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.

Posted by Kerry N. Jardine at 08:30 PM | Permalink | Comments (0) | TrackBacks (0)

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.

Posted by Scott J. Eldredge at 02:46 PM | Permalink | Comments (0) | TrackBacks (0)

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.

Posted by Scott J. Eldredge at 08:49 PM | Permalink | Comments (0) | TrackBacks (0)

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.

Posted by Kerry N. Jardine at 02:28 PM | Permalink | Comments (0) | TrackBacks (0)

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.

Posted by Scott J. Eldredge at 08:43 AM | Permalink | Comments (0) | TrackBacks (0)

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.”

Posted by Kerry N. Jardine at 08:35 PM | Permalink | Comments (0) | TrackBacks (0)

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.

Posted by Kerry N. Jardine at 08:25 AM | Permalink | Comments (0) | TrackBacks (0)

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.

Posted by Kerry N. Jardine at 08:21 PM | Permalink | Comments (0) | TrackBacks (0)

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.

Posted by Peter W. Burg at 08:31 AM | Permalink | Comments (0) | TrackBacks (0)

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.

Posted by Kerry N. Jardine at 02:19 PM | Permalink | Comments (0) | TrackBacks (0)

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.”

Posted by Kerry N. Jardine at 08:27 AM | Permalink | Comments (0) | TrackBacks (0)

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.”

Posted by Seth A. Katz at 02:21 PM | Permalink | Comments (0) | TrackBacks (0)

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.

Posted by Seth A. Katz at 08:16 AM | Permalink | Comments (0) | TrackBacks (0)

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.

Posted by Kerry N. Jardine at 08:14 PM | Permalink | Comments (0) | TrackBacks (0)

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.

Posted by Scott J. Eldredge at 02:08 PM | Permalink | Comments (0) | TrackBacks (0)

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.

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

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.

Posted by Kerry N. Jardine at 02:12 PM | Permalink | Comments (0) | TrackBacks (0)

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.

Posted by Scott J. Eldredge at 08:05 AM | Permalink | Comments (0) | TrackBacks (0)

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.

Posted by Scott J. Eldredge at 08:02 PM | Permalink | Comments (0) | TrackBacks (0)

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.

Posted by Scott J. Eldredge at 02:00 PM | Permalink | Comments (0) | TrackBacks (0)

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.

Posted by Kerry N. Jardine at 08:58 AM | Permalink | Comments (0) | TrackBacks (0)

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.

Posted by Kerry N. Jardine at 08:57 PM | Permalink | Comments (0) | TrackBacks (0)

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.

Posted by Kerry N. Jardine at 02:55 PM | Permalink | Comments (0) | TrackBacks (0)

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.

Posted by David P. Hersh at 08:53 AM | Permalink | Comments (0) | TrackBacks (0)

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.

Posted by Kerry N. Jardine at 08:50 PM | Permalink | Comments (0) | TrackBacks (0)

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.

Posted by Kerry N. Jardine at 02:47 PM | Permalink | Comments (0) | TrackBacks (0)

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.

Posted by Kerry N. Jardine at 08:45 AM | Permalink | Comments (0) | TrackBacks (0)

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.

Posted by Kerry N. Jardine at 08:43 PM | Permalink | Comments (0) | TrackBacks (0)

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.

Posted by Scott J. Eldredge at 02:32 PM | Permalink | Comments (0) | TrackBacks (0)

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.

Posted by Seth A. Katz at 08:37 AM | Permalink | Comments (0) | TrackBacks (0)

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.

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

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.

Posted by Seth A. Katz at 02:35 PM | Permalink | Comments (0) | TrackBacks (0)

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.

Posted by Scott J. Eldredge at 08:31 AM | Permalink | Comments (0) | TrackBacks (0)

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.

Posted by Kerry N. Jardine at 08:21 PM | Permalink | Comments (0) | TrackBacks (0)

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.

Posted by Kerry N. Jardine at 02:09 PM | Permalink | Comments (0) | TrackBacks (0)

A lawsuit has been filed against Medtronic in Indiana alleging the defective Sprint Fidelis leads in its heart defibrillator resulted in inappropriate shocks, severe pain and hospitalization. The malfunctioning lead wires fractured causing the defibrillator to send unnecessary and painful shocks to the client’s heart. The defibrillators monitor the heart rhythm and will deliver electric shocks directly to the heart if it begins to beat erroneously. The shocks are delivered via the lead wires. The suit also claims that Medtronic concealed or downplayed the known health risks so they could continue marketing and selling the device globally. On Oct. 15, 2007, Medtronic removed its Sprint Fidelis heart defibrillator cardiac leads from the market after reports surfaced that linked the devices to patient deaths. As of now 5 deaths have been attributed to the defective medical device. The same day, the FDA concurred and said it was aware of deaths and major complications associated with the fractured leads.

