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« August 2008 | Main | October 2008 »

 

September 30, 2008

Employer of Train Engineer Faces Litigation

Two previous lawsuits that have been filed against the company that employed the engineer in the deadly Metrolink crash near Los Angeles have been combined into one class-action lawsuit. Veolia Transportation is to be sued over labor policies for allegedly not giving employees proper rest breaks, overtime and other benefits. Since the September 12th deadly crash Veolia has been under scrutiny. Federal investigators are reviewing whether fatigue played a role in the collision. The diabetic engineer blamed for the collision was in the midst of a 10.5 hour split shift. Of 222 train passengers, 25 people were killed and 21 remain hospitalized. The Los Angeles Times researchers reported that the crash sent 86 people to hospitals in the San Fernando Valley, Westwood, Hollywood and Ventura County.


Disparity between Children and Adults and Risk of TBI

According to the National Center for Injury and Prevention falls are the leading cause of Traumatic Brain Injury (TBI). A TBI is caused by a blow to the head that does or does not penetrate the skull in a head injury. Falls lead the statistics with 28% of the pie. Motor vehicle accidents have 20% of the portion and 19% are caused by a blow caused by a strike to the head. TBI rates in children ages 0-4 year and adults 75 and older, falls are the highest cause of TBI. Motor vehicle accidents result in the greatest number of TBI-related hospitalizations and are highest among adolescents aged 15 to 19 years old. A strike to the head by collision with a moving or stationary object are the third leading cause of TBI resulting in approximately 1.6 to 3.8 million sports and recreation related TBIs in the United States each year of which most are mild and are not treated in a hospital or emergency department. These statistics highlight a frightening picture of the disparity in the amount of children compared to adults who are at risk of a TBI. All too often a child’s TBI is due to the negligence of another person or business; i.e. birth injuries, bicycle collisions, etc. A helmet sometimes can only go so far in protecting the skull and brain of a child. In these types of cases the child and their family have legal recourse and can seek compensation associated with a TBI. Depending on the severity of the injury, the amount of damages can be quite significant because of the cost of long term care and the inability of the child to earn financial emancipation over his or her lifetime.


September 29, 2008

Brain Injured Football Player Sues City and School District

A lawsuit has been filed with the San Diego Supreme Court seeking unspecified damages on behalf of high school football player Scott Eveland, who suffered a catastrophic brain injury allegedly by the delay of an emergency response team. The family hopes the litigation process will bring to light why a second ambulance had to be called to transport Eveland even though one was currently on site. “To have the ambulance there and refuse to transport certainly was not in Scott's best interest,” attorney David Casey Jr. said. “Our main focus right now is to understand this policy.” Casey said Eveland, who collapsed during the second quarter of a game on Sept. 14, 2007, has permanent brain damage and will require constant care for the rest of his life. “When you have bleeding in the brain, you know, every second counts,” Casey said.


Makers of Oxygen Carrier Meets with FDA for TBI Clinical Trial

During the week of October 20 the U.S. Food and Drug Administration will meet with the biomedical company Oxygen Biotherapeutics, Inc. to discuss any remaining issues the agency might have with their therapeutic oxygen carrier, Oxycyte®. Oxygen Biotherapeutics proposes to continue use of Oxycyte in a Phase IIb clinical trail in Traumatic Brain Injury. “At that meeting, we will be extensively prepared to resolve any remaining issues and concerns the FDA may have,” said company chairman and CEO Chris J. Stern, DBA. “We view this as a positive development, as the agency has also offered to review the Company's overall development plan. This may contribute to reducing regulatory risk at future stages such as Phase III. We will constructively use the dialog and its documentation process to align the clinical and non-clinical development plan for TBI with potential endpoints for Phase III and towards an eventual registration.” The company's planned multi-center, double-blind, placebo-controlled study would enroll up to 300 patients. 200 patients will be allowed for enrollment through a $1.9 million grant from the United States Department of Defense to M. Ross Bullock, M.D., Ph.D., of the University Of Miami Miller School Of Medicine, Department of Neurosurgery. Dr. Bullock is the principal investigator for the planned Phase IIb clinical trial. The clinical trial date will depend on the outcome of the FDA review process.


September 26, 2008

Government Grant to Fund Brain Imaging Advancements in TBIGovernment Grant to Fund Brain Imaging Advancements in TBIGovernment Grant to Fund Brain Imaging Advancements in TBIGovernment Grant to Fund Brain Imaging Advancements in TBIGovernment Grant to Fun

St. Louis University researchers are beginning a study that’s focus is to improve treatment of brain injuries for civilians and combat veterans funded in large part by a $5.3 million grant from the Department of Defense. They will be using advanced imaging technology to create better maps of the brain in an effort to develop therapies that target areas of the brain that retain function, but are unable to communicate with the rest of the brain. Researchers will examine 200 people with brain injuries and use a control group of people with uninjured brains. The study participants will undergo three types of imaging tests, as well as neuro-cognitive testing. The resultant data will be a compilation of how a patient's brain is working. SLU researchers have access to three types of imaging equipment a 3 Tesla MRI, 64 Slice PET/CT and MEG (magnetoencephalography) The MEG is an unusual and vital imaging technique that is used in only a handful of facilities. After a traumatic brain injury some regions of the brain continue to function, but if the neural pathways are destroyed the brain in unable to communicate with the rest of the body. As little as 10 years ago, scientists believed that a TBI caused irreversible damage, but have since learned that the brain can remarkably rewire itself. Researchers hope the compiled data will assist in quantifying levels of injury, diagnosing injuries faster without advanced imaging equipment and determine which patients will benefit the most from rehabilitation.


