vote in January.


Study Finds Discrepancy between Practice and Attitudes Toward Medical Errors

There is a gap between physicians' attitudes and their real-world experiences admitting medical errors to patients, according to a University of Iowa study. From a survey of faculty physicians, resident physicians and medical students, researchers found that while nearly all respondents indicated that they would disclose a hypothetical error, less than half reported having disclosed an actual minor or major medical error. The survey results are published in the online version of the Journal of General Internal Medicine. The study's lead author Lauris Kaldjian, M.D., Ph.D., associate professor of internal medicine in the UI Roy J. and Lucille A. Carver College of Medicine and director of the college's Program in Biomedical Ethics and Medical Humanities and his colleagues received survey responses from 538 people from academic medical centers in the Midwest, Mid-Atlantic and Northeast regions of the United States. Survey questions focused on respondents' attitudes toward disclosing medical errors; whether they would disclose an error from a hypothetical medical situation; and whether they had ever disclosed a real-life medical error.

Ninety-seven percent of the faculty and resident physicians indicated that they would disclose the hypothetical medical error that resulted in minor medical harm (resulting in prolonged treatment or discomfort) to a patient, and 93 percent responded that they would disclose the error if it caused major harm (disability or death) to a patient. However, only 41 percent of faculty and resident physicians reported actually having disclosed a minor medical error, and only 5 percent responded as having disclosed a major error. Additionally, 19 percent acknowledged having made a minor medical error and not disclosing it; 4 percent indicated having made and not disclosing a major error. Taken at face value, the responses would imply that more than half of the physicians surveyed have never made a medical error in their careers. This is striking, Kaldjian noted. "It seems fair to assume that all of us have made at least a minor error, if not a major error, sometime in our careers," he said.

Fear of malpractice has been cited as a reason why doctors do not disclose medical errors, but the study authors report that their survey found that physicians who had been exposed to malpractice litigation were not less inclined to disclose errors. The researchers also found differences among the survey respondents based on training level. Physicians with more experience were more willing to disclose medical errors, suggesting that with increased clinical competence and confidence, doctors become more comfortable with error disclosure, according to the study. Kaldjian also noted preliminary survey data showing that physicians who indicated that forgiveness is an important part of their spiritual and religious belief systems were more likely to disclose medical errors to their patients. "This is not to say that forgiveness should be a course in medical school," Kaldjian said," but it does suggest that medical schools should consider ways to encourage trainees to draw upon the deeper personal beliefs they bring to the practice of medicine that may be relevant to the challenges of disclosing medical errors."


Patients win right to know in Ontario

For the first time, Ontario patients will be able to easily discover if a doctor has been found guilty of medical malpractice, has a criminal conviction and why or what limits have been put on a physician's license. Public light will be shone not only on the records of doctors, but those of all regulated health professionals, from nurses to dentists to acupuncturists. All will now be required to report findings against them to their respective professional colleges. And those colleges must release the information to the public. As well, findings against medical professionals will no longer be wiped clean after six years. These changes are all amendments to legislation moving through the Ontario Legislature to improve hospital safety. In addition, all Ontario hospitals will be required to report safety information such as medical errors to the province, which will make it public on websites. These changes to existing provincial legislation will ensure that the public will have a right to know.

This is all part of improving quality of care, said Health Minister George Smitherman. "If you measure things, you hold yourself to a test," the minister told the Star yesterday. "This is, accordingly, a big step forward. But it's not just about me saying this and you recording it in your newspaper. It is a really complicated and challenging step. We'll have to work really hard with a lot of different players to make it work well." Those partners are the Ontario Hospital Association, the Ontario Medical Association and all the regulated colleges such as the College of Physicians and Surgeons of Ontario.

"We've had several discussions with government over the last several weeks," said Patrick Nelson, a spokesperson for the OMA, the professional group representing 24,000 doctors. Nelson said it was important to the OMA that health professionals maintain their right to a fair hearing. They believe doctors' rights would be denied if complaints were publicly posted without due process. "We needed to make sure that action only be taken on transparency if a health professional has been found guilty of misconduct. It's not fair to take action before a hearing or finding." The changes do not go as far as releasing complication rates of individual doctors or surgeons.


Maker of Oxycontin Pleads Guilty, Agrees to Pay $600 Million in Fines

Purdue Pharma, the company that markets OxyContin, pleaded guilty in a Virginia Federal Court today, admitting that they misled regulators, doctors and patients about the drug's risk of addiction and its potential to be abused. Three executives of the company, including its president and top lawyer, also pleaded guilty as individuals to charges of misbranding. The three agreed to pay fines totalling $34.5 million. "Misbranding" means to mislabel a drug, fraudulently promote it, or market it for an unapproved use.

Purdue Pharma has marketed OxyContin, a powerful long-acting narcotic, as posing a lower risk of abuse and addiction than other painkillers because of its time-release formula. Purdue marketed the drug aggressively, and sales of the drug reached $2.8 billion between 1995 and 2001. Purdue's sales reps promoted the drug to general practitioners who had little training in the treatment of serious pain, and just as little training in recognizing the signs of drug abuse.

Experienced drug users and teenagers soon discovered that chewing an OxyContin tablet, or crushing one and then snorting or injecting the powder produced a "high" as powerful as heroin. By 2000, addiction to OxyContin and related crime skyrocketed in many parts of the U.S.

Purdue Pharma and its executives acknowledged in court that the company had fraudulently marketed OxyContin for six years as a drug that was less prone to abuse and had fewer narcotic side effects. Company documents show that company officials recognized, even before the drug was marketed, that doctors would be very concerned about prescribing a high-powered narcotic which was likely to be abused or cause addiction. So they developed a fraudulent marketing campaign claiming that OxyContin was less prone to those problems. Federal officials said that, among other things, company sales representatives were allowed to draw their own fake scientific charts that they distributed to doctors to support misleading claims.

Some of the $600 million paid by the company will be used to settle civil lawsuits, and some will go to federal and state agencies.


May 10, 2007

Texans traveling to Mexico to receive cheaper medical care

More Texans are traveling to Mexico for medical care and by crossing the border, patients can cut their costs by more than half. A Harvard-trained cardiologist, state-of-the-art equipment and modern facility are things found not in a hospital in the United States, but one in Monterey, Mexico. "We follow, pretty much, American medicine," surgeon Dr. Hector Calvo Saenz said. Brian Woods, a North Texan, crossed the border for Lasik eye surgery. "I think we're seeing a trend now that regardless of what side of the border you're on, you're going to get equivalent treatment," he said. "It was cost effective enough just to go down there and pay it on a credit card." The price was $1,200. In Texas, it would cost nearly $4,000. He had the procedure in Monterey, where medical care is about one-third the cost of U.S. care. Experts advise Americans to keep in mind that malpractice laws are not the same in foreign counties.

Patients are going not just for elective surgery, but for life-saving treatments. For example, the heart imaging equipment at the Monterrey hospital is the best in the world. Experts estimate at least 150,000 Americans travel abroad every year for lower cost medical care. Mexico is among the top destinations for medical tourism. Location is a plus. The Christus Muguerza Hospital in Monterey is just a 90-minute drive from the Texas border. Now, patients pay out-of-pocket, but that could change. "U.S. companies will be able to receive claims and to pay these hospitals," said Alejandro Paez Aragon, with Nuevo Leon Economical Development. Hospitals in Monterey are expected to qualify soon for international certification, so Americans can use their insurance in Mexico. It's part of a strategy to attract more medical care business. "We think that that area could eventually also become an area for retirees that could come from the U.S.," Aragon said. Plans are in the works to develop a colonial town just outside Monterey. It's just a 15-minute drive from the new medical center, meaning more aging Americans may decide to pair retirement with nearby, lower-cost healthcare.


Restaurant Pulls Hamburgers after Injury

Cracker Barrel and a hamburger supplier were investigated after a patron in South Carolina reported cutting her mouth on a piece of metal embedded in a patty, causing the chain to pull burgers from hundreds of restaurants. The chain has not confirmed what the object was, but they have removed burgers from more than 300 restaurants that were produced on or around the same date as those served in the Myrtle Beach restaurant where the woman was cut, said Julie Davis, spokeswoman for the Lebanon, Tenn.-based restaurants. "We are putting out a wide net," Davis said Tuesday. "We are taking this very seriously." The burgers which are delivered to the restaurants frozen and pre-formed came from Cargill Meat Solutions of Wichita, Kan., which is the chain's largest burger supplier, Davis said. "We're working to gather the information needed to come to a solid conclusion in this matter," said Mark Klein, a spokesman for Cargill's meat businesses. "No one should be jumping to conclusions until the investigation is concluded."

Myrtle Beach police said Irene Grann, 56, was taken to a hospital Saturday night after she began bleeding from her mouth. She complained that something was stuck in her throat after eating part of a burger, police said. The restaurant manager collected a half-eaten hamburger from Grann's table and told police he took a piece of a razor blade from the middle of the patty, according to a police report. An investigator later found "another piece of razor blade barely visible inside the meat," the report said. Grann did not need stitches and was awaiting word on whether she needed more medical testing, said her husband, Mark Grann.


Vermont Hosts Legal Clinics for Returning Vets with Traumatic Brain Injuries

With the increasing number of service members returning from Iraq and Afghanistan suffering from TBI, the rest of the States in the Union should take notice of steps taken in Vermont to assist such victims. U.S. service members, including Vermont soldiers, are coming home in record numbers with mild to severe cases of TBI, many of which go undiagnosed but will require a lifetime of medical care and other support services. In recognition of this growing problem, Vermont Protection and Advocacy, a federally funded nonprofit agency, is sponsoring four legal clinics around the state to help brain-injured veterans, their families and caregivers better understand their legal rights and entitlements as TBI survivors, from Social Security benefits to Medicaid and Medicaid claims, to their legal protections under the Americans with Disabilities Act. The clinics will provide free legal advice and referral services with help from the Disability Law Project and the Brain Injury Association of Vermont.


