Osteopathic surgeon Dr. John A. King, who changed his name to Christopher Wallace Martin in 2006, is facing 122 medical malpractice lawsuits in West Virginia. The first case was to start in the coming week, but will be delayed because King advised his attorney that he will be filing for bankruptcy. If King files for Chapter 7 personal bankruptcy, the federal bankruptcy law requires a 90 day delay that could last for six months or more and requires an immediate cease of all legal proceedings against him. Clever maneuvering on Dr. King’s part, but his victims will continue to suffer the consequences of his malpractice with little recourse.

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Janet Abaray, a Cincinnati attorney for seven women chosen as precursor plaintiffs, filed a motion Nov. 20th in Toledo, Ohio federal court stating that the makers of the birth control patch Ortho Evra misled doctors and regulators by altering and withholding medical data concerning the health risks associated with use of the patch. The seven plaintiffs are all from Ohio and include Sienna Tomko who when 14 suffered deep vein thrombosis in 2005 and Robert Douglas Rosfeld who lost his 25 year-old wife Stephanie to a heart attach after using the patch for only a month.

Johnson & Johnson faces 2,400 lawsuits by women and their families who claim the patch releases extremely high levels of estrogen that cause strokes, heart attacks and blood clots in the legs and lungs. Pre-trial interviews and internal documentation show that J&J learned of the risk in 1999, but chose to mislead the FDA when seeking approval for the patch in 2001. The motion filed states the company “withheld and altered data from the clinical trials which proved that the patch delivered significantly higher levels of estrogen than oral contraceptives. Obviously unaware of the withheld information, the FDA approved Ortho Evra for marketing.” The filing presents the first detailed look at evidence previously confidential and may indicate why J&J chose to settle dozens of cases without going to trial. It further details a clinical trial from 1999, known internally as PHI-014, that measured the amount of ethinyl estradiol, the estrogen component called EE, released 20 micrograms into the bloodstream every 24 hours. The actual results showed 30.4 micrograms when the patch was applied to the abdomen and 38.1 micrograms when applied to the buttocks were released into the system. Dr. Larry Abrams, the now retired company pharmacologist used a “60 percent correction factor” to lower the results relating it to the rate at which the estrogen clears from the body. Another study from 1999, known as PHI-017, measured the amount of estrogen released by the patch and compared it to three forms of pill, finding that the patch delivered two times more estrogen than one pill and three times more than the other two pills. The case is: In re Ortho Evra Products Liability Litigation, MDL 1742, U.S. District Court, North District of Ohio (Toledo).

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In a statement made Monday Nov. 26th the Rhode Island health department director David R. Gifford said this in response to the 3rd brain surgery mistake made at the Rhode Island Hospital, “We are extremely concerned about this continuing pattern.” The hospital has been fined $50,000 and reprimanded by the state Department of Health. This is the third instance this year of a doctor performing brain surgery on the wrong side of a patient’s head. In this most recent case a chief resident started operating on the wrong side of an 82 year old patient’s brain. In February, another doctor performed neurosurgery on the wrong side of a patient’s head. In both cases the patient’s were okay. A patient in August wasn’t so fortunate. He died a few weeks after a third doctor operated on the wrong side his brain. After the death of that patient the state ordered the hospital to take a number of steps to ensure the same mistake would not be repeated. Apparently, those steps were not sufficient enough to keep it from happening again. It appears the Department of Health has good reason to be concerned.

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It used to be that Texas residents who suffered a traumatic brain or spinal cord injury, the wait for services could exceed two months, and has since its inception in 1992. Experts in the system say that it’s critical to get therapy when the brain is still repairing itself, which typically takes six months to two years post injury. This year the Texas Legislature approved an additional $3 million per year for the state program, Comprehensive Rehabilitation Services, for people with brain and spinal cord injuries. It provides inpatient and outpatient therapies designed to help people learn to live independently. As a result of the budgetary increase the wait list has disappeared and the Texas Department of Assistive and Rehabilitative Services is trying to inform the needful that space is available. About 145,000 Texans suffer traumatic brain injuries each year according to the Texas Brain Injury Association’s president, Eric Makowski. Eighty-eight percent of people who go through the state program go on to live at home, said a program specialist with the state agency. The average person's treatment costs $44,000. In the new increase the state will pick up the tab in some cases and in others they are asked to pay on a sliding scale according to their financial means.

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Colonel Geoffrey Ling leads a research program on traumatic brain injury for the Defense Advance Research Projects Agency (DARPA), the research organization of the Department of Defense. He and a group of researchers at the University of Toledo are researching and testing a number of theories of how traumatic brain injury occurs during an IED event or violent blow to the head. Many are in on the project testing other theories, but only two are mentioned here.

Damir Janigro of the Cleveland Clinic Foundation, and a member of the UT, believes that it's ultrasound that's behind the brain damage. He theorizes that ultrasonic waves are causing a leak in the nearly impervious vessels lining the brain. Although capillaries in the rest of the body are designed to leak, brain vessels allow only limited and very controlled substances. Mr. Janigro is now looking at the impact of ultrasound in a laboratory environment in which cells are tested in a simulated blood vessel for their response to ultrasound. If Mr. Janigro's theory proves accurate, it may hold a key for early diagnosis of traumatic brain injury.

Dr. Thomas Papadimos of the University Of Toledo Medical Cente, hopes that nitric oxide may hold promise for treatment. Dr. Papadimos, an anesthesiologist, acknowledges that his hopes for nitric oxide are based on some fairly limited findings, beginning with his own experience with a head injury patient who was also suffering from acute respiratory distress syndrome and high intracranial pressure. At the time he tried nitric oxide, which can temporarily rescue patients in respiratory distress. The nitric oxide made the patient's lungs better, as expected, but, it also seemed responsible for drop in intracranial pressure. "Three weeks later, he was in a rocking chair watching TV. That should not have happened," Dr. Papadimos said. "I thought it was a fluke, maybe dumb luck," he said. Then he found two more cases of similar successful treatments in the medical literature. He said the finding seemed to beg further study. He's applied for a grant to try nitric oxide on comatose patients.

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Bayer HealthCare Pharmaceuticals, in the midst of product safety issues concerning their MRI imaging contrasting agent Magnevist, announced that they have been awarded a three-year contract renewal by HealthTrust Purchasing Group to make the injection available to their HealthTrust network. Bayer holds more that 50 percent of the U.S. market share for gadolinium containing contrasting agents and has the broadest range of FDA approved usage than any other MRI agent for adult and pediatric patients. However, a cloud is over the company due to a link between their product and the debilitating, painful and sometimes deadly disease Nephrogenic Systemic Fibrosis. In fact, in their news release they initiate a warning to readers about who the agent should not be used on, such as those with acute renal insufficiency or perioperative liver transplantation. They further caution for all patients to undergo a screening for renal dysfunction as well as not to exceed the recommended dose and to allow a sufficient period of time for the agent to eliminate itself from the system. What they fail to elucidate is that there are other options available to technicians that do not use the sometimes toxic gadolinium. Toshiba recently announced its fourth generation contrast-free imaging technique known as Time and Space Angiography (TSA). TSA creates images that show dynamic blood flow without using contrast agents. In contrast, Bayer’s press release warns of possible serious and life threatening anaphylactic reactions, as well as cardiovascular and respiratory manifestations when using Magnevist. It makes one wonder what these health groups are thinking to allow their patients access to such a controversial treatment.

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Canadian resident George Dellefountaine is part of a class action lawsuit against the makers of OxyContin, a powerful painkiller. Dellefountaine was in a car crash in 2004 and was experiencing chronic pain. On his doctor’s orders he took the painkiller and ended up addicted. He has since stopped using OxyContin, but still experiences shakes, mood swings and other signs of addiction. Dellefountaine is one of 100 Atlantic Canadians who have decided to file suit against the maker of OxyContin, Purdu Pharma.

It is believed the suit could be worth hundereds of millions of dollars. The suit alleges that the pharmaceutical company's executives misrepresented the drug as suitable for chronic pain relief and underestimated its addictive qualities. The lawsuit will not represent individuals who bought OxyContin on the street illegally for its strength and addictive properties. The street name for OxyContin was “hillbilly heroin.” Last May, Purdue subsidiary Purdue Frederick in Stamford, Conn. and three executives pleaded guilty to misbranding the prescription painkiller and were fined more than $634 million in penalties. The U.S. assistant attorney general said at the time that Purdue “put its desire to sell OxyContin above the interests of the public.”