FDA Blocks Imported Drugs from India’s Ranbaxy

The U.S. Food and Drug Administration has blocked the import of generic drugs made by the Indian company Ranbaxy Laboratories Ltd. citing violations encountered during an inspection earlier this year and poor quality in two of its factories. The generic drugs affected include the generic version of the antibiotic Cipro and cholesterol pill Zocor as well as any pharmaceutical ingredients made at the two plants in India. Further blocked drugs are the antibiotics clarithromycin, the antiviral acyclovir, the cholesterol drugs simvastatin and pravastatin and the diabetes drug metformin. During investigation of the two plants the FDA found violations that could lead to contamination, allergic reactions and other problems and Ranbaxy has not taken the proper steps to correct them, said Deborah Autor, director of FDA’s compliance office. In addition to the import block the FDA said it won’t approve any new products for sale by Ranbaxy until the manufacturing violations are corrected. India has become one of the world's leading suppliers of generic drugs, and concern about Ranbaxy has been growing since FDA inspectors first uncovered quality problems at one of its factories in 2006. However, the FDA told consumers not to worry and not to quit using the generic drugs because as yet repeated testing has found no evidence of contamination, just the threat of them if factory conditions don’t improve. Also, it would be hard for a patient to tell if drugs were made at the suspect factories or at one of Ranbaxy's numerous other factories in 11 countries.


September 25, 2008

Brain Researchers Inform Senate of Brain Technologies

Over the last decade brain research and technology have multiplied. Posit Science Corporation is one of the companies who done extensive research into brain injuries and base there treatments on neuroplasticity, the brain’s ability to reconnect neurons through intensive, repetitive and progressively challenging activity. Posit works with more than 50 brain scientists from leading universities around the world to create training programs that enhance cognitive performance. “Many believe that we have already entered the 'Cognitive Age,' where the greatest value we create comes from what we know,” observed Posit Science Chairman and CEO Jeff Zimman. “In the next few years, newly developed technologies that actually enhance cognitive abilities will not only create our greatest gains in personal productivity, but will also be critical in addressing a host of public policy challenges.” Scientists visiting the U.S. Senate believe that recent breakthroughs in brain research and technology will have a great impact on public policy issues. The Senate Committee on Health, Education, Labor and Pensions (HELP) invited the researchers to the Senate. Scientists summarized more than 30 peer-reviewed papers emphacizing the power of cognitive training technologies and offered hands-on demonstration of products using those new technologies. “Recent studies show that the right cognitive training exercises can improve processing speed, accuracy, attention and memory in older adults,” Dr. Mahncke continued. “Most recently, we have learned that this can be done in ways that generalize to everyday life and persist after the training ends. These gains are large -- roughly equivalent to a reversal in the normal decline we see over a decade in an average person over age 50.” This is an important advancement for those in the public domain that our U.S. Senate is taking notice.


Institutes of Medicine’s Conclusion on Medication Errors

The Institute of Medicine’s focus is to develop a strategy to improve the quality of American health care. They have compiled and analyzed a massive collection of data and reports by researchers in their endeavor. One such endeavor is to recommend measures in an effort to decrease the amount of preventable medication errors in hospitals. A report cited remarkable progress in using system approaches to enhance safety, reduce errors and maximize quality in industry, but that health care “is decades behind in terms of creating safer systems.” Another report stated that “most adverse events are preventable, particularly those due to error or negligence.” A study focused on the pharmacy’s order entry process since most errors were known to occur there. Order entry errors among pharmacy employees ranged from 0 to 112 over 2 months. Errors were often the result of misunderstandings, distractions and interruptions and the illegibility of handwritten scripts. As a result it was recommended to institute computerized physician order management and the education and supervision of pharmacy technicians among other steps. The simple step of discussing each medication prescribed with a patient informing them of potential side effects and drug interactions eliminated the instance of many medication errors. The Institute of Medicine's recommendation for quality improvement is based on many years of data observation, collection, and analysis. This work was performed by practitioner-researchers and efficiency consultants from many disciplines. The resulting recommendations are striking in their straightforward practicality and in their insistence that process factors determine output


September 24, 2008

Deadly Train Crash Could Challenge Liability Cap

The latest fatal Metolink crash that killed 25 and injured 135 people may exceed the federal liability cap put in place in 1997. That year the federal cap of $200 million was put in place during the reauthorization of Amtrak and imposed by congress for any one accident. Wrongful death and catastrophic injury awards in the Metrolink crash could exceed the cap and lawyers and legal scholars differ in their predictions of whether the cap will be deemed constitutional or not. Lawyers believe they will prevail in proving the cap unconstitutional while legal scholars using caps in medical malpractice, airline crashes, workers’ compensation and defective drugs argue otherwise. The debate over Metrolink's potential vulnerability is academic at this point, because there hasn't been a case in which juries have awarded damages anywhere near the $200-million limit. According to the Public Citizen, a national nonprofit group committed to protecting health, safety and democracy, what may undoubtedly benefit in the litigation is the availability of information provided to the public, thus resulting in possible new regulations.


Man and Wife Awarded in Malpractice Trial

In June 2003 a Clayton, Michigan man underwent hernia surgery and got more than he bargained for. During the surgery the doctor nicked the man’s small bowel and failed to repair it causing him to have a septic reaction and increasing his stay at the hospital. The extended stay incurred several hundred thousand dollars in medical bills. A medical malpractice lawsuit was filed against the doctor who performed the surgery. After a two-day trial the jury found the doctor negligent and awarded the man and his wife $1.2 million. The $1,115,210.68 awarded to the man included money for bills not covered by insurance. His wife was awarded $50,544 for being “deprived the comfort, companionship, society, and services of her husband.”


September 23, 2008

Medical Errors in Children

When medical mistakes happen to children it is especially upsetting since they have little voice in their treatment options. In the case of medical treatment in children we rely on the medical establishment to know what the best course of action is and accurately execute the treatment. For instance, a 6-year-old boy went into surgery for a wandering eye. When he came out he was crying hysterically, vomiting and screaming “I wish I was dead,” according to his mother. When she tried to get more pain and anti-nausea medication for her son the nurse insisted that she calm him down before he disturbed anyone. The nurse thought he was simply throwing a tantrum. After a certainly agonizing 20 minutes another nurse walked by and the mother asked her for help. The second nurse checked the intravenous line in the boy’s ankle and saw that it was inserted incorrectly and was not dispensing any medication. She immediately fixed it and brought the boy pain and nausea relief quickly. Medical mistakes can have more serious consequences in children, doctors say. A study in the journal Pediatrics in April found that problems due to medications occurred in 11 percent of hospitalized children and that 22 percent of them were preventable. Children are also the victims of diagnostic errors, incorrect procedures or tests, infections and injuries.

