Neuroscientists at Arizona State University have found a new treatment for brain disorders such as Traumatic Brain Injury and Alzheimer’s. In an article in the Oct. 29 issue of the Journal Public Library of Science they reported they have developed pulsed ultrasound techniques that remotely stimulate brain circuit activity. “We were quite surprised to find that ultrasound at power levels lower than those typically used in routine diagnostic medical imaging procedures could produce an increase in the activity of neurons while higher power levels produced very little effect on their activity,” lead investigator William “Jamie” Tyler said. The findings are encouraging. If the noninvasive ultrasound technique proves helpful in the treatment of TBI then the door this treatment opens for victims of TBI is significant. Tyler and the other ASU researchers will now focus on further research into the influence of ultrasound on intact brain circuits and hope to use the low intensity ultrasound in pre-clinical trials for the treatment of neurological diseases.

Posted by Kerry N. Jardine at 08:33 PM | Permalink | Comments (0) | TrackBacks (0)

In a recent Bloomberg Health News article the company speculated that pharmaceutical company Johnson & Johnson has spent as much as $68.7 million in settlements over its birth control patch Ortho Evra. While that amount may be staggering to some, the settlements prevent the victims or their families and their lawyers to speak about it. Without foreknowledge of a products possible danger how can future potential victims make an informed choice? The settlements included 20 young women who died as a direct result of the patch and a staggering 1,330 victims are part of a class-action lawsuit currently being litigated in Ohio. As many as 4,000 complaints have been filed concerning the controversial patch and yet Johnson & Johnson refuses to pull it from pharmacy shelves. The consumer advocacy group Public Citizen has gone so far as to ask the U.S. Food and Drug Administration to recall the birth control patch. By every indication the manufacturer J&J certainly has no plans to safeguard women’s lives and voluntarily recall it themselves. The decision to continue to sell it indicates that the company may not have their consumers’ best interest at heart and that money is the driving factor, not responsible pharmaceutical treatment.

Posted by Seth A. Katz at 08:31 AM | Permalink | Comments (0) | TrackBacks (0)

On October 21, 2008 lawyers met with the Court to discuss the process for selecting the first Nephrogenic Systemic Fibrosis lawsuits for trial and which of the five gadolinium contrast agents the plaintiffs’ were exposed to during MRIs. The use of gadolinium based contrast agents used in MRIs has been linked to NSF in patients with moderate to severe kidney dysfunction. As of now almost 400 NSF lawsuits have been filed against the 5 manufacturers of the contrasting dye. In an effort to centralize and coordinate pretrial litigation the U.S. Judicial Panel of Multidistrict Litigation transferred all the NSF federal cases to Judge Dan Polster in the U.S. District Court for the Northern District of Ohio in February 2008. Judge Polster has been assigned to nearly 300 of the lawsuits. Lawyers representing the individuals and families whose lives have been affected by NSF are pushing the court to begin trial quickly because many of their clients are sick and may not survive a lengthy litigation.

Posted by Peter W. Burg at 02:27 PM | Permalink | Comments (0) | TrackBacks (0)

Earlier this year the Endoscopy Center of Southern Nevada and the Desert Shadow Endoscopy Center were under investigation for unsafe practices of reusing syringes and medicine vials. A total of 63,000 former patients of the clinics were possibly exposed to the potentially deadly hepatitis C virus. The Nevada Health Department has notified the former patients to get tested for hepatitis B, C and HIV, the virus that causes AIDS. No cases of hepatitis B or HIV have been linked to the outbreak. However a number of hepatitis C cases have arisen. District officials have concluded that nine cases of hepatitis C have been linked to the unsafe practices at the two clinics. According to Brian Labus, the Southern Nevada Health District’s senior epidemiologist, “In putting everything together, we've identified 114 cases in total linked to the two clinics.” The other 105 people were diagnosed with the disease since becoming patients at the clinics, but could have contracted the disease in other ways, Labus said. Health officials say those diagnosed with the disease are receiving treatment. Hepatitis C can cause swelling of the liver, stomach pain, fatigue and jaundice. Even when no symptoms occur, the virus can slowly damage the liver. A widow of one of the clinic’s former patients has filed a lawsuit alleging her 60-year-old husband’s hepatitis C diagnosis and death in 2006 was the responsibility of the unsafe practices at the clinics. As a result of the investigation and the outbreak the two clinics have been shut down and the Doctors associated with them have surrendered their license to practice medicine pending the results of health district and police investigations. The former clinic owners are facing more than 120 lawsuits alleging medical negligence and a class-action by patients who claim emotional distress.

