According to a University of Connecticut team of researchers there may be a link between the prevalence of cesarean section birth and the cost of medical malpractice premiums, claims Dr. Jeffrey Spencer a fellow in maternal fetal medicine. After a review of deliveries at the Harford Hospital between 1991 and 2005 the number of c-sections raised in line with the state’s increase in medical malpractice premiums. During that time, there were 64,767 deliveries, of which 15,021 (23 percent) were cesarean deliveries. Of the 15,021 cesarean deliveries, 8,045 (59.5 percent) were primary or first-time cesarean deliveries, while 6,076 (40.5 percent) were repeat cesarean deliveries. Over the same expanse of time the malpractice rates increased substantially. Normal vaginal delivery is considered safer than a c-section for both mother and baby. C-sections are only recommended when complications such as slow or long labor of fetal distress indications. “Most of the large malpractice cases result from a poor fetal outcome, that is, an expected ‘normal’ baby is born with health problems or has a bad outcome for whatever reason,” says Spencer. “The MDs get sued because they didn’t do all that was possible for the baby – meaning perform a cesarean.” Nationwide, cesarean deliveries accounted for 30.2 percent of all deliveries in 2005, compared to 20.7 percent of deliveries in 1996. The rising rate of cesarean deliveries has triggered a debate over whether the increase can be attributed to medical necessity.

Posted by Scott J. Eldredge at 05:01 PM | Permalink | Comments (0) | TrackBacks (0)

The “loss of chance” doctrine came into play in a wrongful death lawsuit against a physician who failed to order the appropriate tests for his patient for several years after the patient complained of debilitating stomach pain. The Massachusetts Supreme Judicial Court ruled that physicians can be held liable when their negligence decreases a patient’s chance of survival. The plaintiff in the case died of gastric cancer in 1999 after complaining for several years to his physician about stomach pains, but his doctor did not order diagnostic tests until May 1999. The delayed tests supported the diagnosis of gastric cancer, but the plaintiff’s time had run out and he died five months later. Chief Justice Margaret Marshall wrote, “Where a physician's negligence reduces or eliminates the patient's prospects for achieving a more favorable medical outcome, the physician has harmed the patient and is liable for damages.” The jury awarded $160,000 to his estate for pain and suffering caused by the physician's negligence. It also awarded $328,125 to the plaintiff’s widow and son for the decedent's loss of chance.

Posted by Scott J. Eldredge at 07:58 AM | Permalink | Comments (0) | TrackBacks (0)

Earlier this year the Endoscopy Center of Southern Nevada exposed thousands of patients to Hepatitis C. In a ruling by Clark County District Court Judge Allan Earl a class-action lawsuit can go ahead against the clinic. The clinic lawyers attempted to prevent patients who didn’t suffer actual physical injury the ability to recover damages. The judge rejected their arguments. Judge Allan Earl ruled patients who weren’t made ill can claim emotional distress after being exposed to Hepatitis C by the clinic’s reuse of syringes and vials of medication. A court spokesman says the clinic is currently facing 121 lawsuits. The judge did dismiss claims that the clinic should be held liable under product liability and warranty laws because the clinic didn't sell vials of anesthesia and supplies to patients.

Posted by Kerry N. Jardine at 01:54 PM | Permalink | Comments (0) | TrackBacks (0)

Many lawsuits have been filed in recent months involving two recalled drugs, the blood thinner heparin and the heart drug Digitek. What sets these apart is the link between the recalled drugs and China, who has been at the center of a number of recalls including toys, pet food and toothpaste recently. In past pharmaceutical litigation, plaintiffs’ lawyers alleged a “failure to warn” about possible risks of a drug that caused injury and death. The heparin suits are the first to be brought against a pharmaceutical manufacturer with ties to China. More than 40 lawsuits have been filed against the manufacturers of heparin so far and the number is expected to climb. In the past six months, about a dozen manufacturers, primarily Baxter International Inc., as well as their distributors and suppliers, have recalled much of the nation's supply of heparin after a contaminant was discovered in the drug linked to allergic and sometimes deadly reactions. The contaminant was tied to a supplier in China. According to the FDA, 124 deaths have been associated with the contaminated heparin. “This is going to be the tip of the potential iceberg in terms of Chinese manufacturing and drugs,” said attorney William M. Audet, a plaintiffs lawyer who has brought several drug cases and anticipates filing up to 60 lawsuits involving heparin and Digitek.

http://www.burgsimpson.com/digitek.html

Posted by Kerry N. Jardine at 08:19 AM | Permalink | Comments (0) | TrackBacks (0)