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Volvo Cars recently announced its decision to recall 56,000 cars because of two issues that could cause severe consequences and car accidents. Spokeswoman for Volvo Cars, Maria Bohlin confirmed that 38,000 diesel car 2006 models of S60, V 70, XC 70 and XC 90 have been linked to a material fault in the engine that could cause it to catch fire. Another recall involving 18,000 of the newer V 70 and XC70 models relates to a side air bag weakness. She goes on to explain that the fuel injector bolts, located on top of the motor cylinder are faulty and can potentially cause a diesel fuel leak into the motor, possibly causing an engine fire. It was not made immediately clear how many fire incidents there have been. Bohlin said with the air bag issues, “there’s a risk they don’t launch fast enough.” The faulty cars have been sold mainly in the U.S. Britain and Sweden.

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Traumatic Brain Injury recently has come to notoriety since ABC’s Bob Woodruff shared his experiences after suffering one himself. Yet services and appropriate care are lagging in the ability to care for this growing group of people. The groups at risk for traumatic brain injury are of course the soldiers fighting in off-shore wars, but also males are almost twice as likely as females to sustain a TBI, 0 to 4 year olds and 15 to 19 year olds are the age groups at the highest risk and African Americans suffer the highest death rate according to the CDC.

Ben Fuller suffered a traumatic brain injury in a 2004 car accident and is currently warehoused in a medical center room. Fuller is slow to react to any action around him and sits in a wheelchair staring into space for long periods of time. When not staring into space, he is prone to profane and violent outbursts. His parents and family have spent three frustrating years running into roadblocks in the system searching for the needed services for Ben. Unable to find residential services the Fullers looked elsewhere. The medical center Ben was in at the time agreed to pay for a three-month stay at the Florida Institute for Neurologic Rehabilitation. Ben Fuller may be one of the fortunate ones, many other TBI victims end up institutionalized in jails and mental health hospitals or simply become homeless. The absence of a coordinated system of rehabilitative care for brain injury victims is largely due to a deficiency of public and private funding. The lack of understanding by lawmakers and insurers makes money scarce. Private insurers, Medicare and Medicaid don’t see services to TBI victims as medically necessary. Often, residential and community services for TBI patients are either too expensive or don't exist. Health insurance has strict limits on the type of treatments it will cover. The lifetime cost of care for TBI patients range from $600,000 to $1.9 million. Ben’s family has already surpassed $500,000 dollars and the medical system still doesn’t know where to put him or how to fulfill his rehabilitative needs.

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To resolve 2,600 claims against Medtronic and their Sprint Fidelis leads defects the company has agreed to pay around $130 million. That is up $55 million from the original proposed amount of $75 million from the initial settlement in July. The extra money will help Medtronic reach a resolution with the additional 600 claims that have since been filed over the heart defibrillators. The claims are over the battery defects in the implantable defibrillators, which send electric shocks to the heart to correct potential fatal heart rhythms. Rob Clark a spokesman for Medtronic said, “There is nothing new to report in this case. If there were a significant or material change in this case, we’d communicate that.”

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Raymond Burns suffered a traumatic brain injury while in a car accident that knocked him unconscious briefly. He thought he was fine at the time of the accident, but soon realized cognitively he was not. He was a CEO of a software development firm when he began to notice difficulties in his day to day activities. Losing his train of thought in conversations, unable to organize papers on his desk, incapable of reading his own handwriting were just a few of the symptoms he experienced. During a support group meeting another traumatic brain injury survivor expressed what Burns felt. “We’re no longer what we used to be,” said Peggi Robart. “You’re not going to get back to yourself again. That self is gone.” Robart joined the support group four years ago, after an electronic sign in an airport shuttle bus fell on her head. Joining the support group was one of the first steps Burns has taken in accepting that his life has changed dramatically and permanently. “I knew I needed to get some help. I'm finally coming to terms with this, but it's very tough.”

Many survivors of traumatic brain injury suffer not only from the physical wound but also from the realization that even though they look normal and have returned to physical health, they are disabled cognitively in ways that do not reflect their former identity. One of the first steps that survivors and their loved ones have to face is that TBI victims may exhibit symptoms that make them seem mentally or developmentally ill. Through support groups and other programs, the Brain Injury Association seeks to educate and prevent TBI. Doctors know much more about how the brain works and have improved the detection and treatment of people with brain injuries

Posted by Kerry N. Jardine at 09:40 AM | Permalink | Comments (0) | TrackBacks (0)

LegalView.com announced that it will launch an informative and detailed Nephrogenic Systemic Fibrosis blog on its website to inform victims of further findings regarding this debilitating and often deadly disease. Nephrogenic Systemic Fibrosis has been linked to the use of Gadolinium, a chemical dye used in magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA) tests. The blog offers resources, jury verdicts and information about attorneys for those who need help from a staff knowledgeable in the area of NSF

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An Altoona, PA woman has joined hundreds of others across the country in filing a lawsuit against the pharmaceutical company Ortho McNeil for marketing the Ortho Evra birth control patch which is linked to serious side effects. The patch has caused blood clots, heart attacks, strokes and death in women nationwide. Attorney Howard L. Nations filed the lawsuit on behalf of Helen Chandler Faretta in the U.S. District Court in Johnstown. The case will be transferred to the federal district court in Toledo, Ohio, where all of the Ortho Evra cases are being heard. The product remains on the market with FDA approval because the company has attached a warning label about the possible side effects of using Ortho Evra. Worldwide, the FDA-equivalent agencies in Canada, Great Britain and Japan have refused to allow the drug on the market because of its high output of estrogen. The pharmaceutical company altered the product in those nations to make them safe, but the FDA only requires a warning label. According to the lawsuit, Faretta was prescribed the product from July through August 2004. On Aug. 27, 2004, she experienced severe leg pain and was diagnosed with a blood clot in the leg and was immediately taken off the patch. Her attorney is seeking damages on nine counts, including a charge that the company violated Pennsylvania’s Unfair Trade Practices and Consumer Protection Act. Nationwide only a few of the lawsuits have been settled so far, including one involving a death.

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In an unusual medical malpractice case in Connecticut, a six member Superior Court jury awarded a 47 year old developmentally disabled man’s estate $3.5 million. What makes this case so unusual is that the award was not based on the man’s employment or dependent status. His lawyer John Jessep said, “This was a purely a non-economic verdict. My client did not have a full-time job. But the verdict shows a jury can evaluate anyone from any walk of life and assess fair damages.” The jury found that his treatment at the hospital was negligent and qualified as medical malpractice. Ackley was brought to St. Vincent's by his father in February 1999 and was apparently suffering from pneumonia. “His body was being starved of oxygen," Jessep said. "They failed to provide proper supplemental oxygen.” As a result, Jessep said Ackley's heart became overworked and eventually stopped. The lawsuit accused the hospital of failing to administer proper respiratory care, to monitor his heart rate and frequency of respiration and admit him. In response, “St. Vincent' s would like to express its deepest sympathy to the Ackley family for their loss. We believe Mr. Ackley received appropriate medical treatment and are disappointed with this decision,” said Noreen McNicholas, the Medical Center's director of marketing and communications.

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A brain injury attorney in New Jersey obtained a significant $4.15 Million settlement on behalf of a client who sustained a serious traumatic brain injury as a result of a desk hutch falling on him while at his place of work. The defendant’s doctors tried to completely dispute that the client suffered any brain injury, arguing instead that his memory loss and other cognitive issues were psychosomatic. However, through cross-examination the doctors admitted that the man’s brain injury was caused by the incident, regardless of whether deemed psychosomatic or not. Once the argument was heard the defendant was under pressure and settled at $4.15 million. A traumatic brain injury can have lifetime consequences often making it impossible to retain a job with significant income to cover the cost of daily expenses. If possible, it behooves victims to seek legal counsel to determine if a monetary response can be obtained to help with those expenses.

Posted by Kerry N. Jardine at 06:33 AM | Permalink | Comments (0) | TrackBacks (0)

The Kent County Health Department of Michigan recently advised patients who were under the care over the past 15 years of a dermatologist by the name of Dr. Robert Stokes, should undergo tests to determine whether they've been infected with viruses, including Hepatitis B, Hepatitis C and HIV. Since April 2007, 10 former patients have filed medical malpractice lawsuits against Stokes and his medical assistant claiming he performed unnecessary procedures of which some have left lasting scars. One woman accused him of using scare tactics on her to have moles removed by claiming she had the beginning stages of cancer. After he removed moles from her 10 times and left her deeply scarred she sought a second opinion from a dermatologist who said they were not dangerous or cancerous. Nearly 15 years later she learned that Stokes not only scared her into unnecessary medical procedures, but also risked infecting her through unsanitary practices. A 74 year old man estimates he saw Stokes 75 times over a 5 year period and had 30 procedures performed on him that required the use of scalpels, sutures that could have been inadequately sterilized. Stokes told him that he had numerous moles and skin growths that tested positive for basal cell carcinoma and melanoma yet his new doctor said nothing in his records show any cancerous growths. One woman sued Stokes in 1999 when he misdiagnosed a lesion on her lip as herpes when in fact it was cancer leading to several surgeries and disfigurement. Another woman claimed he performed 104 unnecessary biopsies. Attorney William Mills, who filed the lawsuits, refused to comment pending the outcome of Stokes' sentencing in federal court on fraud charges. It's unclear how much the patients could receive in damages, since the federal government is seeking Stokes' assets. The Tort reformists should take note of such cases. As has been illustrated here, it is not in the best interests of the system to prohibit or limit damage awards.