Posted by David P. Hersh at 08:14 AM | Permalink | Comments (0) | TrackBacks (0)

Since Texas passed its Proposition 12 in 2003 essentially protecting doctors from medical malpractice lawsuits, Texas Medical Board officials are now facing an avalanche of patient complaints. Legislators have questioned the board about why complaints against doctors are taking so long to resolve. The board reported 1,894 active investigations as of late February. That number has been growing since 2003, before it hovered around 600 to 800 active cases, said Mari Robinson, director of investigations and compliance for the medical board. What complicates matters is that doctors don’t trust the board. Lawmakers have heard from physicians that they view the medical board as adversarial and retaliatory. Rep. Fred Brown, a Republican who chairs the subcommittee, said in trying to improve "public relations" with doctors, the medical board needs to address the perceived problems of manipulation of anonymous complaints, conflict of interest, violation of due process, breach of privacy and retaliation against those who speak out. Legislators questioned the exorbitant length of time the complaint process takes, as much as a year. Texas Watch executive director Alex Winslow said the board must work effectively to keep patients safe. “Since patients have largely lost their access to the legal system, it is incumbent upon the medical board to vigorously oversee the medical profession,” Winslow said. “If that inconveniences a few doctors, so be it.”

Posted by Scott J. Eldredge at 08:18 PM | Permalink | Comments (0) | TrackBacks (0)

The U.S Supreme court in February ruled that people affected by malfunctioning medical devices could not sue for damages because the devices had federal approval through the U.S. Food and Drug Administration. Medtronic was the defendant in the Supreme Court case. This month federal legislation is expected to be introduced to better clarify the original Medical Device Amendments from 1976. The 1976 amendments sought to block state court lawsuits because jury verdicts could interfere with FDA’s ability to regulate the design and labeling of medical devices. The new bill called the “Medical Device Safety Act” would state that existing federal law governing medical device approvals does not "modify or otherwise affect" lawsuits brought in state courts. It is being drafted by U.S. Reps. Frank Pallone, D-N.J., and Henry Waxman, D-Calif. This bill would broaden the laws terms thus opening up victims’ ability to sue over problems they or their loved ones experienced with defective medical devices, regardless of whether the FDA had approved its use.

Posted by David P. Hersh at 02:12 PM | Permalink | Comments (0) | TrackBacks (0)

Channel 7 news in Denver reported on a clinical trial testing a new handheld device called the NeuroThera in victims of brain injuries, including those who suffered stroke. The device delivers high-intensity infrared energy via a laser to a patient's head to stimulate inactive mitochondria in brain cells to prevent or slow further cell death. Mitochondria are a protein that serves as a power supply to cells. The clinical trial is hoping to prove that once the injured and energy starved brain cells are empowered by the mitochondria, they should be able to resume function. In stroke patients the NeuroThera works by keeping surrounding brain tissue alive while supply of blood, oxygen and other nutrients are blocked. The clinical trial is sponsored by the developer PhotoThera and is being tested at the University of North Carolina, Duke University Medical Center and three other North Carolina hospitals. An earlier study of the device was used on stroke patients of whom 70 percent treated with NeuroThera within 24 hours improved compared to 51 percent who were not treated with the device. Researchers in North Carolina are hoping to enroll 660 patients to test NeuroThera in the near future. The availability of a handheld and transportable device to treat traumatic brain injury is attractive with a myriad of applications.