The recent report of Dennis Quaid’s newborn twins medication error has been a catalyst for the spat of media reported pharmacy errors. A number of cases have been brought to light including the death of a young child after a pharmacy filled a prescription with many times the dosage prescribed by his pediatrician. The latest Digitek recall of the heart drug medication whose pills were twice the size they should have been, making them twice at potent caused the death of a man who took the prescribed dose but died of an overdose. A more recent announcement came from the U. S. Food and Drug Administration involving the recall of a large portion of two pharmacies’ medications due to expiration or possible counterfeits of a number of drugs in their stores. The two pharmacies involved were in Baltimore at The Medicine Shoppe. It may never be known how many lives have been put at risk because of pharmacy errors. It is imperative to protect yourself by doing as much as possible to determine the accuracy of your prescription order. If ever any side effects are experienced, contact your physician immediately for consult.

Posted by David P. Hersh at 06:45 PM | Permalink | Comments (0) | TrackBacks (0)

The U. S. Food and Drug Administration is harnessing the power of the internet in an effort to inform tech and online savvy folk of any complications or health concerns such as those experienced after using a defective drug or product. Their most recent post was targeted at young women between the ages of 15 and 44. Almost two months ago a YouTube video was targeted at warning this population of the dangers of venous thromboembolism and the use of the Ortho Evra Patch. So far three such videos have been posted. This is the latest move by the FDA in a campaign to improve public awareness about the dangers of the patch. The videos include information about two studies done previously that show an increased risk for life-threatening side effects among women aged 15 through 44. The more recent YouTube video focuses on the recent label changes brought about by the two studies, both of which show that women in this age group are at an increased risk for blood clots. The YouTube video also encourages women to talk to their health care provider before electing to use the patch. The question remains whether this latest move by the FDA will be effective enough in protecting future young women. According to the YouTube presentation, the video has only been seen 113 times since it was posted July 2 and that includes the visit that brought about this blog. TV commercials have not been informative enough in explaining the risks. It would seem that women are still finding out about the dangers after they have already been to the hospital for treatment of the side effects. ">Ortho Evra Patch. So far three such videos have been posted. This is the latest move by the FDA in a campaign to improve public awareness about the dangers of the patch. The videos include information about two studies done previously that show an increased risk for life-threatening side effects among women aged 15 through 44. The more recent YouTube video focuses on the recent label changes brought about by the two studies, both of which show that women in this age group are at an increased risk for blood clots. The YouTube video also encourages women to talk to their health care provider before electing to use the patch. The question remains whether this latest move by the FDA will be effective enough in protecting future young women. According to the YouTube presentation, the video has only been seen 113 times since it was posted July 2 and that includes the visit that brought about this blog. TV commercials have not been informative enough in explaining the risks. It would seem that women are still finding out about the dangers after they have already been to the hospital for treatment of the side effects.

Posted by Seth A. Katz at 09:41 AM | Permalink | Comments (0) | TrackBacks (0)

A common surgery left a woman a widow in 2002. Mrs. Thornburg’s husband underwent surgery to install an automatic implantable cardiovascular defibrillator when the anesthesia team failed to notice his deteriorating vital signs. After a considerable amount of time his lack of breathing led to the deprivation of oxygen to Thomas L. Thornburg’s brain causing severe brain damage. The defibrillator temporarily helped Thornburg’s heart condition, but the 62-year-old man eventually died. When doctors were faced with repairing another cardiac episode they decided not to render medical treatment even though the final episode was treatable. Doctors said Thornburg’s mental state and living conditions influenced their decision. Thornburg’s widow file suit against the hospital where the surgery was performed. In a pre-trial settlement the hospital agreed to pay $115,000 for the wrongful death allegations. A jury’s verdict ruled $1.54 million was to be given. The $1.54 million verdict includes $1.1 million for non-economic losses which exceeds West Virginia's non-economic cap by $850,000, but the case pre-dated medical malpractice reform that decreased the cap from $1 million to $250,000.

Posted by Kerry N. Jardine at 09:44 PM | Permalink | Comments (0) | TrackBacks (0)

A lawsuit calling into question the constitutionality of Illinois’ limit of personal injury awards in medical malpractice cases is expected to come before the state’s Supreme Court this fall. The Supreme Court at least twice before have ruled the limits to be unconstitutional on the grounds they violate the separation of judicial and legislative powers. The most recent was in 1997 when the Supreme Court struck down a 1995 law that included a $500,000 limit on awards for non-economic damages. The medical institution claimed that doctors were leaving the state because of the amount of malpractice suits filed. Philip Corboy Jr., president of the Illinois Trial Lawyers Association, believes it was an insurance crisis rather than a litigation crisis. Corboy said filings of medical malpractice lawsuits had been declining for several years before the new law. This latest case stems from a filing by Frances LeBron whose daughter was seriously injured at birth in October 2005. She suffers mental impairments and cerebral palsy and requires 24-hour care the rest of her life. In November, Cook County Circuit Judge Diane Larsen sided with plaintiffs and declared the law unconstitutional and invalid in its entirety. She said the statutory limits on awards interfered with juries' authority to award appropriate compensation for injuries.