Posted by Scott J. Eldredge at 08:23 AM | Permalink | Comments (0) | TrackBacks (0)

InfraScan Inc. recently received approval for its handheld brain hematoma detector from the European Union. InfraScan developed the device to assist first responders and emergency room personnel in detecting traumatic brain injuries. A quick assessment of patients with a potential traumatic brain injury greatly increases patient outcomes if treated within an hour of the injury. While technology exists such as Computer Aided Tomography (CAT), many hospital facilities lack the neurological capabilities to treat TBI. Therefore, if first responders are in possession of a device such as InfraScan’s they can determine which hospital to send the patient to that will best treat the TBI. The device is small and portable and can detect the presence and location of a brain trauma based on differential NIR light absorption between the brain trauma and uninjured brain tissue. InfraScan will present the results of a 400 patient multicenter study to the FDA later this year and hopes to launch use of the device in the U.S. shortly thereafter.

Posted by Kerry N. Jardine at 06:20 PM | Permalink | Comments (0) | TrackBacks (0)

In the first three months of 2008 the number of serious drug reactions and deaths reported to the U.S. Food and Drug Administration set a new record high according to the health industry watchdog group the Institute for Safe Medication Practices (ISMP). The FDA received 20,745 reports of serious drug reactions between January and March 2008 which is 38 percent higher than average and is the highest for any quarter reported. The 4,824 deaths between the three months was nearly a threefold increase. The two drugs at the center of the reports and are responsible for the most reactions were the blood thinner heparin imported from China and Chantix an anti-smoking drug from Pfizer. Chantix is at the top of the list for serious drug reactions. Earlier this year the FDA warned that Chantix may be linked to psychiatric problems, including suicidal behavior and vivid dreams. The ISMP study found that heparin accounted for 779 reports of serious drug reactions, including 102 deaths with a possible 238 deaths associated to the tainted heparin. “The FDA is aware of the increasing number of reports, and we take them seriously,” said spokesman Christopher DiFrancesco. Previous ISMP research has shown that reports of serious drug safety problems had increased markedly since the late 1990s. This seems to be an alarming trend in today’s drug market. The FDA must be overwhelmed by the increased reports of serious drug side effects which could offer the drug companies an opportunity to push through possibly dangerous drugs because of the FDA’s increased workload.

Posted by Kerry N. Jardine at 09:15 AM | Permalink | Comments (0) | TrackBacks (0)

In Nevada a family doctor is under investigation by state authorities for his questionable prescription drug practices. Regardless of several complaints filed against him with the Nevada State Medical Examiners Board, he is still in possession of his medical license and his practice has not been restricted. Dr. Kevin Buckwalter has been accused of writing excessive doses of pain killers, many leading to death and addiction. After a review of patient provided medical records, expert Dr. Andrea Trescot, a nationally known pain management specialist told the Las Vegas Sun, ““He (Buckwalter) needs to have an emergency revocation of his license.” Among Buckwalters’ patients was a man that was prescribed more than 20,000 pills to treat pain from a neck injury. The number of pills led him to enter an addiction recovery program. A 26-year old woman died after overdosing on painkillers. She had more than 150 painkillers prescribed to her a month and up to 300 extra-strength Xanax pills at a time. Another woman died from complications of a side effect she experienced. Another woman killed herself after being prescribed 310 pills of oxycodone to kick an OxyContin addiction. Medical experts working with the Las Vegas Sun felt Buckwalter’s care was so poor it may constitute medical malpractice. It’s unconscionable that considering his poor level of care that Buckwalter can still practice medicine.