Two injured in skydiving accident

Two men were critically injured in a skydiving accident near the Taft Airport in Taft California. The skydiving instructor and a student were making a tandem jump when their main chute failed to operate and they were apparently unable to deploy their reserve chute fully. Both men were reported in stable condition and expected to recover. Dave Chrouch, owner of Skydive Taft, said the two men were instructor Dave Wessels, 23, of Clovis, and a student whose first name is Alex, who lives in Southern California. Both suffered major head trauma and other injuries. Both were still unconscious in the intensive care unit at Kern Medical Center Monday morning Apr 30th. Wessels suffered a severely broken leg and the student suffered a broken pelvis. Both have concussions, but CAT scans showed no bleeding or other major trauma to their brains.

Witnesses said the main chute didn't operate correctly and it was cut away. It fell to the ground about 150 yards south of where the skydivers landed. The second chute also failed to deploy properly. Chrouch said they are still unsure what happened. He said the men jumped from a plane at 12,000 to 13,000 feet, and then developed a problem with the main chute on the way down. "Apparently they had a broken line on the main canopy. The reserve didn't open properly. It was about three-quarters open and hanging up," Chrouch said. He estimated the main chute was opened around 5,000 feet and that Wessels cut it away and opened the reserve around 3,000 feet. The reserve also failed to deploy properly. Chrouch said Wessels was a very experienced tandem jumper. Problems with the main chute force skydivers to cut it away and open their reserve chute on rare occasions, but Chrouch said it is extremely unusual to have problems with both chutes. The men were traveling 20 to 30 miles per hour when they hit the ground, just missing a tree and power lines.


May 08, 2007

Product Used In MRIs Under Investigation

In the last eight months O'hara Wells has bound to a wheelchair while his body is slowly shutting down. He was diagnosed with NSF, or Nephrogenic Systemic Fibrosis. "It (NSF) was actually caused by the medical care he received.," says Bob Spohrer, Wells' attorney. Spohrer says the harm came from a product that can be used in an MRI. It is a contrasting agent called Omniscan, which is made of metal and manufactured by GE Healthcare. The agent helps doctors see the result of an MRI better. Wells says he was given the dangerous product in August 2006, when he had two MRIs done at the Mayo Clinic in Jacksonville. The diabetic says he was being treated at Mayo for kidney problems and was on dialysis. Wells says days after the MRIs were done, the changes started. "My hands starting drawing up, my legs starting drawing up and everything was getting real hard," says Wells.

GE Healthcare sent out an advisory to healthcare professionals two months before Wells had his MRI's done at Mayo. The letter alerted doctors to a number of patients with kidney problems being diagnosed with NSF after being given Omniscan. The FDA also sent out a warning. Six months later, GE Healthcare sent out another advisory alerting that new case reports strengthened the association between Omniscan and NSF.

"We believe they (GE Healthcare) have inadequately warned the medical community about this life-threatening problem," says Spohrer. Wells says he asked his doctors at Mayo about how this could happen. "I said why give it to me in August if they were told not to use it. He (the doctor) said somebody made a mistake," says Wells. Spohrer believes thousands could be affected. Right now, more than 19,000 people in Florida and Southeastern Georgia are on kidney dialysis. "If they (Mayo) were unaware of this problem, then how many other facilities around the country are unaware of this problem?" It's a problem with no treatment and no cure. Wells says he has been given a death sentence. "I was angry but I've gotten to the point now I've accepted it because I can't do anything about it...only make sure other people are not put in that position." Wells, who was once on a kidney transplant list, has been taken off because of NSF. Right now, Spohrer Wilner says it is handling two cases involving Omniscan and NSF. Spohrer says it has just filed a lawsuit in federal court against GE Healthcare for negligence. Spohrer says it is likely it will also file a lawsuit against the Mayo Clinic.


FDA Investigates Eli Lilly Over Zyprexa Documents

The Food and Drug Administration has opened an inquiry to determine if Eli Lilly submitted biased or incomplete data for its once-popular antipsychotic, Zyprexa. In recent years, Zyprexa has been linked to rapid weight gain and diabetes.

Specifically, the FDA is inquiring about an Eli Lilly document from 2000 which shows that patients taking Zyprexa in a clinical trial were 3.5 times more likely to develop high blood sugar than patients in the control arm. That document was never submitted to the FDA. Instead, a document was submitted months later which showed no difference in blood sugar levels between those taking Zyprexa and those in the control arm.

A spokesman for Eli Lilly said that the FDA had been provided with all the data and that the company is "working very closely with the FDA" on this issue. Another company document said that the earlier, undelivered, report was checked for errors, and that the later report was accurate.

Eli Lilly earns about $4 billion per year from Zyprexa sales, though demand for it is down in the United States due to concerns about the drug's tendency to cause weight gain.


Ohio high court hears challenge to injury award caps

In an Ortho Evra Case pending in Ohio a woman’s lawyer is accusing Ohio lawmakers of siding with corporations over injured consumers. This case marks the first time that the justices have directly taken up caps on damages since its divisive 4-3 ruling in 1999 that they were unconstitutional. "The state of Ohio and the legislature have prejudged Miss Melisa Arbino's case," said attorney Janet Abaray. "They've passed a statute that states that, without considering Miss Arbino as an individual, without considering what happened to her, and considering any evidence, her damages for pain and suffering are to be capped arbitrarily based upon a number selected by the legislature." To uphold the caps, she said, would reverse case precedent dating back to the 1800s.

U.S. District Court Judge David Katz in Toledo asked the state Supreme Court to determine whether the latest caps passed in 2004 are constitutional because the answer could affect lawsuits affecting dozens of plaintiffs pending in his court over Johnson & Johnson's Ortho Evra birth-control patch. The law does not limit damages in catastrophic cases, such as those involving paralysis or loss of limb. Nor does it limit damages for lost wages, medical costs, and other measurable out-of-pocket damages in less serious cases. The law, however, does cap harder-to-quantify non-economic damages for such things as pain, suffering, and mental anguish at $500,000 per injury, $350,000 of which could go directly to the injured person. The law also limits punitive damages to twice the amount of economic damages awarded in the case. "Doesn't that one-size-fits-all fly in the face of due process?" asked Justice Paul Pfeifer, the sole remaining justice who voted with the majority in 1999 to strike down prior caps.

Framed as an economic development issue, lawmakers had argued that damage limits add predictability to Ohio's litigation climate and prohibit juries from using non-economic damages to punish defendants. "Is $250,000, up to $350,000, and no cap at all if the cause involves a catastrophic injury, a meaningful remedy?" asked Irene C. Keyse-Walker, attorney for Johnson & Johnson. "We would suggest that it is." Chief Justice Thomas Moyer, who dissented in the 1999 decision, noted that limits have been placed on a plaintiff's "inviolate" right to trial by jury. To have no limits, he said, would be "uncontrollable." "The General Assembly made a policy decision that says, sure, you can have a right to jury, but we're going to place certain limits on that right," he said.


Court: Med-tech student cannot be sued

An emergency medical student cannot be sued for tearing a patient's esophagus during a botched procedure, the Indiana Supreme Court ruled. The ruling Wednesday, however, clears the way for W. Ruth Mullins to sue two doctors involved in the operation and their practices. Mullins sued after a student in the University of Saint Francis' emergency medical technician program, LaRea VanHoey, tore Mullins' esophagus trying to insert a tube into her throat to keep her airways open during surgery in 2000. That damage required a second surgery, and Mullins had to spend more than a month in the hospital recovering. Weeks before the procedure, Mullins' surgeon, Dr. Marvin E. Eastlund, provided her with an informed-consent document stating she did not want health-care students in the operating room. Mullins also signed a document from Dr. Kathryn Carboneau, the anesthesiologist, that said only Carboneau or "a physician privileged to practice" anesthesia care would perform certain duties.

A trial court judge granted summary judgment for all the defendants in the case, ending the lawsuit without a trial. But the Indiana Court of Appeals ruled in 2005 that the case could go forward against the student, doctors and their employers. Wednesday's ruling granted summary judgment to VanHoey, saying there was no evidence she intended to harm Mullins, a requirement to prove battery. Mullins' attorney, Sherrill Colvin, said he is satisfied with the court's ruling and is ready to move forward with the case, including a possible trial. Eastlund, Carboneau and their private practices still must defend the lawsuit. The state cap on medical malpractice awards is $1.25 million.


Conference aims to aid in awareness of traumatic brain injury

When Donalyn Sjostrands’s husband Homer Jones was struck by a hit-and-run driver while riding a bicycle seven years ago, the only physical injury he sustained was a broken finger and a cracked helmet. Six months after the incident, Sjostrand said her husband found an explanation for symptoms he was still experiencing; he had a traumatic brain injury. “We were informed by our attorney that 90 percent of couples divorce within five months of a spouse getting TBI, and it has been seven years and we are still going strong,” Sjostrand said. “I quickly realized that my love for him was conditional, but over time, I was able to develop unconditional love for him. It hasn’t been easy, but we are actually closer now than we were before.” She said her husband, who had previously been diagnosed with a slight concussion, went to the Making Headway Center for Brain Injury and Recovery for help with his TBI, and the organization was so helpful that Sjostrand joined the board of directors.

