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December 31, 2007

Oregon Supreme Court Lifts Limit on Liabilities

The Oregon Supreme Court ruled that the family of a brain-damaged child can pursue damages from Oregon Health & Science University. This opens the door for compensation to be sought by people hurt by public employees. The court ruled that the liability cap of $200,000 violates the constitutional rights of Jordaan Michael Clarke, 9. In 1998 Jordaan suffered permanent brain damage while in the intensive care unit at OHSU hospital. The decision will affect state agencies, local governments and school districts. It cannot be appealed, but the Chief Justice left open the possibility that a legislative move could be made to the Oregon Constitution by raising the caps. In a concurring opinion made by Justice Thomas Balmer, "The arbitrarily low cap on damages for medical malpractice claims against OHSU and its employees is a problem that has long called for a legislative solution," Balmer wrote. "In my view, the Legislature should, at least for medical malpractice claims, increase the existing claims limit substantially and immediately and, perhaps, retroactively." Sen. Ginny Burdick, D-Portland, said the Legislature earlier this year looked at raising the caps to between $1 million and $2 million but couldn't reach an agreement that satisfied various groups, including trial lawyers and OHSU.


Insurer Accused of Age Discrimination

Jamaica Hospital Medical Center in Queens, New York is accusing Oxford Health Plans of engaging in age discrimination for people in need of acute rehabilitation and traumatic brain injuries against patients enrolled in Medicare Advantage. Oxford Health Plans shows the pattern of discriminations according to data released. “Our data clearly shows a pattern of age discrimination by Oxford that can be characterized as elder abuse,” David P. Rosen, chief executive of the hospital and its parent company, MediSys Health Network. In a statement he quoted that from Jan. 1 2006 to August 2, 2007, of 58 Oxford-insured patients referred by doctors for acute rehabilitation or traumatic brain injury rehabilitation, 46 were denied coverage. That is an 80 percent denial rate. The hospital has yet to file a lawsuit or complaint with regulators and Oxford’s parent company UnitedHealth has not commented on the findings. Under Medicare Advantage, the government pays insurance companies for taking on the risk of covering elderly patients' health needs. This is just another example of the types of hurdles traumatic brain injured patients face daily in the healthcare system.


Ortho Evra Federal Lawsuit Non-economic Damages Rejected

In a response to a closely watched federal lawsuit stemming from the Ortho Evra birth control patch, the Ohio Supreme Court upheld a 2004 law capping damages for pain, suffering and other non-economic claims in personal injury cases. This particular case involves Melisa Arbino who suffered a series of potentially fatal blood clots in her brain and lungs in 2005. Arbino maintains the clots were the result of her use of the Ortho Evra birth control patch. She is one of the fortunate ones. There have been a number of deaths in young woman who have used the patch. Ortho Evra is still being prescribed, but its label has been modified to inform users of the potentially serious side effects. Fortunately, the law does not limit damages in catastrophic cases involving paralysis or loss of limb and also does not limit economic damages. The Supreme Court decision does not bode well for victims of Johnson & Johnson’s irresponsible choice to withhold valuable and informative research studies on the effects of the Ortho Evra patch and its users.


December 28, 2007

Malpractice claims to proceed regardless of bankruptcy

Dr. John A. King, the doctor who filed bankruptcy after 124 malpractice claims were filed against him, has been told by the U.S. Bankruptcy Judge that eight of the 124 claims can go to trial. The eight lawsuits alleging medical malpractice can continue toward trial while he settles his debts in bankruptcy court, Judge Thomas B. Bennett ordered. Each of the eight malpractice claims against King, alleges he made mistakes in surgeries and harmed patients during his six months at Putnam General Hospital. They hired King in November 2002 and suspended his privileges the following May after a review of his work. He later surrendered his West Virginia medical license and left the state. Now living in Alabama, King filed for bankruptcy under Chapter 7 last month.


Nursing home’s wrongful death case to go to trial

The estate of Martha O’Neal moved forward with a wrongful death suit against Bethlehem Woods Nursing and Rehabilitation Center in Fort Wayne, Indiana. O’Neal fractured her femur in August 2001. After surgery she was transferred to the nursing facility. A few days later, O’Neal’s surgical incision was torn because the wheelchair given her was too small. During her stay at Bethlehem she was left on a bed pan for six hours causing her severe ulcers. The following September, a Bethlehem employee found O’Neal lying in a pool of her own blood following a dialysis treatment. She was then transferred to a hospital, but died Nov. 6th. Her estate filed the wrongful death claim against Bethlehem Woods in October 2003, but Bethlehem argued that O’Neal’s case should be handled under the medical malpractice law where the statute of limitations is two years from the occurrence. The trial court agreed and dismissed the case, but attorneys for the estate appealed and argued the case should be handled under the wrongful death statute of limitations, which is two years from the date of death. In this case, the estate met the limitation for wrongful death, but was filed a month late for medical malpractice. The appellate court ruled that the wrongful death law applies and was sent to the trial court for further proceedings, including a possible trial.


December 27, 2007

Doctor and Wife Team Indicted

A 65 page indictment against a Kansas physician and his nurse wife alleges that they and their assistants wrote unlawful prescriptions for narcotic painkillers, muscle relaxers and other drugs such as Fentanyl, Methadone, Morphine and Oxycodone. A Topeka, Kansas grand jury returned the 34-count indictment against Dr. Stephen J. Schneider, 54, and his wife, Nurse Linda K. Schneider, 49. Stephen Schneider has already had several medical malpractice suits filed against him in the past. This latest indictment charges them with conspiracy, unlawful distribution of a controlled substance, health care fraud, illegal monetary transactions and money laundering. The indictment alleges 56 of Stephen Schneider’s patients have died from accidental prescription drug overdoses in the last five years, but only four deaths have been attributed to drugs prescribed out of their clinic. However, Schneider has not been charged with the death of these patients. The indictment also says that Schneider Medical Clinic operated seven days a week and was open for 11 hours daily. Patients were scheduled 10 minutes apart and the clinic billed more than $4 million to health benefit programs. Some of his patients knew him as “Schneider the Writer”, “the pill man” and “the candy man.”


Medical Malpractice Suit Settled for Family of Slain Reporter

David Rosenbaum, 63, was a reporter with the New York Times’ Washington bureau. In January 2006 he was beaten with a pipe while being mugged near his home just days after he had retired. The emergency workers who responded to the scene initially thought Rosenbaum had been drunk and didn’t try to determine whether he was injured. The driver of the ambulance did not take Rosenbaum to the closest hospital, but took him to a hospital almost two miles out of the way. Rosenbaum’s family filed a lawsuit against the Howard University Hospital in DC and the emergency workers accusing them of negligence and medical malpractice. The hospital settled for an undisclosed amount of money.


New Study Determines Renal Failure Patients Only Ones in Danger of NSF

According to the American Journal of Roentgenology, published by the American Roentgen Ray Society, adverse allergic reactions to gadolinium are minimal in patients without renal failure. Their study is in response to the recent concerns associated with the disease Nephrogenic Systemic Fibrosis and the use of Gadolinium contrasting dyes. “Over the past few years, the utilization of contrast-enhanced MRI has markedly increased; it’s increased by 65% at our institution over the previous five years,” said Dr. Dillman. This is due in large part to a variety of new applications, such as magnetic resonance angiography (MRA) and abdominopelvic MR imaging,” he said. “Consequently, the number of intravenously administered gadolinium-containing contrast material doses over the same time period has significantly increased. Based on the extensive use these intravascular contrast agents, we felt that it was once again time to study their safety profile,” he said.


December 26, 2007

Helmets and Kids Safety from TBI

With the Holiday season coming to a close and children venturing outdoors to try out their new bikes, scooters, etc. it is a good time to raise awareness once again to the dangers of Traumatic Brain Injuries. Bicycles are associated with almost half (47%) of traumatic brain injuries suffered by children. According to the bicycle Helmet Safety Institute, helmets reduce the risk of serious brain injury by 85%. Unfortunately, fewer than 41 percent of children ages 5 to 14 wear helmets while riding a bike or scooter and of those who wear a helmet, 35 percent of them wear it incorrectly according to the National SAFE KIDS Campaign. Remember to only purchase helmets with a certification sticker from Consumer Products Safety Commission, Snell, ASTM or ANSI. These companies make sure the helmets meet current safety standards. Go to www.consumerreports.com to research safety malfunctions, recalls and helmet ratings. Most importantly, if a child severely hits their head while wearing a helmet, throw it away. In fact, if some manufacturers are notified of a severe head impact without injury, they will replace the helmet for free.


Severely Beaten Cop Suffers TBI

A 17 year veteran police officer was severely beaten in the summer of 2007 while trying to arrest an alleged church burglar. The perpetrator grabbed Sergeant Mike Kane’s baton and beat him with it, then proceeding to strike Kane several times in the face with his fist. The beating caused him to suffer a traumatic brain injury. He still suffers from the affects of his brain injury; blurred vision, dizziness and he has to take medicine every night to fall asleep. Sergeant Kane is still unable to return to his job because of his TBI, his doctors say that he may never return. "I'm going back, I'm not going to give this guy the satisfaction of that," Kane said. Kane is now left with trying to provide for his wife and little girls.