Posted by David P. Hersh at 02:36 PM | Permalink | Comments (0) | TrackBacks (0)

As an effort to keep medical consumers apprised of the latest advances in potential medical answers to tough medical issues, it is with interest that we inform readers of a new treatment for Traumatic Brain Injury that is peeking on the horizon. After a positive meeting with the U.S. Food and Drug Administration, Oxygen Biotherapeutics, Inc has announced that it will expand its clinical trial plan for its perfluorocarbon therapeutic oxygen carrier and liquid ventilation product called Oxycyte in the use of Traumatic Brain Injuries. Patient enrollment is anticipated to begin in the first quarter of 2009. The study will be conducted in the United States with and additional trial planned for Canada and possibly Switzerland. The clinical trial will ascertain the correct dose of Oxycyte to affect a better outcome for patients on the Extended Glasgow Outcome Scale (EGOS). The EGOS is a scale determining the level of disability a TBI patient has incurred. Both the U.S. and Canadian studies will be multi-center studies focusing on finding the lowest dose that reduces thrombocytopenia (having fewer than normal number of blood platelets per unit volume of blood associated with hemorrhaging) and still provide clinical benefit in traumatic brain injury. “This gives us a more efficient way to advance our clinical trials. It is extremely important to bring Oxycyte another step forward because we have a level of obligation to TBI patients and their families," said company chairman and CEO Chris J. Stern, DBA. "Right now there is no medical treatment for TBI patients and mortality is 20 - 25 per cent. Additionally, of those that survive, half are unable to return to the lives they had before their injury. The procedure in the dose escalation studies is designed to find the safest dose level of our drug and to bring it to market in due course. These dose escalation studies are the foundation to move to the next step of enrolling and treating TBI patients and showing what Oxycyte can do to help them recover and lead normal, productive lives.”

Posted by Kerry N. Jardine at 11:29 AM | Permalink | Comments (0) | TrackBacks (0)

A Wisconsin family has been awarded more that $11.4 million in damages for their son who suffered brain injuries during his birth in 2005. The jury agreed unanimously in the decision. The doctor in the malpractice trial was cleared of wrongdoing, instead the nurse midwife and nurse were charged with the negligence. In their suit, the family claimed hospital staff “failed to act appropriately and to deliver Laine (the infant) in a timely fashion” and argued that the nurse midwife misread fetal monitoring strips showing the baby in distress. The boy now suffers from the debilitating and life-altering condition cerebral palsy. The family’s award will cover $310,369 for past medical and health care expenses, $5 million for future care, $387,000 for loss of earning capacity, $3.25 million for past and future pain, suffering and disability and $2.5 million for the parents’ loss of society and companionship. The family’s attorney summed up in a statement, “This is not an award. This is barely compensation. But it will change Laine’s life and make the family’s life reasonable.”

Posted by Scott J. Eldredge at 08:33 AM | Permalink | Comments (0) | TrackBacks (0)

At four years old Jordan Boyd’s life and the life of his family changed forever. He was at a neighbor’s house getting his haircut for his birthday party. When someone shouted that his birthday friends were arriving he ran across the street and was struck by a speeding vehicle. Jordan remained in a coma for four months and was hospitalized for ten after sustaining a traumatic brain injury. Jordan is now 22 he has difficulty walking and talking and has minimal use of his arms and hands as well as legally blind. Tragedies such as this are happening all over the United States daily and yet many remain in the dark about the devastating life-altering consequences. “I had no idea what a brain injury meant,” said his mother, Joanna Boyd. “Nobody should have to learn about brain injury the way I did, in an intensive care unit. Brain injury is a life-altering experience for everyone.” The Brain Injury Association of New Jersey has been a lifeline for Joanna Boyd’s family. On Oct. 18, Jordan will join hundreds in the 2008 Walk for Thought/Cycle for Safety event held by the Brain Injury Association of New Jersey. Jordan will be riding in honor of his 21 year-old friend who had a brain injury and passed away this summer. The statewide event raises much-need funds for services, increases public awareness, celebrates the achievements of people living with a brain injury and honors those who have suffered a TBI, but cannot walk in the fundraiser.

