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« March 2008 | Main | May 2008 »

 

April 30, 2008

Paralyzed Man Awarded $87 Million

A Forney, Texas man was partially paralyzed when a rented U-Haul moving truck ran over him because of a faulty emergency brake and worn-down gears. A Dallas County jury agreed that U-Haul was at fault and awarded him $87 million. Talmadge Waldrip rented the U-Haul truck in September 2006 to help his daughter move. As he stopped the struck and got out, it started rolling backwards knocking him down and crushing his bladder and pelvis. Two years and more than 14 surgeries later he still cannot walk and requires 24 hour care. Many who have rented moving trucks have experienced the same type of company incompetence when reporting or experiencing problems that are ultimately ignored by the company. The attorney for the Waldrip’s and the jury agreed, “This verdict is a verdict for safety,” attorney Ted Lyon said. “U-Haul trucks are not safe. They don’s fix them.” Waldrip said his lawsuit was not about money. “I want them to know they can't treat people like this and rent a vehicle that is not roadworthy," he said.

 


 

Small Percentage of Medical Malpractice Cases go to Trial

Medical malpractice cases can last years while exacting an emotional toll on both sides of the lawsuit. Attorneys say that regardless of outcome neither side feels like a winner. About three-fourths of cases that end up at trial conclude in the doctor’s favor. Yet, physicians are blaming their patients for frivolity when then elect to sue to change how they practice. Both attorneys and physicians say that death or injury from a medical procedure does not necessary equate with negligence by the doctor. Oftentimes families file lawsuits simply because they want to know what happened. If a lawsuit goes to trial medical records become available that provide valuable insight into what really happened. In reality most cases are dropped early because the alleged malpractice could not be found against the doctor or institution. Of those that do go to trial nationwide, only 27 to 29 percent result in a verdict for the plaintiff. The numbers suggest the courts are weeding out frivolous lawsuits, contrary to doctors' claims.

 


 

April 29, 2008

Malpractice Trial Seeks Long Term Care for Toddler

An Orange County girl at the age of 20 months fell into a swimming pool at her family’s home in November 2003. When taken to the hospital doctors wrongly pronounced her dead and disconnected her breathing tube. More than an hour later a police detective noticed her chest was moving and summoned doctors who were able to revive her. She is now 6 and suffers permanent brain damage. The family has filed medical malpractice lawsuit claiming doctors at Anaheim Memorial Medical Center grossly misjudged their assessment of the little girl. The lawsuit is seeking punitive damages and the girl’s mother hopes the judge and jury will award enough money to help take care of her daughters long term needs.

 


 

FDA and China at odds in Heparin Contaminations

China and the U.S. Food & Drug Administration traded barbs on whether the contaminant found in the blood thinner Heparin was the link between 81 deaths triggered by severe allergic reactions. Federal health officials insisted new tests indicate a solid link. China argued the contaminant could not be the “root cause” of the problem. Raw Heparin is derived from pig intestines, often processed by small and unregistered workshops in China. The raw ingredients from the recalled Baxter’s heparin came from a Wisconsin-based Scientific Protein Laboratories which is known to own the Chinese factory, Changzou SPL, as well as buying additional raw Heparin from other Chinese suppliers. The FDA warned Changzhou SPL that it does not have an adequate system for ensuring that the raw materials it uses are free from any impurities. However, agency officials are still unsure at what point the deadly contaminant was introduced. The FDA also noted that as many as 12 companies in China are involved in the supply chain for Heparin. Hundreds of patients have suffered severe allergic reactions to the doses of the contaminated blood thinner. In its warning letter to the Chinese company, the FDA said it will recommend disapproval of any new applications listing the company as the manufacturer of any active pharmaceutical ingredient. It cited “significant deviations” from good manufacturing processes. Germany also discovered the contaminant and recalled batches of Heparin after some patient illnesses.