CBIR held an annual conference “TBI Changes Everything” at the Red Lion Hotel Friday May 4th, bringing more than 150 nurses, doctors, patients and family member from throughout the state and Oregon to learn more about the condition. Jeffrey Smoller, director of community development with CBIR, said the primary purpose of the conference is to spread understanding of TBI. He said so many people sustain internal brain damage who have no physical signs of injury. “If you were to take all the cases of spinal cord injuries, multiple sclerosis, AIDS, breast cancer and heart attacks, then multiply the sum by six, you would still not equal the amount of mild to severe traumatic brain injuries that occur each year,” Smoller said. “It affects everyone, in all demographics, all socioeconomic levels. It is a much bigger problem than recognized, and people do not talk about it.” Dr. Harriet Zeiner, PhD. said many with TBI are demoted or fired from their jobs, divorce from their spouses or have problems with the law because of substance abuse, self-medication or anger outbursts. Although TBI cannot be “cured,” Zeiner said, recognizing TBI is the first step to coping and compromising a new lifestyle that can preserve relationships. Sjostrand said the techniques she and her husband have learned with CBIR have significantly helped the two manage, and said the biggest help has been communication. “I feel so alone, he feels so alone and we feel so isolated because no one knows what we are dealing with,” Sjostrand said. “He is tall and handsome, and you can look at him and not be able to tell anything is wrong. It is so wonderful to be able to talk to people who know what is going on, who know what we are going through.”


Boxer sues after suffering brain injuries in 2001 fight

The state of Kentucky has agreed to pay $1.2 million to former heavyweight fighter Greg Page to settle allegations that it allowed an unsafe fight in 2001 at which he suffered catastrophic brain injuries. The settlement signed this week also calls for boxing regulations enacted last year to be called the "Greg Page Safety Initiative." It says the state will establish a medical panel to advise the Kentucky Boxing and Wrestling Authority and to review the conditions of boxers who might be at risk of injury. The state admitted no liability in the settlement, which will be paid by the state from its general fund on behalf of those who were members of the Kentucky Athletic Commission at the time of the fight. The state settled to avoid the cost of litigation.

Patricia Page, the boxer's wife and guardian, said the settlement provides "a paltry sum, considering what he's lost." But she said the money will allow them to buy a handicap-equipped van and other things to make her husband more comfortable. Patricia Page, a customer relations agent for the Metropolitan Sewer District, said she and her husband live from paycheck to paycheck. She said her husband is excited about the proposed safety changes and that the amendments to Kentucky's boxing rules will bear his name. "He feels like he's a martyr for a cause," she said.

Page, a former World Boxing Association heavyweight champion, slipped into a coma after the 2001 fight in Erlanger, then suffered a stroke during surgery. He was left paralyzed on his left side and requiring use of a wheelchair. He was hospitalized twice last year and must be fed through a feeding tube, his wife said. The suit filed by Page in 2002 alleged that the members of the Athletic Commission failed to meet their duty under the law to provide an ambulance or medical personnel with appropriate resuscitation equipment and failed to have a physician continuously present on site. The complaint also said the state failed to provide health insurance to cover Page for fight injuries.


Six people suffer injuries in train derailment

A train carrying solid jet propulsion fuel used in the space shuttle derailed early last week injuring six people. The derailment occurred when a trestle bridge over a swampy area collapsed. The Alabama Emergency Management Agency said the four derailed train cars landed on their side on the ground in the woods next to the tracks, none of the cargo spilled, and there appeared to be no fire. Twelve rail cars remained upright because the trestle sank evenly to the ground. The Marengo County Emergency Management Agency coordinated the rescue of six passengers aboard the train. EMA officials said five of the six received only minor injuries mostly consisting of broken bones, cuts and abrasions. Three of the six injured persons were airlifted to hospitals. One was treated and released another was listed in critical condition and the other one as in good condition. The derailment was in a remote stretch of track the Choctaw County line. Marengo County Sheriff’s Deputy Kenneth Collier said he was unaware of any threat posed to the public. “You can’t get any further out in the woods than this,” he said. John Reese, public information officer for the Alabama Highway Patrol, said the derailment took place between 8:30 and 9 a.m. The first 911 call to Marengo County came at approximately 9 a.m.

Eight rocket motors were on the train when it derailed. The rocket motors are used to propel the solid rocket boosters of a space shuttle. Each solid rocket booster uses four rocket motors each. The fuel in the rocket motor, aluminum perchlorate, has the consistency of a rubber eraser and there was no danger of it igniting, according to NASA. NASA spokesman Kyle Herring said the segments were not scheduled for use during the next shuttle flight. It was the second time in less than a week that the train jumped the tracks while carrying the booster segments across the country from the manufacturer, ATK Launch Systems Group of Promontory, Utah, to Cape Canaveral, Fla., Herring said. Last Friday, two axles on one car came off the tracks for unknown reasons about 60 miles west of Salina, Kan., while the train was traveling at less than 20 mph, Herring said. The train was back on the tracks after several hours, the spokesman said. NASA officials said two locomotives, a train car behind them, and one car with a shuttle booster overturned. A spokesman for the manufacturer, Bryce Hallowell, said the train was taking the same route to the Kennedy Space Center that has been used for 30 years or more. The train trip can take more than a week.


Prom season begins with fake accidents

Pennsyvania Conemaugh Township area high school students held a fake car accident with local emergency medical services, police and fire departments to inform students about the consequences of drunken driving. Their prom was approaching and Shannon Hahl with Students Against Destructive Decisions or SADD, wanted them to be aware of the choices they make. SADD is a student organization set up to inform students about the dangers of drug and alcohol abuse. SADD member Jen Mlaker said the program was free for the school and consists of volunteer workers who want to demonstrate the response effort to a vehicle accident. The demonstration included volunteers from Conemaugh Township's emergency medical services, police and fire departments along with nearby firefighters outside the Township. Approximately 600 students gathered around the school parking lot to watch the demonstration as police cars, ambulances and fire trucks arrived at the scene. The student actors were tended to by firefighters and medical workers and placed into ambulances. During the response, a helicopter arrived and landed in the field next to the high school. Students watched as medical workers placed one student onto a stretcher and carried him to the helicopter.

After the demonstration, local emergency workers talked to the students about making good decisions and about the dangers of drunken driving. Emergency medical worker Russ Miller said he thinks this is a great way to inform students of the dangers of driving under the influence of alcohol. The demonstration shows how the departments work together at the scene of a drunken driving accident and how medical services respond to the injured victims, said emergency medical service worker Terry Ruparcic. “I think it's the only way to relate to them to truly show what it takes at a tragedy like this,” Ruparcic said.


Soldier Injured In Iraq Receives New Home Thanks To Anonymous Donor

In Pennsylvania thanks to an anonymous donor, an organization is building a new handicap-accessible home for a soldier who was badly injured in Iraq. The company, Homes for Troops, offers soldiers such as James Fair new hope to recover with dignity. Three years ago, Fair suffered catastrophic injuries Iraq. In 2003, he was within range of a bomb that devastated his body. He lost both hands and was blinded. Shrapnel is littered throughout his body, too. An anonymous donor paid at least $100,000 for the land and construction of Fair's new home. The anonymous donor sent a letter that was read to Fair, saying, "Dear James, all of your fellow Americans cannot thank you enough for what you have done for your country. The words thank you do not in any way come close in expressing out deepest feelings and admiration for you." "It's a little overwhelming," said Fair. "It's hard for me. I'm very thankful for it." The home will be uniquely adapted to Fair's needs, including voice-activated commands for his navigation. And for meticulous needs, Fair will have the assistance of foot-controlled devices to take the place of the hands he no longer has

The donor of the land wants to remain anonymous and chose not to come forward so that his presence does not upstage Fair's enormous sacrifice.


Product Used In MRIs Under Investigation

http://www.burgsimpson.com/nsf.htmlIn the last eight months O'hara Wells has bound to a wheelchair while his body is slowly shutting down. He was diagnosed with NSF, or Nephrogenic Systemic Fibrosis. "It (NSF) was actually caused by the medical care he received.," says Bob Spohrer, Wells' attorney. Spohrer says the harm came from a product that can be used in an MRI. It is a contrasting agent called Omniscan, which is made of metal and manufactured by GE Healthcare. The agent helps doctors see the result of an MRI better. Wells says he was given the dangerous product in August 2006, when he had two MRIs done at the Mayo Clinic in Jacksonville. The diabetic says he was being treated at Mayo for kidney problems and was on dialysis. Wells says days after the MRIs were done, the changes started. "My hands starting drawing up, my legs starting drawing up and everything was getting real hard," says Wells.

GE Healthcare sent out an advisory to healthcare professionals two months before Wells had his MRI's done at Mayo. The letter alerted doctors to a number of patients with kidney problems being diagnosed with NSF after being given Omniscan. The FDA also sent out a warning. Six months later, GE Healthcare sent out another advisory alerting that new case reports strengthened the association between Omniscan and NSF.

"We believe they (GE Healthcare) have inadequately warned the medical community about this life-threatening problem," says Spohrer. Wells says he asked his doctors at Mayo about how this could happen. "I said why give it to me in August if they were told not to use it. He (the doctor) said somebody made a mistake," says Wells. Spohrer believes thousands could be affected. Right now, more than 19,000 people in Florida and Southeastern Georgia are on kidney dialysis. "If they (Mayo) were unaware of this problem, then how many other facilities around the country are unaware of this problem?" It's a problem with no treatment and no cure. Wells says he has been given a death sentence. "I was angry but I've gotten to the point now I've accepted it because I can't do anything about it...only make sure other people are not put in that position." Wells, who was once on a kidney transplant list, has been taken off because of NSF. Right now, Spohrer Wilner says it is handling two cases involving Omniscan and NSF. Spohrer says it has just filed a lawsuit in federal court against GE Healthcare for negligence. Spohrer says it is likely it will also file a lawsuit against the Mayo Clinic.