TBI tool successful for survivor

Two years ago 31 year-old Ryan Reitmeyer was hit by a 37 foot cabin cruiser on a Texas lake. The impact crushed his skull, paralyzed him and sent him into a coma. The surgeon told Ryan’s father Doug that he could probably save him, but he would likely never speak or live independently again. After four months he was walking with assistance and talking, but he had no memory. Doug Reitmeyer began to search for tools to assist further with his son’s memory. In his search he found Dr. Michael Merzenich of the Univ. of Calif. San Francisco, a neurologist and neuroscientist. "Understand now that the brain is continuously capable of positive change that at any age it can be driven in a corrective direction using the right behavioral approaches," said Dr. Merzenich. He founded Posit Science based on the principal that the brain is a plastic organ and will continue to improve given the right tools. Posit's Brain Fitness program found the exercises improved memory and processing speed in older adults. Doug Reitmeyer and Dr. Merzenich reached an agreement. Doug provided Ryan for Dr. Merzenich’s research in traumatic brain injury recovery using the Posit Science. The exercises assisted in the incredible recovery of substantial memory from none. Ryan is now living independently and driving again. Dr. Merzenich believes Ryan will continue to improve, as will the technology posit offers. "One of the beautiful things about this approach is it's not like a drug where you have a chemical compound which is unchangeable, we can devise a strategy for Ryan and that strategy can be ultimately changed and improved over and over again. Three years from now we will provide much more complete and elaborate training tools for someone like Ryan," said Dr. Merzenich. Posit is partnering with Easter Seals to make its brain fitness program available for free to returning war veterans suffering from brain injury.


December 24, 2007

Beneficial Molecules in Brain Being Studied

Neuro-surgery researchers are testing a pathway in the brain to see if it might lead to new ways which could reduce long-term damage and complications as a result of a traumatic brain injury. Brain injury researcher Dr. Kenneth Strauss said a patient may survive the initial traumatic brain injury, but not the swelling in the brain that occurs days later. Strauss said, “Sometimes a patient will come into the neurosurgery intensive care unit, wake up from a concussion or short coma and three, four, five or six days later basically do a nose-dive.” The problem surfaces during the days after the initial trauma where the brain produces response molecules. Some of these molecules cause swelling and further injury to the brain, but others appear to be protective. Strauss's research team has been awarded a $1.7 million dollar grant from the National Institutes of Health to find a way to help boost the brain molecules that are beneficial. “We're actually looking at the formation of the beneficial compounds and trying to tweak the brain to make more of those that are beneficial,” he said. If this research is successful, Strauss said it could contribute to a new class of medications that might boost these helpful molecules and therefore reduce complications from traumatic brain injuries. The goal is to reduce the odds by helping the brain heal itself. The research is being conducted only in laboratory studies, but human trials are the next step.


Gadolinium Dye Link to NSF Becoming Irrefutable

Nephrogenic Systemic Fibrosis (NSF), also known as Nephrogenic Fibrosing Dermopathy (NFD) is rare, but so far has only affected people with pre-existing kidney problems. The link between Gadolinium MRI dyes and NSF is gaining ground and quickly becoming irrefutable as the cause of the debilitating and sometimes deadly disease. In 2006, researchers discovered a direct association between NSF and the use of Gadolinium MRI contrast dyes. Since then, several other studies have reinforced the link between NSF and Gadolinium. The FDA in 2006 first warned doctors of the side effect. In 2007 the FDA ordered the manufactures of Gadolinium to add a black box warning, the strictest type of FDA warning, to their product labels advising of the risk of NSF to people with kidney problems. NSF leads to excessive formation of connective tissue in the skin and internal organs and is characterized by high blood pressure, burning, itching, swelling and hardening of the skin. Other symptoms include red or dark patches on the skin, pain deep in the hip bones or ribs and muscle weakness. Researchers at Yale University have reported that 95-percent of those with NSF had an MRI that involved Gadolinium two to three months before their symptoms appeared. Researchers at Massachusetts General Hospital also have found that kidney patients who had undergone MRIs with Gadolinium were 10 times more likely to develop NSF than patient who had not been exposed to such agents. Unfortunately, there are no effective treatments for NSF, although some patients have improved following a kidney transplant and there are no other alternatives to gadolinium based MRI contrast agents.


Medtronic Settles Marquis Defibrillator Lawsuits

Medtronic, Inc. announced that it has agreed to settle lawsuits relating to its Marquis line of implanted cardiac defibrillators. Under terms of the settlement, Medtronic has agreed to settle 2,682 cases for $95.6 million plus $18.5 million in attorneys' fees. The cases in the settlement are from February 2005 when Medtronic advised doctors about a potential battery problem that could cause certain implantable defibrillators in its Marquis line to fail. The settlement is a compromise and there is no admission of liability. No additional sums will be paid by Medtronic for third-party claims or attorney fees. "We are pleased to settle these cases and put the matter behind us," said Pat Mackin, senior vice president and president, Medtronic Cardiac Rhythm Disease Management. "We prefer to focus our resources on areas that are beneficial to physicians and patients, rather than prolong this litigation. We know the Marquis line of defibrillators continues to provide life-saving therapy for thousands of people around the world, and they remain among the most reliable ICDs ever manufactured by Medtronic."


December 21, 2007

Study Published on Group of Brain-injured Vietnam Vets

A study published in the online journal, Brain reports on Vietnam veterans who suffered brain injuries showed a quicker decline in the cognitive functions as they grew older. It was found that the rate of decline can be predicted by how intelligent they were and what level of education they completed before their injury. Interestingly, those who completed a higher education and were considered more intelligent showed less decline in cognitive functioning in the years following their brain injury. Dr Grafman, the senior investigator in the Cognitive Neuroscience Section at the National Institute of Neurological Disorders and Stroke, National Institute of Health, Maryland, USA, and his colleagues studied a group of Vietnam veterans with penetrating head injury (PHI) 36-39 years after the injury. The veterans were part of the Vietnam Head Injury Study, a follow-up study of about 2,000 Vietnam veterans that has been running since 1967. This report is on the third phase of the study, and it looked at a total of 199 veterans who are now in their mid to late 50s. He believes that greater intelligence is an indicator of the brain’s ability to establish multiple neural connections and that this enables the brain to recover better from injury. This new information on the decline in cognitive functioning seen in the head injured veterans could mean that they might have to take early retirement from employment and might be less able to manage domestic responsibilities. However, the research could be useful for the men, their families and their doctors. “By telling patients and their families that later in life they will be at risk for a more rapid decline in certain abilities compared to unimpaired individuals can be difficult to hear,” he said. “But it can be helpful in terms of long term planning and, potentially, practices could be developed that might protect against it, like staying physically fit and intellectually active.”


Illness Linked to Syringes Tainted with Bacteria

Medical syringes used by patients in home treatments for cancer and other illnesses have been contaminated with the bacteria Serratia marcescens (Sur-AY’-she-uh mar-SUH’-sens). About 40 people have fallen ill in Illinois and Texas, 20 of which were outpatients from Rush University Medical Center in Chicago. So far no deaths have been linked to the infection. The Rush doctors traced the infections to heparin-filled syringes from the company Sierra Pre-Filled in Angier, N.C. Federal investigators are inspecting the cases. Syringes from the same batch were also sent to Colorado, Florida and Pennsylvania, but at this time no infections have been reported from those states. The infections can cause fever and chills, but respond well to antibiotics. Of the 20 outpatients affected, 14 required hospitalization. The pre-filled syringe lot responsible is 070926H. Patients who think they used the recalled syringes should contact their doctors. Bacteria were found in fluid from the pre-filled syringes but it is uncertain if the original contamination was in the heparin, the saline used to dilute the drug, or the syringes themselves.


Analysis Shows Obese Wait Longer for Organ Transplants

Dr. Dorry Segey of Johns Hopkins University, a transplant surgeon, recently completed a study showing people who are obese wait longer for a transplant than average weight people. The research was based on an analysis of records from 132,353 patients on the national kidney transplant waiting list between 1995 and 2006. The findings were published in the Journal of the American Society of Nephrology. The reason assigned to the discrimination is that the very obese have a greater risk for complications. The study showed that morbidly obese patients who average about 100 pounds over their ideal weight were 44 percent less likely to get a transplant than normal weight patients. Those just slightly less obese were 28 percent less likely to get a transplant. Dr. Segev argues that once someone has been accepted for a waiting list, the patient should progress to the top normally. He also believes the doctors and transplant staff do not consciously choose slimmer candidates over their obese patients. “I don't think any of this is conscious,” Segev said. “It would be hard to imagine any of us in our field would deliberately act against the welfare of our patients. That's not what we do, but there are all sorts of subconscious forces that are happening and there's clearly an unintended bias in practice.” He explains there may be two factors creating the bias. First the main insurer for kidney transplants, Medicare, pays a fixed rate regardless of the difficulty of each case, meaning the transplant hospital eats the added costs for complications. Second, transplant centers with lower survival rates risk losing Medicare funding. With American society increasingly gaining weight and entering the ranks of the medically obese, the implications of the study are worrisome.