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http://www.burgsimpson.com/malpractice.htmlNew York State health officials notified 628 patients that they should be tested for hepatitis and H.I.V. infection because they were treated years ago by an anesthesiologist who used improper procedures for preventing the spread of blood-borne diseases. The anesthesiologist, Dr. Harvey Finkelstein, first became the focus of a state health investigation in 2005 after two of his patients contracted hepatitis C. At that time investigators found that CDC recommended practices were being violated by Dr. Finkelstein, 52, when he reused syringes while drawing medication from vials. For example in one case he opened a new syringe, but drew medication from a used vial, thus causing the patient to contract hepatitis C. Raymond Bookstaver, 49 was one of two patients initially identified as having been infected by Dr. Finkelstein’s improper use of syringes. “I feel like I went to a doctor for help, and what I got instead was a death sentence,” Mr. Bookstaver said. His hepatitis is being treated, but erupts unpredictably, causing him to suffer flu like symptoms including nausea, vomiting and aching that leaves him bedridden. Dr Finkelstein is not the only doctor, more doctors in the state have been reported to state health officials in the last several years for reusing syringes.

In January 2005, the Health Department began an investigation to determine how many of Dr. Finkelstein’s patients were infected by the vials of medicine that he had used more than once. Investigators notified 98 patients who received injections in the three weeks before, during and after Dr. Finkelstein’s two patients were infected, telling them to get tests for blood-borne infections including hepatitis and H.I.V. After the findings the state expanded its investigation to cover from 2000 to 2005 because it was in 2000 when Dr. Finkelstein told the investigators that he began using one syringe to draw doses from numerous vials. In a statement released, the state health commissioner, Richard Daines, said “the department identified all 628 patients who had received injections between Jan. 1, 2000, and Jan. 15, 2005, after a thorough review of medical records at all sites where this physician practiced.”

The troubling question remains. Why did it take so long for the health department to notify patients? County and state officials traded blame over the 34-month delay. Michael Duffy, a lawyer who specializes in medical malpractice cases and vice president of the New York State Academy of Trial Lawyers, said that the long delay in notifying the 628 potential victims of Dr. Finkelstein’s practice was especially troubling because none would be able to seek damages in court.

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After the recall of its Sprint Fidelis leads, Medtronic has reported that their second-quarter revenue was reduced by $150 million to $250 million. Following the recall in October, Medtronic was targeted by a patient suit alleging emotional distress and negligence. The plaintiffs are seeking restitution, disgorgement of profits and punitive damages. An analyst said to clients that while the Fidelis lead recall would hurt earnings, cost control efforts and a low tax rate could help. Further that, “Physician conversations suggest doctors think the recall is more of a near-term 'hiccup' than a permanent stain for Medtronic -- potentially positive for longer-term share retention.” Shares of Medtronic fell about 10.9 percent during the second quarter and roughly 10.8 percent since the start of fiscal 2008.

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More soldiers are returning from war with post traumatic stress disorder and traumatic brain injury and The Better Brain Injury Care Coalition of West Virginia said they're not receiving the care they need at home. While armor may save the soldier’s life, the explosions they are experiencing often cause traumatic brain injuries. The Pentagon lists nearly 4,500 brain injured soldiers from Iraq and Afghanistan and some soldier screenings have found up to 60 percent have come home with a TBI. The Better Brain Injury Care Coalition is made up of the West Virginia National Guard, the Veterans of Foreign Wars, the American Legion, the Brain Injury Association of West Virginia and the West Virginia Traumatic Brain/Spinal Cord Injury Rehabilitation Fund Board. Armed with news out of the Pentagon the agencies together want to bring the necessary care home to VA clinics across West Virginia so they do not have to go to Walter Reed. “Without having services in West Virginia, they have to go to Walter Reed and they just want to come home,” said Ginger Dearth, a representative from the West Virginia Traumatic Brain/Spinal Cord Injury Rehabilitation Fund Board. This group wants state lawmakers to make treatment made possible in West Virginia.

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The Hope Project is a pilot project and the first of its kind set up to combine military and civilian people with brain injuries on a college campus, where those recovering from traumatic brain injuries are treated as students rather than patients. The patients share two hours every Monday through Thursday, half from military and half civilian, listening to each other's experiences with their traumatic brain injury. The Hope Project encourages students to help each other increase their self-sufficiency and independence. By calling participants students, the project takes the emphasis off of healing and onto learning. The program is at Virginia Polytechnic Institute and State University's Northern Virginia Center. Funding for the $245,000 program comes from state government, rehabilitation groups and memorial funds, but Virginia Tech is the biggest donor. Life skills therapist Charlene Kelly said at first, students were scared or aggressive in social situations. Others cursed all the time. “It was a challenging setting to start educating in, but that's changed,” Kelly said. "People are being respectful of others and are socially integrating, and that is our goal." Since the program combines those with civilian and military backgrounds, students learn quickly about proper social behavior. Regardless of their backgrounds, Hope students understand each other's physical, cognitive and psychological struggles in performing everyday activities.

Posted by Kerry N. Jardine at 11:23 AM | Permalink | Comments (0) | TrackBacks (0)

Rapper Kanye West lost his mother under the care of a doctor who performed cosmetic surgery and who is now under intense scrutiny. Los Angeles coroner's officials completed the autospy of Donda West in an attempt to discern whether the 58-year-old former professor did indeed die of complications from surgery. Donda West had the procedure on a Friday and was sent home instead of a recovery center. The next evening, she was in cardiac arrest and pronounced dead shortly after arriving at a hospital. Dr. Jan Adams is the surgeon in question. Records show that Adams has had malpractice suits filed against him previously as well as alcohol related driving arrests and a recommendation by the Medical Board of California to revoke his license. While details of the individual cases have not been released, in August 2001, Adams was ordered to pay $250,000 to one claimant. Just one month later, Adams lost another case and ordered to pay $217,337. Eight additional malpractice lawsuits were filed against Adams following procedures performed over the past two years. David T. Thornton of the Medical Board cited in detail two drunken-driving arrests. The more recent DUI charge reports that Adams had a 0.10 blood alcohol level. He was eventually placed on five years probation, sentenced to 96 hours in county jail and ordered to attend 60 AA meetings while enrolled in an alcohol and counseling program. It is thought that medical malpractice caps are to prevent “frivolous” lawsuits, but what is to be done when victims and their families have no recourse when they have been severely harmed or as in the case of West, killed?

Posted by Scott J. Eldredge at 05:47 PM | Permalink | Comments (0) | TrackBacks (0)

Chicago Cook County Circuit Court Judge Diane Joan Larsen struck down a medical liability reform law, ruling that caps on non-economic damages for medical malpractice are unconstitutional re-igniting debate over one of the Legislature's most contentious issues. This is the first challenge to the 2005 law which capped non-economic damages to $500,000 per doctor and $1 million per hospital. Predictably, the American Insurance Assn. felt the decision was a disappointment. The Association hopes the caps are found constitutional on appeal. The landmark decision was made in a case that alleges a physician failed to respond quickly enough during complications in the birth of a baby girl who was born with severe brain damage. Illinois enacted a medical malpractice reform law in 2005 after more than 44 verdicts or settlements in excess of $5 million in Cook County were judged the previous year, according to the AIA. An appeal will go directly to the Illinois Supreme Court

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A Pennsylvania doctor will stand trial in the death of a 5-year-old autistic boy after administering a controversial drug used in lead poisoning. Dr. Roy Kerry, 69, used the wrong drug while trying to use Chelation therapy and administered it incorrectly, a pediatrician testified at his preliminary hearing, adding that his actions were “extremely reckless.” After receiving the therapy, the boy went into cardiac arrest in Kerry’s office. Chelation therapy is approved to remove heavy metals from the system, but the FDA has not approved it for treating autism. A district judge determined prosecutors had enough evidence to proceed with the case and ordered Kerry to stand trial for involuntary manslaughter. The Centers for Disease Control and Prevention reviewed the boy’s autopsy and said the boy died because the doctor administered a drug that removes calcium from the blood, disodium EDTA, rather than calcium EDTA, which is FDA-approved to treat heavy metal poisoning. Kerry also will stand trial on charges of endangering the welfare of a child and reckless endangerment. The doctor has no prior conviction, so is unlikely to face the maximum sentence of decades in prison. John Gismondi, the family's attorney, agreed with the district judge's decision and said, “It was obviously reckless conduct. He did something no doctor in the world would do."