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

In June 2004 Minnesota boy, Keaton Bowden was riding his bicycle without a helmet and was hit by a pickup truck. “He woke up from the coma and we got a whole new son. Whole new personality. Different issues from any other typical now 15-year-old,” said Jay Bowden, Keaton's father. Once an all-star athlete, Keaton suffered a traumatic brain injury and now struggles to focus on a video game for more than five minutes. His emotions can change in lightning speed from smiling and agreeable to explosive rage without provocation. Contrary to doctors’ expectations he is walking again, but the frustrations and battles are neve rending for Keaton and his family. “He's in history right now and he gets all the facts confused sometimes. Last year he was in history and he thought the FBI was following him when they were talking about Watergate,” recalled Amanda Bowden, Keaton's mother. Ardis Sandstrom, the executive director of the Brain Injury Association of Minnesota cited troubling facts, “We see 75 percent of marriages fail after brain injury. We see families just fall apart.” Sandstrom said more than 10,000 Minnesotans go to hospitals each year for head trauma, and too often they go home not knowing they've suffered a brain injury. “So I want parents to think about when your child is suddenly acting out, go back and think were they in any kind of an accident that they may have hit their head because they usually get misdiagnosed,” she said. Every injury is different, but Keaton's brought all the classic problems including trouble concentrating and problem solving, and loss of memory and coordination. Prevention of traumatic brain injuries includes helmets for any risky sports and seatbelts and car seats for anyone in a vehicle. Keaton laments, “Please wear a helmet. If not your life is going to change forever, like mine did.”

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

In a possible breakthrough for neurological research the identification of a new marker is making it possible to track brain stem cells for the first time. In explaining the discovery of tracking stem cells in the brain Dr. Mirjana Maletic-Savatic, assistant professor of neurology at the State University of New York says, “This is a way to detect these cells in the brain, so that you can track them in certain conditions where we suspect that these cells play a certain role. This is also very applicable for situations where people envision the transplantation of stem cells into the brain,” Alzheimer's, Parkinson's, multiple sclerosis, traumatic brain injury or stroke, cause debilitating injury to the human nervous system and/or brain. However, because stem cells have the potential to develop into other types of cells, scientists believe they might be manipulated to repair or replace lost cells and tissues. “There are two major areas where you can find them in the brain, one is the center for learning and memory, called the hippocampus, and the other is around the brains' ventricles," Maletic-Savatic explained. Stem cells in the hippocampus are particularly useful, because memories always change, so the brain needs new cells with which to store and interpret them. Application and stem cell treatment for those with traumatic brain injuries is years away, but if a medication can be derived to target the brain’s ability to stimulate the neural cells to recreate, called neurogenisis, it would be a boon in brain injury treatment.

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

Four months ago a three-year shield that prevented the Nevada Legislature from touching a medical malpractice cap law expired. Now, a health scare caused by unsafe syringe use in a Nevada clinic is triggering a reevaluation of current malpractice award caps. Lawmakers and lawyers are calling for a review of the punitive damages caps. Not many are suggesting the pain and suffering caps at $350,000 should be removed, but perhaps reinstating exemptions for gross negligence or extreme cases. They say the hepatitis C outbreak linked to unsanitary syringe use at a Las Vegas clinic that sickened six people and put at risk 40,000 more is a prime example of an extreme case for which victims need better compensation. Proponents of reexamining the caps argue that doctor immunity fails to deter unsafe practices. They also argue that $350,000 is a paltry sum for someone who contracted a chronic life-threatening disease because of a doctor's negligence. Since finding the unsafe practices at the Endoscopy Center of Southern Nevada, state health officials have started inspecting 50 surgical centers across the state and have so far uncovered unsafe infection control practices at more than half a dozen other clinics. Changing the caps would be politically difficult. Regardless of lawmakers being loath to go against the will of the people, a change would be difficult to get through the Republican-controlled state Senate and past Gov. Jim Gibbons.

Posted by Scott J. Eldredge at 08:57 AM | Permalink | Comments (0) | TrackBacks (0)

A Colorado House committee delayed action on a bill last month that would increase the amount juries can award in certain medical malpractice suits after doctors threatened it could force them to stop practicing and make health care more expensive. Supporters say the bill simply returns the law to where it was under the state’s original tort reform before being changed in 2003. A host of witnesses told Colorado lawmakers they had little legal recourse after a medical malpractice event left them or loved ones disabled for life. One expressed sympathy but said “I feel for the doctors, but their lives go on. Ours are forever changed," said Janine Vitetta, whose daughter, Krysta, is confined for life in a wheelchair. The proposal (Senate Bill 164) would apply to cases where someone has been disfigured or impaired. It would allow those people to sue for up to $1 million in economic damages, although the judge could allow jurors to award more money. It would increase noneconomic damages from $300,000 to more than $460,000. Melissa Kuipers, legislative director of the Colorado Trial Lawyers Association, said there is no evidence it would increase premiums. She said low reimbursement rates are responsible for the state's health care crisis. Opponents said the state shouldn't be making it easier to sue when it's trying to expand access to health care. They also warned the bill could force patients to drive longer distances. They seem to have missed the point.

