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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