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Nine residents from Illinois, Wisconsin, Kansas and New York have filed suit against the manufacturer of the birth control patch Ortho Evra and several pharmacies in St Clair County Circuit Court, Illinois. The suit alleges that Ortho Evra caused them pulmonary emboli, venous thromboembolism and other severe injuries. The pharmacies named in the suit are American Drug Stores, Osco Drug, Walgreens, B&D Pharmacy and Rite Aid. It further contends that Ortho-McNeil Pharmaceutical and Johnson & Johnson in negligence designed, developed, manufactured, tested, packaged, promoted, advertised, marketed and distributed the patch. The complaint states, “Defendants negligently and improperly failed to perform sufficient tests, if any, on women using and/or wearing the Patch during clinical trials, forcing Plaintiffs and their physicians, hospitals and the United States Food and Drug Administration to rely on safety information that applies to an oral contraceptive agent....” Further, the complaint states that defendants had a right to know that the patch administered a much higher level of hormone at a 60 percent level contrary to the 30 percent level when using the oral pill contraceptive. The suit was filed on November 1st and includes Johnson and Johnson Pharmaceutical Research and Development and R.W. Johnson Pharmaceutical Research Institute as well.

Posted by Seth A. Katz at 12:40 PM | Permalink | Comments (0) | TrackBacks (0)

A medical device similar to the Medtronic implantable defibrillators has reportedly been implicated in a number of cases of perforated hearts. The medical journal PACE reported that wires from the St. Jude Medical Inc. implantable defibrillators are known to have perforated four patient’s hearts. According to the journal, one patient had a wire move from inside the heart out to a quarter inch from the patient’s skin. Regardless of the difficulties experienced by these heart patients, the company has issued no recall. Last month, Medtronic Inc. acknowledged five patient deaths linked to breaks in its Sprint Fidelis wires, which have since been recalled. All four of the patients with the St. Jude wires had them removed. Dr. Stephen C. Vlay wrote in a PACE editorial that the wire problems are especially troubling because the perforation often isn't discovered until it is well through the heart wall. One woman had no sign of problems. Doctors discovered her perforation in a routine follow-up visit after her defibrillator had been implanted. The defibrillator had not been delivering a sufficient jolt. Doctor's found the perforation in another woman after her defibrillator shocked her five times within one 24-hour period. Vlay believes that doctors may not have been reporting the wire problems because they thought they were isolated events. “It was only when multiple case reports emerged from different geographic areas and were submitted for publication that editors recognized a problem that seemed to be neither isolated nor rare,” he wrote.

Posted by Kerry N. Jardine at 06:36 PM | Permalink | Comments (0) | TrackBacks (0)

Saab, the Swedish aviation, defense and car manufacturing company is launching an in-car warning system that uses two tiny infrared cameras linked to a dashboard computer to monitor alertness in drivers. Research shows that 20 percent of accidents are caused by tired drivers falling asleep at the wheel. Saab has dubbed it the driver attention warning system. It is designed to detect the beginnings of drowsiness and inattention. The two miniature infrared cameras are focused on the driver’s eyes and measure the driver’s rate of eye blinking. The images are then analyzed by software that triggers a series of alerts when it recognizes the pattern of eyelid movement that indicates the onset of drowsiness. When the cameras detect a long duration of eye-lid closure, three warnings are initiated. At first, a chime sounds and a text warning message “Tired?” is displayed in the main instrument panel. If no affect, a speech message “You are tired” is then spoken through the audio system. At the last, a stronger warning tone and the message, “you are dangerously tired, stop as soon as it is safe to do so!” will come over the audio system. The system is reset and immediately reactivated only when the driver presses a button in the fascia. If the system detects a constant peripheral vision rather than full eyes on the road it will activate a seat vibration. The infrared cameras can even detect through dark glasses. "Many drivers do not stop and get out of the car if they are feeling drowsy. So we are trying to help drivers to help themselves," Arne Nabo, head of the human vehicle integration team at Saab said. The new system will undergo an eight-month field trial before released to the general public. Such a detection system should be well received and have a positive impact on the driving population, including semi-truck drivers by helping stop preventable car accidents in the future.

Posted by Kerry N. Jardine at 12:35 PM | Permalink | Comments (0) | TrackBacks (0)

As with many states a new study concluded that Minnesota is unprepared to meet the mental health needs of veterans returning from the wars, especially those with a traumatic brain injury. Rep Al Juhnke is chairman of the House Veterans Affairs Committee and has authored a legislative bill earlier in the year that also funded the new report. He expressed that better identification of the TBI affected soldiers will help lead to a better treatment and enable them to return to a productive civilian life. The 55-page report was commissioned to look at any unmet needs in the veterans care system and to recommend ways to address them. There will be a bonding bill to help build a veterans facility. Once the bill passes the state likely will get on the priority list to receive additional federal funds for the project. The report describes a “haphazard and patchwork” system of care for returning soldiers. Many of the returning veterans struggle with substance abuse, post-traumatic stress or depression. Health care systems, particularly in rural Minnesota, often lack the resources or expertise to appropriately address the mental health needs of veterans.

While reviewing health facilities across the state the study found that, “No facility surveyed demonstrated a well-integrated multi-specialty program that could address veterans’ needs in a unified and comprehensive fashion.” There’s an especially large gap when it comes to diagnosing and treating traumatic brain injuries. Dr. William Sheehan, the study’s author, is a psychiatrist in private practice and he wants to prioritize the planning so that veterans can receive help sooner so they do not drift into chronic unemployment, homelessness and marital problems or worse. “That’s ultimately what happens to these people if we don’t appropriately recognize that they have a serious brain injury,” he said. “This is really getting away from the idea of waiting until people are utterly impaired before serving them.”

Posted by Kerry N. Jardine at 06:33 AM | Permalink | Comments (0) | TrackBacks (0)

MSNBC recently reported the case of a woman who is suffering from the after affects of an MRI using a gadolinium contrasting agent. Gadolinium-based dyes are injected into a patient to highlight specific tissue types making them easy to differentiate from other tissues on an MRI. The MRIs can be administered without a contrasting agent, but they are considered to be significantly less useful. To complicate matters, gadolinium is the only contrasting agent approved for use in most MRIs.

Sarah Fracella of Santa Barbara, California cannot open a bottle without assistance and has difficulty sitting and walking all because of the gadolinium contrast agent used in an MRI she participated in. Fracella is now afflicted with Nephrogenic Systemic Fibrosis, an incurable, painful and sometimes deadly disease. Fracella, 38, expressed, “I don’t think there’s been a day in the last, probably, two years that’s gone by that I haven’t cried at least once about this.” For most people, gadolinium is harmless and is naturally secreted through the kidneys and expelled from the body, but for those with a kidney disorder that disallows such excretion the consequences can be severe. The FDA in May, 2007 asked the manufacturing companies that produce gadolinium dyes to include a “black-box” warning saying patients with kidney problems could develop NSF after their first exposure. Shawn E. Cowper, a dermatologic pathologist at Yale who first identified the condition in the United States with Philip LeBoit of the University of California-San Francisco, said as many as 1 in 20 kidney patients could be at risk of contracting NSF after undergoing an MRI using gadolinium. NSF has been confirmed in children and the elderly, but tends to affect the middle-aged most, according to the International Center for Nephrogenic Fibrosing Dermopathy Research. The FDA recommended that all patients with kidney problems ask their doctors not to us the gadolinium dyes in MRI exams, unless there is no alternative. Numerous lawsuits have been filed against GE Healthcare and a number of other companies who manufacture gadodiamide, the type of gadolinium implicated in a large majority of the cases known to date. GE Healthcare said that the company does not comment on pending litigation but that in general, it believes it has “a number of meritorious defenses.”

Posted by Kerry N. Jardine at 09:40 PM | Permalink | Comments (0) | TrackBacks (0)

China is facing further difficulties in their relationship with the global economy when their exported toy, Aqua Dots, poisoned several children in the U.S. China’s government has suspended its worldwide export of the toy covered with a toxic chemical that metabolizes into a “date rape” drug when ingested. Nine children have been confirmed as ingesting the toy beads and sickening them, according to the Consumer Product Safety Commission. Tests showed the Aqua Dots were coated with the industrial chemical 1,4-butanediol. The “date rape” chemical is known as gamma hydroxy butyrate and may cause breathing problems, loss of consciousness, seizures, drowsiness, coma and death. In addition to the nine in the U.S., three children in Australia have also been stricken. In the U.S six of the children hospitalized came from Texas, Delaware, New Hampshire, Illinois and Utah. The U.S. recall covers 4.2 million of the Aqua Dots toys, which are colored beads that can be made into designs and then fused together when sprayed with water. The recall is the latest in a host of product quality issues that has tarnished the image of the country as an exporter of reliable goods. Australia-based Moose Enterprises, the toy’s maker has said the product was manufactured in China, but neither the company nor the Chinese government has identified the factory or factories where they were produced. Companies worldwide are increasingly outsourcing manufacturing. Often choosing Chinese factories for their cost and quality, but burgeoning competition among factories and the rising cost of labor, land and fuel are putting pressure on profits, causing some producers to cut corners. Aqua Dots were supposed to have been coated with the nontoxic 1,5-pentanediol, a chemical commonly used in computer printer ink, but that chemical generally sells for three or four times the price of the toxic compound 1,4-butanediol found on the toys.