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

A woman went to three separate hospitals trying to get care for her symptoms of nausea, vomiting, headaches, numbness in her arms, legs and face that she had experienced for three days. A simple CT scan would have revealed the culprit, a brain tumor. Her lawyer contends that each of the hospitals refused to adequately diagnose her because they knew they would only be reimbursed $135 dollars by Medicaid for a procedure that cost $3,000. A Philadelphia jury agreed and found each of the hospitals negligent in their care of the 20 year-old mother who is now blind, paralyzed and brain-damaged. They awarded her $11.2 million, including $5.9 million for future medical expenses. The woman currently lives near Boston with her mother, uncle, sister, four brothers, and a 4-year-old daughter born just four months before the brain tumor was discovered. She needs the help of her family to take care of herself and her daughter.

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

Ever since the military enacted cognitive testing before and after deployment of our soldiers, a number have been recognized as suffering a traumatic brain injury earlier. Still, it would be even more ideal if there was a technology that recognized the injury at the time it was incurred. The Brain Trauma Foundation, with the support of the Defense Department, is developing a handheld eye-tracking device that will enable military medical personnel to determine on the battlefield within seconds if a soldier has sustained a traumatic brain injury. Historically, TBI has been difficult to detect and was often under-diagnosed because the condition was confused with psychological rather than physical injury. Perhaps in the near future this technology will be available to first responders to emergencies and injuries stateside, such as EMTs, and will assist in the immediate detection allowing for treatment earlier. A rapid cooling technique, used in spinal cord injury, could be applied in route to emergency care for traumatic brain injuries. A number of innovative techniques, drugs and rehabilitation processes are being tested in clinical trials and some are close to FDA approval. The future is looking a little less bleak for families and for those who have suffered a TBI.

Posted by Kerry N. Jardine at 09:36 AM | Permalink | Comments (0) | TrackBacks (0)

An Indianapolis family is fighting for the right of their traumatic brain injured child to educational services mandated by law. Mikey Berns, 5, suffered a traumatic brain injury when a 150 pound cabinet fell on him last October. Mikey’s mother, Amy Berns, said the school district has refused to allow the boy to attend full day kindergarten at a local elementary school because they don’t believe he needs the services. Mikey’s doctor disagrees, saying it is vital to the boy’s education and development. His mother goes on to say, “That first six months and then that year mark is the most critical time frame in order to recoup those skills that were damaged from the injury.” Since the school refused to allow Mikey to attend full-day kindergarten, his family enrolled him in one-on-one instruction at a learning center at a cost of nearly $1,200 a week. His family is asking the school district to reimburse them for the private programs since law mandates care for special educational students and for the attorney costs mounting in their fight. “The government provides funding for special education children so that money is given to the schools so that they can implement an individualized education plan specific to that child's needs,” Berns said. “That's what they've failed to provide for him.” The school system countered, “Hamilton Southeastern provides a free and appropriate education to any of its students with special needs according to state and federal guidelines. This is an instance where the parents and school district disagree about what is appropriate,” Said a statement from Marianna Richards, director of school and community relations. This is just one example of discrimination against individuals with a traumatic brain injury.

Posted by Kerry N. Jardine at 06:34 PM | Permalink | Comments (0) | TrackBacks (0)

Paige Connard was in a cycling accident over Memorial Day weekend that left her with numerous injuries including a traumatic brain injury. She was wearing a helmet at the time, but the accident was severe enough that doctors had to remove a portion of her skull and right frontal lobe to alleviate pressure. Connard’s husband Gerry Jeffs was told by doctors that this was as bad as it gets. Before the accident Paige was a speech pathologist and the bitter irony is that she is to undergo speech therapy along with physical and occupational therapy. Her family says that they have yet to face the nightmare of insufficient medical insurance coverage that so often victims of TBI and their families go through. Currently, Connard is staying at CareMeridian in Gilroy, CA a facility that specializes in brain and spinal cord injuries. Those who have gone through the process of rehabilitation know how expensive it can get, with therapists known to charge about $100 an hour. According to Jeffs, their insurance coverage is good, but will not be enough to cover the therapy costs. Fortunately, Connard's friends and family have been there to support her both financially and emotionally, but many of the other thousands of Americans who have suffered a TBI are not so blessed. Some estimates of the total cost of TBI rehabilitation and recovery can be pegged at more than $1 million. It is important to know what recourse is available for victims of a TBI, so talk to a lawyer knowledgeable in the area.