Posted by Scott J. Eldredge at 08:55 PM | Permalink | Comments (0) | TrackBacks (0)

A medical malpractice case involving a diabetic won an $8.8 million verdict. David and Shirlyn Gallagher filed the claim against the intensive care nursing unit at Southern Baptist Hospital in Jacksonville, Florida. Shiryln Gallagher is an insulin-dependent diabetic and was brought in for surgery following a heart attack. While recovering from surgery, the intensive care nursing staff failed to provide her with insulin causing her to go into cardiac arrest. It took 40 minutes of doctors trying to save her before they realized she was in need of insulin. Gallagher revived once she received the insulin, but suffered a severe brain injury that will require extensive physical therapy and a lifetime of care. The verdict was split into two categories: $4 million for economic damages and $4.8 for non-economic damages. The non-economic judgment is significant because it challenges Florida's current statute that caps non-economic medical malpractice claims at $1.5 million.

Posted by Scott J. Eldredge at 02:53 PM | Permalink | Comments (0) | TrackBacks (0)

The latest information regarding pharmacies and mis-filled prescriptions is pointing to a shortage of pharmacists across the nation. The shortage is leading many to work longer hours while filling an increasing number of prescriptions as well as relying on pharmacy technicians who are not as qualified to perform the job. What is troubling is pharmacists pull in high salaries. The average income from 2006 was $93,500 according to the U.S. Department of Labor. Chain pharmacies such as Walgreens and CVS often pay higher salaries than independent pharmacies. It appears pharmacists are leaving the industry because of increased pressure to do more in less time. Recent surveys by pharmacy advocacy groups have found that there are thousands of unfilled pharmacist positions in the country, while demand for prescription drugs has increased for years. Besides the risk of errors, not having enough pharmacists can lead to shorter pharmacy business hours and longer waits for customers to have their prescriptions filled.

Posted by David P. Hersh at 08:51 AM | Permalink | Comments (0) | TrackBacks (0)

Traumatic brain injury expert Gerard Gioia, PhD, Chief of Neuropsychology at Children’s National Medical Center and director of the Safe Concussion Outcome, Recovery and Education (SCORE) Program, has published a “10 steps’ successful concussion management program for children based on his work in the area. Currently, most concussion and TBI management programs for youth sports lag behind collegiate and professional sports. Yet the system is still unaware of the serious consequences of brain injury on a developing brain. “Implementing an effective sports concussion management program is essential to safeguard young participants and reduce long term risks,” writes Dr. Gioia. “Management of this serious injury must consider the various effects in the home, school, social and sports environments.” The program for mild traumatic brain injury (TBI)/concussion management is an easy to understand translation of the neuro-cognitive testing model used for professional athletes who have suffered from a mild TBI. It uses computer-based testing and standardized parent and teacher reports of the student athlete’s neuro-cognitive functioning. The SCORE program is funded by the Centers for Disease Control and Prevention (CDC). Research and education about proper treatment of mild TBI helps dispel ignorance among athletes, parents, coaches, teachers, and physicians about the serious and long term consequences of these injuries. The “ten steps” include defining more accurately when it is safe to return to the field and the classroom. Dr. Gioia is a primary author of the CDC tool kit that instructs physicians on proper diagnosis and management of concussions. The toolkit employs the Acute Concussion Evaluation (ACE), developed by Dr. Gioia and his colleague, Dr. Micky Collins, to improve the physician’s initial identification and treatment of mild TBI.

Posted by Kerry N. Jardine at 08:49 PM | Permalink | Comments (0) | TrackBacks (0)

Hypothermia therapy has been around for over 50 years and was used in heart surgery before the development of the heart-lung machine. A new application for hypothermia therapy is at the center of a pivotal trial underway in Houston at the Memorial Hermann-Texas Medical Center. The trial is intended for treatment of traumatic brain injury. Dr. Guy Clifton, a neurosurgeon began studying hypothermia’s effects after seeing TBI animals suffer less damage when their body temperature was cooled to two degrees below normal. The theory behind hypothermia’s benefit is that it causes a decrease in the metabolic rate, allowing the body to use less oxygen, controlling swelling while slowing the production of chemicals, harmful to the brain, released following a head trauma. In the 1990’s a similar study failed. The hope for the new study involves starting the cooling process earlier, within a couple hours, and using the therapy on those 45 or younger. In the failed study, Clifton found that those who had good outcomes either were admitted soon after injury or came in with a body temperature already below normal. Further, those who were older fared worse rather than improved. Dr. Gregory O'Shanick, national medical director for the Brain Injury Association, and Dr. Clifton express optimism that the current trial will vindicate the therapy.