 


 

Dental Center and Dentist Sued for Grossly Unnecessary Care

When a mother took her 5 year-old child to a Charlotte, N.C. dental center to have her teeth cleaned, little did she know she would put her baby in the hands of a crooked dentist. The dentist performed 14 pulpotomies, similar to root canals, and mounted 14 stainless steel crowns on Antavia’s baby teeth the same day. Further, the employees of the center restrained Antavia by tying her down on a “papoose board” and refused to allow her mother in the room. Angela Digsby, Antavia’s mother, expectedly filed suit against the Medicaid Dental Center, alleging dental malpractice. The lawsuit was filed after the clinic owners agreed to pay $10 million to resolve allegations that they made fraudulent claims to the North Carolina Medicaid program for unnecessary dental work on poor children. In the suit it was stated that the dentists and co-owners of the Medicaid Dental Center policy was to “perform as much treatment as possible in one appointment.” This is not the first such malpractice incident at the clinic. In 2003 allegations were revealed that the center performed unnecessary dental work on children. In 2005 the N.C. Board of Dental Examiners disciplined nine dentists after an investigation revealed questionable practices. According to board documents, at least eight children, some as young as 4, had multiple teeth pulled and root canals performed during single appointments at MDC clinics. Some had as many as 16 pulpotomies and stainless steel crowns during the same visit.

 


 

April 28, 2008

Doctors and Lawyers on Basketball Court to benefit TBI

New Mexico doctors and lawyers faced off against each other on a court, but it is not in litigation, it’s on a basketball court to raise money and awareness for Traumatic Brain Injury. The Friends Helping Friends support group hosted its 22nd annual charity Doctors vs. Lawyers basketball game April 24th. In this court battle everyone wins. The game raised enough money last year to send people to a state conference to educate them about traumatic brain injury, what resources are available and the latest research and treatment. One of the support group’s participants is Heather Hales, she is married to Tyson who sustained a traumatic brain injury in 2000 while working in an underground coal mine in Utah. Tyson spent three months in a medically induced coma and once he awoke he spent an additional two years of rehabilitation. “I feel the effects of the injury every day,” he said. “I always have to write down everything because I have no short-term memory. I listen. My hearing is fine. I pay attention, but I just can't remember things.”

 


 

National Sports Concussion Summit Reports on Concussion Denial

At the second National Sports Concussion Summit it was announced that thankfully to the increased awareness and the recognition and consequences of head injuries in athletics, concussion denial is decreasing. “It's taken a long time to get there, but right now I think the public awareness is huge,” Dr. Robert Cantu of the Neurologic Sports Injury Center at Boston's Brigham and Women's hospital. “It's as if the Berlin Wall of concussion denial has fallen,” said sports agent Leigh Steinberg, noting a significant shift in both attitude and action within sports since the first summit was held a year ago. Steinberg, who helped organize the summit along with the Sports Concussion Institute, is sponsoring a California program that will institute “baseline testing” in 1,400 high schools, where athletes are given a cognitive exam that can be repeated after injuries to measure brain impairment. Other states like Hawaii have introduced such testing as well. Similar neurological tests were made mandatory last year in the NFL. Sports agent Leigh Steinberg is well known for representing clients whose professional career ended after a number of concussions. He described a moment in 1993 when he saw Troy Aikman after the Dallas Cowboys defeated the San Francisco 49er in the NFC title game. “He asked me where he was,” Steinberg said. “He asked me if he'd played that day. He asked me if he'd won. I said, 'Yes, you're going to the Super Bowl.' Ten minutes later he asked me where he was again.” Steinberg said he knew at that point he had to work on maintaining the minds as well as the money of his clients and other athletes. “It terrified me,” he said.

 


 

April 25, 2008

FDA reported contamination concerns at Merck vaccine plant

Based on an unpublished study, the Food and Drug Administration found potentially serious problems at Merck & Co.’s plant located in the Philadelphia suburbs. Contaminated children’s vaccines were among the 49 concerns cited by the federal regulators ranging from failure to follow good management practices to contamination of bulk lots of vaccine. Inspectors from the FDA visited the Merck plant between November 2007 and January 2008. In December, Merck recalled 1.2 million doses of its vaccine against Haemphilus influenza type B because of a sterility problem discovered in October and quarantined almost a year’s worth of other suspected doses. At this time the FDA has not ordered the plant to stop production while reviewing Merck’s responses to their report.

 


 

Portable Blood Analyzer Expected to Help Prevent NSF

Patients at risk of renal failure or kidney disease have a new tool that can help radiologists determine the safety in use of Gadolinium in Magnetic Resonance Images. Gadolinium is a contrast agent used to highlight soft tissue in patients before an MRI. Gadolinium has been found to be linked to the devastating and sometimes deadly disease Nephrogenic Systemic Fibrosis in patients with renal failure or kidney disease. MEDRAD, Inc. has developed a handheld device called the i-STAT System that can be used to analyze patients’ blood on the spot and deliver results of a variety of diagnostics in less than 3 minutes. Test cartridges in the unit provide an array of nine metabolic tests in the measurement of renal function for those with diabetes, kidney insufficiency and advanced age. The i-STAT is expected to successfully predict patients’ risk for gadolinium induced Contrast Induced Nephropathy (CIN) and Nephrogenic Systemic Fibrosis (NSF). The device can thus help radiology departments more efficiently maximize safety and care.