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

A traveling bathtub will be seen rolling down a mall in Minnesota to launch a campaign to prevent traumatic brain injury. We may ask what a bathtub has to do with TBI. The traveling bathtub scene is intended to bring attention to the number one cause of TBI which are falls. The Hennepin County Medical Center (HCMC) will have an interactive Brain Bar Kiosk that will include an educational display that will allow visitors to build their own brain and share it through an online gallery. Campaign workers will be recognized by their bathrobe and slipper apparel. Following the mall appearance, the Brain Bar will visit the Minnesota State Fair and the Minneapolis bike Tour. More than 1.5 million traumatic brain injury incidents are reported in the U.S. every year. Traumatic brain injury is the leading cause of death and disability among children and young adults.

Posted by Kerry N. Jardine at 04:31 PM | Permalink | Comments (0) | TrackBacks (0)

Sergeant Andrew Birzer had a military career spanning 17 years, but after experiencing a traumatic brain injury from a roadside bomb in Afghanistan he made the decision, “I'd rather be more sedated than more angry.” Birzer’s situation is not an unusual one. After the explosion four years ago, Birzer didn’t seek medical help and started another tour for thirteen months in Iraq. “I just ignored the headaches. The headaches, as far as I was concerned was stress from the situation,” he said. His family however, knew something was very different the moment he arrived home. Now his short term memory is poor and he takes dozens of medications for depression and anxiety. Sergeant Birzer’s situation speaks the same for thousands of non-military types who have suffered a traumatic brain injury. Thankfully, Birzer was finally diagnosed and now receives full time counseling and therapy to help with his life as a husband and father.

Posted by Kerry N. Jardine at 09:29 AM | Permalink | Comments (0) | TrackBacks (0)

In an unusual move against a hospital who allegedly failed to treat a patient, the plaintiff has filed a 10-count lawsuit alleging the lack of treatment put him in danger. The lawsuit is not a medical malpractice lawsuit, but brings in a federal statute called the Emergency Medical Treatment and Active Labor Act. Robert Olszewski is at the center of the federal suit and claims that he went to the Mayo Regional Hospital emergency room in Maine twice within 17 hours for chest pain, headache and fever and was not given an appropriate medical screening. After the second visit and decline of a proper medical screening he went to another hospital where they found he had suffered from a mild heart attack. The Emergency Medical Treatment and Active Labor Act was initially passed as an anti-dumping statute since hospitals at the time were turning people away who didn’t have insurance or money. Since the act was passed, when someone goes to the emergency room, the hospital must do an appropriate medical screening to determine whether the person is in an emergency condition and if so, the patient cannot be transferred until stabilized. Attorney Michael J. Waxman of Portland, who is representing Olszewski said, “We can fit this into the contours of that statute because he really wasn’t given an appropriate medical screening, certainly not the second time, maybe not even the first time he visited Mayo. He wasn’t given any screening, as a matter of fact,” Waxman said. When experiencing chest pain, the first reaction should be a medical screening to determine whether a heart attack is responsible.

Posted by Scott J. Eldredge at 02:26 PM | Permalink | Comments (0) | TrackBacks (0)

In January 2006, a bypass surgery was performed on Michael Derrick's left leg at the Regional Hospital of Jackson, Tennessee. In March 2006, Derrick said he went back to the doctor to report that he was experiencing fevers and chills. His doctor told him he had the flu. About a week later, Derrick went to another hospital in Nashville in severe pain. There they informed him he had to have emergency surgery on his left foot. Doctors told him a bacterial infection had spread into his left leg and that it would have to be amputated. “When I got to Baptist Hospital, they told me I was nearly dead from the infection,” said Derrick. He said doctors told him it was either his "life or limb." The ensuing medical malpractice lawsuit filed alleged that Michael Derrick’s doctor was negligent in his post-operation care. During eight post-surgery visits his doctor did not properly diagnose Derrick as having a bacterial infection until it had spread to the point that amputation was a medical necessity. The jury found in Michael Derrick’s favor and awarded him $1.5 million. “While we're disappointed they (jury) did not find in our favor, we did receive a fair trial in front of 12 fine citizens of Madison County,” said the attorney for the defense.