December 20, 2007

Man with TBI disappears for 23 days

Scott Tidgell, a 23-year-old Duluth, ND man went missing between October 10th and November 2nd. He was eventually found at a rest stop in Menomonie, WI. The unusual part of his disappearance was that he doesn’t remember what he did for the 23 days he was missing. It is believed he suffered from a memory lapse, possibly brought on after illness and stress exacerbated the effects of five concussions he received in the past. Surprisingly, while he was gone Tridgell was able to pay for meals at restaurants, get gas for his truck and drive, but evidently could not find his way back to Duluth, call his family or ask for help. Multiple concussions, such as the four Scott received in youth sports, can compound the damage that each one alone would do. “If he could do all those basic things why couldn’t he ask someone, ‘Can you help me find Duluth?’ ” said Dan Wallerstein, a rehabilitation physician who works with brain injury patients. He further added that successive injury adds more dysfunction to the brain. Skip Silvestrini, who works with brain injury patients at the Duluth Clinic, said automatic actions, such as driving, don’t require much effort from the brain. To realize where he was and how he would get back to Duluth may have required more effort than his brain could have given. Even after cognitive rehabilitation there is no certainty that a patient with a traumatic brain injury like Tridgell’s could ever recover his missing memories.


Boat Propeller Causes Catastrophic Head Injuries to Boy

Two men are charged with leaving the scene of an accident, failing to render aid, and face an enhancement charge of causing great bodily injury. The driver’s charges include speeding and being under the influence. Labor Day weekend in September 2006, Dallen McIntyre, 11, was hit by a boat while knee-boarding behind his father’s personal watercraft. The father testified that the boat suddenly made a sharp turn and came toward them, knocking Dallen into the lake. The two men fled after hitting him. The impact with the propeller of the boat split the boy’s head and nearly killed him. He suffered catastrophic head injuries and has undergone several surgeries. An expert who manufactures propellers examined the propeller in question and determined that the damage was caused by the collision with the boy’s head. The examination concluded there were no scuff marks, chips or scratches, indications that the man’s boat propeller was responsible for the severe damage to Dallen. "The impact was great," the expert said, noting it was not easy to damage the propeller.


LegalView.com Updates Avandia Information Portal

LegalView.com recently updated its Web portal concerning new risks associated with the use of Avandia in Type II diabetes patients. In a recent study out of the Salk Institue for Biological Studies in La Jolla, California has found that long term use of Avandia, also known as rosiglitazone, causes an increase in bone fractures and breaks among patients who use it. Tests showed that the drug increased bone degradation cell activity. GlaxoSmithKline, makers of Avandia, acknowledge the increased risk of bone fractures and breaks among patients taking the drug, especially in older women, but the company did little to make users aware of this increased risk. LegalView.com remains the premiere site for legal information and its many legal information portals are used to serve people suffering from preventable diseases, illness and unfortunate accidents.


December 19, 2007

Sensor Helmets and Transcranial Doppler

Bob Woodruff of ABC News recently reported on four new technologies for troops and athletes that show incredible promise in treating and preventing traumatic brain injuries and concussions. Currently Virginia Tech football players are wearing special helmets that monitor and collect data on impacts to the head. The military is measuring the power of explosions on test dummies wearing the same type of sensor helmets. Transcranial Doppler is another technology being developed which measures blood flow inside the brain and helps doctors determine the course of treatment as soon as the injury occurs. The Transcranial Doppler shows an extreme increase in blood flow making it a useful medical tool for troops. The third new gadget is the Wobble Plate. It will measure how wobbly a patient is after an impact or explosion and compares it to their normal state. Doctors use the readings to diagnose the level of trauma. Lastly, a more affordable and portable model is being designed and is the Hand-Held Doppler. When it is held up to the side of the head it hears the rate of blood flow and any changes in sound will enable the operator to determine how much blood is flowing through the artery and possibly what is happening inside the brain. This technology could be especially useful on the front lines to determine whether military doctors need to remove part of the skull to allow blood to flow more freely. Each of these technologies has great importance in the treatment and prevention of traumatic brain injuries.


TBI Survivor Reinvents Himself

If hope has been lost after you or a family member suffered a traumatic brain injury, the following is the story of a survivor and should assist in dispelling further fears.

“I am a nurse on the brain injury unit at the Rehabilitation Institute of Chicago (RIC). This job means a lot to me because at one time I was the patient. More than 22 years ago, I had an accident while working in a steel fabrication shop. I fell more than 15 feet from a ladder to the floor. While one coworker called 911, another coworker held my unresponsive body. I started to turn blue, so while he waited for help, he put me in a bear hug and squeezed me, "the way they do on TV," he said. I started breathing again, but to his surprise blood started gushing out through my left ear. He didn't know if he had saved me or helped kill me. He had ruptured my ear drum, which allowed the blood and cerebral fluid that was building pressure in my head to escape, quite possibly saving my life. I had suffered a traumatic brain injury, caused by a basal skull fracture, in addition to a separated shoulder. My short-term memory and speech were affected, and I suffered some left-sided paralysis. So, following my hospital stay, I started rehabilitation through outpatient therapy. I participated in cognitive therapy and physical and occupational therapies and admired the therapists and nurses who helped me find my way back. After I was released from the hospital and went through ongoing rehabilitation, I was able to fine-tune some of the more creative skills I hadn't been using for a while, such as carving, woodworking, and music. I started playing my guitar more, which was an escape from the daily challenges of recovering from a brain injury. More than a year after my injury, I was released to go back to work, but I had a list of restrictions preventing me from returning to iron work. After several job attempts, I knew I had to make some decisions about my future. Thinking about the life experience I had been through in recovering from a brain injury during the previous year, I was struck with the fact that I wanted to make a difference for people, just as the nurses and therapists had made a difference for me. I found a job that provided tuition reimbursement, and I went back to school and began the steps toward a nursing career. I enrolled in the nursing program at Prairie State College in Chicago Heights, Ill. Balancing school while working 70 hours a week and taking care of my home and family was the ultimate challenge. But nothing was going to stop this future nurse!
“One of my favorite things about working at RIC is being a part of the long-term care plan. This gives a nurse a chance to get involved with the patient and family. Also, I'm able to use my other passions, like music, in my career. Some brain injury patients lose their ability to speak, so I have to find creative ways to communicate. Music is universal and has no boundaries, so it is a perfect tool to use when I want to connect with someone. Also, science suggests that sound stimuli helps hasten the growth of neurons and help them to find or create new pathways that once were thought to be lost forever because of traumatic brain injury. Three years ago I took my guitar to work and played for a "sundowner," a patient whose circadian clock had been altered because of the nature of his brain injury, resulting in inconsistent sleep patterns. The music helped him fall sleep without medication, when nothing seemed to help before. His response to the music was a real breakthrough. Today, eight years into my nursing career, I wouldn't change a thing about my life. If I hadn't been injured, perhaps I wouldn't have discovered nursing. It's almost as if I don't have to work any more — I can't believe they pay me for what I do!”



Fort Collins Family Launches TBI foundation

Fort Collins, CO resident, Nate Jorgenson, 29, was hit by a drunk driver more than three years ago, fracturing vertebrae in his neck and causing a deep brain hemorrhage. He had to learn how to walk and talk again. In response to his recovery experience his mother Debbie Jorgenson, launched the Shared Journeys foundation, a non-profit targeted at helping people with traumatic brain injuries regain their independence. Her goal is to establish a transitional living facility as well as a day-rehabilitation program that would assist TBI victims in relearning skills such as personal care, meal preparation, money management and socialization. Nate is working on his physical training certificate so that he can help clients through their recovery. Nate himself is still two years away from being able to live on his own. During the month of March, the brain injury awareness month, Debbie Jorgenson plans to have a community-wide fundraiser. There are resources available in the community to help people recovering from traumatic brain injuries, but there are gaps, said Christy Dittmar, clinical director for the Center for Neurorehabilitation Services in Fort Collins. The center provides services to about 600 clients a year, about half of whom have suffered traumatic brain injuries. It takes years to recover from such injuries, and continuing care is extremely important after the acute care has ended, Dittmar said. That care helps to transition people back to living independently, the final goal for many patients.


December 18, 2007

Suit against makers of the Ortho Evra patch filed in Illinois

In Illinois a St. Clair County woman has filed suit against Ortho-McNeil Pharmaceutical claiming her use of their popular Ortho- Evra transdermal birth control patch caused her to develop deep vein thrombosis. Connie and husband Larry Lager filed the product liability suit October 17th against Ortho-McNeil Pharmaceutical, Johnson &Johnson and their Pharmaceutical Research and Development group. They claim the defendants relied on safety and risk information from previous studies done against contraceptive pills, thus not being further and sufficiently tested in clinical trials. The Lagers’ team of lawyers filed the compliant stating, “Defendants knew or should have known that the intake of hormones contained in Ortho Evra through the Patch would result in a level or estrogen...much higher (approximately 60% higher) than the levels associated with intake through the oral route, such as with birth control pills.” Additionally, the Lagers claim the defendants failed to take into consideration warnings from the Food and Drug Administration which determined that blood clots could be a problem with the patch.