 


 

April 24, 2008

Chinese Say Chemical Didn’t Cause Heparin Reactions

An investigation conducted by the China National Institute for the Control of Pharmaceutical and Biological Products concluded that the contaminant found in the blood thinner heparin was not the cause of reported problems. Baxter International, Inc., the maker of the drug, recalled most of its heparin products in February due to reports of allergic reactions and death. Of the batches of heparin linked to problems, however, only some contained an altered form of chondroitin sulfate. The raw ingredient in heparin is manufactured in China.

The FDA has said that the oversulfated chondroitin sulfate was found in the heparin, but has not definitively linked it to the reported problems. Chinese health officials plan to visit Baxter’s plant in New Jersey.

 


 

Rehab Therapy Increases Gray Brain Matter in Brain Injured

The University of Alabama at Birmingham has developed a rehabilitation therapy for those with brain injuries caused by stroke. Constraint Induced (CI) therapy produced significant increases in the amount of gray matter created in patients receiving the therapy. “This changes all of our perspectives about what is possible in the brain,” said UAB neuroscientist Edward Taub, Ph.D., a study author and the developer of CI therapy. “For years, science thought the adult brain was hardwired, with no ability to change or adapt. Now we have further proof of the concept of neuroplasticity, the brain’s remarkable ability to respond to damage to compensate for the injury.” Constraint-induced therapy (CI) forces the use of the affected side by restraining the unaffected side intensively for two weeks. Other researchers worldwide have documented the same success. The changes observed worldwide were dramatic improvements in use of brain injured affected arms or legs and increased blood flow and stimulation of brain cells. Dr. Taub also reported noticeable and promising changes for those with blunt force trauma to the brain resulting in a traumatic brain injury. “We’ve shown that CI therapy can harness the plasticity of the brain for therapeutic effect in conditions with few practical treatment options,” Taub said. Exactly what causes the increase in gray matter thus the increase in physical and functional success still remains elusive. Taub speculates there are several possibilities. It may be due to an increase in the amount of blood vessels in the brain, or in the number of synaptic connections established between neurons, an increase in the amount of glial cells, or the intriguing possibility that the brain is creating more neurons. “The idea that the brain can make new neurons in adulthood…neurogenesis…has only been accepted by the scientific community in the past several years,” said Gitendra Uswatte, Ph.D., associate professor of psychology and study co-author. “These findings open the door to the possibility that the brain can indeed recover from traumatic injury by creating new brain cells to replace those lost by injury.”

 


 

April 23, 2008

Relying on FDA to Judge Safety of Ortho Evra Patch is a Mistake

The manufacturers of Ortho Evra, Johnson & Johnson, are hoping to use a legal doctrine called preemption as a defense against claims that the birth control patch has caused blood clots and death. Their argument is that if a drug or medical device has been approved by the FDA than its safety cannot be questioned in individual lawsuits. An editorial from the New York Times revealed its belief that the FDA is sorely short of skilled scientists and overwhelmed by its responsibilities that they might miss detection of important information and clinical results. Also according to the editorial, J&J might soon “get a helping hand” from the U.S. Supreme Court, which has blocked many lawsuits over “faulty medical devices” such as the recent decision concerning Medtronic’s faulty leads in one of its defibrillators. The Times continues that preemption is a “perverse legal doctrine,” and if it “continues to spread, the public will be deprived of a vital tool for policing companies and unearthing documents that reveal their machinations.”

 


 

Ortho Evra Patch Manufacturing Problems not Disclosed to FDA

Manufacturing flaws have come to light in the production of the Ortho-Evra Birth Control Patch. Johnson & Johnson, makers of the patch, have already disclosed data on how the numbers were altered to make the patch look safe. The Food and Drug Administration were misled by the world’s largest pharmaceutical company about estrogen levels before and after patch sales began in 2002 according to the filing. It was found that manufacturing defects made the patch unstable and the dosage unpredictable. J&J’s manufacturing problems at its facility in Redwood City , California, caused variations in the rate of release of estrogen from the patch. The company also could not replicate in its commercial patch the results obtained in clinical trials because the levels of estrogen varied from batch to batch. Disclosure also revealed that J&J scientist, Patrick Caubel urged the company in 2003 to conduct epidemiology studies because of an abnormally high number of clotting disorders and death associated to patch use. The company hid those problems from the FDA. It is believed that Johnson & Johnson was desperate to get Ortho Evra to the market because it was losing patent protection on its best-selling birth control pill. The FDA was told by J&J that the patch was expected to release less estrogen than the pill, not more. A multitude of lawsuits have been settled by J&J including one awarding the family of a deceased 14-year-old patch user $1.25 million.