Posted by Kerry N. Jardine at 12:37 PM | Permalink | Comments (0) | TrackBacks (0)

Ohio Democratic State Representative Michael Skindell was in a bicycle accident in August, suffered a broken collarbone and ruptured spleen, but credits his helmet for saving him from a more serious traumatic brain injury. The state lawmaker says he wants Ohio to require bike helmets for all children. Skindell’s proposed bill would fine parents $25 if their children are found to ride without a helmet. Low-income families would benefit by being provided helmets from proceeds of the fine. Twenty other states and Washington D.C. already have similar laws in place requiring children to wear bike helmets.

Posted by Kerry N. Jardine at 06:35 AM | Permalink | Comments (0) | TrackBacks (0)

In one of the largest defective drug settlements ever, Merck & Co. will pay $4.85 billion to end thousands of state and federal lawsuits over its painkiller Vioxx. Merck officials estimated that if the deal is accepted it would end 45,000 to 50,000 personal injury lawsuits involving U.S. Vioxx users who suffered a heart attack or ischemic stroke. Merck’s executive vice president Kenneth Frazier said, “Without this settlement, the litigation might very well stretch on for years,” and called the agreement responsible and reasonable. The negotiating teams met more than 50 times in several states and spent hundreds of hours on the telephone over many months to come to an equitable deal. Merck stressed that the agreement is not a class action settlement and that it is not admitting fault. Analyst Steve Brozak of WBB Securities called Merck's handling of the litigation “a Harvard casebook study of how to deal with a problematic product.”

Posted by Kerry N. Jardine at 12:30 PM | Permalink | Comments (0) | TrackBacks (0)

Since the Food and Drug Administration recalled the Sprint Fidelis leads wires used in Medtronic’s cardioverter defibrillators (ICDs), the company’s shares have dropped 18 percent, from $56.33 to $45.99. The FDA noted that broken leads are causing “inappropriate shocks” in patients who have the medical devices implanted. On October 15th, the company said it would stop selling the Fidelis leads and that they may have contributed to the deaths of five patients. Medtronic had received 679 reports of injuries caused by fractures in the leads. Last February, the Minneapolis Heart Institute told Medtronic that it would no longer use the leads.

Posted by Kerry N. Jardine at 06:32 AM | Permalink | Comments (0) | TrackBacks (0)

A new report by the National Alliance to End Homelessness and the Homelessness Research Institute found that veterans make up roughly 26 percent of the homeless population, but only 11 percent of the general population. Iraq and Afghanistan war veterans are becoming homeless quicker than their brother Vietnam veterans. Senator Tom Harkin of Iowa vows to push a measure to ensure federal housing programs will reach the veteran population. “It’s not right for our returning heroes to be left out in the cold by their government,” said Harkin. “It is imperative that we in Congress and the Bush Administration take immediate action to reverse this awful trend. Our government cannot make the same mistakes with the veterans of this generation that they did with the veterans of my generation.” It has been found that the main reason for the increase in the number of homeless veterans is the high rate of post-traumatic stress disorder (PTSD) and traumatic brain injury (TBI) amongst the current war veterans. To address the issue, Harkin co-sponsored the “Homes for Heroes Act”, a bill which would ensure the Department of Housing and Urban Development (HUD) is targeting veterans with their homeless assistance programs. Harkin also co-sponsored the Veterans Traumatic Brain Injury and Health Programs Improvement Act, which would help the VA provide better care for veterans with TBI and assist homeless veterans. He also contributed in passing the measure “The Dignified Treatment for Warriors Act” that is to improve military medical facilities so they are capable of treating for TBI and PTSD. Provisions of the bill were included in the National Defense Authorization Act, the final version of which is currently being worked on in a House-Senate Conference Committee.

Posted by Kerry N. Jardine at 06:29 AM | Permalink | Comments (0) | TrackBacks (0)

The New York Comedy Festival this year benefited the Bob Woodruff Family Fund for Traumatic Brain Injuries. The Bob Woodruff Family Fund helps people injured while serving in the U.S. Armed Forces. Its emphasis is on traumatic brain injury (TBI) and combat stress disorders. Conan O’Brien hosted the event with the stars Lewis Black, Robin Williams, Brian Regan and Bruce Springsteen taking the stage for comedy and musical performances. “Stand Up for Heroes,” was part of the fourth annual New York Comedy Festival. It brought a big audience of more stars as well as entertainment industry executives. In expressing his gratitude Woodruff to the many supporters said, “All these media titans and sometimes competitors united in the same cause.” His wife started the laughs by recounting how she bought him a plaque for his 45th birthday after his injury. It said: “If it's not lethal, it's no big deal.” Springsteen played some tunes and his motorbike was auctioned off for $85,000 while Robin Williams closed the fund raising night with his typical flair.

Posted by Kerry N. Jardine at 09:28 PM | Permalink | Comments (0) | TrackBacks (0)

On October 14, 2007, Medtronic recalled the Sprint Fidelis lead wires in their product once five deaths were linked to the malfunctions. The leads are small wires which connect an implantable cardiac defibrillator to a patient's heart and deliver a jolt of electricity in order to correct an irregular heartbeat, such as during a heart attack. According to Medtronic, the Sprint Fidelis leads are more than twice as likely to break within 30 months as other lead wires manufactured by the company. Imperfections in the wires may cause a defibrillator to fail to deliver a life-saving jolt during a heart attack or may cause the device to deliver unnecessary painful and repeated shocks to the heart. The Food and Drug Administration has received at least 1,600 reports of patients who have experienced injuries or malfunctions due to problems with the Sprint Fidelis leads. Approximately one-third of these patients suffered unnecessary shocks to their hearts as a result of fractures in the lead wires. Several injured patients experienced a malfunction in their Sprint Fidelis leads and have filed lawsuits against Medtronic. These lawsuits have alleged that Medtronic continued to sell the lead wires despite the fact that they knew the product posed a greater risk for injury than its other defibrillator wires. Some experts believe that the Sprint Fidelis leads, which are known to be the thinnest made by Medtronic, may have been too fragile to be used safely with defibrillators. Medtronic is already facing more that 1,000 lawsuits over the 2005 recall of some defibrillators manufactured by the company. With more than 268,000 Sprint Fidelis leads currently in use, some financial analysts believe that the company could be facing an even greater number of lawsuits over the Sprint Fidelis recall.

Posted by Kerry N. Jardine at 12:25 PM | Permalink | Comments (0) | TrackBacks (0)

KeyNeuroteck Pharmaceuticals is a biotechnology company focused on the development of drugs used in autoimmune and degenerative disorders of the central nervous system. It recently announced the start of a new clinical study that will evaluate the use of a cannabinoid receptor agonist to treat stroke patients called KN38-7271 to be held in Germany. Currently, KN38-7271 is being tested in an international Phase II study in patients with traumatic brain injury (TBI). In those cases the cannabinoid receptor agonist activates receptors in the brain by strengthening important natural protection mechanisms and preventing excessive inflammatory reactions. Dr Frank Striggow, CEO of KeyNeurotek Pharmaceuticals, said, “The start of an additional clinical study underlines our ambitions in neurodegenerative brain disorders and acute brain injuries. It is our goal to offer urgently needed, novel therapeutic options to doctors and patients as soon as possible." At present there is no effective therapy for comatose traumatic brain injury patients so a Phase IIa trial is underway to determine efficacy of KN38-7271 for them. KeyNeurotek has developed innovative therapies for the treatment of various neurodegenerative diseases of the central nervous system including traumatic brain injury (TBI), as well as stroke, Alzheimer's disease and urinary incontinence/overactive bladder.

Posted by Kerry N. Jardine at 06:23 AM | Permalink | Comments (0) | TrackBacks (0)

A study that was undertaken in 2006 by the Harvard School of Public Health challenges the long held belief that frivolous litigation is rampant and expensive. The researches analyzed past medical malpractice claims to determine the number of imprudent lawsuits and determine their outcomes. They found that the claim of frivolous lawsuits may be disproportionate to the medical establishment’s claim. In one third of claims they found that if the suit lacked clear evidence of medical error the plaintiffs received no compensation. Further, the number of worthy claims that did not get paid was larger than the number of unworthy claims that were paid. The findings appeared in the May 11th, 2006 issue of The New England Journal of Medicine. The authors of the study reviewed 1,452 closed claims and determined of 90% of the claims involving serious physical injury leading to permanent disability or death that 63% were due to error and the remaining 37% lacked evidence of error. Seventy-two percent of the reviewed claims not involving error, did not receive compensation. Bottom line: the malpractice litigation system seems to get it right about three quarters of the time.