"...Plaintiffs seek compensatory damages as a result of Connie Lager's use of the Patch, which has caused her to develop and suffer from deep vein thrombosis, as well as other severe personal injuries which are permanent and lasting in nature, including but not limited to, suffering, physical pain, permanent scarring and disfigurement, and mental anguish, including diminished enjoyment of life, and any and all lasting complications, such as Plaintiffs need for lifelong medical treatment, medical monitoring and/or medications, and a fear of developing further adverse health consequences," the complaint states.


Ortho Evra makers pay $1.25 Million in Death of 14-Year-Old

Johnson & Johnson settled a lawsuit in an agreement to pay $1.25 million dollars to the survivors of Alycia Brown, a victim of two blood clots in her lungs due to the use of the Ortho Evra transdermal birth control patch. Her lawyer, Janet Abaray, could not further elucidate because of a confidentiality agreement. Alycia used the patch for several weeks prior to the appearance of the blood clots in May of 2004. 5 million women are thought to be using the patch of which 2400 are filing or have filed lawsuits against Johnson & Johnson claiming strokes or clots in their legs or lungs. The company has already settled dozens of cases before trial. The Brown agreement highlights how much J&J is willing to pay to possibly avoid shedding light on the company’s safety concerns about the patch before market release in 2001. Details of the Brown agreement were found in a file of a lawsuit by the family of Zakiya Kennedy, who was 18 when she died on April 2, 2004, after using the patch. Court records show that a confidential settlement was reached in that case on Oct. 11. Another trial is scheduled for trial in St. Louis which involves the death of Ashley Lewis, who was 17 when she died in late 2003 after using the patch.

The Food and Drug Administration warned in November 2005 that the patch may cause clots and expose women to 60 percent more estrogen than oral contraceptives. In February 2006, another study found a twofold increase in the risk of clots compared with women who took the pill. Johnson & Johnson has not revealed details of the reserves for Ortho Evra cases. It said in an Aug. 8 regulatory filing that it faces numerous product liability cases and believes any liability “will be substantially covered by existing amounts accrued in the company's balance sheet and, where available, by third-party liability insurance.”

The case is Michael Brown v. Johnson & Johnson, 06-40013, U.S. District Court, North District of Ohio (Toledo).


Bankrupt Doctor Files Suit against Hospital

In another twist involving Dr. John A. King who has 122 medical malpractice suits pending against him, he has filed suit against the hospital he had privileges with. King has filed a lawsuit against Putnam General Hospital, its former owner and several hospital administrators and physicians. He seeks more that $531 million in damages claiming Putnam General defamed his character to hospitals, medical care providers and the public as well as improperly billing patients for services he performed and overcharged him for office rental fees. King seeks $500 million in compensatory damages, $31.5 million in punitive damages and $35,000 in legal fees and monthly payments. Earlier in the month, King filed personal bankruptcy papers that delayed the 122 malpractice suits against him indefinitely. King has lost and surrendered medical licenses in the states of West Virginia, Florida, Georgia, Michigan, New Jersey, Ohio, Pennsylvania, Texas and Virginia. Finally, last year King changed his name to Christopher Wallace Martin.


December 17, 2007

NY Dept of Health warns additional 8500 patients of exposure

New York State Department of Health announced it would be sending out an additional 8,500 letter to patients treated by Dr. Harvey Finkelstein. As in the original 628 letters delivered in November 2007, the Health Department is urging former patients to get tested for blood borne diseases including Hepatitis B, Hepatitis C and HIV. The hope is that all of Finkelstein’s patients between 2000 and 2005 will be warned. The medical malpractice occurring at the doctor’s practice first came to the attention of the Nassau County Health Department in December 2004. Then it was discovered that two people with Hepatitis C had been treated by Finkelstein. In January 2005, state and local health officials investigating Finkelstein went to his office to watch him work. The investigators discovered that Finkelstein reused syringes on a patient, resulting in a backflow of blood from the previous patient. Apparently, the doctor routinely reused syringes in this way. It is disturbing that it took the Health Department 3 years to determine and warn former and current patients of Dr. Harvey Finkelstein’s.


Healthcare System Errors Impact Malpractice Claims

The Doctor’s Company, a physician-owned medical malpractice insurer recently released a report on what impact health system errors have on medical malpractice claims. They conducted a claims analysis and found that health system errors contributed to 30 percent of settled claims. Of 363 closed settled claims from 2004 to 2006, the top health system errors were, medication-related (32 percent), communication (27 percent), health system infections (18 percent), medical records (13 percent) and wrong-site surgery (5 percent). These errors account for 95 percent of the total system errors in The Doctors Company’s analysis. Additionally, the analysis indicated that internal medicine, family practice and psychiatry represent nearly half of all medication-related errors such as: Lack of medication monitoring (43 percent) and dosage mistakes (26 percent). They account for 69 percent of the medication-related errors. Organizations such as the National Patient Safety Foundation are working to eliminate these five types of system errors. This analysis was undertaken to improve healthcare. Dr. Troxel, MD medical director of The Doctors Company concludes, “As the leading physician-owned professional liability insurance company in the U.S., our claims represents a sample of all medical malpractice claims and errors throughout the healthcare system. We believe that malpractice claims are a valuable source of information on preventable medical errors and that public disclosure of this data will contribute to the advancement of patient safety.”


Misdiagnosis Results in $2.5M Award

A woman received HIV treatments for nine years before discovering she never had the virus that causes AIDS. In response Audrey Serrano filed suit against Dr. Kwan Lai after he repeatedly failed to order definitive tests even after monitoring showed no presence of the deadly virus in her blood. The combination of drugs she took triggered depression, chronic fatigue, weight loss, loss of appetite and inflammation of the intestine. A jury sided with her and awarded $2.5 million in damages. Her attorney, David Angueira responds to the verdict, “It is one of the clearest cases of misdiagnosis that I have ever seen and it's based in part on a presumption that people who engage in certain types of conduct are more likely to have HIV and AIDS than other people without really listening to the patient.” The jury reached its verdict after two days of deliberations. The damages could total about $3.7 million including prejudgment interest. Serrano filed the lawsuit in 2003 after she became suspicious of her diagnosis and had herself tested at another hospital.


Public Citizen Advocates for Better Tracking in NY for Malpractice

The nonprofit consumer advocacy organization, Public Citizen, recently reported on the lack of proper oversight and discipline in New York State’s medical malpractice disclosures. New York citizens are at a disadvantage from other states because they are unaware of which doctors have been investigated for medical malpractice. State officials add that The Office of Professional Medical Conduct, the agency responsible for disciplining physicians, does not do enough to excise misconduct and malpractice. Other states generally allow access to information on doctors currently under investigation for malpractice, but New York law prohibits it. OPMC only investigates a doctor when a settlement of $500,000 or more is awarded, a judgment is made against them, or if a mother or child dies during child birth. According to a report by NY State Comptroller Thomas DiNapoli, “OPMC management concentrates little effort on proactively identifying cases of potential misconduct or ensuring that they have received all complaints.” Public Citizen further reports that patients suffer for the lack of oversight of bad doctors, those that make errors like surgery on the wrong limb, or on the wrong patient. Additionally, New York needs to create a way to track all incidents of doctor and hospital error that result in harm to a patient. It concludes that “If the state cleans up its act, the problems that the insurance companies and doctors bemoan will disappear and receiving medical care in New York will become a lot safer,” said Joan Claybrook, president of Public Citizen.


December 14, 2007

LegalView.com Offers Information on Malpractice in Nursing Homes

As the population of individuals who are being housed in nursing homes and assisted living facilities increase the incidents of medical malpractice will grow. In response, LegalView.com has launched a new practice area that offers information to those whose family members have entered or will soon enter into one of these facilities. The purpose is to make individuals aware of how to protect themselves and their loved ones from negligence and physical and emotional abuse in nursing homes and ALFs. The consequences of neglect and abuse can put individuals at risks such as dehydration, malnutrition and sometimes even death. Currently, in excess of 36 million people in the United States are 65 years old or older. As the Baby Boomer generation ages, by 2050 the number of individuals 65 years or older will reach a whopping 86.7 million. LegalView believes that the best care should be provided for these individuals, which is why it has launched the nursing home legal information practice area at nursing-homes.legalview.com, to offer support and resources for older individuals and their families. LegalView provides additional information regarding how to contact a nursing home attorney if such a case of neglect and abuse occur to a loved one.


After Arbitration Kaiser Permanente will pay $1.8 million in malpractice case

Ted Blackwell, 45, went to a Kaiser clinic complaining of neck pain and a headache. He received an injection and was sent home. Still in pain two days later, he returned to Kaiser for further assistance. His daughter requested a CT scan because he was behaving as if he was disoriented, but the doctors deemed it unnecessary. Another two days passed when Mr. Blackwell collapsed and had to undergo emergency surgery for bleeding in his brain. In the previous two clinic visits he was not diagnosed with cerebral bleeding caused by a brain aneurysm. The doctors thought his headache was the result of his grief over the recent death of his brother. Kaiser Permanente will now pay $1.8 million to him and his family because he is now permanently brain damaged and cannot work. The award decided through arbitration will cover pain and suffering and lost wages, but the rest will be used to cover around-the-clock supervision now necessary for the rest of Blackwell’s life. In California, malpractice judgments are capped at $250,000 for pain and suffering. Additional monetary damages result from loss of wages and need for ongoing care.