Posted by Kerry N. Jardine at 09:27 AM | Permalink | Comments (0) | TrackBacks (0)

The consumer advocacy and nonprofit group Public Citizen has petitioned the FDA to phase out sales of the Ortho Evra Birth Control patch over a six-month period. “Ortho-Evra is a poor choice for women,” wrote Dr. Sidney Wolfe, director of Public Citizen's Health Research Group. Johnson & Johnson released the alternative form of birth control in 2001 marketing it in such a way that it would be preferable to the birth control pill because it provides lower and more stable estrogen levels and would be easier for women to use. Studies since then have shown otherwise, J&J’s claims have proven false. Even with stricter “black box” warnings on the packaging, Public Citizen says that the serious risks outweigh any benefit of the use of the patch. J&J’s compliance to the stepped up warnings are not enough to protect young women electing birth control. “Had Ortho-Evra been designed as a pill, it is unlikely to have been approved because of its increased estrogen content,” Wolfe said. The patch exposes women to up to 60 percent more estrogen than the pill. Studies suggest that women using Ortho-Evra have twice the risk of blood clots as women taking the pill, and are also at increased risk for other side effects such as breast discomfort, nausea, vomiting and severe menstrual pain. The FDA has updated the drug's label with warnings about blood clots three times since 2005.

Posted by Seth A. Katz at 02:23 PM | Permalink | Comments (0) | TrackBacks (0)

An Irish teenager suffered permanent brain damage when he received excessive doses of an experimental drug used to treat leukemia. A high dose of Methotrexate, a toxic drug used for cancer treatment, was administered intravenously as well as 14 additional injections into the boy’s spine over a nine-week period that allegedly led to neurological injuries. According to the protocol of treatment the correct dosage in the same period of time should have been six and not 14 injections. The excessive amount caused neurological brain injury and the boy now has the intellectual capacity of a 7-8 year old. He will require round the clock care the rest of his life. The 14 year-olds parents brought a claim of negligence against the hospital and the oncologists who treated him. The claim was settled for 2.7 million Euros, plus costs. The judge, who approved the settlement, was told the case was settled after "protracted negotiations". The settlement will help his parents care for him the rest of his life.

Posted by Scott J. Eldredge at 08:20 AM | Permalink | Comments (0) | TrackBacks (0)

As part of the Food and Drug Administration Amendments Act of 2007, the FDA has developed a website catering to consumers and professionals questions about prescription drug information. The website offers links to such areas as drug labeling, risk evaluation, clinical trials and drug-specific safety information. The site also provides links to quarterly listings of drugs that are being evaluated for safety issues, FDA warning letters, import alerts, recalls, market withdrawals and safety alerts and consumer articles on drug safety. “By placing Web links to these up-to-date resources on a single page, we're helping consumers and healthcare professionals find drug safety information faster and easier,” said Dr. Paul Seligman, the FDA's associate director of safety policy and communication. “This type of communication is aimed at helping consumers and healthcare professionals make well-informed decisions about medication use.” The website is available at //www.fda.gov/cder/drugSafety.htm.