In a separate study, a group examined effects of increases in malpractice insurance premiums on the delivery of health care services and the impact of state tort reforms and found that it has had only a modest effect on the supply of physician services. A lead author in that study also concluded that aside from caps on noneconomic damages, most tort reforms adopted by states in response to malpractice crises have not been effective in boosting physician supply or reducing insurance or litigation costs. The state contrary to the evidence is Texas. The medical boards responsible for approving licenses to doctors for Texas practices are inundated with requests from out of state. This begs the question, does that mean the malpractice system is broken or that below par doctors are trying to get a job. There’s a saying that half of all doctors graduate at the bottom of their class. The study is available at http://www.rwjf.org/publications/synthesis/reports_and_briefs/issue10.html

Posted by Scott J. Eldredge at 06:20 PM | Permalink | Comments (0) | TrackBacks (0)

In 2006 Washington State passed a Medical Malpractice law that prevents public disclosure of individual hospitals’ adverse events or incidents to be reported. An adverse event includes errors such as performing surgery on the wrong body part or leaving objects in surgery patients. This was discovered in a written memo from The Attorney General’s Office to the Department of Health. The issue received a great deal of attention after the Health Department agreed to stop publicly disclosing such adverse events at the request of the Washington State Hospital Association. The Health Department has collected and disclosed such errors since 2000, but the association argues that the 2006 law can now mean that hospital-specific disclosures can be stopped. The Health Department agreed pending a legal opinion from the Attorney General’s Office. After a deluge of complaints to the hospital association, officials there said they would work to change to the law so that the hospital-specific reports could continue to remain public and will include more content about individual hospitals’ reporting errors. In the legal interpretation, Assistant Attorney General Geoffrey Hymans said the state's Public Records Act was changed by the medical-malpractice law to specifically exempt any notifications or reports of adverse events or incidents made under that law. Those changes also prevent disclosure under the law passed in 2000, Hymans said.

Posted by Scott J. Eldredge at 01:19 PM | Permalink | Comments (0) | TrackBacks (0)

The second largest Medical Malpractice payout in Maine has been awarded to a woman whose son was born in 2002 with cerebral palsy. The jury agreed that the midwife during the 16 year-olds delivery did not notify the head doctor that the boy was in distress during delivery and did not order a Caesarean section, thus causing a lack of blood and oxygen to his brain. The woman won $7.96 million from the hospital and midwife that will be used for the boy’s past and future medical care.

Posted by Scott J. Eldredge at 06:17 AM | Permalink | Comments (0) | TrackBacks (0)

An article found in the Journal of American Medicine has found a striking connection between hypopituitarism and traumatic brain injury. Hypopituitarism is a failure of the pituitary gland to produce hormones, especially a deficiency in growth hormone, which has been known to result in dwarfism. The study used the MEDLINE database to search for articles published between 2000 and 2007 using a combination of words including traumatic brain injury, hypopituitarism, growth hormone deficiency as well as a number of other search words. The original objective was to review research on hypothalamopituitary dysfunction as an unusual consequence of traumatic brain injury. What was found was that neuroendocrine dysfunction (the impaired ability of a nerve cell to release a chemical messenger into the bloodstream) following traumatic brain injury may occur with a much higher prevalence than previously suspected. This is a potentially serious but treatable complication of brain injury. What they identified was 19 studies including 1137 patients in the chronic phase after traumatic brain injury (as well as aneurysms) and the prevalence of hypopituitarism was greater in patients with severe traumatic brain injury and evolved over time. Patients with posttraumatic hypopituitarism showed an impaired quality of life. The research concluded that hypotituitarism is a common complication of TBI and aneurysm and may contribute to poor recovery and morbidity.

Posted by Kerry N. Jardine at 12:16 PM | Permalink | Comments (0) | TrackBacks (0)

A night in August 2005 would change the life of a 29 year-old forever. Ryan Reitmeyer was driving a Sea Ray Jet Ski when he ran into a 35 foot boat cabin. He hit the left side of his head and was in a coma for more than a month. His brain was swollen with a traumatic brain injury. The doctors removed part of his brain after a CT scan revealed the part that controls speech was hemorrhaging. The doctors said that Ryan would probably die, and if not that he would never be able to speak or feed himself again. Even after surviving, the medical professionals warned the Reitmeyers that their son would need anti-seizure medications, intense therapy and probably lifelong supervision. His central nervous system was still damaged so the doctors suggested activities to encourage neuroplasticity (keeping the brain active so it can heal itself).

Today he is doing Karate and taking lessons in Comedy Improv. As part of his recovery he undergoes treatments to stimulate his brain and force blood into damaged parts of his head. To aid his recovery, Ryan Reitmeyer has a full schedule of activities, including karate to keep his brain active so it can heal itself. He starts his day by doing 4 miles on a stationary bike. He does biofeedback training with his physical therapist twice a week and karate class four times a week. He also practices reading, math and writing several times a week, as well as comedy improvisation. Though Reitmeyer depends on state and disability insurance, his parents have used money from savings and taken out second mortgages on their homes. His expenses have exceeded $1 million dollars in medical treatment and rehabilitation. For those who survive, lifetime recovery can cost more than $3 million.

Posted by Kerry N. Jardine at 07:12 AM | Permalink | Comments (0) | TrackBacks (0)

The war in Afghanistan and Iraq has brought attention to traumatic brain injuries of more than 100,000 Washington residents suffering the same debilitating symptoms. This year the Washington legislature has approved a set of state funding programs and services for TBI patients. The funding has increased to about 10 times what it usually spends. Before this year the state was known to spend only $200,000 a year on programs and services for TBI survivors. State Rep. Dennis Flannigan, D-Tacoma, said he realized more needed to be done. His legislation, House Bill 2055, imposed a $2 fee on all traffic tickets and estimates the fee to bring in $1.9 million a year for TBI programs and services. The Brain Injury Association of Washington received a boost of public awareness when the experiences of Bob Woodruff, a journalist for ABC News who was critically injured by an improvised bomb and suffered a TBI himself, became public. Woodruff has since written a book and has helped start the Bob Woodruff Family Fund for Traumatic Brain Injury. Flannigan's bill was introduced two weeks after Woodruff's book came out. Without it, Flannigan said, it was "very doubtful" the bill would have passed. The bill created a 24-member advisory committee to oversee creating a public-awareness campaign, a statewide referral network and facilitation of support groups.

Posted by Kerry N. Jardine at 08:10 PM | Permalink | Comments (0) | TrackBacks (0)

In an encouraging step, Ft. Carson Major General Mark Graham has asked for the civilian population’s help and advice for soldiers returning from the two wars. Since he has become the top general at Ft. Carson, his mission has been made clear, “Provide the best care possible for soldiers returning from Iraq.” He announced that he is expanding the Warrior and Family Community Partnership program and is asking local and national experts for their recommendations on how to provide the best care for the soldiers and their families. "We do a lot of work here with post-traumatic stress disorder, mild traumatic brain injury and also other soldiering issues and challenges that we're having because of the war on terror with our soldiers and families," Graham said. "We care about soldiers." Elizabeth Hawkins, executive director of ONE Freedom, a Boulder-based nonprofit that has been helping soldiers returning, is one of the civilian groups that has helped Fort Carson soldiers. "Graham is potentially building one of the first bridges, as I see it, between not only the service members and care providers but a bridge between the military and civilian world," Hawkins said. "It sounds like an outstanding first step to me." Fort Carson estimates between 20 percent and 30 percent of soldiers returning from Iraq have a behavioral health issue. A survey by the Mountain Post showed nearly one in five soldiers suffered a mild traumatic brain injury while deployed.

Posted by Kerry N. Jardine at 01:08 PM | Permalink | Comments (0) | TrackBacks (0)

At the request of the U.S. and foreign health officials Bayer AG has stopped worldwide sales of its anti-bleeding drug Trasylol. A Canadian study suggests that the drug is linked to a 50 percent higher risk of death than other drugs in the same clinical trial. The Food and Drug Administration asked the company to stop selling the drug until it could review further results from the study. Trasylol is used to prevent excessive bleeding during heart bypass surgery. It is also known as Aprotinin and works by blocking enzymes that dissolve blood clots. It is designed to stem blood loss and enable patients receiving heart bypass surgery to avoid transfusions. The suspension of the drug may be temporary for some patients. The FDA said it was exploring with Bayer whether to make the drug available on a restricted basis for use by physicians in certain patients they believe could benefit from the drug. Bayer estimates Trasylol has been used in roughly 4.8 million patients over the last 14 years. The Canadian study comparing Trasylol with two other drugs was halted when preliminary results suggested Trasylol exposed patients to a greater risk of death. The actual number of deaths was not available. The FDA said it requested the drug be pulled rather than wait the six weeks for further definitive results.