NY Councilman Proposes Plan to Protect Patients from Malpractice

In response to the recent case against Dr. Harvey Finkelstein, City Councilman Eric Gioia is introducing a plan that pressures city hospitals and health clinics to give patients information about medical malpractice and their doctors. He wants the facilities to direct patients to the state’s website, nydoctorprofile.com where they can determine if their doctor has faced any disciplinary action or lost any malpractice cases against them. Dr. Harvey Finkelstein would appear on the website since he has had 10 malpractice settlements against him in the last 10 years. Dr. Finkelstein may have infected numerous patients with hepatitis C because of improper sanitation practices. Dr, Finkelstein’s case is just one example of what would be made available to patients through the website.


Boy with Cerebral Palsy to be cared for with an $8M Malpractice Award

A jury on Thursday October 25th in Auburn, Maine sided with the plaintiff and awarded almost $8 million to a 5-year-old brain damaged boy and his mother in a medical malpractice lawsuit against the hospital and one of its midwives. Odysseus was born in April 2002 to his 16 year old mother Sasha Emond. Emond believed that the midwife who attended her at Central Main Medical Center should have recommended an emergency cesarean section when her unborn child appeared to be in fetal distress. Ultimately, Odysseus was born with cerebral palsy due to lack of blood and oxygen to his brain. “He will never be able to function in any activity of daily living without round-the-clock care, and what this jury gave him today is the ability to get that care," said Odysseus' lawyer. The hospital’s pretrial screening panel believed that it and its staff had complied with all guidelines. It took the jury 2 days to come to the decision for the plaintiff.


Heart patients ponder whether to replace potentially faulty wire

Medtronic’s recent troubles concerning the Sprint Fidelis leads in their heart defibrillators has brought up the question among patients whether they should replace their defibrillators or not. Patients and their doctors are pondering whether they should risk another operation on the off chance that they have one of the potentially faulty wires. To complicate matters, Medtronic has agreed to provide only $800 dollars towards the replacement procedure that could exceed $12,500 dollars and take 90 minutes or more. Up until now, insurers are deciding whether to cover the operation on a case-by-case basis, unless the lead has already fractured. The number of patients with the potentially faulty wires makes this a widespread problem and the recent issue Medtronic has faced has drawn renewed scrutiny to how the medical devices are approved and regulated. In fact, this episode has led to investigations in both houses of Congress. Daniel Schultz, director of the Food and Drug Administration’s center for devices and radiological health concurs, “It seems like a good time to figure out where we are in regulating leads and what we can do better.”


December 13, 2007

New Helmet to Help Determine Impacts in Brain Injuries

Simbex LLC and their high-tech helmet is helping sports teams and the military learn more about head injuries. They have been awarded a $3.6 million research grant to facilitate the study of brain injuries. The helmet contains sensors that measure and record the force of impacts to the head. It is already in use by many football teams looking to detect and prevent injuries. The military has been given 20 combat helmets with the system. The Head Impact Telemetry System, HIT, includes a helmet, data transmitter and a console that detects, records and analyzes helmet impacts, sending a warning to a coach or military commander of an impact that has the potential to cause a concussion or traumatic brain injury. The goal is to improve the understanding of mild traumatic brain injury to develop new ways to prevent, diagnose and treat the injuries. The inventors of the helmet said, “The ability to capture large amounts of field data on head impacts and to correlate those impacts with actual diagnosed concussions and the clinical data associated with those injuries is unprecedented, and will certainly lead to new findings and opportunities for preventing and treating sports-related brain injury.”


Report Shows ATV Use Not for Children

It seems intuitively obvious that children should not be allowed to drive an ATV. Comparatively, children are not allowed to drive motorcycles. The question remains, why the disparity in the law. The number of injuries children have sustained has more than doubled between 1995 and 2005. Ultimately 40,400 children were treated in emergency rooms in 2005 for accidents related to ATV use. Findings presented by the Radiological Society of North America (RSNA) reported the numbers. The 40,400 figure represents nearly one-third of all ATV-related injuries treated in 2005. Reported deaths number 120 in the same year. The fatalities represent only the children who died at the hospital, not those who died at the accident site. While wearing helmets and protective clothing might limit some of the injuries, there still remains the issue of whether children should be riding ATVs at all.

The RSNA study included 500 children admitted to Arkansas Children's Hospital following ATV accidents. They ranged in age from six months to 19 years. Head injuries included 85 skull fractures, 66 cases of hemorrhage and 59 traumatic brain injuries. Spinal injuries included 21 spine fractures and 5 spinal cord injuries. Lung injuries were present in 36 children. Spleen, liver, kidneys and pancreas injuries were found in 70 children. Limb fractures occurred in 208 children with broken legs being the most common. There were 12 amputations, including 9 partial foot amputations, one upper limb amputation and one below-knee amputation. There were six fatalities and several cases of long-term disabilities. One patient was a 2 year-old who was found unconscious beside a flipped ATV. She suffered a severe brain hemorrhage that left her with permanent disabilities.


Virginia woman awarded $1.5 million after TBI

The Augusta County Circuit Court of Virginia has awarded Vickie Johnson-Rankin $1.5 million. Johnson-Rankin and her family were hit head-on by a drunk driver. She lost her job due to the traumatic brain injury she suffered in the accident. The jury deliberated for two hours before the award. All too often victims of such crimes are unable to access the necessary care and seek recourse because of their injury. Vickie Johnson-Rankin’s jury award is the exception rather than the rule.


Families of struck bicyclists suing driver and company

Recent Denver natives and bicyclists Bryce Lewis and Caleb Hall were struck by a dump truck on a notoriously dangerous intersection in Seattle in September. Lewis was killed instantly. The families of the two 19 year-old men have filed suit against the driver of the truck and the owners, Nelson & Sons Construction Co. Inc. The corner it happened has hit cyclists four other times and pedestrians twice in the past three years. Lewis and Hall were riding in the bike lane on Sept. 7 when the dump truck turned right and plowed into them, according to the King County Superior Court lawsuit. The attorney for the two families said, “The primary duty is on the vehicle turning right to make sure there aren't people in the bike lane or in the crosswalk.” The dump truck driver could face a citation or criminal charge. Seattle police are still investigating and have not yet forwarded the case to King County prosecutors. Hall and Lewis had moved from Denver to Seattle just two weeks before the accident. Neither was wearing a helmet when they were hit.


December 12, 2007

China Aware of Complication Associated with Gadolinium and NSF

Chinese agencies have become aware of complications associated with the use of gadolinium contrast agents used in MRIs. They are warning doctors of the link between gadolinium and the disease nephrogenic systemic fibrosis. The population at risk is those with serious kidney problems such as kidney failure. The kidneys of the people are incapable of eliminating the dye through normal body functions. Gadolinium attaches to specific tissue types highlighting them from other tissues so they can be viewed better by MRI technicians. What remains troublesome is that gadolinium is the only contrasting agent approved for use in most MRIs. The alternatives are Feridex I.V. and Teslascan, but they are limited in use for only examinations of specific liver problems. The NSF symptoms identified is the severe thickening of the skin leading to immobility and can affect the liver lungs and heart. NSF has been confirmed in children and the elderly, but tends to affect the middle-aged most commonly, according to the International Center for Nephrogenic Fibrosing Dermopathy Research. Men and women are affected equally.


Oxycyte™ to Conduct Phase 2b Trial in TBI

Synthetic Blood International, the makers of Oxycyte™, will be conducting a double blind, placebo controlled Phase 2b trial in treatment for traumatic brain injuries. Oxycyte™ is a therapeutic oxygen carrier and blood substitute. The Phase 2b trial is designed to compare Oxycyte™ with current therapies of TBI. The company is expected to enroll 120 to 150 patients at six major neurosurgery centers. “Our Phase 2b trial protocol design was developed to provide what we believe will be definitive results with Oxycyte as a therapeutic treatment for TBI,” stated Dr. Bullock of the University Of Miami Miller School Of Medicine, Department of Neurosurgery. “Positive data from the pilot study in TBI patients demonstrated that Oxycyte was more effective in increasing brain oxygen tension levels and impacting other brain chemistries that contribute to favorable clinical outcomes in TBI patients than breathing either 100 percent or 50 percent oxygen. If we see similar results in the larger patient population, we believe that it is likely that the government may deem Oxycyte immediately useful for battlefield settings.”


Ski Racer’s Life Spared by use of Helmet

Up and Coming ski racer Richard Long, 15, survived traveling 40 to 50 mph. and slamming into a tree head first at Arapahoe Basin. His survival is attributed to the helmet he was wearing. Long was slalom training at A-Basin when he lost control prior to the ski accident. His doctor, Dr. Stewart Levy, chief of neurosurgery at St. Anthony’s Central, held the dented liner of the helmet in an interview and showed where the helmet shell had shattered at the point of impact behind the left ear. Long is suffering from aphasia, the ability to find and voice words and express thoughts due to bruising of his left temporal lobe, considered a traumatic brain injury. Long’s other injuries included a broken collar bone, shoulder blade and a ruptured spleen. Long was a member of the Ontario Alpine Ski Team which trains skiers for Canada’s national ski team. His father, a ski coach, said his son was perhaps one of the two best skiers in North America in his age group. Dr. Levy said that 10 years of data on ski-related trauma shows that helmets reduce the risk of fatality by 80 percent and reduce the risk of brain injury by 65 to 75 percent. Long’s parents hope that Richard will regain his ability to walk, recover full speech skills and even return to skiing.