Posted by Kerry N. Jardine at 02:47 PM | Permalink | Comments (0) | TrackBacks (0)

Based on a survey conducted in the U.K. and thought to be the first of its kind, victims of brain injuries are experiencing disturbing levels of isolation, discrimination and prejudice. Of greater concern is that the discrimination not only comes from social prejudice, but in the lack of care and attention from the healthcare industry. According to the survey, 60% of respondents had experienced discrimination from at least one service, such as health or social care, benefits or employment and more than two thirds of brain injury survivors believe they are socially discriminated against. The survey also revealed that respondents have experienced a lack of post-acute health care, difficulties in obtaining benefits or poor treatment from social services. One case in point is Kirsty Offord’s, she regularly faces prejudice as a result of her brain injury. “My brain injury is largely invisible,” she said. “Yet ten years on I still battle with daily life and I have to suffer abuse as a result. I've been verbally abused by a bus driver while trying to use my disabled pass as he thought I was a fraud, been humiliated by a library receptionist when I was struggling to fill out a form and my balance problems mean I am often refused access to pubs on the assumption I'm drunk. Knowing you can't do all the things you once could knocks your confidence enough, without being humiliated in public as well. I'm often treated like a second class citizen just because people are too quick to judge,” she added. The survey conclusions are a good indication of what Americans with brain injuries are experiencing stateside.

Posted by Kerry N. Jardine at 08:45 AM | Permalink | Comments (0) | TrackBacks (0)

Prescription mistakes made by big-chain pharmacies are starting to be reported more frequently after an initial investigation by USA Today revealed how careless the industry has become. The latest report comes from New York City. There is no regulatory data kept on how many mistaken prescriptions are filled each year. However, the New York Public Interest Research Group estimates four out of every 100 prescriptions are misfilled by New York pharmacies, physicians and hospitals. The New York City Health Department and the U.S. Food and Drug Administration could not provide any figures of the number of prescription filled incorrectly. It is estimated that 350 million prescriptions are filled in New York each year which means based on the New York Public Interest Research Group’s estimates, 14 million prescriptions were in error. Health professionals pinpoint the mistakes to a number of factors. Pharmacists are overworked because of a pharmacist shortage in the country. Doctor’s illegible handwriting can lead to the incorrect medication or dosage being prescribed. Finally, profit. Pharmacists are expected to fill a certain amount of prescriptions per hour. What’s alarming is pharmacies are not required to report to federal or state agencies of mistakes made unless they want to. “What is disturbing is we don't know how significant (the problem is) because nobody is actively looking,” said Arthur Levin, director of the Center for Medical Consumers, a Manhattan-based, nonprofit health-care advocacy group. “It's a serious safety issue,” Levin said. “There are very few actions taken by the Pharmacy Board. Either we live in Pharmacy Nirvana or there's something wrong with the process.”

Take the case of Kerri Durante. When Ms. Durante picked up a respiratory drug for her 10-year-old daughter, it wasn't until she got home and opened the box that she realized her pharmacy had dispensed five times the prescribed dose of the primary steroid ingredient. If she had not caught the excessive steroid amount the mistake could have affected the child's growth as well as other harmful effects. While appalled over the carelessness on the part of the pharmacy, Ms. Durante was not surprised. This was the third time in six months involving different pharmacies that she was given the wrong medication or wrong dose. One of the mistakes included receiving another patient’s anti-depressant instead of an antibiotic to treat an infection after surgery. Ms. Durante believes the problem is limited to the big-chain pharmacies, perhaps because those pharmacists are not as concerned with one on one relationships as would be experienced at independent drug stores.

Posted by David P. Hersh at 06:37 PM | Permalink | Comments (0) | TrackBacks (0)

Results presented at an American College of Cardiology conference in Chicago Sunday, Mar 30th and published on the Internet by the New England Journal of Medicine announced that a key trial of Vytorin failed. Parallel to the report, leading doctors urged the return to the older, successful treatments for high cholesterol, such as statins. Results showed Vytorin failed to improve heart disease even though it worked as intended to reduce three key risk factors. “People need to turn back to statins,” said Yale University cardiologist Dr. Harlan Krumholz, referring to Lipitor, Crestor and other widely used brands. “We know that statins are good drugs. We know that they reduce risks.” Two Congresssional panels ordered investigations into why it took the drug makers almost two years after the study’s completion to release their results.