May 07, 2007

Study Reveals Innovative Technique that May Help TBI and Stroke Victims

Among the many effects traumatic brain injury (TBI) and stroke may have on the brain, the gaps and severed nerves left by brain trauma are the most severe. Gaps and severed nerves in traumatized brain tissue can result in loss of hearing, sight, muscle control, and other vital bodily function

A Massachusetts Institute of Technology research team, headed by neuroscientist Rutledge Ellis-Behnke, has discovered an innovative way to use microscopic nano-fibers. The researchers have found a way to used the nano-fibers to help nerves grow over brain gaps to reconnect with areas of the brain affected by the gaps.

Microscopic nano-fibers are made of short strings of proteins that can self-assemble under special conditions. Ellis-Behnke and his colleagues have taken advantage of nano-fibers' unique feature to restored sight in hamsters with simulated TBI and stroke symptoms. The scientists coated severed optical nerve tracts with a liquid containing microscopic particles that self-assembled into a nano-fiber lattice structure. The lattice structure gave the severed optic nerves a foundation to regenerate and reconnect. In nearly all of the animals tested, vision was found to be restored.

"It almost looks like it’s re-knitted itself back together, almost like you would darn socks or fix a sweater," said Ellis-Behnke of the results.

Ellis-Rehnke's team hopes that the same technology can be used in the near future to improve the lives of TBI and stroke victims.


Show Focused on TBI's To Air on NPR

ABC newsman Bob Woodruff will be featured on a 2-hour radio program on NPR. Tomorrow, May 8, 2007, at 2 PM Eastern Standard time, NPR's Talk of the Nation will air live from the National Naval Medical Center in Bethesda, MD. The show will focus on Woodruff's struggles with his traumatic brain injury (TBI) recovery, current TBI patients at Bethesda, and their families.

On January 29, 2006 Woodruff sustained a TBI while traveling outside of Baghdad. The vehicle he was in was hit by an improvised explosive device and the explosion seriously injured Woodruff and his cameraman. Both men were treated for TBI's at the U.S. Air Force Hospital of south of Balad. After returning to the U.S., Woodruff was treated at Bethesda for several weeks.

Woodruff's road to recovery was a long and difficult one and he still has problems remembering words and small details. Since his recovery, Woodruff has made it his mission to raise awareness of TBI's. His documentary "To Iraq and Back: Bob Woodruff Reports" focuses on the consequences of TBI's and the troubles faced by returning Iraq and Afghanistan vets with TBI's.

Other guests on the program include several National Naval Medical Center staff members who will help explain the importance of treating TBI victims quickly and the recovery process involved.


Show Focused on TBI's To Air on NPR

ABC newsman Bob Woodruff will be featured on a 2-hour radio program on NPR. Tomorrow, May 8, 2007, at 2 PM Eastern Standard time, NPR's Talk of the Nation will air live from the National Naval Medical Center in Bethesda, MD. The show will focus on Woodruff's struggles with his traumatic brain injury (TBI) recovery, current TBI patients at Bethesda, and their families.

On January 29, 2006 Woodruff sustained a TBI while traveling outside of Baghdad. The vehicle he was in was hit by an improvised explosive device and the explosion seriously injured Woodruff and his cameraman. Both men were treated for TBI's at the U.S. Air Force Hospital of south of Balad. After returning to the U.S., Woodruff was treated at Bethesda for several weeks.

Woodruff's road to recovery was a long and difficult one and he still has problems remembering words and small details. Since his recovery, Woodruff has made it his mission to raise awareness of TBI's. His documentary "To Iraq and Back: Bob Woodruff Reports" focuses on the consequences of TBI's and the troubles faced by returning Iraq and Afghanistan vets with TBI's.

Other guests on the program include several National Naval Medical Center staff members who will help explain the importance of treating TBI victims quickly and the recovery process involved.


TBI Victim Graduates College with 4.0 GPA

Nearly thirteen years ago, Pattie Lemen was in a devastating car accident that left her in a childlike state. On July 2, 1994, Patti was in a car with her best friend when the care unexpectedly went out of control. Patti's head was knocked out of the car window onto the pavement as the car flipped and the impact caused a severe traumatic brain injury. The accident's TBI broke her neck and left her unable to read or write. She spend over a year at a transitional rehabilitation center where she watched episodes of Barney to relearn all of her cognitive skills.

During Patti's recovery period she found herself a single mother of 2 children without a sustainable job, and she knew her only salvation would be education. Thirteen years after her car accident, Patti is leading a hectic life. She is finishing the last 19 hours of her bachelor degree, graduating with a 4.0 GPA, working part time at the University of Central Missouri as a research assistant, and is enrolled in 2 master's degree programs - all thanks to Barney videos, Hooked on Phonics, and her own persistence.
Now 40 years old, Pattie is too busy with her hectic schedule to remember the child she became during her recovery period.

“The little sister trying to make those brownies and playing on the ice that day to a 4.0 … it doesn’t seem like those connect,” said Kayce Lemen, Patti's 20 year old daughter who goes to the same college as her mother and has the same major.

“It makes me smile to know what she’s accomplished. It’s been a long way back, and I’m so proud to be in the same classes with her," said Kayce.


New Bill Introduced by Senators to Evaluate New Needs of Returning Vets

The Homecoming Enhancement Research and Oversight (HERO) Act was recently introduced by Senators Barack Obama (D-IL) and Claire McCaskill (D-MO). The new legislation calls for a new comprehensive research study to thoroughly evaluate the physical and mental health of returning vests to readjust the needs of vets returning from Iraq and Afghanistan.

According to the American Psychological Association, 60% of war service members have family responsibilities and over 500,000 children have at least one parent deployed. There is a lack of knowledge of the new needs of returning vets and the HERO Act aims at raising awareness for the new needs. The HERO Act will include: more research on the mental and physical health needs of returning vets and their families; an assessment on gender specific needs and concerns; an assessment of the needs and concerns of minority vets; increased education on how the VA must address new needs; and development of new strategies to address each of the new needs.

Caring for our returning service members is one thing we can still get right about this war, said Senator Obama. We must ensure that we give our service members, veterans and their families receive the treatment, care, and assistance they need to rebuild their lives. The challenges do not diminish for many service members when they return home because the legacy of war takes a physical and emotional toll. As we bring this war to a resolution, its our duty to honor the commitment of these heroes by meeting their long-term needs.


May 04, 2007

Training May Help Brain Injury Victims with Memory Problems

Sherrie Hanna is the program coordinator of an ongoing study at Mayo Clinic in Rochester, Minnesota. The study examines the potential benefits of memory training for people who have memory problems associated with mild cognitive impairment (MCI). Mild cognitive impairment can result from a variety of degenerative brain disorders such as Alzheimer's and the after effects of a traumatic brain injury (TBI).

Hanna's study is not entirely complete but her initial findings have been promising. Memory techniques used in the study are designed to help those with mild cognitive impairment go back to living their everyday lives. Hanna main technique to help her patients is a pocket calender with specific scheduled events kept with the patient at all times. Great success has been found with this type of memory training in individuals who have an MCI. "We're testing it with people who have mild cognitive impairment. While the physical causes of their memory problems are different, the practical outcome is the same. And the system seems to work for both," said Hanna.

Writing things down in a calender may sound like a task too simple to cure memory loss but Hanna wants to prove otherwise. It is well known that writing things down helps it stick in your memory and saying it out loud as you're writing it down can help cement it in your memory. This simple fact has helped Hanna help restore memory functions in several of her patients. "Almost every person in the study has said that it has helped them. That has been very satisfying. Some people are still at it after more than a year. That's really something, to have people change the way they do things and have it stick," said Hanna.

Currently, there is no distinct time-line for the completion of Hanna's study.


Nevada Reviews Doctor Apology Bill

A medical malpractice attorney blamed insurers for a lack of compassion during a hearing Friday on a bill to let doctors apologize to patients for an adverse medical result without having the apology used against them in court later on. The Nevada Trial Lawyers Association and the Nevada State Medical Association are at odds over SB174, called the "I'm sorry" law, but their criticisms of the current system both revolved around insurers' prohibitions against apologies by doctors. SB174, sponsored by Sen. Joseph Heck, R-Henderson, would make statements of apology, regret, or condolence inadmissible in a court case against a doctor. Heck, an emergency room doctor, said similar laws in other states greatly reduced malpractice cases. Hospitals which encouraged apologies saw lawsuits and settlements costs reduced, in some cases by up to 50 percent. Heck said the immunity granted by the bill would reassure insurance companies they can rid their contracts of prohibitions against apologies.

Both groups said apologies could help doctors show compassion toward patients when they need it most and would enable the doctor to help make the person "whole" again. Dr. Keith Brill told the Assembly Judiciary Committee that when doctors don't apologize, patients are more likely to get angry and sue. Bill Bradley, a medical malpractice attorney who spoke for trial lawyers, said insurers and doctors ought to be honest anyway when a patient clearly was wronged and needs compensation. He opposed the bill on grounds it would eliminate evidence of negligence, the doctor's own admission. "There ought to be accountability. If that physician is willing to say, 'I'm accountable, I did this wrong,' then that physician and insurance company ought to be able to say, 'We don't need lawyers involved in this and let's get this person whole again.' I just don't see that happening," Bradley said.