Medical errors in children pose a greater threat because they are physically small and their kidney, liver and immune systems are still developing. If children take a turn for the worse, they can deteriorate more rapidly than adults. Children also are less able to communicate what they are feeling, making it difficult to diagnose them or know when a symptom or complication develops. Parents need to be the eyes, ears and advocates for their children. “Parents have to pay attention and speak up,” said Dr. Steve Selbst, professor of pediatrics at Jefferson Medical College in Philadelphia, who conducted the study on malpractice suits. “You know your child, and if you feel something’s wrong, go up the chain of command.” There are steps that can be taken to protect a child in the hospital. Here are some tips from experts quoted in the New York Times for parents to lower the chance their child will be harmed by his or her treatment. Make sure your child wears an identification bracelet at all times. Ask all health care providers to wash their hands before approaching your child. Ask the surgery team if they know exactly what the procedure is they are about to undertake. Take time every day to review with the physician and nurses the medications being taken and any other information about your child’s care. Be aware of any redness and swelling around catheters and incisions. Ask questions; be sure to understand what is being done for your child. Carry a list of the medications your child is taking and remind doctors about any allergies your child has. Be familiar with the medications prescribed so if any side effects occur they can be recognized. Bottom line, be vigilant, aware and knowledgeable and the chances your child becomes a victim of medical negligence will decrease.


OHSU and Oregon Trial Lawyers Agree on Increase of Tort Cap

Oregon Health & Science University and the Oregon State Trial Lawyers have agreed to new limits on how much a government agency can pay in medical malpractice trials. Their recommendation to the legislature and the Governor’s office would raise the current liability cap of $200,000 to $1.5 million and would eliminate the $100,000 cap on pain and suffering. Legislators won’t consider changing the law until next year and if passed, it won’t go into effect until July 1, 2009. The new "per-claim" limit of $1.5 million would then start, and increase by $100,000 a year for five years to $2 million. The cap on incidents involving multiple claimants would start at $3 million and increase by $200,000 a year for five years to $4 million. After the five-year period, both limits would increase annually by 4 percent. The proposal would apply only to injuries that occurred after the Supreme Court decision. In a statement, Gov. Ted Kulongoski said the proposal will “ease the tough decision-making” and “seek the appropriate balance between protecting taxpayers' money and compensating victims of negligence.” OHSU is one many state agencies covered by Oregon's tort cap, but it has the most at stake given the frequency and size of its medical malpractice claims.


September 22, 2008

Settlement of Rezulin Lawsuit to Provide Money for Research

Eight years ago a class-action lawsuit was launched against drug manufacturers Warner-Lambert Co. and Parke-Davis regarding their diabetes drug Rezulin that was found to have caused severe and sometimes fatal medical issues in those who took it. In December 2007 County Circuit Judge John Hutchison approved a $17.1 million settlement agreement. A number of individuals eligible to receive damages did not claim their money which resulted in a surplus of nearly $8 million in unclaimed monies. The unique settlement arrangement allowed for the unclaimed money to go to diabetes treatment and research in West Virginia. Two orders signed by Hutchison last Wednesday awarded $2.25 million to the Marshall University Joan C. Edwards School of Medicine Rural Health Program and $5.67 million to the West Virginia University Department of Pediatrics. Marshall’s funds will be used to help its diabetes center promote better treatment of diabetes issues and add a new focus on diabetes and related disorders to its mobile medical center, which travels around the state performing cancer screenings in rural areas. West Virginia University will use the funds to research a possible link between obesity, diabetes and asthma in the state’s children. Hutchison commended the efforts of both lawyers in the case saying, “I believe the plan for the distribution is an outstanding example of cooperation between the two parties involved, and the distribution is absolutely in the best interest of the citizens of the state of West Virginia.” he said.


Man Wins Supreme Court Appeal in Statute of Limitations Trial

An Alabama man’s lawsuit has been reinstated by the state’s Supreme Court in a malpractice case against a local hospital and one of its emergency room physicians. The court said the original Madison County Circuit Court erroneously dismissed the case previously. Francis Price Crosslin went to the hospital’s emergency room in February 2002 complaining of nausea, dizziness and weakness. A battery of tests, including a CT scan, revealed that Crosslin had a tumor on his pituitary gland, but the hospital and doctor failed to inform Crosslin of it that day. Crosslin returned to the hospital in September 2005 complaining of loss of vision in his left eye and decreased vision in his right eye. It was only then that he learned of the tumor and it was removed two days later. Crosslin claims that because of the hospital and doctor’s negligence he has been left with severely limited vision in both eyes. Attorneys for the hospital and doctor had argued that any injury done to Crosslin occurred on Feb. 23, 2002, and he failed to file a malpractice complaint within two years as required under the Alabama Medical Liability Act. The original trial judge agreed and dismissed the case. Thankfully, Crosslin’s attorney argued in their appeal that the alleged malpractice may have occurred some time after Feb. 23, 2002, and within the statute of limitations. The Supreme Court agreed and had this to say about the case, “Crosslin's complaint does not foreclose his ability to prove that the injury caused by Huntsville Hospital's and Dr. Calvert's alleged malpractice did not occur until some time after the actual act of malpractice (Feb. 23, 2002) and therefore within the applicable time period.” The case will return to the Madison County Circuit Court.


September 19, 2008

JAMA Report Reveals Chronic Pain Common in TBI

In the August 13, 2008 edition of the Journal of the American Medical Association a study titled “Prevalence of Chronic Pain after Traumatic Brain Injury” was submitted. Dr Charles W. Hoge, of Uniformed Services University of Health Sciences (USU) was the author of the study. USU is the nation’s federal school of medicine and educates health care professionals who are in service to the Department of Defense and the U.S. Public Health Service. The study was a compilation of 23 studies using 4,206 veterans of the Operation Iraqi Freedom and Operation Enduring Freedom questioning veterans 3 to 4 months post return to stateside. Dr. Hoge reported that chronic pain is a common complication of TBI and is not associated with psychologic disorders such as PTSD and depression. Surprisingly, chronic pain was also found to be common among patients considered to have sustained a minor brain injury as well.