The FDA approved the drug in 1993, but began re-evaluating the drug's safety after a January 2006 publication of two studies that linked the drug's use to serious side effects, including kidney problems, heart attacks and strokes. More recent studies further suggested the drug also raises the risk of death. One of those studies previously was withheld by Bayer from the FDA due to what a company investigation later characterized as a "regrettable human error."

Posted by Kerry N. Jardine at 07:05 AM | Permalink | Comments (0) | TrackBacks (0)

A new hope may be made available to people with catastrophic spinal cord injuries. New experimental therapies to be tested in clinical trials could improve the treatment of people with spinal cord and brain injuries as well as stroke or other severe movement disorders. The new therapies include an experimental, custom-made antibody to NOGO-A. NOGO-A is one of several inhibiting proteins to nerve fiber growth that are produced naturally in the human spinal cord and brain. It soon will be evaluated as a therapy for patients who are newly paralyzed from spinal cord injury. NOGO-A is one of several proteins whose existence in the adult body helps to explain the limited ability to grow new brain and spinal cord tissue. These inhibitory proteins are silent during embryonic and fetal development and even during the first few months of an infant's life. They limit the ability of the adult brain and spinal cord neurons to re-grow fibers that have been cut by injury. The study’s objective is to restore the fiber-growing capability of the brain and spinal cord by preventing NOGO-A from fulfilling its function as an inhibitor to fiber growth and regeneration. In the animal trial the anti-NOGO-A antibody enabled damaged spinal cords to partially regenerate and thus restored some motor function. The clinical trial is known as STASCIS and has to date enrolled more than 240 patients. The study is based on the understanding that within hours of a spinal cord injury a patient should undergo surgery to reduce pressure on the cord in order to limit damage. Initial evaluations of the trial have indicated that immediate surgery is safe and encourages the recovery of function.

Posted by Kerry N. Jardine at 08:03 PM | Permalink | Comments (0) | TrackBacks (0)

Banyan Biomarkers will be initiating a multi-center, international clinical trial to prove the effectiveness of the company’s protein biomarkers and their ability to detect traumatic brain injury in 2008. The clinical trial will be held at the R. Adams Cowley Shock Trauma Center at the University of Maryland Medical Center, Orlando Regional Medical Center in Orlando, Florida, University of California Davis Health System in Sacramento, California, University Pecs and University of Szeged in Hungary and the University of Padova in Italy. Banyan has developed a panel of biomarkers that will be tested in the blood and cerebrospinal fluid from over 200 severe traumatic brain injury patients. If the study proves effective, the results will be submitted to the FDA for another trial. This clinical study will be the first effort to systematically evaluate a biomarker in brain-injured patients. The U.S Department of Defense, Congress and the National Institutes of Health have helped financially support this endeavor.

Posted by Kerry N. Jardine at 01:02 PM | Permalink | Comments (0) | TrackBacks (0)

When Vermont Senator Ed Flanagan announced that he suffered a traumatic brain injury in 2005 after a near-fatal car accident, the state legislature began to explore a recommendation to increase motor vehicle registration fees by $1.00 to create a trust fund to assist Vermont citizens suffering from TBIs. The legislative study committee responsible for the decision is expected to release a report on the needs of victims suffering from head injuries including the draft bill to create the new trust fund in mid-December. Representatives of the Brain Injury Association of Vermont estimate that the fund could bank about $600,000 in revenue annually. "The details are still being worked on, but what we are considering is providing targeted case management for Vermonters with traumatic brain injuries who (sic) wouldn't otherwise have assistance," said Sen. Ed Flanagan, the chairman of the committee. "The fee would create a special trust fund to help people out if they have run through all their services through their health insurance provider or may not have insurance at all."

Posted by Kerry N. Jardine at 07:00 AM | Permalink | Comments (0) | TrackBacks (0)

LegalView.com is a complete online resource for anything legal and they recently re-launched their portal on the painful, debilitating and sometimes lethal disease Nephrogenic Systemic Fibrosis. Burg Simpson is a member and partner in this informative website on this disorder. The site can be found at http://nephrogenic-systemic-fibrosis.legalview.com. Visitors who would like to learn more about NSF and its related health issues are encouraged to visit this site. LegalView.com recognizes that NSF will be a public health problem for decades. The new website provides additional information on treatment resources and can help victims and their families find an attorney in their state.

Posted by Kerry N. Jardine at 12:54 PM | Permalink | Comments (0) | TrackBacks (0)

The main causes of serious car accidents are usually attributed to the use of alcohol and/or drugs and excessive speed. However, a study from Sweden has found that driver fatigue, slippery surfaces, bad judgment around curves, and over-correcting when panicked are additional scenarios in serious accidents. The Swedish study believes that these latest scenarios should be considered when designing new vehicle safety features. The researches have published their findings in the International Journal of Vehicle Safety. The University of Technology of Sweden researchers used a methodology know as the Driving Reliability and Error Analysis Method (DREAM) to determine the cause of 38 single vehicle crashes.

They found that the causes could be put into four groups. The first group was vehicles that drifted off the road or into oncoming traffic because of fatigue, sleepiness or distraction. The second group lost traction because of slippery surfaces. In the third group, loss of control in driving around a bend was a factor due partly to the high speed the vehicle was traveling. The drivers would overestimate their driving skills or had little experience in maneuvering at the right speed around a bend. Finally, drivers who panicked would lose control by over-correcting their steering to get out of trouble.

Vehicle safety has improved considerably in recent decades with the development of driver and passenger air-bags, side-impact protection devices, anti-lock break systems and traction control. With this DREAM analysis, manufacturers could use the finding to design new features that can compensate for the causes found in each of the crash scenarios. The development of sensors for crash prevention and detection and the activation of safety measures such as airbags and pre-tensioning systems could now take into account the unpredictable factors involved in single vehicle crashes.

Posted by Kerry N. Jardine at 12:52 PM | Permalink | Comments (0) | TrackBacks (0)

Dr. Pat Sample a professor at Colorado State University in the Occupational Therapy department and her colleagues recently completed a study of Traumatic Brain Injury survivors from the 1995 Oklahoma City bombing. In their study they discovered that many of the TBI survivors had never been informed about their brain injury or received any sort of assistance or rehabilitation following the bombing. When talking to survivors Dr. Sample said that a few of the men responded, “you know, they just basically told me that I'm going to be stupid now, and good luck.” She continues, “Who knows what really went on back then, but that’s the message they left with, you’re wrecked and good luck.” The Federal P. Murrah bombing survivors represent a significant community with TBI that struggles with daily life and doesn't receive the help they need. In response to the study findings, Sample and other occupational therapists, social workers and psychologists at CSU are working to remedy the situation for other TBI victims. CSU's Center for Community Partnerships (CCP) helps TBI survivors connect with services in the community, especially with job assistance. Judy Dettmer, a social worker and direct services coordinator for CCP, said TBI survivors have trouble because "often brain injury is not visible." Society doesn't ask why a person is struggling and why he or she can't just get on with their lives. They often have to adjust from independence to relying on others. Some may only need small things, like day planners with alarms to remind them of routine activities. It's sometimes as simple as needing someone to come in and put "sticky notes all over the house," Sample said. Insurance rarely covers long-term help so CCP finds services for people who could not otherwise afford them. "Nobody ever shows up here with money, but they're the ones who really need the help," Sample said

Posted by Kerry N. Jardine at 06:51 AM | Permalink | Comments (0) | TrackBacks (0)

A doctoral thesis written by an Australian man at the Victoria University shows that even a mild bump to the head of a child or teenager can cause life-long brain damage and symptoms similar to attention deficit hyperactivity disorder. Dr. Steve Sflekas reported this in his thesis titled “Working Memory Impairments in Children and Adolescents after Traumatic Brain Injury” while working towards his PhD in Clinical Neuropsychology. The thesis challenges the common assumption that the brain recovers to its same level after a small injury. His research found that children who suffered mild head injuries might score well in basic hospital and standard clinical neuropsychological screening tests, but up to six months later, they can continue to have difficulty concentrating, especially with multiple visual and auditory sources of stimulation. “A child with this type of head injury could listen to their teacher, but not write at the same time”, he said. “A large number of children are being wrongly diagnosed post-injury. Many are discharged without proper assessments and told there is no damage. Others are assumed to have learning disorders or ADHD when they show problems later, when in fact, it relates back to their bump on the head,” he continued. Using simple paper and pencil tests developed for the elderly to detect dementia could also be used on these children to test working memory. Children and teenagers assessed with mild brain injuries should participate as soon as possible in rehabilitation programs.