 


 

April 22, 2008

Doctor Discovers Nerve Cell Regeneration in Brain Injuries

Dr. Samuel Weiss, Director of the Hotchkiss Brain Institute at the University of Calgary, received the distinguished Gairdner Award for his work in finding nerve cell regeneration in adult neural stem cells. Dr. Weiss found that the adult brain can produce new adult stems cells that can grow into new brain cells called neurons. The stem cell regenerative work is Stem Cell Therapeutics Corp.’s therapeutic approach to traumatic brain injury, stroke and multiple sclerosis. Dr. Weiss’ study uses a therapeutic regimen of two approved and clinically well known drugs, human Chorionic Gonadotropin (hCG) and Erythropoietin (EPO) that stimulates the growth of new neurons to replace the brain cells that were lost or damaged. Animal studies showed a significant recovery of motor function when the regimen was applied 24-48 hours post stroke injury.

 


 

Another 11 of 124 lawsuits settled for victims of botched surgeries

Former patients of the controversial Dr. John A. King and their families have settled 11 more medical malpractice lawsuits with the company who employed King to perform surgery. The settlements were made with the Hospital Corporation of America, the nation’s largest for-profit hospital chain, and Putnam General Hospital. Dr. King was an osteopathic physician at Putnam General between November 2002 and June 2003. In the short time of his employment he generated more that 124 medical malpractice suits. In mid-March HCA and Putnam settled 70 medical malpractice lawsuits related to Dr. King’s employment. When in Alabama during his time at American Family Care clinic another two medical malpractice suits were filed by patients treated by him. In November 2007, King filed for bankruptcy. He is now seeking to become a real-estate appraiser in Tennessee.

 


 

April 21, 2008

Bill Could Help TBI Centers Treat Injuries More Effectively

In Sioux City, Opportunities Unlimited, a treatment and support center for those suffering the affects of a Traumatic Brain Injury could provide additional resources and assistance if President Bush signs a bill passed by the Senate 324-1. It could help the group treat its patients more effectively. The attendees all have a story of injury to rehabilitation and the day to day struggles they still experience. Stephanie Reinsch from the center says, “They were living full productive wonderful lives with their families working in the community doing the things we take for granted everyday.” She says the Act on President Bush's desk will increase research and funding for Traumatic Brain Injuries and is a great step for attendees at Opportunities Unlimited. Reinsch continues, “So any increase in awareness any increase in funding is going to be helpful to everyone whether they're a civilian or a military men or women.” Through raising awareness it may increase treatment options for TBI suffers at the center. Treatment of mild to moderate TBIs is thought to cost up to $2 million in the first year alone.

 


 

Construction Accident Leaves Man with Hospital Bills and Brain Injury

A construction accident that left a man with a serious head injury had a piece of his skull placed in his abdomen until the swelling in his brain went down. Jairo Rodriguez was working in a basement for a construction business that was uninsured at the time of his injury. A piece of brick wall fell on him pinning him against another brick wall causing him to hit his head and lose consciousness. “They had to keep that part of the skull (or bone material) alive,” said his wife, Jessie Rodriguez. “He had suffered a blood clot to his brain and there was so much blood and swelling, he had a drainage tube from inside his brain.” The doctors are ready to remove the piece of bone from his abdomen and reattach it to the rest of his skull. The couple has already amassed $25,000 in hospital bills before the surgery and the surgery will cost an additional $10,000. Jairo has regained the ability to walk and talk, but the far-reaching implications of his injury will cause many financial and emotional difficulties for him, his wife and their 2 year and 3 month old sons.