MRI Reveals Recovered TBI Patients’ Brains Work Harder

In a study appearing in the September 9th release of Neurology researchers reported that even though someone may have recovered well from a traumatic brain injury based on cognitive tests, the patients often report mental fatigue and not quite feeling the same as they did prior to injury. The brains of people who've recovered from head injuries have to work harder than the brains of healthy people to perform at the same level, said researchers at the Rotman Research Institute at the Baycrest Centre for Geriatric Care, in Toronto. Functional MRI was used to assess brain activity in those recovered from brain injury and compare it to individuals who have not suffered a TBI. The eight patients in the study suffered diffuse axonal injury (DAI) most commonly caused by falls, motor vehicle accidents and injuries where the brain is violently shaken inside the skull resulting in the widespread disconnect of brain cells. “Our imaging data revealed that DAI patient brains had to work harder to perform at the same level as healthy, non-injured brains. Specifically, the brain injury patients showed a greater recruitment of regions of the prefrontal cortex and posterior cortices compared to healthy controls,” study leader Dr. Gary Turner said in a Baycrest news release. The researchers hope their findings will help in the development of future treatments that ultimately improve their cognitive abilities.


September 18, 2008

Pikes Peak Hike Benefits Traumatic Brain Injured

The Brain Injury Association of Colorado holds an annual Pikes Peak Challenge to benefit survivors of traumatic brain injuries. The fundraising event is held annually in September and includes a hike to the summit of Pikes Peak in Manitou Springs after a 13 mile ascent. Funds raised by the Pikes Peak Challenge helps provide direct services to two thousand survivors, families and professionals annually. Several thousand more are served through community outreach programs. Programs include support groups, community education and prevention, the Outdoor Adventure Challenge, volunteer programs and more.


Yoga Used to Improve Balance in Seniors and Avoid TBI

According to the Centers for Disease Control and Prevention the fall-induced traumatic brain injury death rate for people 80 and older increased by 60 percent between 1989 and 1998. Further, seniors who have fallen previously or who stumble frequently are two to three times more likely to fall within the year. The risks increase if you are a white female who has fallen previously or have lower body weakness, vision problems, or are taking more than four medications. In an unusual study, researchers from the School of Podiatric Medicine at Temple University found that females aged 65 or older can benefit from a specific form of Yoga called Iyengar. The yoga program used chairs and other props to help with body placement. After the nine-week program researchers found that participants had a faster gait, increased flexibility, improved single-leg stance and an increase in confidence in walking and balance. A profound difference in how weight was distributed on the bottom of the foot helped maintain balance. Jinsup Song, D.P.M., Ph.D., Director of the Gait Study Center at Temple University School of Podiatric Medicine, says, “People are gaining more confidence as they stand and walk at the end of the yoga intervention. People are more aware of their body posture. It [yoga] opens up a whole range of treatment options we didn’t think we had before.”


September 17, 2008

Malpractice Case Claims Off-label Drug Prescription Caused Disability

A man seeking psychiatric care for depression and anxiety is suing his psychiatrist for the off-label use of the anti-psychotic drug Geodon alleging the drug is responsible for his diagnosis of extrapyramidal symptoms and tardive dyskinesia. Extrapyrmidal symptoms are movement disorders such as the inability to initiate movement or the inability to cease movement. Tardive Dyskinesia is a neurological disorder caused by the long-term use of neuroleptic drugs generally prescribed for psychiatric disorders. The geodon.com web site state that the Pfizer drug Geodon is approved “to treat acute mania and mixed episodes associated with bipolar disorder” and approved to treat schizophrenia. The suit states that plaintiff Donald Moss continued the regimen of Geodon for two years, “even after plaintiff had a transient ischemic episode or minor stroke.” After Moss discontinued his use of the drug he began to experience dry eyes and later drooping of his eyelids that got so bad that he would have to pull them open to be able to see. The complaint states “More specifically, the prescribing of the anti-psychotic drug Geodon for depression was inappropriate medical care, the failure to first try the use of less dangerous drugs before use of an anti-psychotic such as Geodon was inappropriate, the prescribing of Geodon to a patient with plaintiff's 20 year history of diabetes mellitus was inappropriate, the failure to warn of the serious potential side effect was inappropriate, and prescribing the drug for the length of time and strength of dose prescribed was inappropriate for the plaintiff.” The plaintiff is seeking damages for loss of earning capacity, disfigurement, medical expenses and the loss of enjoyment of life.


Complex Regional Pain Disorder Post Surgery

A medical malpractice lawsuit brought by a Maryland woman highlighted the disorder Complex Regional Pain Disorder or CRPS. Donna McNeal underwent surgery to mend the pain she was feeling in her neck, hand and elbow as well as the “tingling” in her hands. Post surgery she experienced pain in her upper extremities particularly her arm as “cold, sharp, pins and needles, with throbbing and burning in her armpit described as “thousands of bees stinging.” According to the Reflex Sympathetic Dystrophy Syndrome Association, CRPS is a neurological condition that causes the nerves to “send constant pain signals to the brain” and is characterized by a severe, burning pain and tissue swelling with up to 1.2 million people affected by the condition. The condition is brought on by any type of traumatic injury. It is often seen following surgery to treat carpal tunnel syndrome. In the end her doctor prescribed formal physical therapy and painkillers and recommended McNeal to see pain specialists who ultimately diagnosed her CRPS. She has been unable to return to her job and suffers from pain in all of the joints of her right arm. The lawsuit was dismissed with prejudice after an orthopedic surgeon serving as a defense expert witness said he found no medical literature showing a patient developing CRPS following the common procedure McNeal underwent.


September 16, 2008

Find a Team of Dedicated Supporters to Help Recover from TBI

Recovering from a traumatic brain injury is a long and hard process of rehabilitation and dedication. It can take years to gain just a little bit of what was lost in memory and physical and mental disability. It’s important to explore all options and find a team of supporters that will work diligently in the brain injured favor. Don’t take “no” for an answer. Complete recovery may not be possible, but with a team composed of doctors, psychologists and family who are dedicated to rehabilitation much of what was lost can be recovered. In fact a Pennsylvania woman who was struck by a truck while riding her bicycle in 2005 suffered severe brain injuries. She spent two weeks in a coma and endured several surgeries and extensive rehabilitation. Three years later she competed in an Ironman competition. In her own words, “I'm high functioning as described by neuropsychologists, but I'm about 80-percent of my capabilities and working hard every day to try to overcome that and get back a normal lifestyle.”