Some lawmakers on the panel were skeptical about how doctors could express an apology without then lying on the stand about their own negligence. Assemblyman William Horne, D-Las Vegas, pushed several times on the issue, asking what a doctor would say if, after giving an apology, he was asked on the stand if he was negligent. Dr. John Martin, president of the Clark County OB/GYN Society, said an effective trial lawyer would be able to provide ample evidence if negligence did occur. "If you said 'no' to taking out the wrong kidney, you'd be an idiot. A good plaintiff's attorney should be able to prove you did it, whether you admit it or not," Martin said.


Ex-BAR/BRI Leader Unhappy with Deal

The National Law Journal reports, the former president of BAR/BRI who initiated a nationwide antitrust lawsuit against the publisher of a bar review course is joining three named plaintiffs in objecting to a recent settlement of the case. Stan Chess, now president of LawTV Inc., which operates Web sites such as www.LawSchool.com, is the fourth objector to a $49 million settlement filed with the courts on Feb. 2. Ryan Rodriguez v. West Publishing Corp., No. 05cv3222 (C.D. Calif.). The settlement resolves a class action against West Publishing, owner of BAR/BRI, and Kaplan Inc., which makes the preparatory coursework for the Law School Aptitude Test (LSAT). The lawsuit claims the two companies conspired to monopolize the law exam market and overcharged law students by $1,000 each. Plaintiffs sought triple an estimated $300 million in damages on behalf of nearly 300,000 law students who took the course from 1997 to 2006. With the settlement, each class member is expected to receive about $125. A federal judge is expected to approve a final settlement on June 18. In court papers filed in March, Chess called the settlement grossly inadequate. "It doesn't accomplish anything," he said, noting that "the amount of money is not consequential to the defendant or the class members. There aren't that many attorneys who will fill out forms for $125." Chess is the latest to object to the settlement. Three named plaintiffs have criticized the monetary relief as too low and the injunctive relief as inadequate, since the original lawsuit sought to break up BAR/BRI

Chess, who worked for BAR/BRI until 1994, told The National Law Journal that he was laid off as chairman and chief executive of West Publishing's West Bar Review in July 1997, about one month before Kaplan signed a letter of intent to buy West Bar Review from The Thomson Corp., parent company of West Publishing. The deal fell through. Chess said he was told by a Kaplan employee afterward that BAR/BRI had struck a deal with Kaplan to stay out of the bar review business. In return, BAR/BRI agreed not to get into the market for LSAT preparation. West Publishing acquired BAR/BRI in 2001.


High Cost of Brain Injuries

If you ride a bike, rollerblade or drive a car, you are at risk of suffering a traumatic brain injury. LaDeane Peterson knows that well. She is the administrator of the Wing House, a traumatic brain injury home in Rochester, MN. Everybody says that it will not happen to them, but there are 100,000 Minnesotans living with traumatic brain injury. Three of them live in the Wing House, where they are re-learning life skills damaged by their brain injuries. “Our goal is to get them to be as independent as possible and functioning at the highest level possible,” Peterson said.

It costs up to $7,000 a month to rehabilitate these people. They, like most people, do not have insurance that covers a brain injury so they rely on what's called a traumatic brain injury waiver, federal and state money that can pay for dramatic recovery, but only for a certain part of our society. "I don't want to say hopefully, if you're going to have a brain injury, you have it before you turn 65,” Peterson said. “But now the way the funding is you really need to have it before you turn 65.” That loophole may have cost Judy Ray her life. Her daughter Patti Waseen said Judy was broadsided by a dump truck and while she survived the crash, which happened when she was 64 years old, doctors didn't diagnose the brain injury until after she turned 65. "You come to the realization your hands are tied, absolutely tied,” Waseen said. “One right after the other, nobody can help you." People who are 65 and older only qualify for an elderly waiver. The family says that meant Judy, a vibrant, active, mom and grandma could not go to a traumatic brain injury home. She only had enough funding to live in a nursing home. " I got a call December 30th after the dinner hour and they said she collapsed to the floor and died,” Waseen said. She died choking on mashed potatoes. Public Health nurse Jo White is angry that Judy Ray was forced into a facility not designed to care for brain injured people. Judy’s family believes she would still be alive if she had the funding to recover in a brain injury home.

Scott Cooper lived at the Wing House after injuring his brain. Not too long ago Cooper could barely put one foot in front of the other. Now he's not only walking, he's getting married. "She knows my shortcomings, the good side of me, the bad side of me and the whole nine yards,” Cooper said. Cooper struggles with short term memory loss but uses a daytimer to cope. He wishes employers would give him a chance the way his fiancee has. The faces of traumatic brain injury are all different, but with the proper funding and therapy they can lead meaningful lives.


Migraine sufferers may have form of brain damage

Scientists in the U.S. are suggesting that people with migraines may also be suffering from some form of brain damage. The scientists have found evidence that migraines may also be acting like tiny transient strokes, leaving parts of the brain starved for oxygen and altering the brain in significant ways. The scientists at the University of Rochester in New York along with a team at the Danish pharmaceutical group Novo Nordisk have found in studies with mice a process called cortical spreading depression (CSD). CSD changes in cells is the same in migraine as in stroke and head trauma. The researchers led by Dr. Maiken Nedergaard, a neuroscientist, found as brain cells swell and become starved of oxygen similar brain damage can occur as with concussions and strokes. They say their finding may help explain why migraine sufferers have a higher risk of stroke. Their findings suggest that migraine sufferers should not simply seek pain relief but should instead take drugs to prevent the migraine, which is often preceded by an "aura", a series of visual disturbances that can include flashes of light or black areas. The research team suggests giving oxygen may help reduce the damage.

By combining two recently developed imaging technologies, Nedergaard's team was able to achieve a look at the process the brain of a mouse experiences as a migraine unfolds. The team discovered a complex chain of supply and demand regarding blood flow and oxygen. They saw a swelling occur and the brain cells became starved of oxygen followed by damage to nerve cells specifically the dendrites, the long, thin spikes that stretch from one nerve cell to another. The researchers say the revelation has clinical implications, as other research has found that cortical spreading depression constitutes the neurological basis of migraine with aura, and spontaneous waves of CSD may contribute to secondary injury in stroke and traumatic brain injury. Nedergaard says the visual disturbances known as auras that many migraine sufferers report that precede the headaches, in at least one out of four migraine sufferers which might involve floating black spots, flashing light, or some other visual changes, might actually be a visual sign that parts of the brain are short of oxygen. As many as 28 million people in the United States are affected by the severe and debilitating migraine.

Women are far more likely to suffer from migraine and as a rule common pain medications have little effect. However a class of drugs called triptans, also called serotonin agonists, and ergotamine drugs, can be used to prevent the worst effects if patients take them at the first sign, for example when an aura first begins. The researchers found that by giving the mice rich doses of oxygen the wave of brain effects seen in CSD appeared to shorten the duration of the wave of brain effects. Apparently migraine and cluster headache patients are sometimes treated with high-pressure oxygen. The researchers say it remains unclear whether the effects of migraine are permanent, and earlier research differs on the issue. The research is published in the current issue of the journal Nature Neuroscience.


The heartbreak of brain break

Rajul Jandial is a neurosurgeon at UC San Diego and scientist at Burnham Institute for Medical Research in La Jolla and he writes his thoughts on TBI. It's tough to turn on the television without seeing Dr. Robert Jarvik, inventor of the artificial heart, talking about his favorite cholesterol drug, Lipitor. More Americans suffer traumatic brain injuries than heart attacks, but the issue is only now capturing our attention, but you'll find nothing advertising a drug that might help people with traumatic brain injury. Yet more Americans suffer a brain injury every year, than suffer heart attacks. Most who suffer a brain injury are young. Given their average lifespan and the nature of their injuries, those young people with brain injuries will require many more years of care than will the elderly or middle aged who suffer heart attacks. So, where's the TBI commercial? More important, where's the TBI drug? Since the biology of brain injury is so poorly understood, there isn't a medication that might serve as motivation for pharmaceutical companies to promote TBI awareness.

Even as military injuries raise awareness about brain injuries, we should remember that it's not just soldiers who are at risk. In domestic life, brain injuries are caused by falls, sports injuries, assaults and most common of all, motor-vehicle crashes. Though seatbelts and airbags have reduced the often lethal concussive injuries once associated with traffic accidents, another type of auto-related injury has emerged, closed-head injury. Pick up an egg and gently shake it. The motion you feel inside is similar to what happens to the head during a sudden car crash. When the skull stops its forward or backward motion, the brain keeps moving, ultimately bouncing against the inside surface of the skull. And, unlike its relatively smooth exterior, the interior of the skull is full of bony prominences and ridges against which soft, vulnerable brain often is damaged.

There is no marketable, miracle drug for TBI. There is, instead, a painstaking effort on the part of many to help the injured get back as much of their mental facilities and intellectual acuity as possible. This effort is hampered by the fact that the brain is the slowest organ to heal; sometimes it doesn't seem to heal at all, and many times it seems to improve just a bit, and only after a very long time. Perhaps it is time to take the long view of public health, for leaders in health care and in politics to reconsider the lack of effort dedicated to the prevention and to the treatment of brain injury. Are heart attacks a problem? Absolutely, and we should take care of the elderly, continue research on things like cancer and heart disease. Also, we should make a commitment to living not only longer, but also better and more fruitfully. As we invest energy and funding into the middle aged and elderly, we also should pay attention to the less publicized illnesses of the young and seemingly invincible.