Posted by Scott J. Eldredge at 08:24 AM | Permalink | Comments (0) | TrackBacks (0)

A lawsuit has been filed against Actavis Totowa on behalf of a woman who lost her husband to the defective drug Digitek in Denver. The lawsuit charges that the pharmaceutical company distributed the defective Digitek heart drug pills that contained dangerously doubled dosages of the drugs’ active ingredient digoxin. Digitek is used to treat irregular heartbeat or heart failure. The woman alleges the defective pills caused the death of her husband in August 2007. This was more than a year after FDA inspections of the manufacturing plant revealed they failed to comply with federal regulations to ensure the safety of its medications. The FDA issued a Revised Warning Letter to Actavis Totowa, LLC on February 1, 2007 finding that the inspection of the company's Little Falls, New Jersey facility that took place July 10, 2006 through August 10, 2006 revealed that drug products manufactured at that facility were adulterated under the meaning of the Federal Food, Drug and Cosmetic Act. In April 2008 the FDA recalled the double dosed drug after a number of deaths and adverse events. In August the widowed wife filed the federal lawsuit in the United States District Court in Denver, Colorado

Posted by Seth A. Katz at 09:34 AM | Permalink | Comments (0) | TrackBacks (0)

On a website as a service of the U.S. National Library of Medicine and the National Institutes of Health is a report on the clinical findings of three individuals treated with extracorporeal photopheresis who were afflicted with Nephrogenic Systemic Fibrosis. NSF has been strongly linked to the use of gadolinium contrasting dyes used in MRIs and those experiencing renal or kidney dysfunction. Up until this report no known treatment was available. NSF is characterized by the severe stiffening of joints and skin often causing the victim to be handicap-chair bound and can even cause death. The experimental treatment has shown that in each of the three cases mobility improved. Extracorporeal photpheresis treatment is a form of dialysis that involves treating the blood with photoactive drugs that are then activated when the blood is exposed to ultraviolet light. The blood is then reintroduced to the body effectively helping the body’s immune system fight the disease. At the end of four cycles of ECP all three patients showed a clinical response with the softening of the skin. At the completion of the treatments all experienced improved range of motion in all four limbs. The researchers are confident this may well prove to be an effective treatment of a previously untreatable and sometimes terminal condition.

Posted by Peter W. Burg at 10:31 AM | Permalink | Comments (0) | TrackBacks (0)

An Orlando, Florida family is reeling from a decision to fine a hospital pharmacist a meager $1,000 dollars in the death of their 3-year old son. The parents of Sebastian Ferrero brought him to Shands Hospital at the University of Florida in Gainesville to see why he wasn't growing as fast as he should. The doctors prescribed a growth drug and the Shands pharmacist filled it 10 times the amount needed. The parents said the decision to fine the pharmacist responsible such a low amount was just a slap on her wrist and a slap in their face. The Ferrero’s called on Governor Charlie Crist to step in. They said they'll send a letter to the governor, asking him to launch an investigation. The pharmacist who filled the prescription in error has been ordered to attend further training on how to fill prescriptions. The hospital will pay $850,000. The family said it plans to use the money to help build a new Children's Hospital, in hopes that this kind of medical mistake never happens again.

Posted by David P. Hersh at 08:28 AM | Permalink | Comments (0) | TrackBacks (0)

A bill signed into law by New York Governor David A. Paterson gives broader powers to the State Department of Health to investigate medical wrongdoing as well as publicly identifying physician who are charged with misconduct or malpractice. The law was prompted by the Dix Hills doctor, Harvery Finkelstein who is accused of exposing thousands of patients to blood borne diseases such as Hepatitis C, HIV and AIDS because of unsafe and unsanitary practices of syringes and single dosage bottles being used multiple times among patients. Finkelstein most recently settled a malpractice lawsuit with a man who claimed he contracted hepatitis C in Finkelstein’s office. Unbelievably, Finkelstein has settled an unprecedented 11 malpractice lawsuits inside of a decade, one of the highest in the state. The Finkelstein case and its many challenges in recognizing and disciplining errant doctors provided a basis for what the health department needed to conduct better disciplinary and infectious disease investigations, said state Health Commissioner Dr. Richard Daines. In addition, the new law expands the state’s ability to investigate private medical offices and permits health officials more freedom to communicate with the public and discipline physicians. Most significantly, legislators said that the bill allows the state Office of Professional Medical Conduct to use medical malpractice histories to initiate misconduct probes. The health department was strongly criticized by patient advocates after it was revealed it negotiated with Finkelstein for his office records, a process that helped delay public notification to over 10,000 of Finkelstein’s patients for an incredible three years.