FDA Approval of Rapid Patient Cooling Device in TBI

At the University of Texas Health Science Center researchers have been given FDA approval to study a new rapid cooling device in a clinical trial for patients with traumatic brain injury. Life Recovery Systems’ ThermoSuit(R) System was approved for clinical study under the Investigation Device Exemption by Dr. Guy Clifton at U of T. The study will attempt to determine if the induction of hypothermia in three intervals at 2 and a half hours, four hours and maintained for 48 hours after severe traumatic brain injury will result in an increased number of patients with positive outcomes at six months and twelve months post injury. A previous study performed by the same researchers indicated that later cooling was ineffective in reducing brain injury side effects. “If the study proves to be successful, the ThermoSuit System could potentially benefit thousands of patients with traumatic brain injury,” said Milton Frank, Life Recovery Systems' COO. “Traumatic brain injury is the 'signature wound' of the Iraq war, and LRS is hopeful that early cooling will be beneficial to a number of military casualties.” The study will employ 240 patients and is entitled the National Acute Brain Injury Study: Hypothermia IIR and is being sponsored by the National Institute of Neurological Disorders and Stroke.


September 15, 2008

Brain Injury Patients Employ More Brain Power

A new study found that traumatic brain injury patients may have to employ more of their brain power than they did before their injury to perform the same tasks prior to injury. Researcher Dr. Gary Turner said, “Specifically, the brain injury patients showed a greater recruitment of regions of the prefrontal cortex and posterior cortices compared with healthy controls.” The brain injured participants in the study showed increased activity in different parts of the brain than the uninjured control group. In addition, they said, because traumatic brain injury is often associated with chronic pain, depression, and anxiety, “it is plausible that any reduction in neural processing efficiency resulting from brain injury may be exacerbated by secondary impacts of comorbid physical or psychological impairments.” In other words, further physical or mental trauma to the head may delay recovery.


Tainted Food, Medicine and Infected hospitals

Canada and the United States have had their share of brushes with death and disability linked to outbreaks of Listeriosis in packaged foods, Salmonella in peanut butter, spinach and jalapenos, Clostridium difficile in hospitals and exposure to defective medicines and medical products. All of which come from improper handling, manufacturing or just plain negligence. In an environment where people are being put in danger time after time and live in a state of fear of the next contamination a line needs to be drawn. The companies, hospitals and manufacturers need to know that negligence and poor oversight cannot continue as business as usual because business as usual is killing people. Until such a time that they start to take responsibility for their product, whether it is a service or a consumable, the people need to take the lead and seek an advocate in their fight against irresponsibility. That advocate is an attorney who because of the state of affairs in the corporate arena has ample experience in fighting the giants.


September 12, 2008

Lawsuit Filed in C. Difficile Hospital Deaths

A coroner’s report last year claimed that shoddy infection control and hospital cutbacks in maintenance and room cleanliness is responsible for a Clostridium difficile outbreak that ultimately killed 16 people and sickened 70 others in a Montreal hospital. Relatives of patients who were either infected with the illness or died from it have filed a class-action lawsuit against the local health authority seeking up to $10 Canadian million in damages. The outbreak at the Hopital Honore-Mercier in St. Hyacinthe is considered one of the worst. “We want to send a strong message that infection control must be maintained as a priority by hospitals, administrators and staff,” medical malpractice lawyer Jean-Pierre Ménard told a news conference. “It's not enough for public-health officials to say that it was a virulent strain.” What is especially upsetting is that Quebec had already dealt with a C. difficile epidemic in 2004-2005, yet no one seems to have learned any lessons from the earlier outbreaks added Ménard. The class-action is seeking compensation on three levels. For those who got infected, those whose infections were severe enough to require surgery and for relatives who lost loved ones. C. difficile is a spore-forming bacterium that can last up to 70 days on hospital surfaces. The bug is a major problem in hospitals across Canada, the United States and Europe.


Know your Rights: The Auto Insurance Maze

Chances are you or a loved one will be in a car accident unfortunately. When this happens most are unprepared and are sucked along the roller coaster ride of what needs to done when. In the maelstrom people don’t find out what their rights are, what forms of assistance they have access to and what steps they need to take to protect themselves or their loved ones. The first action is to stay calm, call the police and if an ambulance is offered take it. As the shock of the situation may not allow you to feels injuries yet.

As time goes on cover the following:

Contact your insurance company and apply for accident benefits. Regardless of who is at fault in the accident the insurance company has an obligation to provide you with accident benefits. You must contact your insurance company within seven days of the accident and apply for benefits within 30 days. If you were injured while a passenger whether it is under your own policy or not, you can still claim accident benefits under the policy of the other person. Again, do not refuse medical treatment at the scene of the accident.

If you are discharged be proactive in your recovery and see your doctor.

If you hit your head in the accident or lost consciousness take any headaches, memory loss or other cognitive changes very seriously and seek medical attention immediately. Some brain injuries do not manifest themselves for days. Usually a neuropsychologist can determine whether you have sustained a brain injury. The accident benefits insurer should pay for urgent medical evaluations, such as neuropsychological testing or MRI.

As soon as possible contact the insurance company of any other vehicle that caused or were part of the accident. Within 120 days of your accident, you must notify these individuals, in writing, and advise them that you have been injured and that you intend to pursue a claim for compensation against them.

If you did not exchange insurance information at the time of the accident the insurance name and policy number will be on the police report. Send the letters by registered mail and keep a copy for yourself. If you receive a letter from someone who has been injured, send it to your insurance company immediately. Know your rights to compensation and be aware of any statute of limitations in filing. If you feel it is necessary to claim compensation for damages from those responsible you can file a lawsuit seeking damages for “pain and suffering” or “lost income” that will be paid by the individual’s auto insurance company.

The long and twisted road through the insurance maze can be overwhelming. By now the importance of having auto insurance should be made clear. They are there to help you when you have been in an accident, but are not always helpful in assisting you get what you paid for and is rightfully yours. If you feel powerless or confused consider hiring someone who can aid you in the process. Attorneys have experience and know the system and can bring you relief quicker.