 


 

Malpractice Premiums and Tort Reforms do not cause Exodus

In the March 2008 edition of the Journal of Empirical Legal Studies research has been published revealing that most obstetrician-gynecologists do not relocate or close up shop because of liability risks and increases in malpractice premiums. This is contrary to the popularly held belief that dramatic increases in premiums cause relocation or discontinuation of their practices in high-cost states. Researchers led by members from George Mason University and the Harvard School of Public Health measured the effects of malpractice risk related to insurance premiums and tort reforms using the number of OB/GYNs in the United States between 1992 and 2002 nationwide. The study concluded that the number of OB/GYNs statistically had no significant relation to cost of malpractice insurance or tort reforms. In fact, it was found that most did not relocate out of state or discontinue their practice as well as causing any impact on helping states attract and retain OB/GYNs.

 


 

April 18, 2008

Statistics Reveal Lack of Frivolity in Malpractice Lawsuits

In the settlement of a medical malpractice suit in New Hampshire, statistics were revealed for that state that showed evidence contrary to the popularly held belief that most medical malpractice suits are frivolous. The Superior Court in Nashua, New Hampshire has a reputation for favoring doctors and the defense. Data analyzed over several years of trial verdicts including medical malpractice trials found that plaintiffs won only 41 percent of the time. In fact, in 20 out of 23 malpractice cases tried over the last 15 years the juries ruled in favor of the doctors. The average award in the three won cases was less that $7,000, far less then the cost of preparing for a trial.

 


 

Website launched in Illinois providing doctor profiles

In an effort to empower medical consumers the state of Illinois launched a new website that provides information about physicians in the state. The website will inform the public of any malpractice judgments and settlements over the last five years. Other furnished information includes doctors’ education, felony convictions, hospital affiliations, serious misdemeanor convictions, specialties and what types of insurance they accept. State Rep. Mary Flowers (D) said patients deserve the information provided on the physician profile website and that it empowers them to discuss any medical malpractice data with physicians. Eric Bleyer, president of the Sangamon County Medical Center, said he hopes patients will not discredit physicians because of malpractice settlements listed on the website. “I don't think that most physicians are opposed to people knowing about this information,” he said, adding, “The problem is people interpreting this information.” According to the Department of Financial and Professional Regulation, the Web site received 77,200 hits in one weekend.

 


 

Traumatic Brain Injury Act Reauthorization in Utah Congress

Utah Senator Orrin Hatch introduced a bill more than 10 years ago to improve the screening and treatment options for Utah residents suffering from traumatic brain injuries. The bill that funds treatment and outreach programs for TBI victims is up for reauthorization in the state’s senate. Brain Injury Association of Utah executive director Ron Roskos said, “This traumatic brain injury act opened a lot of doors that may have been closed prior to that. We look at the acquired brain injury waiver, the traumatic brain injury fund that just passed the grant that the state of Utah received through the traumatic brain injury grant, and then the ongoing research and information we receive through the Centers for Disease Control. Those are phenomenal things.” The Traumatic Brain Injury Act Reauthorization has passed through the Senate and House, where it was amended. It now heads back to the Senate for approval. Meanwhile, Utah's Legislature approved a TBI fund this year to help disabled Utah residents access treatment. The CDC reports that in Utah alone there are 44,000 Utah men and women living with the disabilities associated with traumatic brain injuries.

 


 

April 17, 2008

When left on its own TBI recovery minimal

Anne Forrest was an economist with the Environmental Law Institute, a think-tank devoted to protecting the environment, when 12 years ago she was rear-ended and sustained a mild traumatic brain injury. Now, she’s hoping that she has recovered enough to be able to drive again in May. She told medical professionals gathered at a presentation on mild traumatic brain injury about the hurdles she’s experienced in the physical, emotional and financial obstacles. The presentation was organized by a rehabilitation center specializing in brain injury, to raise awareness about the injury and the struggles TBI victims face. During her presentation she expressed how the injury left her enervated stealing her ability to work long hours. She lost her balance and her short-term memory while limiting her speaking abilities and causing frequent headaches. Her primary care physician and insurance provider expected her symptoms to disappear within two years. When she didn’t improve she was accused of malingering, a condition psychologists define as the intentional exaggeration of physical or psychological symptoms. As the years progressed she received speech and language therapy and was assisted in re-learning life lessons and found the proper tools for managing her daily life with the assistance of a brain injury treatment center. Anne Forrest’s experience highlights one of the most troubling issues for TBI patients, the lack of knowledge in the insurance industry, medical profession and the public.