Woman paralyzed in rear-end crash sues automaker

Donna Grimes is paralyzed from the neck down because the Ford Motor Co. didn't listen to its own engineers about fatal flaws its car seats pose in rear-end crashes, a Palm Beach County jury was told by her attorney James Lowe. Attorneys representing the auto manufacturer in the multimillion-dollar lawsuit say it is untrue. The mother of five is paralyzed because a car slammed into the back of her 2000 Ford Explorer at 60 mph, attorney David Kelly said. "The Explorer seat is not defective," he insisted. "The injuries were caused by the severity of this crash, and Ford did not cause the severity of this crash." The different views of the 2001 wreck are similar to those raised in lawsuits against car manufacturers throughout the nation. Grimes was alone in her Explorer, when a Toyota Solara ran into her vehicle. Her seat flew back, throwing her head-first into the back seat and breaking her neck. Witnesses said they found her seat belt around her calves. The driver of the much smaller Solara, which was heavily damaged in the crash, walked away uninjured. "She should have walked away," said her attorney James Lowe. "Donna didn't walk away because her seat broke."

Ford has known about the problem since the early 1990s, when a public uproar erupted over news reports about the dangers of car seats collapsing in rear-end crashes. A team of Ford engineers reviewed the problem and recommended that changes be made. Their advice was ignored, Lowe said. A key problem is the system that allows front seats to recline, Lowe said. Metal teeth that are designed to keep a seat in a certain position were sheared off when Grimes' Explorer was hit. "Why did the Explorer seat collapse like that? Because Ford ignored the recommendations of its own engineers," he said.

Kelly argued that neither the design of the seat nor that of the recliner system is flawed. Ford has studied the problem. He said, like other manufacturers and federal car safety regulators, it was determined that a seat that moves during a crash is far safer than one that rigidly stays in place. When the seat moves back, it absorbs some of the energy from the crash, he said. "If the seat doesn't absorb the energy, the body will," he said. Crash tests of seats that remain in place show that a person is much more likely to sustain far more severe, possibly fatal, neck injuries than those sitting in seats that recline backward in a crash. "If Mrs. Grimes had been in a more rigid seat it would not have changed the injury result," he said. "In fact, it could have been worse."


May 03, 2007

NFL's TBI Committee Invites Outside Experts to Summit

The NFL's traumatic brain injury (TBI) committee is holding a summit to discuss TBI's effects on NFL players on June 19th. Physicians and athletic trainers from each team have been invited, as well as outside TBI experts. This is the first year that outside experts have been invited to the NFL's brain injury summit.

The NFL committee decided to invite outside experts in an effort to alleviate recent negative criticism. The NFL has been the focus of public scrutiny lately as experts have openly disagreed with their studies' findings. Recent NFL reports released information that suggested that NFL players have little to no risks of permanent brain damage after sustaining a concussion. The committee's commissioner, Roger Goodell, invited outside experts to push for more positive changes in the NFL.

According to a recently NFL survey, 52% of all players who suffered a concussion returned playing in the same game. Outside medical experts hope to get the chance to prove to the NFL that concussions are serious brain injuries and can lead to permanent brain damage.

"It's not a hard sell. That's where medical evidence is right now. That's where the majority of medical opinion is. If they're serious [about player safety], it's not a hard sell," said Michael V. Kaplen, president of the Brain Injury Association of New York.

Goodell also has other plans to improve the NFL's reputation regarding TBI's. The commissioner is considering using required baseline neuropsychological tests to diagnose concussions. Currently all teams us some sort of baseline testing but having a mandated test would make diagnosis more efficient and uniform.


Engine shutdown led to 2005 collision between jets

A Northwest Airlines pilot's decision to shut down the left engine on a DC-9 was a the probable cause for the jet's ground collision with an Airbus A319 in May 2005 at Minneapolis-St. Paul International Airport, according to a federal investigative report. The National Transportation Safety Board (NTSB) took nearly two years to reach that conclusion about the incident, in which the DC-9 crashed into the Airbus at 16 miles per hour near a gate shortly after the DC-9 landed. Not long after the DC-9 left Columbus, Ohio, for the Twin Cities the pilots were aware they had a problem with the right hydraulic system. Hydraulic systems power the landing gear, steering and braking. The left hydraulic system was operating properly. When the captain shut off the left engine after the plane landed in the Twin Cities, the airplane experienced a loss of steering and brakes. A second accident factor cited by the NTSB was the "fatigue fracture of the rudder shutoff valve which resulted in the loss of right-side hydraulic pressure."


The DC-9 and the A319 collided near a gate, and fuel poured into the DC-9 cockpit. The captain sustained serious injuries, and seven airline employees and passengers were treated for minor injuries. There were 94 passengers on the DC-9 and 39 passengers on the Airbus. An Air Line Pilots Association spokesman said Tuesday that the union could not comment on the NTSB report. Northwest spokesman Bill Mellon said Tuesday that Northwest developed an inspection procedure for its fleet relating to the rudder shutoff valve. He declined to comment on other aspects of the NTSB report.


Outside medical experts to join NFL summit on concussions

Medical experts outside the NFL have long disagreed with the findings of the league's concussion committee. Now, some of those experts will get a chance to make their points in person. Commissioner Roger Goodell has summoned physicians and athletic trainers from every team, as well as his concussion committee, to a summit on mild traumatic brain injury June 19 in Chicago. The league also invited a number of concussion experts who have criticized the league's research. In the wake of controversy surrounding the suicide of Andre Waters and the onset of Alzheimer's disease-like symptoms in 34-year-old Ted Johnson, he wants to ensure that players who have suffered from concussions are treated appropriately. Goodell said he is seriously considering mandating baseline neuropsychological tests to aid in the treatment of concussion victims. Computerized baseline tests would be administered at the beginning of a player's career or the start of the season to have a cognitive comparison once a player has suffered a concussion.

According to Dr. Andrew Tucker, the Ravens' team physician, all teams use some form of neuropsychological testing now. He tests the Ravens who play at positions of highest risk - running back, wide receiver, defensive back and quarterback - along with players who had concussion issues in the past. Tucker, a longtime member of the league's concussion committee, said this isn't the first seminar involving NFL medical personnel and outside experts. He said there was a similar meeting in New York in the 1990s when the concussion committee was first getting started.

Michael V. Kaplen, president of the Brain Injury Association of New York state, has been one of the most vocal critics of the NFL concussion committee. He disagrees with the committee's contention that there is no proof of long-term repercussions for a player who has suffered repeated concussions. He also said a player who has suffered a concussion should not return to the same game and should remain sidelined for at least a week. According to an NFL committee study, 52 percent of players who suffered a concussion during a six-year period returned to the same game. Kaplen said he doesn't believe it will be hard to convince the NFL that allowing 52 percent of concussed players to return is the wrong move. He hopes to be invited to Chicago.


Neb. County Sued in Gastric Bypass Surgery Medical Malpractice Case

Douglas County in Nebraska might have to pay a hefty price for an employee's failure to deliver. The county finds itself as the defendant in a medical malpractice lawsuit because the original defendant was never served papers. Eugenia Kudym of Omaha is asking for $450,000 in damages, the amount her attorney said she could have recovered from her physician after she suffered complications from gastric bypass surgery in 2003. A judge last year ruled that a server from the sheriff's department did not properly serve Kudym's physician. Meanwhile, the statute of limitations for malpractice lapsed, eliminating the physician from possibly having to pay damages. For the county to be held liable, Blakeman must prove malpractice occurred and that the county's error cost Kudym the opportunity to seek damages from the physician. "The more difficult side is proving the medical malpractice claim,'' Blakeman said. "The fact the judge has decided (the county) didn't successfully serve the doctor sits in our favor. In essence, it's been determined that the county didn't perform.''

Kudym, 47, underwent gastric bypass surgery in May 2003 at the Nebraska Medical Center. She later suffered complications, including the inability to keep food down. She became malnourished and couldn't walk. Kudym's physician told her that her suffering would pass, but relief didn't come until weeks later when a pharmacist friend recommended an enzyme that offsets complications from gastric bypass. Kudym began feeling better almost immediately after taking the enzyme with her food. “The complications she experienced after the surgery should have been diagnosed and could have been easily dealt with by the doctor and should have been recognized by the doctor,'' Blakeman said. "He, in essence, put her off.''

Blakeman filed a lawsuit in Douglas County against the physician in July 2005, less than two years removed from Kudym's complications, but withheld having papers served until he could get an expert's opinion on whether the malpractice claim would hold up in court. In Nebraska, an attorney has six months to have the defendant served with papers after filing a lawsuit. Blakeman asked that the physician be served in January 2006, just days before the six-month time limit expired. Blakeman said he received notice that the papers were served. "At that point, I'm figuring my client is protected,'' Blakeman said. However, the physician claimed in a court hearing that he was never served. Records showed that the physician was out of his office on the day the server claimed to have given him the papers, and Judge Patricia Lamberty ruled in his favor. By then, it was too late for Blakeman to have the lawsuit served again. Blakeman filed the lawsuit against Douglas County last week. The physician may have to testify in the case against the county. "He has nothing to lose financially,'' Blakeman said, "but he might want to defend his practice.''


Hiker who lost arm while hiking trains for Paralympics

Mike Scholte begins his training for a national cross country ski team 13 years after he was nearly killed while hiking by a falling boulder that severed his left arm and broke his anklebone. With Canada hosting the Olympics in Vancouver in 2010, the country is hoping for a good showing at the Paralympics, which take place immediately following regular Olympic competition. Scholte said he is one of 12 representing Ontario. Although Scholte said he has always been a sports enthusiast and a recreational cross country skier, he has been seriously training as a competitive cross country skier for one year. He often competes with non-disabled athletes and looks forward to training with other disabled athletes.