Posted by Scott J. Eldredge at 01:25 PM | Permalink | Comments (0) | TrackBacks (0)

In an effort to prove malpractice, sometimes the victim is unable to testify on their behalf because of the incapacity the malpractice caused. For example, a 50 year-old woman was operated on to remove an enlarged goiter, a thyroid gland found in the neck. The known post-operative treatment is to be given calcium because if levels of calcium fall too low a patient’s swallowing and breathing become difficult. In this case the operating surgeon ordered calcium to be given, but she never received it. The next morning the patient was very agitated and had difficulty swallowing. Later, she complained of shortness of breath and increased swelling in the operated area of her neck. After continuing to struggle to breathe she went into respiratory failure; eventually sustaining brain anoxic encephalopathy (brain damage caused by lack of oxygen) and fell into a coma. The family of the woman understandably decided to bring a malpractice lawsuit to the hospital. During trial, she was unable to testify because she was in an incapacitated state and because of this the case had to rely on experts’ testimony and the analysis of hospital records and pretrial depositions by the hospital employees. During the deposition proceedings it was found that a second year resident, who had been at the hospital for three weeks, checked on the patient the night of the surgery but failed to administer the appropriate tests and instead told the nurse she was fine. The implications are intuitive, thankfully her family had the resources of a plaintiff’s attorney.

Posted by Scott J. Eldredge at 08:22 AM | Permalink | Comments (0) | TrackBacks (0)

A jury of peers awarded a woman $4.5 million for pain and suffering earlier this year in a malpractice case involving a gynecologist who left a 40 x 40 centimeter gauze sponge in her stomach after surgery. The woman then reported chronic pain to her doctor for months, but he failed to respond to her complaints. Another judge last month reduced the award to $1.3 million, citing a Maryland state cap on non-monetary losses such as pain and suffering is limited to $650,000. Attorneys for the woman are troubled by the unconstitutionality of the decision. The woman’s attorney Robert J. Goldman said, “For various reasons, it kind of takes the decisions out of the jury’s hands.” Goldman maintained that juries should be relied upon to decide appropriate awards for damages, not state-imposed caps. “This cap the legislature has put on has unfairly affected people who have been injured through medical malpractice,” Goldman said. The constitutionality of statutory caps for non-economic damages has not been addressed by the U.S. Supreme Court.

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

The Department of Defense is in the process of distributing $300 million on research for traumatic brain injury and post-traumatic stress disorder. To put the amount in perspective, it is the most spent in one year on medical research since a $210 million breast cancer study in 1993. The distributions will fund 171 research projects. Gregory O’Shanick, national medical director for the Brain Injury Association of America, said the funding initiative is “without a doubt an all-time high” in spending by the government on traumatic brain injury and post-traumatic stress disorder. As is expected, civilian victims will benefit directly from the military studies. By contrast, the National Institutes of Health, the world’s largest government sponsor of medical research with an annual budget of $28 billion, spends about $80 million per year on TBI research, according to the NIH. “It is huge,” said Ross Bullock, director of neurotrauma at the University of Miami School of Medicine and lead investigator in a Pentagon-funded study of a drug designed to improve oxygen flow to damaged brain cells. “It is the just the most enormous thing that has happened in traumatic brain injury research.” According to Navy Capt. E. Melissa Kaime, head of the Congressionally Directed Medical Research Programs office the new research will focus considerable attention on TBI and studies are expected to complete between 18 months and 5 years. She further says that the military funding will go toward evaluating up to 20 different medications for TBI and studying ways of regenerating damaged brain cells. Half of the $300 million in Pentagon funds have been distributed, and all will be paid out by Sept. 30, Kaime said.

Posted by Kerry N. Jardine at 01:13 PM | Permalink | Comments (0) | TrackBacks (0)

With gas prices at an all time high more and more individuals are taking to the roads on their bicycles in order to save money, help the environment and maybe lose an extra pound or two. The Department of Health and Human Services and Making Headway Center for Brain Injury Recovery are taking this opportunity to remind those who elect to cycle their way about to be sure to wear a helmet. Wearing a helmet can prevent or limit the amount of head trauma experienced, thus evading the life changing effects of a traumatic brain injury. When about to purchase a helmet remember the following: check to be sure that the helmet is safe by making sure it dons stickers from the American National Standards Institute (ANSI), the Consumer Product Safety Commission (CPSC) or the Standards for Protective Headgear (SNELL). If it has one of these it has been deemed acceptable for cycling use. The helmet should also fit in such a way that it is level across the top of the head, should not move more than an inch in any direction and the straps should be adjusted so they are snug. If in a bike-related crash, replace the helmet because often the damage to the bicycle helmet cannot be seen and its level of safety has been compromised. Not all states require helmet usage in bicycling, but the obvious advantages to wearing one are apparent. While a TBI occurs every 21 seconds in the U.S., 85 percent of all TBI is preventable.