 


 

New Technology could be applied in TBI

New technology currently being used for patients who suffered a brain bleed could have positive applications for those suffering from a traumatic brain injury. It is the NESS L300 neuroprosthesis. Those who suffer a brain injury often experience “toe drag” that makes it physically difficult to balance and walk. NESS stands for Neuromuscular Electrical Stimulation System. The device is strapped just below the knee with a sensor located in a shoe sends a wireless signal during a step that causes an electrical stimulation in the brain causing the toes to lift. The L300 rebuilds the connection between muscles and the brain and once the brain retrains itself the device is no longer needed. “Although patients can continue to use the device if they need to, in most patients the therapy retrains the brain,” said Jean Gaylord a Rehabilitation Admissions coordinator. “Parts of the brain near the damaged part learn to take over the functions. The L300 can be used to treat a number of conditions including stroke, traumatic brain injury, multiple sclerosis, cerebral palsy and incomplete spinal cord injury." She also said Medicare and some private insurance companies cover the use of the NESS devices.

 


 

Medicine Errors Preventable

Results from a study released recently found that medication errors and overdoses harm roughly one out of 15 hospitalized children. The number is exceedingly higher than earlier estimates. In response, the Joint Commission, an independent organization that accredits most of the nation’s hospitals, alerted hospitals to weigh children in kilograms instead of pounds when they are admitted. Weight in kilograms is the traditional way used to calculate the proper dose for children, but some hospitals still weigh them in pounds. In addition, the Joint Commission said hospitals should keep adult medications away from pediatric care units and avoid storing adult and children’s medicines in the same automatic dispensing machine or drug cabinet. The warning reminds hospitals that pediatric errors are common, but avoidable.

 


 

April 16, 2008

Construction worker awarded $14.6 million in amputation case

Vermeer Central Illinois, a heavy equipment dealer was held accountable in a 2002 highway construction accident that caused the amputation of employee’s leg below the knee. A jury awarded Bobbi Jo Craver, a construction flagger, $14.6 million after a jury found Vermeer and construction company G.M. Sipes, responsible for the construction accident. At the time of the incident G.M. Snipes bypassed safety features by using wire to manually hold open a fuel solenoid because the machine would unpredictably shut down. The manipulation made the emergency stop button inoperable. Workers lost control of a concrete cutter which ran over Craver before entering traffic and striking a tanker truck. Vermeer was found negligent by not removing the wire and not telling G.M. Snipes to stop using the cutter until after the engine problem was fixed. G.M. Snipes has been known to previously bypass safety features on other machines as well. The construction company was also found responsible, but will not have to pay anymore than $200,000 in worker’s compensation because of how the law is structured.

 


 

Bill supported by the Calif. Senate for Veterans with TBI

California state Senator Joe Simitian in his “Oughta Be A Law” contest has awarded Jerome Blum this year’s winner. Blum never fought in combat, but as a military doctor 50 years ago he saw first hand the effects of combat on others. Once Blum learned that thousands of troops returning from Iraq and Afghanistan were suffering from undiagnosed traumatic brain injuries he decided he wanted to do something about it. He approached Sen. Simitian and proposed the bill SB1401 that would require the state Department of Veterans Affairs and the California National Guard to provide information to vets about brain injuries and the care that’s available to them through the U.S. Veterans Administration. Typically care is provided by the federal government, not state. The military is required to check for these types of brain injuries, but often no immediate symptoms present themselves in the veterans. However, once they return home and try to adapt to their civilian life they experience memory loss, personality changes and a host of other problems. Blum’s empathy for the veterans turned into action. When he retired a few years ago, he decided that he would do what he could to help the Gulf War veterans so that the tragedies the Vietnam veterans experienced would not be repeated. Blum was invited to Sacramento to testify before the Senate Veterans Affairs Committee about the cost to the state, human and monetary, of failing to screen veterans. “If we do not diagnose these men and women and treat them, they will become substance abusers,” he told the committee. “They will beat up their husbands and wives. They will end up in prison, which costs $52,000 a year. Forget about morality, just look at the bucks.” If the bill passes, California will be one of the first states to provide such services to its veterans. The bill was unanimously supported and will now go to the Appropriations Committee.

 


 

Project “Totes of Hope and Comfort” targeted at TBI families

An organization known as Mothers Against Brain Injuries is trying to make the hospital experience for the family a little more comfortable. The group offers “Totes of Comfort and Hope” that contain personal comfort items, hygiene products and brain injury literature in large canvas bags. The bags are given to the family member of a traumatic brain injury victim with 48 hours of their hospital arrival. Tracy East-Porter is the brainchild of the organization. Her teenage son suffered a serious traumatic brain injury in a car accident. Currently the project is limited to 21 Florida hospitals, but the service is of such value that perhaps future growth will occur.