Scholte was hiking on the Bruce Trail 13 years ago with his wife and two friends. "It was just one of those freak accidents where a piece of the escarpment fell off. It was about the size of a minivan. It was huge," said Scholte. The boulder hit the left side of his body, severing the arm and breaking the anklebone. His wife ran ahead while his friend began carrying Scholte back to the parking lot. Eventually a helicopter was sent in to rescue him. He said although the loss of the arm was the more visible injury, the injury to the foot was in some ways worse. His doctor thought he would never walk again. He was in a wheelchair for many months and it took several more years for what he calls a full sports recovery. Once he achieved that he reintegrated into sport and said he has had to use a lot of creativity to make it work. Scholte skis with one pole and uses his body to compensate. "Disability is in your brain," he said. "So many people limit themselves to what they can and can't do.” Despite it all he said he wouldn't change a thing if he could.


Novavision Presents Vision Restoration Therapy Data at the AAN Annual Meeting

NovaVision presented data at the American Academy of Neurology (AAN) 59th Annual Meeting showing that more than 70% of study participants, stroke and traumatic brain injury (TBI) survivors with visual field defects, demonstrated an improvement of greater than three percent following a standard six-module course of NovaVision VRT™ Vision Restoration Therapy™. NovaVision VRT™ is the first and only FDA-cleared medical device or rehabilitative therapy clinically proven to improve visual field defects in stroke and TBI survivors who have been left partially blind due to their condition. Patients receive a customized program designed for their visual problems to use at home daily. Through a specific pattern of visual stimuli that gauge the user’s ability to identify and react, users can gradually expand their visual fields and restore lost vision. VRT is based on the science of neuroplasticity, the brain’s ability to adapt and form new connections to compensate for injury. The average improvement in stimulus detection was 12 percent. Previous studies suggest that people who regain three percent or more of their visual field have functional improvements that may include enhanced quality of life, better reading, watching television and athletics. Age, type of visual field defect, or the amount time since the injury had no impact on the results.

Data supports that regardless of how much time has elapsed since a stroke or brain injury, therapeutic interventions such as VRT can improve visual field loss. This improvement can result in functional gains that were once believed lost forever. NovaVision diagnostic testing maps areas where vision may be improved, and therapy targets and stimulates regions within the brain’s vision-processing areas. VRT is based on more than 10 years of research with clinical studies published in leading journals including Nature Medicine, Neurology, and The Journal of Cognitive Neuroscience. More than 1,000 patients have been treated with VRT and clinical results are positive.


Louisiana Physicians Sue State for Care Provided To Low-Income and Uninsured After Hurricane Katrina

Nearly 400 Louisiana physicians at a hospital outside of New Orleans on Monday sued the state for $100 million, saying they were never reimbursed for care they provided at no cost to low-income and uninsured patients after Hurricane Katrina. The lawsuit filed by 381 physicians, claims that Louisiana failed to reimburse them for treating indigent patients since the state-funded Charity Hospital in New Orleans closed on Aug. 29, 2005, following Hurricane Katrina. According to the suit, the state has "inappropriately shifted its responsibilities" onto private physicians while "depriving" doctors of compensation. The hospital is not a party in the lawsuit.

Barton Farris, medical director of the Jefferson Parish hospital's laboratory, said the state Department of Health and Hospitals allocated $120 million in 2005 to hospitals that care for low-income and uninsured patients, but no funding went to private practices that provided charity care. Hospital records show that 30% of patients admitted to the West Jefferson emergency department after Katrina were low-income or uninsured. In addition, low-income or uninsured patients seeking care outside the emergency department accounted for 13% of hospital admissions, compared to 5.4% before the hurricane.

Bob Johannessen, a spokesperson for the state health and hospitals department said that there was "no mechanism" to pay physicians for uncompensated care costs. He noted that the state receives federal funds to pay hospitals for charity care, but not doctors. According to Johannessen, the federal government in March 2006 paid hospitals and doctors for uncompensated care provided from Aug. 24, 2005, to Jan. 31, 2006, $8 million of which went to doctors. He added that the state has asked several times for additional federal funds to compensate doctors, but none have been provided.


May 02, 2007

Some Prescribed Drugs Aren’t FDA Approved

Most everyone assumes if a doctor prescribes a drug or it's available through a pharmacy, then it's been approved by the Food and Drug Administration. That statement however, is not true. Hormone replacement therapy is a common treatment for women going through menopause. In the past couple of years studies have found the drugs can have dangerous side effects. One study released last week found women taking the drugs had twice the risk of breast cancer. Even though it's been prescribed to thousands of women, the drug Estratest has never been approved by the FDA. Debbie Burke started experience the signs of menopause so her doctor prescribed her Estratest. It is a widely prescribed combination of synthetic estrogen and testosterone to treat the symptoms of menopause. “The testosterone in it caused my face to break out really bad,” Burke said. “It also made hair grow on the face. I didn't like that, so she cut me off.” Burke took Estratest for five years, but she didn't know the drug had never been approved by the FDA. "I thought every pill, everything, had to be approved by the FDA before it could be put on the shelves," she said. By law, all drugs are required to get FDA approval before they are sold.

Since Estratest has been on the market since 1964, most people assume it's been approved. "I don't know how it got on the market," registered pharmacist (RPh), PhD Marvin Sheperd said. Marv Shepherd is the director of the Center for Pharmacoeconomic Studies at University of Texas School of Pharmacy. He doesn't understand why it's stayed on the market, either. The maker of Estratest applied for approval in 1979, but the FDA turned them down. The company tried again in 1981. Twenty-six years later and there is still no approval. The company doesn't hide the fact. Its literature clearly states, "This product has not obtained FDA pre-market approval."

A federal appeals court in Atlanta said it was baffled and wrote, "It is incomprehensible that Estratest has been allowed on the market without approval for 35 years." They added, "There can be no good excuse for allowing a company to violate the law for 35 years."

Estratest isn't the only unapproved drug on the market. The FDA admits there are several hundreds. In June 2006, the FDA announced it was cracking down, but unapproved drugs like Estratest are still being sold. There are some safety concerns due to new studies on drugs used to treat the symptoms of menopause. The largest study had to be stopped because of safety concerns and last week the New England Journal of Medicine released another study that showed an increased risk of breast cancer among women who took the hormone replacement drugs. These studies are not going unnoticed. Consumer group Public Citizen put Estratest on its list of worst pills because of its link to breast cancer. In August of last year, the National Women's Health Network filed a petition asking the FDA to force the manufacturer to stop selling it. Two public interests groups have filed a class action lawsuit in California against the maker of Estratest.


No-malpractice contracts test boundaries of medicine

If you want to see Ridgewood gynecologist Ruth J. Schulze, you'll have to sign a contract promising never to sue her for malpractice. The veteran physician and a dozen other gynecologists in New Jersey require the contracts as a condition of treatment. Schulze sees it as the only way to control the rising malpractice premiums. However, patient advocates and legal experts are troubled by the idea of asking patients to sacrifice their legal rights and they worry that the practice could spread. By signing, patients agree to forgo their right to a jury trial and agree to binding arbitration. Pain-and-suffering awards are capped at $250,000. Punitive damages are limited. The contract blames patient lawsuits for "ever-escalating" malpractice insurance rates. Other New Jersey physicians are asking patients to sign a contract promising not to sue for malpractice. As a condition of treatment, a patient agrees to binding arbitration rather than a jury or court trial, a practice attorneys and patient advocates strongly discourage.

Patient advocates, however, say these contracts have no place in a doctor-patient relationship. "They're asking patients to sign away their rights preemptively before they've even delivered medical services," said Laura MacCleery of Public Citizen Health Research Group, a Washington, D.C., patient-advocacy organization. "This is outrageous." Gary Saperstein, a Teaneck lawyer and president of the Association of Trial Lawyers of America-New Jersey, doesn't think the contracts will hold up in court. "People are under duress when they're seeking medical care," he said. "I think it's unconscionable that they're trying to conduct business in this form and fashion."


Double Amputee Gears Up for Ironman

It has been a year of firsts for Scott Rigsby of Coeur D’Alene, Idaho. In October 2006, he became the first double amputee to complete a half Ironman on prosthetics. In March, the 38-year-old Georgia native was the first below-the- knee double amputee in the world to complete a marathon. In April, he got his picture in Sports Illustrated for the first time. Now, he has his sights set on becoming the first double amputee to complete a full Ironman on prosthetics anywhere.