Car Camera Records Bad Driving

The Drive Cam is a device that can be installed in cars to watch any adverse events while someone is driving. This is a boon to parents who are nervous about letting their teens drive unaccompanied. The Drive Cam starts recording if it detects such things as braking too hard, unsafe speeds, loud music or turning a corner too fast. The camera is pointed at the driver and out the window. The video is then sent back to a parent who sees a split screen of the event at teensafedriver.com. A report card is then sent that shows weekly driving grades. If parents use the car, their bad driving habits will also be reported. The camera can also be triggered to record by tapping on the window in the event of a dangerous situation such as car jacking. The Drive Cam gives parents peace of mind and helps their kids be aware of safe driving practices.


December 11, 2007

Traumatic Brain Injury Center of Excellence to be built for Veterans

A new facility funded by an impressive 600,000 private donations is in the planning stages for a “traumatic brain injury center of excellence.” It will be built on the grounds of the National Naval Medical Center in Bethesda, MD. The cost could range from $50 to $70 million dollars. Bill White, president of the Intrepid Foundation, says that the project will be expedited and built considerably faster than any government sponsored building. “This is different. This is brain stuff. The scale is much more significant in terms of what is needed from a technological standpoint,” White said. One of the donors is the Fisher family. They are known for building and donating the Fisher House Comfort Homes to house military families at little or no cost near military and VA medical facilities. White said the vision for the new project is that “when you go through the center of excellence, we’ll keep an imaginary string tied to you,” to make sure service members and veterans are getting the necessary treatment. The project is targeted to help veterans avoid the consequences of TBI, like homelessness, unemployment, and drug and alcohol addiction. “The government can’t do everything. We have to do what we can to help these kids,” White said.


Brain and Spinal Injuries on the Rise in Winter Sports

According to 51 sources of data from ten different countries, the number of skiers and snowboarders acquiring traumatic brain and spinal injuries is steadily increasing. The research was published in Injury Prevention. The publication reports the number of serious brain and spinal injuries has risen over the last 15 years. Head injuries account for 15 percent of all injuries sustained by skiers, while the numbers of serious injuries snowboarders experience are four times higher than in 1993. Adult males 35 and younger are three times more likely to suffer from a TBI. The authors of the report attribute the increase in injuries to people skiing and snowboarding faster and attempting more complicated maneuvers


Canadians Cleared to Sue Medtronic Over Defective Defibrillator Batteries

Ontario Superior Court Judge Alexandra Hoy certified a class-action lawsuit in a ruling December 6 that makes it possible for Canadians to seek Medtronic profits for damages in a lawsuit claiming the company failed to warn consumers of a defect in the batteries installed in its defibrillators. In October, Medtronic agreed to pay $130 million to settle U.S. claims against the defibrillators. In 2003 Medtronic discovered that their batteries ran out faster than the four to seven years that they were supposed to last. It wasn’t until two years later that the company advised doctors of the defective batteries. In Canada 2,416 patients had the devices implanted. Since February 2005, 613 of them had been removed or replaced as of June 2007. At this time no deaths or injuries have been reported as a result of the malfunction. The case is Between Frank Peter and Medtronic Inc., Ontario Superior Court of Justice (Toronto). Case No.: 05-CV-295910.


December 10, 2007

The Brain Injury Survivor’s Guide

Arkansas residents Beth and Larry Jameson have written a noteworthy new book for survivors and their families affected by traumatic brain injuries. The book titled, the Brain Injury Survivor’s Guide, Welcome to Our World is thought to be a must for patients and their families. Seventeen years ago Beth suffered an anoxic stroke while in the hospital causing brain injury. Beth had to re-learn almost everything. In the learning process the couple developed an effective system to re-acquire basic skills and deal with the devastating changes in lifestyle. The system eventually helped Beth maintain a full-time job. The strategies designed to improve memory, cognitive skills and behavior are what constitutes The Brain Injury Survivor’s Guide. An example is the BRAIN system, a mnemonic designed to recall a series of memory exercises that are essential for living with a brain injury. Memory Seeds are small pieces of information such as pictures that can grow into a fully formed memory. There is a chapter devoted entirely to checklists from health insurance information to what to take when leaving the house. This book is recommended for anyone who wants to understand more about the traumatic brain injury experience from the patient’s perspective as well as providing information on the role of caregiver and tips on how to deal with the medical profession. The Brain Injury Survivor's Guide shows brain injuries do not have to be life ending.


New Contrast Agent May Help Prevent NSF

Luna Innovations Incorporated has been awarded a grant from the National Heart, Lung and Blood Institute to develop a new agent used in MRI. The carbon nano-material based contrast agent does not contain gadolinium, the dye linked to the devastating disease Nephrogenic Systemic Fibrosis. Although it is being developed at this time for the diagnosis of coronary artery disease (CAD), the expanded significance can assist in MRIs used on individuals with kidney failure and halt the risks of gadolinium exposure. Luna’s contrast agent is anticipated to give a physician not only improved diagnostics, but safety in the non-gadolinium product when exposing the dye to at risk individuals. The product, Trimetasphere® encloses the metallic signal molecule so that it cannot escape and cause harm to a patient. Through this mechanism the Trimetasphere®-based agent may help in preventing Nephrogenic Systemic Fibrosis. In May, the FDA issued a black box warning for the current gadolinium-based contrast agents used in MRI to increase awareness of the risks of NSF in patients with kidney problems.


Controversial Drug Avandia Linked to Osteoporosis Risk

After the recent controversies facing the makers of Avandia and the risk of heart failure, a new issue has emerged with the popular drug. According to the online issue of Nature Medicine, researchers found that the drug increased the degradation of bone in mice. This could explain why diabetics taking Avandia long term have had an increased risk of fractures due in large part to drug induced osteoporosis. GlaxoSmithKline, Avandia’s makers, has acknowledged that a study found a higher risk of fractures among woman taking the drug for diabetes. In the past the assumption was that the fragility of bones in diabetics was the result of naturally reduced bone-building activity and not increased bone removal. The finding “has led to a better understanding of the challenges associated with long-term treatment of patients with Type II diabetes,” said Ronald M. Evans of the Salk Institute for Biological Studies in La Jolla, Calif., lead author of the report. He goes on to say that the discovery was fortuitous. “Considering the widespread use of these drugs and the known action in people it is surprising that such a key observation had been missed,” Evans said. The research was funded by the Howard Hughes Medical Institute and the National Institutes of Health.


December 07, 2007

Traumatic Brain and Spinal Cord Injuries Increasing on Slopes

A team of Canadian researches have suggested that the increasing popularity of ski and snowboard related acrobatics and high speed have expanded the incidents of traumatic brain and spinal cord injuries that have occurred worldwide. An article published in the British journal, Injury Prevention, encourages skiers and snowboarders to wear helmets to reverse the trend of these types of injuries. “We feel that every skier and snowboarder of every age, of every skill level should be wearing a helmet,” said senior author Dr. Charles Tator, a neurosurgeon at Toronto's University Health Network and the founder of ThinkFirst Canada, a charity devoted to prevention of traumatic brain and spinal cord injuries. “We really strongly recommend helmets. There's very good evidence that helmets provide protection.” Tator and his colleagues did a systematic review of medical literature spanning January 1990 through December 2004. They found 24 articles linking traumatic brain and spinal cord injuries with skiing and snowboarding. One U.S. study they used showed an increase in ski related deaths over a 21-year period. Another article reported that the incidence of spinal cord injuries rose by 130 percent in children and 407 percent in adolescents. The studies further showed that snowboarders were substantially more likely than skiers to suffer serious head and cord injuries. The authors of the study strenuously encourage increased helmet wear and call for the ski and snowboard industries to promote helmet usage.


Settlement in Ford Lawsuit Further Defined

In a blog posted from November 30th, there was a report that the settlement of a class-action lawsuit brought against Ford Motor Co. would end all outstanding rollover-related lawsuits against the corporation. To further define the settlement, it will end the class-action status brought by Ford Explorer owners who believed their vehicles lost value because of their perceived danger. This does not preclude any pending personal injury and wrongful death lawsuits involving the sport utility vehicle.


Astonishing Recovery from TBI

Darren Campion of Minnesota was an officer in the Army on leave in 1999 when he was stabbed in his back and ear by two men in a Wisconsin bar. They accused him of looking at one of their women. His injuries comprised of a traumatic brain injury and stroke, putting him in a coma for weeks. Doctors told him he had a 99 percent chance of ever walking again. Now at 33 he has trouble speaking because of his injuries and has to speak one word at a time, sometimes getting frustrated when he can’t say something. Like many trapped in a disabled body he knows what is going on in his head, but has trouble articulating it. As he says, “Brain, excellent, talk, really bad.” His speech therapist from the time of his rehabilitation, Jack Avery, never thought that Campion would come as far as he has. He has exceeded all expectations in terms of his return to independent living. His physical recovery has also exceeded expectations. Since Campion’s injuries he has competed in the 2004 Paralympic Swimming Trials, completed several triathalons and 3 24 hour walks. His most recent accomplishment was one of those 24 hour walks wearing a 70 pound rucksack. It was to raise money for a swim team at a rehabilitation and resource center that helps people with disabilities. He credits his success with his belief that physical feats are 90 percent mental and 10 percent physical. He carries a note in his wallet that says “Expect more than others think possible.”