 


 

April 15, 2008

Legislature has voted in favor of expanding aid for brain injuries

The brain trauma bill S. 793 passed with a 392-1 vote by the U. S. House of Representatives in Washington D.C. The bill is intended to expand research into and surveillance of traumatic brain injuries across the U.S. The new legislation is intended to authorize the National Institutes of Health and the Centers for Disease control and Prevention to conduct a study into traumatic brain injury trends across the nation and identify possible treatments. It is also intended to fund state projects to improve access to rehabilitation. National brain injury costs are estimated at $60 billion a year or more. The Senate is expected to send it to President Bush for his signature soon.

 


 

Judge Finds Medical Malpractice suit viable and awards damages

In December of 2004, James. L. Lamb, traveled to Salt Lake City for a routine hernia operation that should have kept him in the hospital overnight. Instead, the doctors severed an artery in his stomach causing him to almost die from severe bleeding during the surgery. He remained in a hospital for an additional four months, undergoing several more surgeries eventually contracting a staph infection and pneumonia during his stay. He requested a transfer to a hospital in Helena, Montana where he underwent skin grafting of a large, non-healing abdominal wound and stayed until March 2005. In November 2007, he was hospitalized for a small-bowel obstruction. Doctors told him that surgery was too risky and they could not help him with his recurring small bowel obstruction problem. He now must wear an abdominal binder to contain his organs that limits him from lifting anything in excess of 10 pounds. Lamb filed his medical malpractice claim under the Federal Tort Claims Act and was awarded $622,739 in damages. According to an order and findings fact brief submitted by the judge who heard his case, Lamb has permanent injuries, including risk of recurrent small bowel obstruction; an inoperable, chronic, debilitating large ventral incisional hernia and scarring and abdominal pain. The original award was for $1.2 million, but under the Utah medical malpractice law, non-economic damages cannot exceed $430,000 so instead the judge awarded additional economic losses of $192,739.

 


 

Ortho Evra makers seek legal protection from litigation

Following on the heals of a Supreme Court decision agreeing with Medtronic’s claim that once a device is deemed safe by the FDA it preempts any lawsuits filed against them claiming injury, Johnson & Johnson is insisting the same for its controversial birth control patch Ortho Evra. In recent lawsuits filed against Johnson & Johnson evidence has been found that internal company documents and emails hid evidence that the patch delivered much more estrogen than birth control pills, potentially increasing the risk of blood clots and strokes. Now Johnson & Johnson is arguing in court that it cannot be sued by women injured by the Ortho Evra patch because the FDA had approved it. More than 3,000 women and their families have sued Johnson & Johnson after suffering heart attacks, strokes and, in 40 cases, death. From 2002 to 2006, the FDA received reports of at least 50 deaths associated with the Ortho Evra patch. The FDA did not inform the public of the potential risks until November 2005, six years after Johnson &Johnson’s own study showed the high estrogen distribution.

Plaintiff’s lawyer Janet Abaray of Burg, Simpson, Eldredge, Hersh, & Jardine, said that Johnson & Johnson took advantage of an agency overwhelmed by its many responsibilities. “Johnson & Johnson knew that FDA does not have the funding or the manpower to police drug companies,” Ms. Abaray said. A series of independent appraisals have concluded that the FDA is poorly organized, scientifically deficient and short of money. In February, FDA commissioner, Andrew C. von Eschenbach, acknowledged that the agency faces a crisis and may not be “adequate to regulate the food and drugs of the 21st century.” David Vladeck, a professor at Georgetown Law School said that the FDA does not test experimental medicines and in fact relies on the drug makers to be honest while reporting the results of their tests. When the pharmaceutical and medical device companies fail to follow FDA rules they are rarely penalized by officials. The Ortho Evra case suggests that Johnson & Johnson, like other drug makers, is not always quick to tell the FDA about potential problems with its medicines. The Supreme Court is to rule on a case next term that could make preemption a legal standard for drug cases.

 


 

April 14, 2008

Second Phase Trail to Begin for Oxycyte Application in TBI

Following on the heals of a successful traumatic brain injury phase II-a trial and Food and Drug Administration’s acceptance of the results, Synthetic Blood International, Inc. will file its intentions with the FDA for a phase II-b clinical trial in the use of its product Oxycyte for TBI within days. The company plans to include a multi-center, double-blind and placebo controlled study enrolling up to 300 patients. A major portion of the study was made possible by a Department of Defense $1.9 million grant. Oxycyte is a perfluorocarbon (PFC) therapeutic oxygen carrier and blood substitute.