September 11, 2008

Young Girl Catastrophically Injured Awarded $2M

A young girl and her family recently settled with a group of companies in a lawsuit over a bike accident that left a young girl, Hailey Kramer, now 12, with catastrophic injuries. Her mother, Robin Kramer, filed suit in October on her daughter's behalf, seeking damages from the companies that designed and built Lake Haven Drive, where Hailey was injured on June 24, 2005. Bax Engineering, Bax Development Inc./J.C. Bax Construction Co. and the Forest Lake Estates trustees recently settled with the Kramers for $2 million. There are other defendants in the case that have yet to go to trial or settle. While riding her bike she fell and hit the side of her face on a wooden post alongside the road. The doctors said that wearing a helmet probably would not have prevented her injuries. The family’s attorney said the defendants cut corners to save money and built a road with a 17 percent grade in defiance of a county’s ordinance that says slopes on private roads cannot exceed 12 percent. The family’s attorney says the settlement allows the Kramers to modify their home to allow wheelchair access, install devices which help move Hailey in and out of bed and into the bathroom and pay for experimental medical treatment not covered by insurance.


The Road to Seeking Medical Malpractice Advice

When making a decision whether to contact a medical malpractice attorney there are a number of things to keep in mind. Even if you feel as though you have good reason to you might also feel it will be a waste of time. The truth is if you’re armed with just a little bit of knowledge of what malpractice attorneys do for their clients, the decision would not be so tough. Many medical malpractice attorneys offer free consultations. It is important to find an attorney with experience in the malpractice trial arena. Such attorneys will help you define whether your claim is legitimate. Legitimate complaints include birth injuries especially those resulting in brain damage, a misdiagnosis or lack of diagnosis for such illnesses as cancer, death due to medical negligence, nursing home abuse, prescription medication errors and defective drugs or products that have caused injury. It is important to find the right attorney for you. When searching for a medical malpractice attorney, make sure that you are comfortable working with him. This can be a very traumatic time in your life and feeling that you have someone on your side is important.


September 10, 2008

FDA orders “black box” warning on rheumatoid arthritis drugs

Those who have taken the rheumatoid arthritis drugs Enbrel, Remicade, Humira and Cimzia may be at risk of possibly fatal fungal infections. So far 240 cases have been reported to the U.S. Food and Drug Administration who have developed the fungal infection histoplasmosis of which 45 have died so far. That is a 20 percent fatality rate! The FDA has ordered stronger warnings for the immune suppressant drugs because the drugs lower the body’s defenses to fight various kinds of infections. The FDA's Dr. Jeffrey Siegel became concerned when it was discovered that doctors seem to have been overlooking these types of infections. The infection mimics the flu and is prevalent in much of the middle part of the country. It can have particularly grave consequences if it isn't caught early and spreads beyond the respiratory system to other organs of the body. Siegel said the investigation began with the case of a woman taking one of the drugs who died of histoplasmosis. After her death FDA officials searched the agency’s database and found an additional 240 cases of fungal infections. Of the 240 cases, 21 of them were late in being diagnosed of which 12 eventually died. That’s more than half! Dr. Siegal announced that the FDA has ordered a “black box” warning, the most severe, to be added to the drugs packaging informing the public about the risk of infections. If patients develop a persistent fever, cough, shortness of breath or fatigue, the FDA is encouraging them to seek medical attention as these are the symptoms of the fungal infection.


Cancer Drug Shows Promise in Treatment of Brain Injury

The cancer drug Bryostatin has been shown to repair brain tissue if it is given within 24 hours after a stroke, according to U.S. researchers. This could have far reaching significance for those who have suffered a traumatic brain injury. In an article published in the latest issue of the Proceedings of the National Academy of Sciences, it was described how Bryostatin repairs and improves memory. In animal tests the drug rescued dying neurons, stimulated the growth of new neuron connections and restored memory. The researchers have asked the U.S. Food and Drug Administration if they could begin clinical trials of the drug. This could be an important and ultimately successful treatment for the estimated $1.9 million who have suffered from some type of brain injury.


September 09, 2008

Texas Opponents of Tort Reform Claim it’s Unconstitutional

A constitutional amendment was approved in Texas in 2003 limiting the amount of non-economic damages in medical malpractice cases to $250,000. The cap was done because Texas physicians had seen a 150% increase in medical malpractice insurance. Since then, medical board disciplinary actions have risen and are continuing to rise, creating patient safety concerns. The board statistics show disciplinary actions have increased 12% between 2003 and 2007. Additionally, Texas physicians have only seen a 24% drop in their medical liability insurance since 2003. Now, opponents of the cap are claiming the caps are unconstitutional and are taking their case to federal court. They argue that caps are preventing patients’ their legal rights. More specifically they are arguing that the Texas law violates patients’ right to a jury trial and due process by setting an arbitrary recovery limit. The case is now pending in U.S. District Court for the Eastern District of Texas.


Rare Texas Supreme Court Ruling Upholds Punitive Damages Award

In a rare and unusual move the Supreme Court of Texas upheld a medical malpractice award for the family of a man who died of a heart attack after waiting12 hours for treatment following his admission to a hospital emergency room for chest pains in 1998. Tort reform limiting non-economic damages to $250,000 were enacted in 2003. The original malpractice trial heard in 2001 jurors awarded the family $9.2 million in compensatory damages and $21 million in actual damages after attorneys for the family successfully argued that Mr. Hogue’s treatment was delayed because of poor hospital policies and lack of staffing. Son and attorney Christopher Hogue now works at the same law firm who helped his family secure the win. In 2004 the total was reduced to approximately $5.4 million based on existing laws limiting damage awards in medical malpractice claims. “We are extremely pleased to finally have this case resolved through this just, but infrequent affirmance of punitive damages,” says the family’s attorney. “This opinion is especially gratifying because the Hogues have had to wait so long for the court to rule. The Supreme Court of Texas is known far and wide for reversing court judgments favoring plaintiffs, particularly in medical malpractice cases, and it is important that this decision is perhaps putting a halt to that trend.” After the ruling, the defendant must pay the family approximately $10 million because of interest on the $5.4 million award.