Posted by Kerry N. Jardine at 06:49 PM | Permalink | Comments (0) | TrackBacks (0)

Peter Gerber is suing several major pharmaceutical companies after contracting the incurable disease nephrogenic systemic fibrosis. The rare disorder is linked to dyes used in MRI scans for patients with kidney failure. The dyes contain a heavy metal known as gadolinium. The disorder is characterized by the stiffening of skin and joints thus restricting movement and has been know to lead to death in some cases because of possible affects on internal organs. No cures have been reported but some patients have seen improvement after treatment to improve their kidney function, according to the International Center for Nephrogenic Fibrosing Dermopathy Research. Mr. Gerber's suit claims that people with impaired kidney function are unable to properly eliminate the gadolinium from their system. Last year, the U.S. Food and Drug Administration issued an advisory that patients with moderate to end-stage kidney disease should avoid having medical scans that use gadolinium-based contrast dyes, such as magnetic resonance images and magnetic resonance angiographies. If the imaging is done, "prompt dialysis" following the procedure should be considered, the FDA said. Mr. Gerber had an MRI before he underwent a kidney transplant. The lawsuit filed in the San Francisco Superior Court names medical centers and the pharmaceutical companies known to develop the gadolinium contrasting dyes. After the advisory from the FDA, the companies put warnings on the gadolinium products.

Posted by Kerry N. Jardine at 12:46 PM | Permalink | Comments (0) | TrackBacks (0)

Researchers at the University of California in Irvine, reports in a new study using mice, that the brain’s own stem cells may have the ability to restore memory after a traumatic brain injury. The stem cells work by protecting existing cells and encouraging neuronal connections. In the experiments, the team was able to bring the animal’s memory back to normal levels as early as three months after treatment. "This is one of the first reports that you can take a stem cell transplantation approach and restore memory," said lead researcher Mathew Blurton-Jones. "There is a lot of awareness that stem cells might be useful in treating diseases that cause loss of motor function, but this study shows that they might benefit memory in stroke or traumatic brain injury, and potentially Alzheimer's disease."

The results of the study were published in the Oct 31st issue of the Journal of Neuroscience. The study showed that after injecting brain injured mice with 200,000 neural stem cells the mice could remember their surroundings about 70 percent of the time, the same as the healthy mice. The brain injured mice who did not receive the stem cell treatment still had memory deficiencies. The researchers also found that in the injured mice injected with stem cells, the cells lingered in the hippocampus (part of the brain linked to memory). Only about 4 percent of those stem cells became neurons, indicating that the stem cells were repairing existing cells to improve memory, rather than replacing the dead brain cells. This new research is a good indicator that using stem cells in brain injured patients may be another and successful way of treating them.

Posted by Kerry N. Jardine at 06:44 AM | Permalink | Comments (0) | TrackBacks (0)

Sanofi-Aventis, the maker of antibiotic Ketek, received a stern warning letter from the FDA which cited numerous serious violations in the drugmaker's safety study. Referring to the study known as "Study 3014," the FDA wrote, ". . . we conclude that Aventis did not adhere to the applicable statutory requirements and FDA regulations governing the conduct of clinical investigations."

Although the problems with Study 3014 were numerous and serious, the FDA's letter focuses on the study site run by Dr. Maria Anne Kirkman Campbell, "a solo practitioner in rural Alabama who had never previously conducted an FDA-regulated study, but randomized 407 subjects into Study 3014 over a 3 months time period (i.e., November 2001-January 2002.)" When the FDA reviewed Dr. Kirkman Campbell's records, they "found that she falsified Case Report Forms (CRFs) that were submitted to the sponsor and falsified documentation to support the existence of a fictitious subject. Dr. Kirkman subsequently pled guilty to one count of mail fraud in connection with this fictitious subject and was sentenced to 57 months in federal prison."

In addition to fictitious patients, other problems cited by the FDA include: 1) lack of valid informed consent by patients enrolled in the study; 2) failure to properly diagnose the condition being studied, i.e. bronchitis, before enrolling the patient and dispensing the drug; 3) failure to inquire whether the patient had sensitivities to certain substances which would have disqualified them from taking the drug being studied; 4) enrolling large numbers of patients in a short period of time during which, in fact, the doctor's office was "closed for lunch and not seeing patients" . . . and the list goes on.

The focus of the FDA's ire is that Aventis, via reports from its agent, PPD Development, was fully aware of the violations, yet "failed to promptly secure compliance from Dr. Kirkman." Since Study 3014 was designed to provide safety data relied upon by the FDA in approving the drug, fraudulent reporting is particularly egregious. Sanofi-Aventis has 15 days to tell the FDA its plan for ensuring that such violations do not happen in future studies, and its response will be followed up by a meeting between the FDA and the drug maker.

Posted by Kerry N. Jardine at 10:28 PM | Permalink | Comments (0) | TrackBacks (0)

A study recently published in the e-zine Archives of Internal Medicine by a group of doctors, reports on medical errors involving trainees from closed Malpractice claims. It is well known that medical care by trainees involves some inherent risks, but the types and causes have not been well known until now. This study analyzed malpractice claims which involved errors made by trainees. The claims were from 1984 to 2004 with the errors occurring between 1979 and 2001. Random samples of claims filed with 5 liability insures were used to determine what injuries and harm occurred. A comparison was made between trainee and non-trainees. Among 240 cases errors in judgment at 72%, teamwork breakdowns at 70% and lack of technical competence at 58% were the most prevalent factors in claims. Their study ultimately concluded that handoff of patients from doctor to doctor and lack of proper supervision should be addressed during the graduate medical education and focus on stengthing this lack in in training.

Posted by Scott J. Eldredge at 06:25 PM | Permalink | Comments (0) | TrackBacks (0)

In the beginning of 2003 a physically active man went to his doctor complaining about disorientation and lethargy. His doctor said that he probably had a calcified mass at the base of his brain, when in fact he had suffered a Transient Ischemic Attack; stroke. Yet, his doctor new that he had a tiny hole in his heart from birth that predisposes people to strokes. The man was Joseph Lamere and in the end he would suffer several more strokes. Attorney John Hopkins has claimed that the family doctor failed to diagnose the original event as a Transient Ischemic Attack and that therefore he failed to provide immediate treatment that would have prevented subsequent strokes that paralyzed the left side of Lamere's body. Instead, he based treatment on an assumption. Lamere ultimately spent 105 days in the hospital. After returning home he still had to have round the clock care. He suffers from short-term memory loss, no sense of time and spends most of his time watching TV or DVDs. He is almost totally dependant on others. Before the strokes he was riding his bicycle, playing indoor soccer and working out on his various exercise machines. Additionally, he has become chronically depressed. At the medical malpractice trial his wife testified "Every once in a while he would say 'I wish I was dead,' meaning that he didn't want to go through this. As active as he was, this was a death sentence for him." If Joseph Lamere’s doctor had taken steps to treat the first attack perhaps he would not be suffering the way he does now.

Posted by Scott J. Eldredge at 12:23 PM | Permalink | Comments (0) | TrackBacks (0)

There was a time when truck drivers were considered the “knights of the highway” and could always be depended upon to lend a helping hand to stranded motorists. That time seems to have vanished with the ever time constrained schedule the truckers follow to deliver their goods. The consequences have now left motorists in danger on state highways. Two truck drivers are at the core of a vehicular homicide that occurred on I-80 in Wyoming Wednesday, Oct. 24th and have been charged in connection with a fatal pileup. One has been charged with aggravated homicide by motor vehicle and was held in the Carbon County Jail. He rear-ended a Nissan Xterra pulling a U-Haul trailer as it slowed, the victim later died at the hospital. As the semi-truck was stopped in the lane another truck driver ran into the back of it, eventually causing a seven vehicle chain collision. That driver was cited for reckless driving and having alcohol in the cab of a commercial vehicle. A patrolman did confirm the bottle of wine was still sealed, but according to the federal motor carrier safety regulations, no alcohol is allowed in the cab of a truck.

Posted by Kerry N. Jardine at 10:15 PM | Permalink | Comments (0) | TrackBacks (0)

The Denver based medical malpractice insurance company Copic reported recently that the rates for most Colorado physicians will not increase for the second year in a row. In fact, they will be distributing $12 million to physicians starting in 2008. The company covers about 6000 physicians. Officials believe the rebate has been made possible because of success with the “3R” program that Copic trains physicians in. The 3R stands for “recognize, respond and resolve.” It encourages physicians to be up front and truthful when informing patients and their families of any medical mistakes that may have occurred. About 2000 physicians have availed themselves of the training. In 1000 cases of medical mistakes made only 45 patients have filed lawsuits since the 3R program was installed, hence the decrease in claims. In the past an environment of dissociation was affected when medical mistakes were made and the patients and their families would go home and get angry because no apology or explanation was offered, thus eventually seeking legal action. This is another example of simple disclosure protecting physicians not Tort Reform Caps.

Posted by Scott J. Eldredge at 06:20 PM | Permalink | Comments (0) | TrackBacks (0)