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

In 2005 Tera Clark, 25, was hit by an impaired driver causing her a traumatic brain injury, broken neck, collapsed lung and broken bones. At first her progress was amazing, but when her recovery started to plateau, her mother decided to try Hyperbaric Oxygen Therapy. HOT is typically used in scuba diving accidents where the victims experience “the bends” because a too rapid ascent caused nitrogen bubbles to accumulate in the bloodstream. The therapy is sometimes used in hospitals to also help wounds heal, but this new treatment is considered “off-label” and experimental. The first privately-owned HOT facility in Arkansas has opened and this new clinic is using the therapy to treat traumatic brain injury. The treatment at The HBO Clinic in Little Rock is not covered by insurance because the clinic uses the oxygen therapy for non-FDA approved uses. For Tera Clark and her family it doesn’t matter because Tera has made significant progress. Her mother Jeana Halter said, “We are six weeks into the process now, and we've seen great improvements with memory, her cognitive skills, her ability to ambulate. Her joints have loosened up drastically. So I've been very pleased with it.” Dr. Gary Villines of The HBO Clinic said, “We can't promise that this will be of miraculous benefit, but there's enough evidence out there to show this is at least worth trying.” Dr. Villines hopes to have Tera walking unassisted within a year. Since he can treat patients in a private setting, and has less overhead than a hospital, he usually charges less than $200 per treatment.

Posted by Kerry N. Jardine at 11:09 AM | Permalink | Comments (0) | TrackBacks (0)

In an effort to determine the prevalence of chronic pain syndromes i.e. headaches in those with mild Traumatic Brain Injury and moderate to severe Traumatic Brain Injury, the Journal of the American Medical Association compiled data from searches executed in databases and articles published between 1951 and February 2008. The search found twenty-three studies including 4206 patients. In twelve of the studies involving civilians as opposed to veterans, they found 1670 patients of which 966 complained of chronic headache (57.8%). The prevalence of chronic pain was greater in patients with mild TBI compared to moderate or severe TBI. The report determined that chronic pain is a common complication in all ranges of TBI.

Posted by Kerry N. Jardine at 08:06 AM | Permalink | Comments (0) | TrackBacks (0)

In the June issue of the American Journal of Kidney Diseases, gadolinium-based contrasting agents used in MRIs was reported to increase the risk for Nephrogenic Systemic Fibrosis. It has been known for some months that there was a link between gadolinium exposure and NSF presenting itself in those with kidney failure. In fact, the U.S. Food and Drug Administration late 2007 issued a “black box”, the most severe warning, for any MRI contrasting products containing the agent. Dr. Alexander J. Kallen from the Centers for Disease Control and Prevention, Atlanta, and colleagues conducted a case-control study of 19 patients with NSF treated at a St. Louis hospital dialysis unit and 57 matched controls from the same unit. The authors reported that 14 patients with NSF had undergone an MRI with a gadolinium injection in the previous year that showed a median interval of 123 days from the gadolinium use in the MRI and the time the disease was detected. Four of the remaining five patients had gadolinium exposure between 16 and 68 months before diagnosis. The risk for NSF increased in steps from one MRI, two to three MRIs, or four or more MRIs, compared with controls. “Providers should carefully weigh both the benefits and potential harms of contrast MRI in their clinical decision making and avoid the use of gadolinium contrast agents if possible in patients with renal failure,” the authors concluded. “If gadolinium contrast is needed, clinicians should use the lowest possible dose and limit the number of future contrast administrations. The mechanism by which gadolinium contrast might cause NSF is unknown,” the researchers add.