September 08, 2008

Fiancé Loses Betrothed to Blood Clot Attributed to NuvaRing Birth Control

In another birth control tragedy a young man’s fiancée was killed and his 11-month-old son has lost his 22-year-old mother to a blood clot in her lung attributed to the use of the NuvaRing, a disk shaped hormone-delivery product that is inserted once a month then removed three weeks later. At the time of Katie Payne’s death her fiancé Anthony Greenfield did not link her collapse in the driveway and death to her choice of birth control until the coroner deputy asked him whether she had used it. His questioning grew so he went online to research more and found many more stories of deaths, illnesses and lawsuits. Katie Payne had just returned home with her son after a trip to the gym. Once she settled him inside she went back out presumably to get his diaper bag, said her stepfather, Jody Cline. Her collapse was recorded by a home security system then a passing neighbor found her soon after. Now her family wants to alert other young women of the dangers of certain kinds of birth control. “I know this killed her,” said her mother, Belinda Payne-Cline. “If they can't do better research or get it off the market, then … the information needs to be more in depth about what can happen.” If no other cause for the clot is found, her death could enter federal databases as another adverse effect of NuvaRing. Last year, the consumer group Public Citizen asked the Food and Drug Administration to ban oral contraceptives containing desogestrel, a variant of one of the hormones in NuvaRing, because some studies showed it doubles the risk of blood clots. NuvaRing's web site and product information warn that one of its hormones, a kind of progestin, may cause more clotting than the progestin in some birth control bills, but it discloses that the difference in risk between the ring and some birth control pills is unknown.


Online Resource for Employers of TBI and PTSD Veterans

The America’s Heroes at Work Web site ( www.AmericasHeroesAtWork.gov) has been launched by the U.S. Department of Labor for use by employers who hire veterans that have suffered a traumatic brain injury and/or post-traumatic stress disorder. The web site includes tools and guidance on how to implement accommodations and other services at the workplace. As well as a toll-free number where employers can call to receive assistance relating to workplace accommodations for veterans with disabilities. The site is also a reservoir of job coaching and mentoring programs. The site seeks to help and encourage employers in their endeavor to not only assist veterans, but to help non-veterans who have suffered TBI and PTSD. America’s Heroes at Work is managed jointly by the Department of Labor’s Office of Disability Employment Policy and Veterans’ Employment and Training Service, in collaboration with other federal agencies engaged in TBI and PTSD programs, including the Department of Defense, the Department of Veterans Affairs, the Department of Health and Human Services, the Department of Education, and the Social Security Administration.


September 05, 2008

Big Pharma Loses in using Drug Preemption Immunity

On August 29th Judge Ronald L. Buckwalter, of the United States District Court for the Eastern District of Pennsylvania submitted a 53-page opinion on the ruling associated with Garrison v. GlaxoSmithKline (GSK) case. As background information, Jake Garrison, 16, was taking the drug Paxil, an anti-depressant and anti-anxiety drug when he committed suicide. The parents filed a lawsuit against GSK the manufactures of Paxil. GlaxcoSmithKline attempted to use a preemption argument, which simply means that if the U.S. Food and Drug Administration has approved a drug or product for use then any litigation brought against the manufacturer for adverse events associated with the drug or product should be dismissed because of said FDA approval. GlaxcoSmithKline’s attempt failed as Judge Buckwalter issued the arguments:

1. “Drug manufacturers have the best information about the safety of their own products and, thus, under the regulations, they have the ability to alter a drug label prior to FDA evaluation and approval.”

2. FDA regulations allow a drug manufacturer to "unilaterally add a warning on a drug, so long as the drug manufacturer has reasonable evidence of an association of a serious hazard with a drug."

3. “Arguably, GSK possessed such reasonable evidence of an association between Paxil and pediatric suicidality as early as 1998, at the conclusion of their own Studies 329 and 377 the data from which initially triggered the FDA’s concerns. The mere fact that GSK elected not to submit the results of those studies until April of 2002, when it filed a supplemental NDA (new drug application) seeking approval of an indication for pediatric use, does not detract from the fact that it may have had reasonable evidence of a hazard prior to that time.”

4. “The mere fact that the FDA had not ordered GSK to include this warning prior to 2002, does not mean that it could not have legally done so.”

5 “A state failure to warn action will not usurp or undermine the FDA’s responsibilities to ensure an accurate label, but rather will close the void in the authority of the FDA, which can neither independently regulate off label use nor require additional clinical trials.”

6 “Tort law can play an important role in filling the gap, and it is consistent with a regulatory system that puts the obligation to warn on the party with the most comprehensive information available: the drug manufacturer.”

This is an extremely important win for plaintiffs’ and their attorneys as the tide in Big Pharma is tending to try and use preemption in an attempt to quash victims rights in seeking damages when a drug company willfully and irresponsibly puts patients at risk.


Brain Injury Awareness and Concussions

Traumatic brain injury used to be associated with a blow to the head, but recent awareness of the injury brought by soldiers returning from wars indicates otherwise. Improvised Exploding Devices or IEDs may not touch a soldier, but the resultant pressure of the explosion can cause a sheering to the tissues in the brain. Regardless of how the injury is experienced the symptoms share a common factor; they interfere with the way the brain works. Neurosurgeon Dr. Jeffrey Crecelius recently wrote an article on the prevention of concussions which are a type of traumatic brain injury. Brain injury can affect memory, judgment, reflexes, speech, balance and coordination. Even though a concussion cannot be seen keep an eye out for the symptoms which can show up days or weeks after the initial injury.

• Nausea
• Double or fuzzy vision
• Headache
• Feeling sluggish or tired
• Trouble concentrating or remembering
• Confusion
• Dizziness or balance problems

If you’ve had a concussion:
• See a health care professional
• Get plenty of rest
• Return to daily activities only after your brain is healed

Prevention:

• Wear a helmet during recreational activities such as biking, skiing, skating, horseback riding, motorcycling, etc.
• Always wear your seat belt.
• Keep your home well lit, fix uneven surfaces, block off stairways.
• If you are older wear thinner, hard-soled, flat shoes to reduce the risk of trips and falls.


September 04, 2008

Association for Justice Invests in Safety of Americans

In an effort to protect American consumers the American Association for Justice, formerly known as the American Trial Lawyers Association, spent more than $1.7 million on lawsuit reform in the second quarter. The Association lobbied on proposals related to medical malpractice reform, the safety of toys and other consumer products, auto and rail safety and the pre-emption of lawsuits in state courts by federal law. This latest information demonstrates the dedication attorneys have for their clients and establishes their willingness to stand up for the protection of people against faulty products and procedures.