Posted by Kerry N. Jardine at 06:16 PM | Permalink | Comments (0) | TrackBacks (0)

In a frightening “déjà vu” moment another company has had to recall their drug because of an increased size of the tablets containing up to twice the labeled amount of the active ingredient. The U.S. Food and Drug Administration is warning that the ETHEX Corp. announced a voluntary recall of 3 lots of their Dextroamphetamine Sufate 5 mg tablets. The risks associated with an over dosage of the drug are tachycardia, hypertension, tremors, decreased appetite, headache, insomnia, dizziness, blurred vision, stomach upset and dry mouth may be increased. The recalled lots were distributed between January 2007 and may 2008. The 5 mg product is an orange round tablet with "ETHEX" and "311" on one side. Any adverse reactions experienced with the use of this product should be reported to the FDA immediately.

Posted by Kerry N. Jardine at 11:13 AM | Permalink | Comments (0) | TrackBacks (0)

A new study undergone by researchers at Vanderbilt University has again shown a strong link between the use of gadolinium dyes and the disease Nephrogenic Systemic Fibrosis found in patients with renal failure. The team of researchers concluded with the warning that gadolinium contrast dyes should be used “judiciously” in patients with kidney disease opining that the benefits should be carefully weighed against the risks. In the study researchers at Vanderbilt analyzed data from case reports submitted to the U.S. Food and Drug Administration. The study found the occurrence of NSF after gadolinium contrast agent exposure depended on the degree of renal dysfunction, amount of contrast agent administered, gadolinium contrast agent stability and the severity of a patient’s kidney disease. NSF has devastated the lives of hundreds of individuals and their families. NSF is characterized by high blood pressure, burning, itching, swelling and hardening of the skin to the point of immobility. Other symptoms include deep pain in the hips and ribs and muscle weakness. In September 2007 the FDA ordered a “black box” warning, the most severe used, to be added to the labels of the manufacturers products including, Bayer HealthCare Pharmaceuticals, Bracco Diagnostics, GE Healthcare and Mallinckrodt. Since then lawsuits have been filed in state and federal courts against the companies for the injuries incurred after the exposure to the gadolinium contrast dyes. As of September 24, there were 287 NSF lawsuits pending in the Multidistrict Litigation. Another 104 lawsuits have been filed in various state courts throughout the U.S.

Posted by Peter W. Burg at 09:36 AM | Permalink | Comments (0) | TrackBacks (0)

In 2004, William Meyer was undergoing chemotherapy for the treatment of leukemia. After his last treatment the 45 year-old three days later was suffering from abdominal pain and diarrhea. His wife phoned the oncologist and was told to buy an over-the-counter medicine for gas. He died shortly thereafter of a severe abdominal infection that could have been treated with antibiotics. Mr. Meyer had an extremely low white blood cell count which is a known side effect of chemotherapy. The standard of care practiced by doctors and nurses is to administer antibiotics. The Salt Lake City V.A. failed in that standard of care. In a medical malpractice claim filed by his family the U.S. Government of Veterans Affairs agreed to pay $950,000 to Mr. Meyer’s family to cover general damages and future loss of income, but maintains it is not at fault.

Posted by Scott J. Eldredge at 12:53 PM | Permalink | Comments (0) | TrackBacks (0)

A Kentucky woman was awarded a total of $9.89 million in a medical malpractice lawsuit filed on her behalf. Latricia Satterwhite underwent surgery on her mitral valve in her heart in April 2006. In preparation for her surgery the surgeon misplaced the hose connecting to a machine that pumps blood during the procedure called a cannula. The misplaced cannula caused too much blood and oxygen to be pumped into her right hand and too little to her brain and thoracic spinal cord. Satterwhite is now a paraplegic and suffers from brain damage. Medical experts testified on Satterwhite’s behalf and convinced the jury that the surgeon was 31 percent at fault in the operation charging him with a little over $3 million in damages. Satterwhite was awarded $455,229.06 in past medical expenses and $4.4 million for future medical bills, $482,538 in lost wages and $4.5 million for pain and suffering. The surgeon was found at fault by a 10-2 vote of the jury, the anesthesiologist 23 percent and the perfusionist, the person who operates the heart-lung machine, was responsible for 41 percent of fault.