Vytorin came out in 2004, which combines Zocor with Schering-Plough Corp.'s Zetia released in 2002, which attacks cholesterol in a different way. The study tested whether Vytorin was better than Zocor alone at limiting plaque buildup in the arteries of 720 people with super high cholesterol because of a gene disorder. The results show the drug had no result according to Dr. John Kastelein who led the study. Many doctors prescribed Vytorin without trying the older, proven medications first, as guidelines suggest. In light of this recent clarification no one should ever stop any heart drug without talking with their doctors and heart specialists first.

Posted by Kerry N. Jardine at 03:33 PM | Permalink | Comments (0) | TrackBacks (0)

Four months ago Zach Dunlap was declared brain dead and doctors were about to remove his organs for transplant. Dunlap was injured in an all-terrain vehicle accident. As family members were paying their last respects, he moved his foot and hand and reacted to a pocketknife being scraped across his foot as well as to pressure applied under a fingernail. After 48 days in the hospital, he was allowed to return home, where he continues to work on his recovery. He and his family were in New York, appearing on NBC's "Today." Even though he has no recollection of the accident that sent him into a coma Dunlap said one thing he does remember is hearing the doctors pronounce him dead. Dunlap’s father said he saw the results of the brain scan and observed no activity and no blood flow, thus agreeing to the harvesting of his organs. Since being released from the hospital his mother said her son is doing “amazingly well, but still has problems with his memory as his brain heals from the traumatic injury.” Zach Dunlap and his family are aware of the time it will take to eventually heal and recover functionality, but their just thankful he’s alive.

Posted by Kerry N. Jardine at 08:34 AM | Permalink | Comments (0) | TrackBacks (0)

The latest research on the bisphosphonate Fosamax shows that long-term use by women is associated with unusual fractures of the thigh bone. The fractures were low-energy, meaning they occurred from a fall at standing height or less. About one-third of women with the unusual horizontal pattern fractures had been using Fosamax on average more than seven years. “These were peculiar fractures that would occur when the women were basically doing nothing,” said the study's senior author, Dr. Joseph Lane, chief of metabolic bone disease at the Hospital for Special Surgery at Weill Cornell Medical College in New York City. Lane said there are several theories as to how the bisphosphonate could be related to the unusual fractures. One is that the drug slows down the development of new collagen which is very strong. Another could be because there is slower bone turnover on the medications. That could mean there may be accumulated micro-damage in the bone, making it more susceptible to fracture in certain women. Lane said that women who've been taking this medication for a long time and have test results that suggest low bone turnover, may want to stop taking the medication for a year but, added this shouldn't be done on their own. The U.S. Food and Drug Administration in January issued an alert to physicians about the possibility of severe bone pain occurring as a result of bisphosphonate therapy. Additionally, last year Fosamax was also implicated in some cases of atrial fibrillation, though the FDA hasn't found evidence to support this association.

Posted by Kerry N. Jardine at 08:32 PM | Permalink | Comments (0) | TrackBacks (0)

In a laboratory environment researches studied the effects of early lead exposure and the brain’s ability to recover from brain injury. Exposure to lead early in life is already known to increase the risk of cancer, renal disease, hypertension and cardiovascular disease later in life and as a result, increasing the risk of stroke and brain damage. Researches already found that brief exposures to lead affected important factors in the brain used for growth and maintenance of neurons and their connections and other forms of brain plasticity. Dr. Jay Schneider, Ph.D., professor of Pathology, Anatomy and Cell Biology and Neurology at Jefferson Medical College of Thomas Jefferson University in Philadelphia said, “Brain plasticity generally refers to the brain's ability to be molded by experience as well as its ability to reorganize anatomically and functionally and recover from injury. It's why people who have relatively small strokes can recover function. The brain has an innate ability to reorganize and repair itself. Our data suggest that lead exposure may compromise or alter this capacity for remodeling that may impair recovery of function following brain injury.” The researches would like to see if such a trend translates to recovery from injuries such as traumatic brain injury. They would also like to explore the notion that childhood lead exposure increases the risk of a child having a poorer outcome from an acquired brain injury.