New MRI Contrast Agent Could be Alternative to Gadolinium

In the wake of a number of injuries occurring after the use of gadolinium contrast agents before an MRI, the U.S. Food and Drug Administration has approved a Fast Track Designation for a new type of contrast agent, ferumoxytol. Gadolinium contrast agents have been strongly linked to the debilitating and sometimes deadly disease Nephrogenic Systemic Fibrosis. Those who have suffered from this disease have previous renal failure in their kidneys. The gadolinium contrast agent is unable to evacuate from the body of an impaired renal system as quickly as those without. The FDA reserves the Fast Track Designation for products intended in the treatment of serious or adverse conditions or have the potential for use in previously unmet needs. This designation helps to accelerate the process of development and review of these products. The quicker approval process of ferumoxytol is driven by the potential that this newer diagnostic agent will be a safe alternative for individuals with chronic kidney disease.


September 03, 2008

Botched Dental Surgery Results in $14.8 million Award

Often not heard in the press, a woman has been awarded $14.8 million after a dental surgery left her disabled and disfigured with her jaw fused shut. The Spokane County Superior Court jury ruled in the case that Dr. Patrick C. Collins, an oral surgeon, was negligent in performing several operations that left Kimberly Kallestad, 29, injured. The ruling includes $10 million in non-economic damages for pain, suffering and disfigurement in “past and future loss of enjoyment of life.” Kallestad is experiencing chronic pain, cannot work and is being cared for by her parents. She went to Collins after injuring her jaw while sledding and says he claimed that he had a near-perfect success rate with a surgery technique that he had developed and would become her "hero" by fixing her jaw. She cannot work and is being cared for by her parents. Other patients of Collins who had trouble testified that he said similar things to them. John Versnel III of Seattle, a lawyer who represents many of the state's dentists in litigation, said the award is the largest dental malpractice verdict in his 21 years of practice.


Could Brain Injury lead to Alzheimer’s?

A study published in the August 29 issue of Science seeks to link Alzheimer’s with previous brain injury. Researchers at the Washington University School of Medicine in St. Louis and from the University of Milan took samples of fluid between the brain cells of 18 patients who were recovering from a traumatic brain injury or ruptured brain aneurysms. Changes in the amount of amyloid beta, a protein that is believed to play a key role in Alzheimer's disease, were thoroughly studied. “Proving that we can directly measure amyloid beta in the human brain is an important step forward for both clinical and basic research, and that may be true not just in Alzheimer's disease but also in other serious neurological disorders,” says co-first author David L. Brody, M.D., Ph.D., a Washington University neurologist. Levels of amyloid-beta in the brain increase as neuronal activity increases. The protein is known for causing plaques in the brains of people with Alzheimer’s disease. Previous studies using mice showed that amyloid-beta is a byproduct of brain cell activity. The studies with people show the areas of the brain that are most active are the most prone to developing Alzheimer’s plaques. This could be an important discovery that could help determine additional long-term side effects of suffering from a traumatic brain injury.


Most Informed of Digitek Recall by Pharmacist

A Tennessee attorney was contacted by a family who believed their loved one died from the overdose of digitalis, the main ingredient found in the heart drug Digitek. In the last few months a number of reports have been made to the U.S. Food and Drug Administration concerning the adverse events people have been experiencing. The drug Digitek was recalled because of a manufacturing error that doubled the thickness, thus the dosage of the heart drug. According to the family, doctors told them they weren’t sure why the person had died. It wasn’t until the family heard about the recall did they make the connection. The manufactures have yet to inform the public how long the production glitch occurred which would give patients and doctors a time frame to be concerned about. Many people found out about the double dosage when they went to have their prescription refilled and the pharmacist informed them of the recall. An Associated Press story reported earlier that Actavis, Digitek manufactures, was asking pharmacists and hospitals to return all prescription drug products made at one of its facilities because it did not pass health authorities’ standards. An inspection of the New Jersey facility by FDA officials “revealed operations which did not meet the FDA’s or Actavis’ standards for good manufacturing practices,” read a statement issued by the company and printed in the story.


September 02, 2008

TBI Boy’s Parents Continue Fight with School District for Rights

The debate between a school district and the family of Mikey Berns is still in the works. An independent hearing officer listened to testimony from experts representing both the family and the school district. Mikey Berns, 5, suffered a traumatic brain injury when a cabinet fell on top of him last October. The parents have been fighting to get him full-time kindergarten schooling saying that their doctor and other experts agree that repetition helps with cognition and memory stability. According to their neuropsychologist, Dr. Bryan Hudson, the boy would benefit from attending both sessions and the school district is obligated to provide that service. “Any time you have material presented more than once, it increases the likelihood that it will be encoded and consolidated for later use,” Hudson said. Dr. Chris Sullivan, a neuropsychologist hired by the school district, reviewed the boy's medical records and told the hearing officer that the boy's memory is solidly average. The school district's attorney asked Sullivan if a longer day of instruction would help Mikey in which Sullivan replied, “"It is not the case more is better. It is how information is presented. Simply repeating curriculum is not necessarily going to produce gains you want,” Sullivan said. If Mikey and his parents win this debate, they want the school district to cover costs of the one-on-one special education he has been receiving.


Scaffolding Collapse in Construction Accident Injures Many

A construction accident in San Diego has injured at least 16 people with at least three of them being life-threatening. The injuries occurred when part of some scaffolding collapsed in downtown San Diego. Rescue crews say about 25 people were on the wooden walkway when its walls and roof fell in. The accident happened where a lot of renovation projects were underway. Investigators are determining the cause of the collapse. Closing the walkway or establishing a detour could have been a prohibitive step and kept 16 people from being injured.


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Burg Simpson Eldredge Hersh & Jardine, P.C. is a law firm serving the Rocky Mountain Region. The firm has offices in Denver, Colorado, Cody, WY, Cincinnati, Ohio, and Phoenix, AZ. The Firm is responsible for the content on the website, this information is not to be interpreted as providing legal services, nor as proposing any form of legal advice.

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