 


 

Ortho Evra Lawsuits Highlight Drug Misrepresentation

In 1996, Johnson & Johnson told the Food & Drug Administration it planned to develop the Ortho Evra patch because it would probably expose women to less estrogen than the standard birth control pills. The company suggested that the women’s body would not break down hormones delivered via the patch as quickly as the pill, so lower doses could be used. The truth was that the patch delivered considerably more estrogen into the bloodstream, a 1999 clinical trial concluded. The study suggested that since up to half of birth control pill’s estrogen is lost in the digestive track, the patch could deliver an amount of estrogen that could be as high as the pill at 76 micrograms. In 1988 the FDA banned birth control pills with more than 50 micrograms of estrogen. The study’s author, who has since retired from Johnson & Johnson, Dr. Larry Abrams, at the time applied a “correction factor” to the 1999 results claiming the patch, delivered 40 percent less estrogen than the trial results showed. According to Dr. Abrams deposition, the adjustment was never part of the study protocol that was filed with the FDA. Clinical trials conducted before the patch was approved showed patients complained of breast soreness and nausea and the side effects seem to be related to high estrogen doses, a company scientist wrote in an e-mail message. The 1999 study and another in 2003 confirmed that the patch delivered more estrogen than the pill. Once the patch was approved, Johnson & Johnson misrepresented it and informed the public it released only 20 micrograms. As the patch was prescribed more and its use rose, reports of side effects increased. By 2004 the death of an 18 year old in New York caused the food and drug officials noticeable concern. In 2005 it announced that it had included a new warning that the patch “exposes women to higher levels of estrogen than most birth control pills.” Since then, an epidemiological study showed women on the patch can have as much as double the risk of blood clots and stroke. Still, lawyers for Johnson & Johnson say that patients should not be allowed to sue the company because the FDA approved the patch and its label.

 


 

Child with Cerebral Palsy awarded in malpractice trial

In a malpractice suit from Florida a jury found a doctor and hospital responsible for Jacob Tomlian’s, 16, cerebral palsy, mental retardation, spastic gait and deafness in one ear due to a delay in performing a C-section. In 1991, during labor, heart-monitoring equipment showed fetal distress. A previous panel of jurors 10 years ago decided in favor of the doctor and hospital. An appeals court reversed the verdict when the jury found the hospital 85 percent responsible and the doctor 15 percent responsible, awarding Jacob and his family $30 million to care for him the rest of his life.

 


 

April 11, 2008

Man found partially liable yet awarded damages in construction accident

Many know how dangerous construction work can be. The recent crane collapse in New York is a heinous example. Construction workers may not know they have a legal right to seek compensation for injuries incurred on the jobsite. On a relatively small scale, recently a Newark, N.J. man who fractured his ankle while working for a framing subcontractor was awarded more than $500,000 for his injury by a jury. Jose Gualberto was using a 10-foot ladder to install joist hangar brackets when the ladder slipped. His leg got caught between rungs and severely broke his ankle in three places. He has amassed more than $50,000 in medical bills so far and still needs more surgery. While Gualberto was found 11 percent liable, the subcontractors were also found liable by the jury. Each company is responsible for a portion of the award. It is imperative that construction workers consult legal advice as an accident, through little fault of their own, can change their life forever.

 


 

Alzheimer’s Drug Shows Promise in Treating TBI

Early evidence from new research out of Dublin has shown that patients with traumatic brain injuries who were treated with an Alzheiher’s drug over a year showed improvements in memory and attention. Currently, individuals presenting with dementia are prescribed Donepezil, sold under the name Aricept. Purportedly it increases levels of a brain chemical linked to memory. Aricept suppresses a natural enzyme which normally breaks down acetylcholine, a brain chemical that allows neurons to pass messages to each other. The study came about in discussions between Alzheimer’s doctors and those treating traumatic brain injury patients at a rehabilitation hospital. Dr. Simone Carter, who led the research, began a pilot study of nine patients and found that a daily dose of Aricept improved memory, concentration and attention while also appearing to reduce fatique. Dr. Simone still believes a larger clinical trail involving 200 or more patients is still needed to prove the efficacy of application of Aricept.