Posted by Kerry N. Jardine at 02:30 PM | Permalink | Comments (0) | TrackBacks (0)

Technology that has been around for up to thirty years has reinvented itself by broadening its application. A new stopwatch-size device called an impulse generator delivers a low dose of electricity through wires attached to the implanted device under the collarbone. Basically, a brain pacemaker. Cleveland Clinic neurosurgeon Ali Rezai is one of a small group of neurosurgeons, psychiatrist and neurologist in the country working on a technique called deep brain stimulation. Deep brain stimulation, DBS, was originally developed to treat Parkinson’s disease and other movement disorders. Now one of the newest applications slated to be studied, but used as a last resort is traumatic brain injury. The brain pacemaker is also being studied as a treatment for disorders such as Tourette's syndrome, obesity, anorexia, stroke recovery, epilepsy, cluster headaches, chronic pain and addiction.

Posted by Kerry N. Jardine at 08:28 AM | Permalink | Comments (0) | TrackBacks (0)

Each year rescue workers extricate hundreds of automobile accident victims from wrecks across the nation. Fire officials are saying new care features are making it harder for them to do their jobs. The equipment available to them is old and has not kept up with the newer car features such as airbags and reinforced steel construction now being installed in vehicles. The dangers faced include pressurized gas canisters that inflate air bags exploding when pierced by cutting tools. Rescuers can be launched from vehicles when the air bags suddenly deploy. Hybrid cars have hidden battery cables that deliver a powerful shock. Even the ubiquitous seat belt pre-tensioners, which quickly tighten the seat belts in accidents, can explode when cut. Rescue workers across the nation are scrambling to update their tools and extrication methods. “It's not more difficult to get them out, just more time-consuming and dangerous,” said Chris Whetton, an engineer and heavy rescue technician for a fire district. It is the law of unintended consequences. As car manufacturers improve and increase safety features on vehicles to keep us safe the more risk drivers are put at because of the length of time it takes to rescue them when in a severe accident.

Posted by Kerry N. Jardine at 08:26 PM | Permalink | Comments (0) | TrackBacks (0)

The Food and Drug Administration recently announced it is investigating a possible link between the allergy and asthma drug Singulair and suicide. The investigation stems from reports of mood changes, suicidal behavior and suicide in patients taking the popular drug manufactured by Merck. This on the heals of four other updates to the drug’s labeling in the past year to include information of the reported side effects tremors, anxiousness, depression and suicidal behavior. The investigation was prompted by three to four suicide reports received since last October. The FDA has stepped up its notification procedures about possible safety issues when it was criticized for acting too slowly on information received on the risks of Merck’s painkiller Vioxx and GlaxoSmithKline’s diabetes drug Avandia. Singulair, first approved in 1998, is part of a class of asthma and allergy drugs that include AstraZeneca’s Accolate and Critical Therapeutic’s Zyflo. As in any situation when a drug has been called into question it is important to still seek medical counsel to determine risks associated for each individual case. "Patients should not stop taking Singulair before talking to their doctor," FDA said in a statement, adding that doctors should monitor patients for suicidal behavior and mood changes.

Posted by Kerry N. Jardine at 08:21 AM | Permalink | Comments (0) | TrackBacks (0)

A 200-patient human trial is about to begin at the University of Miami School of Medicine into the use of Oxycyte applied to traumatic brain injury patients. Oxycyte is a Teflon-like liquid that carries four times the oxygen level of real red blood cells to brain tissue damaged by a traumatic brain injury. Studies have proven that without continuous flow of oxygen, brain cells can die within hours. If it succeeds in civilian trials, it could be used in Iraq in a year or two to help soldiers who suffer traumatic brain injury from IEDs -- improvised explosive devices. “If we can interrupt the cascade of cell death during the hours and days after the initial brain injury, we can save someone from a lifetime of disability,” says Dr. M. Ross Bullock, director of clinical neurotrauma at the University of Miami School of Medicine. He's the lead investigator on the trial. At the same time, other researchers will be studying Oxycyte for use in spinal cord injury. The trials will start in June and will involve 200 patients in hospitals in the United States and possibly hospitals in Toronto, Heidelberg, Germany and Bern, Switzerland. Two-thirds of the patients will be treated with Oxycyte, the rest with inert placebos. Electronic monitors implanted in their brains will gauge the effects.