Posted by Peter W. Burg at 07:01 PM | Permalink | Comments (0) | TrackBacks (0)

A lawsuit has been filed on behalf of a woman who suffered from digitalis toxicity in Birmingham, Alabama after ingesting a tablet of Digitek with twice the amount of digitalis contained in it. Digitek is typically prescribed to treat irregular heartbeat or heart failure. Actavis Totowa and their heart drug Digitek is at the center of the latest recalled drug action by the U. S. Food and Drug Administration. The litigation alleges the double thickness and dosage of the defective Digitek caused her to suffer digitalis toxicity resulting in an adverse reaction including a drop in heart rate, blindness, confusion and incoherent speech. She was hospitalized for more than a month and underwent surgery to implant a heart pacemaker to treat the permanent heart damage she suffered in what is believed to have been caused by the Digitek overdose. The victim's injury occurred only a few weeks prior to April 25, 2008 when the FDA announced a nationwide recall of all Digitek tablets. The suit blames Actavis for failing to heed FDA warnings in July and August of 2006 and February of 2007, that many of the drug products that were produced, manufactured and released to the public by Actavis were adulterated and as a result the drugs were not “the identity, strength, quality and purity they purport to possess.”

Posted by Seth A. Katz at 08:09 AM | Permalink | Comments (0) | TrackBacks (0)

An east Texas woman was prescribed three years ago the heart drug Digitek because of a heart murmur she has had since she was a young girl. After being on the drug for some time, Linda Brinkley began suffering major side effects. Her heart was beating fast, she was shaking, experienced severe headaches and nausea. The complications ended up sending her to the hospital three times between February and April. The last time in the ICU she started coughing and could barely breathe right before she passed out. Later she was told that she had flat-lined, effectively dying on the table. After being brought from the edge of death her doctor informed her it was not her heart condition that caused it, but the medication she was taking for it. She had been taking the drug for a little over a year. Linda is now in the process of filing a lawsuit and she is one of 1,500 Digitek claims in her attorney’s office. A panel of judges is meeting at the end of the month to decide where the claims will be consolidated

Posted by Seth A. Katz at 08:27 PM | Permalink | Comments (0) | TrackBacks (0)

Nine lawsuits have been filed in the U.S. District Court of Newark in New Jersey alleging the drug Digetek was dangerous and defective. One of the lawsuits includes the death of one patient after taking the drug. The lawsuits have been filed against Actavis Totowa LLL and its Iceland-based parent, Actavis Group, a generic pharmaceutical company. Similar lawsuits have been filed in West Virginia and California. The Distributors Mylan Pharmaceuticals Inc. and UDL Laboratories Inc. have also been named defendents. A nationwide recall of Digitek was instituted on April 25 when it was discovered that the pills were double the thickness thus double the dosage. A double dosage of Digitek poses a risk of digitalis toxicity resulting in symptoms of nausea and dizziness, low blood pressure and cardiac instability. The company informed the public that death can result as well and that they had received several reports of injuries.

Posted by Seth A. Katz at 08:15 AM | Permalink | Comments (0) | TrackBacks (0)

Thanks to the men and women veterans of the Afghanistan and Iraqi wars, traumatic brain injury is gaining increased attention. Awareness has increased and so has the detection capabilities using new imaging and biomarker tests to diagnose TBI. Over the last decade researchers have increased their understanding of the physical effects of TBI and the technologies have improved to the point of helping communicate a clearer picture of the injury. In the past doctors would have to rely on an MRI or a CT scan, but those are not as adept at detecting neural damage associated with a TBI. Now there is diffusion tensor imaging, a type of MRI that could illuminate the individual axon pathways. Furthermore, tensor imaging has been found to be useful during recovery, showing doctors which parts of the brain were responding to rehabilitation. A chemical analysis, called a biomarker using proteins or enzymes, can show up in the blood with higher-than-normal or lower-than-normal amounts. Hospitals already use a biomarker test to diagnose heart attack victims and researchers are looking for a way to make diagnosing TBI as simple. There are a number of studies out there concentrating on the treatment of TBI including the neuroprotective abilities of the hormone progesterone and more currently cyclosporin, an immunosuppressant drug usually used in organ transplant patients. Both show promising results. Harvard researchers are currently conducting a clinical trial using citicoline, a type of stimulant that shows signs it might both protect and restore neurons. The Harvard team plans to publish preliminary results of the clinical trial soon.

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

A grant from the National Institute on Disability and Rehabilitation Research has been awarded in the amount of $4.9 million to Carolinas Rehabilitation to study the drug Amantadine in the treatment of traumatic brain injury. The study will conduct research to determine if the drug, which is used to bring TBI victims out of a coma, can be used to limit the irritability and aggression often associated with a brain injury. Physicians from Carolinas Rehabilitation were the first to discover that Amantadine might extend its usefulness. The grant will be used to repeat the physicians’ findings at multiple sites nationwide to determine Amantadine’s efficacy in treating the cognitive dysfunctions often associated with TBIs. Carolinas Rehabilitation is a division of Carolinas HealthCare System of Charlotte, North Carolina which owns, leases or manages 23 hospitals in the Carolinas.

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