In 1986, Rigsby was riding in the back of a pickup truck on a Georgia back road with a landscaping crew. He was 18 and trying to make some cash before going off to college, where he planned to play football at Valdosta State. A semi-truck went to pass the slower moving pickup and as it passed on a tight bridge, the right jack sliced open one of the pickup's tires. "It caused a blowout and we fishtailed into the bridge," Rigsby said. Rigsby had been dragged 328 feet on the pavement and his foot was lodged under the truck. Rigsby said he was "fortunate," because another driver was a former paramedic and, even though they were on a rural back road, there was a nearby house where they could call an ambulance. They were 12 miles from the nearest hospital, he had massive third-degree burns up his back, it was the middle of the summer in Georgia and he was sweating and bleeding on the pavement trapped under a truck. Rigsby spent the next year in and out of hospitals. He lost his right leg the day of the accident, but doctors were able to save his left leg. Twice a day, a nurse would place and then pull off medical strips on his back, which "looked like somebody took a cheese grater to it." "I would clear out the waiting room because I would just scream," Rigsby said. He had 17 surgeries that first year. His left leg was his own, but it was a mess with wounds regularly opening up, he constantly risked infection and it hurt. A doctor told him he would probably be better if they took the left leg off and it was removed in June 1998

"The only thing I knew how to do in January of 2006 was run," Rigsby said. He looked around and talked coach Tony Myers into taking him on to train him for triatholons. Myers' first question for Rigsby, “What have you competed in? Nothing.” That's how we started. "We went outside. He put on his running legs, and he ran around my parking lot and that's all I needed. I thought 'This guy can do this."' Myers said he realized Scott was strong enough so that swimming wouldn't be an issue. The bike portion will always be an issue, he said, since the typical transfer of power happens with the feet. Without telling Coach Myers, Rigsby competed in his first triathlon just months after he began training. In April 2006, after borrowing a friend's bike, in Panama City, Fla. there was a sprint triathlon, which is the shortest-distance triathlon with a 600-meter swim, a 12- mile bike, and a 5K run. "That was it. The next week I did another one and shaved 38 minutes off my time. I ended up doing six (triathlons) in seven weeks. I was working out my issues, man," Rigsby said. "I didn't have enough money to go see a therapist so I'd race every weekend." He stepped it up to Olympic distance triathlons the summer of 2006 and set his first world record in New York City that July by being the first double amputee to finish that distance, which is a 1,500-meter swim, 25-mile bike and 10K run. In March 2007, Rigsby decided to run his first full marathon in Atlanta. No below-the-knee double amputee had ever finished a marathon before. Helping soldiers returning from war to come to terms with a new lifestyle is one of his goals and missions in life.


Fort Carson to Test for Brain Injuries

In Fort Carson Colorado, the Army is faced with thousands of cases of brain injury from the Iraq war and will soon begin testing brain scanning equipment in hopes of finding a more accurate way to identify hard-to-diagnose wounds. Fort Carson hopes to get a new scanning camera soon, that uses gamma rays and radioisotopes, Col. John Cho, commander of the Evans Army Community Hospital at Fort Carson, said. To date, the Army has not extensively used neuroimaging equipment to detect brain injuries in returning soldiers because not enough testing has been done to judge the technology's effectiveness. The move to try to detect brain injuries comes after a recent study at Fort Carson found that 18 percent of troops who had been to Iraq, 2,392 of 13,400 suffered at least some brain damage from the blasts of improvised explosive devices. "They are taking head injuries seriously," said Dr. P. Stephen Macedo, a Washington, D.C.-based neurologist and former doctor with the Veterans Administration.

Doctors often must rely on questioning soldiers to determine if they've suffered brain damage in battle. Cho said that isn't good enough because many injured show no symptoms, while other symptoms can mirror other conditions. "How do you determine that someone has actually had a traumatic brain injury other than asking the soldier?" Cho said. Verbal tests are subject to failure for many reasons, the soldier may not remember, may deliberately withhold information to avoid being discharged, or may not yet be feeling the effects of an injury. Stephen Robinson of Veterans for America, an organization that has accused the Army of discharging soldiers with brain damage, was pleased with the announcement. "After two years of us complaining, they are going to do something," Robinson said.

Fort Carson will use soldiers who have already been diagnosed with traumatic brain injury to test the technology and rate its effectiveness. Results will be delivered to an Army review board. "We feel that we that we can move forward on behalf of the Army and for soldiers faster than other places," Cho said. "Hopefully it will identify a marker that can help diagnose brain damage." The announcement comes as an interagency task force, headed by Veterans Affairs Secretary Jim Nicholson, released a report Tuesday saying injured soldiers and veterans will get more screenings for brain injury.


Brian proves there is life after brain injury

Brian McBrien is a walking example of life after the trauma of brain injury. Back in 1992, Brian was a car-mad young 20-year-old, who relished cars and the freedom being able to drive afforded him. He was passionate about his hobby and even took part in a number of rallies around the country. In September, 1992, Brian's life was turned upside down when he was involved in a serious road traffic accident near his home. He was seriously injured and spent the following eight weeks in a coma and a total of seven months in hospital. On his discharge, Brian found himself facing an uphill struggle to regain his quality of life. In September 1993, he began attending the Brain Injury Treatment Unit at Drumcoo, and in that time he has made tremendous progress. However, even after all this time Brian's short-term memory is poor. Now he has part-time employment, an achievement he could only dream about after the crash. Brian proves there is light at the end of the tunnel no matter how devastating the initial injury seems. Getting back to work has allowed him to indulge his true passion in life which is, all things to do with engines and cars. Through his involvement with the Brain Injury Treatment Unit at the Drumcoo Centre in Enniskillen, Brian secured employment.

The Drumcoo Social Re-integration Program works specifically with people who have suffered brain injury. Through a variety of activities such as swimming, arts and crafts, and eventually after a lot of hard work, the program helps people to return to work. Each of the stages aims to encourage people to reintegrate into society and make a contribution to their community. For Brian, the challenge of getting back to work was immense, but the reward was the chance to get to work with his beloved cars. In January 2006, Brian began working as a valet and from there he has never looked back. He now works two days a week at a garage where he has become an integral part of the team. Brian also attends a weekly horticulture class along with four other men who have sustained head injury. The Drumcoo program is specifically for people who have a traumatic brain injury, brain hemorrhage or early stroke. Niall McGandy, the Deputy Manager at the Drumcoo Centre explained, "Our programs identify needs and provides opportunities for renewing old and developing new interests, increasing confidence and self-esteem. It's about giving respite to caring relatives, developing work or vocational skills, improving domestic skills, where appropriate and optimizing physical function and health and fitness."


TBI's Not Getting Enough Attention

According to the Centers for Disease Control and Prevention, each year at least 1.4 million Americans sustain a traumatic brain injury (TBI) - a public-health concern that is the leading cause of death and disability in children and young adults. More individuals die from a TBI each year than from a heart attack yet TBI's have only come to the forefront of news recently.

Most victims of TBI's are who suffer a brain injury are young. The most alarming fact is that given the average life-span and the nature of their injuries of young individuals, those who sustain brain injuries at a young age will require many more years of care than will the elderly or middle aged who suffer heart attacks.

Yet there is still not definitive TBI drug or treatment.

Traumatic brain injury is often referred to as the "silent epidemic." It affects people in ways that can go unnoticed for months and even years - symptoms that are devastating in the long run. Over the past 10 years, there have been increase efforts by medical professionals to find study TBI's more closely, but since the biology of brain injury is so poorly understood there have not been remarkable discoveries.

There is no marketable, miracle drug for TBI. However, as stories of war victims coming home with severe brain injuries, there has been a new painstaking effort to help those with TBI's This effort is dampened by the fact that the brain is the slowest organ to heal; sometimes it doesn't seem to heal at all, and many times it seems to improve just a bit, and only after a very long time.

As the number of TBI victims rises each year, researchers must rely on past studies to guide them toward better treatments and drugs.


May 01, 2007

Boxing Dangerous Sport for the Brain

Researchers in Sweden found that blows to the head sustained during amateur boxing may lead to brain damage. The study looked at the levels of cerebrospinal fluid after a blow to the head of 14 amateur Swedish boxers. The researchers found that after a head trauma, the cerebrospinal fluid in boxers increases which leads to damage to neurons and other brain cells.

Lumbar puncture was used to determine if there was an increase in levels of biochemical markers for brain injury in the cerebrospinal fluid of the 14 amateur boxers. Each boxer was tested after a fight and three months after a break from boxing. 10 healthy, non-boxer men's cerebrospinal levels were used for comparison.

It was previously found that approximately 20% of professional boxers develop some form of chronic traumatic brain injury. Some studies have suggested that amateur boxers also damage their nervous systems. However, because of the shorter periods of boxing, amateur boxers sustain fewer blows to the head. Amateur boxers also must wear safety equipment, which decreases the severity of brain injuries significantly. All studies were based on an assessment of thinking, learning, memory and other brain functions long after boxing, rather than a test performed immediately after a fight.

"Despite the high prevalence of brain damage as a result of professional boxing, until now there has been little information on the possible risks for brain injury in amateur boxing," said study author Dr. Max Hietala of Sahlgrenska University Hospital in Goteborg.


New Legislation Introduced to Help Vets with TBI

Senators Daniel Akaka (D-Hawaii) and Larry Craig (R-Idaho) introduced new legislation to help veterans returning with traumatic brain injuries (TBI's). The Veteran's Traumatic Brain Injury Act of 2007 was introduced in response to the growing numbers of veterans returning from the front-lines with brain injuries. TBI's have become known as the Iraq War's signature injury as more and more explosives are used. Approximately 30% of all vets exposed to blast situations sustain a TBI and many live with their injuries as symptoms go unnoticed. Failing to diagnose a TBI can lead to degenerative brain damage and even death.

The new legislation requires the US Department of Veteran affairs to improve TBI treatment options and facilities. Specific requirements include:

• The VA must provide all inpatient vets with TBI's with individualized plans for rehabilitation and reintegration.
• The VA must provide more funding for mandatory research, clinical care, and educational programs regarding TBI's.
• VA officials must send vets to a private care facility if a VA hospital is unable to provide any necessary medical treatments.
• A pilot assisted living program will be created for vets with TBI's.

"Hundreds and perhaps even thousands of our dedicated servicemen and women are returning from Iraq and Afghanistan with mild, moderate, and even severe head trauma. The long-term consequences of these injuries are, in many ways, unknown to us. That is why this legislation is so important," said Craig.


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