Posted by Kerry N. Jardine at 08:18 PM | Permalink | Comments (0) | TrackBacks (0)

The class of biphosphonate drugs prescribed for osteoporosis has been known for some time to be linked to osteonecrosis, which is the breakdown of the jaw bone. Fosamax, Boniva and Actonel are the most prescribed drugs for osteoporosis. In knowing the risks it is encouraged to have regular six-month checkups including an examination and X-rays of the jaw. Most dentists are aware of the drugs’ side effects. People with osteoporosis on any of the biphosphonates are also at a bigger risk of developing mandibular necrosis following such dental procedures as tooth extraction. This can cause fracture of the jawbone as well and delayed healing and infections. Patients with breast cancer and prostate cancer often receive IV (infused) biphosphonate. This population is at much greater risk of osteonecrosis of the jaw. Other risk factors include existing dental disease, poor dental hygiene, anemia, infection or abnormal blood coagulation. Dentists are taking precautions now prior to treatment of patients using a version of a biphosphonate by encouraging them to take vitamin D and calcium supplements prior to a dental procedure in the hopes of reducing the risk of osteonecrosis. As is always encouraged if a patient develops jaw pain, joint or muscle pain, stomach upset, cramps or bloody stool while on a biphosphonate let the dentist know or contact a physician immediately.

Posted by Kerry N. Jardine at 02:24 PM | Permalink | Comments (0) | TrackBacks (0)

The recall of Heparin sodium vial products has widened to include a broader recall of the product. American Health Packaging (AHP), subsidiary of the world’s largest pharmaceutical services companies AmerisourceBergen, announced a voluntary recall of 1,421 units (25 vials per unit) of heparin sodium injection vials. The vials were manufactured by Baxter then placed by AHP into individual labeled bags for use in pharmacy automation equipment. The packages were then sold to five hospitals in Georgia and California. Patients have experienced numerous side effects including abdominal pain, burning sensation, chest pain, diarrhea, dizziness, drug ineffectiveness, dyspepsia, dyspnia, erythema, flushing, headache, hyperhidrosis, hypoesthesia, hypotension, including profound and refractory hypotension, increased lacrimation, loss of consciousness, malaise, nausea, pallor, palpitations, paresthesia, paresthesia (oral), pharyngeal adema, restlessness, vomiting/retching, stomach discomfort, tachycardia, thirst, trismus, and unresponsiveness to stimuli. The reports of profound and refractory hypotension usually occur with the first few minutes of bolus administration. It has been discovered that the recalled products contained oversulfated condroitin sulfate that were contaminated by manufacturers in China.

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During the second annual Brain Injury Conference in Nebraska, author Michael Paul Mason, a professional writer and former brain injury case manager for a hospital in Tulsa, gave details of his firsthand experiences observing a military hospital in Iraq that stabilized soldiers who had sustained severe trauma before sending them back to military hospital facilities in the U.S. Masons observations showed that some of the troops aren’t diagnosed with brain injuries right away, but the military isn’t the only area that is challenged by traumatic brain injury diagnosis and treatments. The medical community as a whole has difficulty in properly diagnosing and treating brain injuries. Mason said that while researching his book, “Head Cases: Stories of Brain Injury and its Aftermath,” which was released earlier this month, he knew he had to go to Iraq, the “brain injury capital of the world,” to fully report on the topic. Since soldiers have been returning from the wars overseas with traumatic brain injuries, there has been a massive reassessment of the fundamentals of brain injury, Mason said. The government and medical community have been working to provide better treatment, new medications, prosthetics and new diagnostic and cognitive tests. Through the wars the public has arrived at a greater awareness and advocacy of the issue, but Mason says there is still more work to be done. “I'd like to increase awareness about the issue of brain injury in America,” Mason said.

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Late February certain lots of Heparin were recalled and have been associated with 19 deaths. The lots have also been linked to hundreds of allergic reactions and were marketed by Baxter International and produced in China. The Food and Drug Administration’s have identified the contaminant found as oversulfated condroitin sulfate. Dr. Janet Woodcock, head of the FDA's Center for Drug Evaluation and Research, said “We cannot rule in or out whether this was accidentally or deliberately introduced into the product,” Woodcock said, “We are investigating how it got in.” Condroitin sulfate is a compound in the same family as heparin, so preliminary testing did not identify it, Woodcock said. A different brand of heparin has also been recalled in Germany after 80 patients there became sick, and the German manufacturer said preliminary research has linked the source of contamination to another Chinese supplier. Heparin is made from pig intestines and tiny Chinese family-run workshops near slaughterhouses send the raw ingredients for the manufacturer of Heparin to middlemen before they reach factories.

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