December 06, 2007

Surgeons are for using hypothermia as a treatment in TBI

When Buffalo Bills’ Kevin Everett was treated with cooled intravenous fluids after his injury to induce mild hypothermia it garnered notice among lay people. However, some neurosurgeons have been following the experimental therapeutic treatment for years. As the brain heals after an injury, any further knocks, however minor, can be devastating and even fatal. The theory behind induction of mild hypothermia is to lower the patient’s body temperature to around 91 degrees within 15 minutes of the traumatic injury (in Everett’s case it was a spinal injury) to prevent further damage. This therapeutic cooling treatment is already used to treat infections and reduce blood clotting. Studies from the 1950s show that cooling reduced inflammation and prevented cell damage. W. Dalton Dietrich directed a study at the University of Miami that found in experimental models of brain and spinal cord injury that slight cooling was protective and improved the outcome when used shortly after an injury. As an example, patients whose hearts have stopped can sustain brain damage within minutes from lack of oxygen. Hypothermia reduces the chance of brain damage. The medical establishment has said further study is needed to fine-tune the best temperature and just how quickly the cold intravenous fluids should be administered following injury. They predict the cold intravenous fluids could begin in the ambulance en route to the trauma center.


New Scottish Study Confirms Gadolinium Link with NSF

In a separate and new study researchers in Scotland have once again linked Gadolinium containing contrast agents used in MRIs to the devastating and sometimes deadly disorder nephrogenic systemic fibrosis. Their findings have added to the growing quantity of evidence that strongly associates the onset of NSF with people receiving MRIs who have pre-existing kidney disease. The Scottish study looked at 1,826 patients who underwent renal replacement therapy at two Glasgow hospitals between January 1, 2000 and July 1, 2006. Of those patients, 421 underwent an MRI that involved the use of a Gadolinium based contrast agent. Fourteen were diagnosed with NSF, and of those, 13 had been exposed to Gadolinium during an MRI. The researchers also found that the patients with NSF had received far higher doses of Gadolinium than those patients who were exposed to it but did not develop the disorder. The Scottish study was the second published this month that confirmed the link between NSF and Gadolinium. In their report they suggested that Gadolinium contrast agents be avoided altogether or at the very least in patients with pre-existing kidney issues. Also, in cases where Gadolinium is the only alternative the lowest dose possible should be used.


J&J Disagrees with Crucial Evidence Released in Ortho Evra Case

In the case In re Ortho Evra Products Liability Litigation, MDL 1742, in the U.S. District Court, North District of Ohio (Toledo) internal Johnson & Johnson documents have been made public that show that J&J, “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” according to the motion filed Ortho Evra users Nov. 20 in federal court. Further, pre-trial interviews with Johnson & Johnson scientists show the company knew of the risk in 1999 and still misled the FDA when they were seeking approval in 2001. This new information was previously kept from the public’s knowledge when a judge considered it confidential. The documents being made confidential gave J&J the perfect opportunity to settle out of court in all previous lawsuits. Of course J&J disagrees and a spokeswoman said of the new filing it, “Takes out of context a few documents produced by the defendants in the course of this litigation to create a misleading and unfair presentation. The proper forum for these documents is the courtroom where, looked at in context, the evidence will show that Ortho Evra is safe and effective.” Janet Abaray, the Cincinnati attorney for seven women, declined to comment.


December 05, 2007

Family of Deceased Amputee to Receive $5.8 million in Malpractice Case

A Providence Rhode Island man went into surgery to fix a broken ankle and lost his leg below the knee due to medical malpractice, a Superior Court jury decided, resulting in a $5.8 million verdict. In February, 2001 William Layton’s X-rays showed he’d broken his left ankle. The doctor decided to wait a week because Mr. Layton’s ankle swelled and developed blisters. Prior to surgery a week later the orthopedic surgeon was to about to perform surgery, but neglected to look at Mr. Layton’s ankle until he was under anesthesia. When he examined the area the doctor saw the blisters had worsened, but instead of halting the surgery, he went ahead and performed the procedure. Two months later, the blisters continued to worsen and Layton eventually went to another surgeon who discovered that his foot had become gangrenous and had to be amputated below the knee two months later. Layton sued Feldman and the Orthopedic Group Inc. claiming that the doctor was negligent and failed to get informed consent from Layton before performing the surgery. Layton’s lawyers’ filing explained that Layton was diabetic and suffered from poor circulation, thus developing blisters as the ankle swelled. The doctor did the right thing by waiting a week, but failed to look at the ankle before Layton was under anesthesia in the operating room. Mr. Layton has since died from a heart attack and was not alive for the trial. After 5 1/2 weeks of trial and deliberation, the jury awarded $4.8 million for the loss of Layton’s leg and his pain and suffering, and awarded $1 million to his wife. The award will total $8.9 million with interest and will go to Elaine Layton and her three adult children.


Sinus Infection to Brain Surgery Results in $3M Verdict

A woman went to her doctor for a sinus infection and ended up having brain surgery because of a medical decision the physician’s assistant made. Lynn Flaherty’s symptoms were all consistent with a sinus infection, headaches and nasal discharge, but instead of being prescribed antibiotics she was given steroids. Five days later she developed facial drooping and disorientation. Eventually she went into an emergency room where a CT scan revealed a brain abscess. Mrs. Flaherty was flown immediately to another hospital where there performed brain surgery. Following the first emergency brain surgery, Mrs. Flaherty, with part of her skull removed, went into respiratory failure, was on a ventilator and later had to have follow-up surgery. Her skull has since been replaced by plastic. She had to go to rehabilitation to learn how to walk again and regain the skills to function in daily life. Mrs. Flaherty lost all peripheral vision on her left side, has balance problems and a nerve injury in her right leg.

Mrs. Flaherty is 61 and has not been able to return to work as a real estate agent. She is unable to regulate her emotions and has difficulty with complex cognitive function because of her frontal lobe injury. Lynn Flaherty’s husband, James lost the wife he knew. In an eight day trial and 5 hours of jury deliberation the verdict came to $3 million with $2 million to go to Mrs. Flaherty to cover medical expenses, pain and suffering. The remaining $1 million was awarded to her husband.


New Research Shows Club Drugs can Cause TBI

The drug Ecstasy and other forms of Methamphetamine drugs have been shown by new research from the University of Florida that they can cause traumatic brain injury. The researchers suggest that drugs and traumatic brain injuries release similar chemical reactions in the brain that cause cell death, memory loss and irreversible brain damage. Abuse of this family of drugs lead to the same types of changes in the brain as does a hard strike to the head. Cell loss and protein fluctuations in the brain are present both after a TBI as well as ecstasy. The damaged proteins cause cells to die and cause brain inflammation under the influence of methamphetamine. “Using methamphetamine is like inflicting a traumatic brain injury on yourself,” said Firas Kobeissy, from the College of Medicine department of psychiatry. “People don’t seem to take club drugs as seriously as drugs such as heroin or cocaine.” Kobiessy also warns that those who take three tablets of ecstasy or speed are taking toxic doses that can cause TBI in different areas of the brain. The researchers admit that future study is necessary for them to determine when or if meth-related brain injuries can reverse themselves.


Lawyer ask Judge to Order Monitoring of Fosamax Users

Lawyers are asking a federal judge to order Merck & Co. to develop and provide a program to monitor users of Fosamax, the osteoporosis drug linked to osteonecrosis. Osteonecrosis of the jaw is a condition where a portion of the jaw bone dies and sometimes leaves the bone exposed. A lawyer for the plaintiffs said hundreds of thousands would benefit from such a program which would include regular dental screenings, X-rays and lab tests. The lawyers made the suggestion to U.S. District Judge John F. Keenan as they argued for the case to be certified as a class-action. The Merck attorney believes there is no proven link between degeneration of the jaw bone and patients who use Fosamax. The plaintiffs’ attorney said as many as one in every 296 patients develop severe damage to the jaw, further arguing that a class-action certification would allow for a trial in which a jury would decide whether Fosamax is dangerous and if Merck was negligent when they did not inform the users of the danger. The Superior Court judge has yet to rule after hearing the arguments.


December 04, 2007

Man joins growing number of NSF victims

72-year-old Peter Gerber of San Rafael, Calif. has joined a growing collection of people suing several major health companies for causing him to suffer the painful, incurable and sometimes deadly disease, Nephrogenic Systemic Fibrosis. The gadolinium dyes used to scan his failing kidneys with MRI have been linked to the disease. Peter Gerber’s suit claims people with kidney failure cannot eliminate the gadolinium dyes from their system, ultimately causing them to develop NSF. Last year, the FDA issued an advisory that patients with moderate to end-stage kidney disease should avoid having medical scans that use gadolinium-based contrast dyes. If the imaging is done, “prompt dialysis” should be considered immediately following the procedure. Mr. Gerber had an MRI prior to undergoing a kidney transplant. His lawsuit, filed in San Francisco Superior Court, names medical centers and companies involved in making, distributing and using the dyes, including Bayer Healthcare Pharmaceuticals Inc. and GE Healthcare Inc. Both companies have since added “black box” warning labels to their dyes. “Mr. Gerber was never warned that there was any kind of risk associated with gadolinium, let alone NSF,” said Gerber's attorney. “Because of that, he developed a life-threatening disease that will most likely take his life in a horrible way.” He further indicates, “There is only one identified cause of NSF, and that's gadolinium and there is only one way gadolinium gets into the human body, and that's through these contrasting agents.”


Ford Explorer class action suit settled

In a decision Wednesday, Ford Motor Co. agreed to settle numerous class action lawsuits filed against them regarding the Ford Explorer vehicles that were prone to rollovers and tread separation on the installed Bridgestone/Firestone Inc. tires. The tread separations alone killed more than 250 people and hundreds more were injured, some catastrophically, in car accidents. The federal government began an investigation in 2000 when numerous complaints were received concerning the Bridgestone/Firestone tires installed on the Explorers. In the past several years Ford has faced wrongful death and personal injury lawsuits across the country involving the earlier models of the popular Explorer.

About 1 million people in California, Connecticut, Illinois and Texas will receive compensation via $500 vouchers toward new Explorers or $300 vouchers to buy other Ford or Lincoln Mercury products. The settlements apply to Explorers in model years 1991 through 2001. The vouchers can be applied for through a Web site if the overseeing judge in the case gives preliminary approval to the settlement on Monday 03Dec. A final approval hearing will be held in April after those covered by the settlement have had time to apply for the vouchers. The settlement further requires Ford to distribute information about the dangers of sport utility vehicle rollovers and to restrict safety claims in their advertising. The settlement will end all outstanding lawsuits against Ford stemming from the Explorer rollovers. Customers affected by the settlement will be notified in late December and early January. If the preliminary settlement is approved, a mailed notice will be sent to owners and a toll-free number and Internet site will be announced. The vouchers can be used only by the plaintiffs and their family, but can also be transferred to anyone in one of the four states who are interested in purchasing Ford and Lincoln Mercury products.


December 03, 2007

North Dakota woman seeks medical monitoring in suit against Medtronic

In October, Medtronic acknowledged the Sprint Fidelis wires used in their implantable defibrillators break more often than they expected. Medtronic also admits to the possibility of five deaths being linked to the defective lead wires. The wires connect defibrillator to the heart of a patient. In North Dakota, a woman is seeking a class-action suit against Minnesota based Medtronic because of the potential problems with her implanted defibrillator. Winnifred Leverson’s lawsuit allegations include emotional distress and negligence and she is seeking medical monitoring. Regardless of Medtronic’s and the FDA’s estimates that fractures have occurred in less than one percent of the wires, one death due to product defects is one too many.


Woman describes pain suffered by defective defibrillator leads

A personal injury lawsuit against Medtronic has been filed on behalf of a Kentucky woman in Minnesota state court. Kim Orange seeks damages for physical pain related to electrical shocks she suffered as well as for medical expenses she incurred and will incur for future medical care. Ms. Orange was taken to a medical center after suffering three electrical shocks caused by the defective Sprint Fidelis lead wiring that connected her heart to the defibrillator. At the medical center she suffered two additional shocks the same day and had to undergo surgery to remove the flawed device and implant a new defibrillator system. The extraction of the old and the implantation of the new lead system and defibrillator scarred her frail heart further. She expresses the pain and suffering she endured, “I felt like I was being repeatedly shot or kicked in the chest by a horse. The pain was intense and has the power to knock you down or out of a chair.” She goes on to explain, “You fear that you have a ticking time bomb inside your body that could unexpectedly explode or be triggered by a quick movement or vibration. Exertion such as bending over to make a bed, mowing the lawn and other everyday tasks have become frightening experiences.” Ms. Orange’s physician advised her to take off work. It appears the defect is attributed to the small diameter of the coil and conductors used in the leads, because of this they are subject to stress damage during and after implant. Fracturing then occurs when the conductors are strained.


Blue Cross intends to move TBI victim out of rehab prematurely

High school football player Scott Eveland suffered an acute subdural hematoma (a blood clot on the surface of the brain) and brain swelling during a football game. On September 14th the linebacker staggered off the football field, collapsed and slipped into a coma. He is now out of his coma, but unable to talk, walk or feed himself. Over the objections of his rehabilitation doctor Keyvan Esmaeili, the Eveland’s health insurer Blue Cross of California want to move him to a nursing home. "It's difficult to say if it is time for him to move on. I don't think so," Esmaeili said. "The bottom line is it could delay his progress." Esmaeili, who is the medical director of the Acute Rehabilitation Unit at Palomar, said he is helping the Eveland family appeal the insurance company's decision to move Scott because his recovery progress is not moving quickly. Esmaeili said that currently a doctor sees Scott every day, but at a nursing facility, the doctor visits will decrease to once every three weeks. Additionally, Scott gets three hours of intense physical therapy each weekday, but the treatment will end if he leaves. Esmaeili has modest goals for Scott, but said signs of improvement so far include his ability to simply stay awake longer, breathe on his own, and control his head and neck better and to visually track objects. "He's not the average patient," Esmaeili said. "With severe traumatic brain injury, the recovery is slower. There are benchmarks, tiny little gains." The family is fighting to keep Scott at Palomar Medical Center in Escondido and his doctors tend to agree. For Scott, at the age of 18, giving up on rehabilitation is premature. Regardless of his modest recovery over the past 2 ½ months it is too soon to give up. If the insurance company wants to save money, it behooves them to keep Scott in rehabilitation until such a time as he is able to move into the many programs available for victims of traumatic brain injury.


$5.5M awarded in settlement of oil truck accident

In June 2006, John, 65 and Mary, 61, Reutter of Texas were hit from behind by an empty oil tanker. The accident left Mrs. Reutter with a paralyzed left arm and 40 percent mobility in her right arm. Mr Reutter suffered lower back pain. They settled out of court and were awarded $5.5 million. The Oklahoma-based United Petroleum Transports Inc. and the attorney who represented the driver said they were pleased that the case has been resolved. The Reutter’s lawyer commented, “This is one of the largest settlements in Johnson County. My clients have been generously compensated for their injuries but would do anything to have their health back."


Free online test launched by NovaVision to assist with neurological vision recovery

NovaVision, Inc. is the developer of the FDA approved Vision Restoration Therapy (VRT), which is based on neuroplasticity – the brain’s ability to adapt and form new connections to compensate for brain injury. It is used to restore the vision of patients with neurological visual impairments. VRT maps areas where vision may be improved then targets and stimulates those regions of the brain where vision-processing is located. In excess of 20 percent of Americans who survive stroke or traumatic brain injury suffer from neurological vision loss. The loss makes it difficult for victims to live independently and perform routine tasks such as driving, reading and writing. More than 1,000 stroke and traumatic brain injury patients have been treated with NovaVision VRT and clinical results have proved positive. With this historical success rate, NovaVision has decided to launch a free online vision test for stroke and TBI survivors who desire to determine if a vision deficit exists as a result of their injury. Once it is determined that a vision deficit may exist, the patient can then go to their doctor and request a home-based therapy program to perform twenty minutes twice a day for six months. The interactive test is available at http://www.helpforvisionloss.com/visiontest. Clinical studies presented at the 2007 American Academy of Neurology Meeting and the 2007 International Stroke Conference, show that more than 70 percent of people using VRT saw improvements. "Historically, visual field testing has not been part of the routine evaluations administered after a stroke or brain injury, yet there are millions of Americans struggling with impaired vision as a result of these experiences," said Navroze Mehta, president and chief executive officer of NovaVision. "By offering this free vision test after stroke or brain injury, we can help people gain control of their rehabilitation."


Future faults possible in the Medtronic defibrillators

Deutsche Bank released a research report concerning additional problems on the horizon with the Sprint Fidelis lead wires used in the Medtronic defibrillator devices. Deutsche Bank analyst Tao Levy said in the report that while the impact of the recall was not as severe as anticipated, more distressing news may still be on the horizon. Nevertheless, the lead fractures could continue to require more replacements. Levy said the Fidelis lead may also offer poor sensing capabilities, ultimately leading to inappropriate shocks. "This latter concern is something new we have learned from our clinician contacts, and we could see published in medical journals," he noted in the report. "Bottom line is that while Medtronic has done a good job in managing the Fidelis recall, there will be clinicians who are not only frustrated with the number of leads affected but also by the increasingly poor performance of the lead," Levy wrote. The analyst said this could result in permanent loss of market share in implantable cardioverter defibrillators. A spokesperson for Medtronic said that the company is aware of the report but doesn't have immediate comment. In October, the medical-device maker suspended its Fidelis family of defibrillation leads because of the potential for the wires to fracture. Regardless, the company gave a report on the progress of the lead recall, which resulted in a meager 2% decline in earnings.


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