Posted by Scott J. Eldredge at 09:51 AM | Permalink | Comments (0) | TrackBacks (0)

A Congressional Committee recently said they are investigating the U.S. Food and Drug Administration’s handling of a drug recall at Actavis Totowa LLC’s facility in New Jersey. The Iceland based drug maker in early August recalled 66 drugs made at the New Jersey plant. Prior to this recent recall, the company recalled its heart drug Digitek because in the manufacturing process the pills were made double thickness and caused numerous side effects across the country. The House Energy and Commerce Committee said the numerous recalls from Actavis' New Jersey plant raise questions about the FDA's oversight of drug facilities. “Recalls of this seriousness cause us to question whether FDA was deceived...or did FDA simply fail to conduct adequate and timely inspections of these facilities,” Reps. John Dingell and Bart Stupak, Democrats from Michigan, said in a letter to FDA Commissioner Andrew von Eschenbach. The Representatives said they want to know whether the FDA permitted additional products from Actavis on the market while it knew about problems at the company's plants. The committee’s investigation comes on the heals and is triggered partially by the import ban of more than 30 drugs from the India owned Ranbaxy Laboratories Ltd., one of the world’s largest generic drug manufacturers. Ranbaxy has also been facing investigations by the U.S. Department of Justice and the FDA into whether it made substandard generic drugs. Allegations include that Ranbaxy fabricated evidence to support drug applications and attempted to conceal violations of manufacturing practices.

Posted by Kerry N. Jardine at 12:47 PM | Permalink | Comments (0) | TrackBacks (0)

CORE Health Care in Texas is a provider of treatment for individuals with brain injuries and psychiatric disorders. CORE has developed a unique instructional DVD and manual called the CORE Family Trainer that is designed to train families in how to interact with those who have suffered a brain injury. “We receive calls from families across the country looking for resources, some sort of guidance to help them understand the changes in their loved one with a brain injury and how to effectively communicate with them,” Eric Makowski, CEO of CORE Health Care and president of the Brain Injury Association of Texas, said. “We scoured the country but found that there was no such tool in existence, so we created it.” The DVD and manual packet provides role-playing opportunities that illustrate the common problems friends and families face at home while interacting with their loved ones who have suffered a brain injury. The tools offered through the DVD and manual based in research and are well established principles of treatment found in rehabilitation facilities across the country. To order the DVD, visit http://www.corefamilytrainer.com or call 866.683.1007.

Posted by Kerry N. Jardine at 08:44 AM | Permalink | Comments (0) | TrackBacks (0)

In a recent study of homeless people in Toronto, Canada’s shelter system it was found that 58 percent of homeless men and 42 percent of homeless women had a history of traumatic brain injury. Even though they were homeless, they each had health insurance. In the study, published in the Canadian Medical Association Journal, of more than 900 homeless in Toronto it was found that health problems included an increased risk of seizures, mental health problems, drug abuse and poor physical health status. Dr. Stephen Hwang, a physician and research scientist at St. Michael's Hospital stated that for many the first instance of traumatic brain injury often occurred at a young age and “suggests that in some cases TBI may be a causal factor that contributes to the onset of homelessness, possibly through cognitive or behavioral dysfunction caused by a TBI.” The implications of these findings should enlighten those providing health care to homeless people that the difficult behaviors they may sometimes face could in fact be a result of a TBI. Further, encouraging the health care providers to ask their patients if they have suffered a TBI and if so to offer neuropsychological screening, referrals to rehabilitation programs and other community support systems, wrote the authors of the study.

Posted by Kerry N. Jardine at 06:41 PM | Permalink | Comments (0) | TrackBacks (0)

According to a Bloomberg Health New report Johnson & Johnson has spent at least $68.7 million to settle hundreds of lawsuits filed by women who suffered blood clots, heart attacks or strokes after using the company’s Ortho Evra birth control patch. J&J has avoided trials through the confidential settlements and court papers do not indicate how much the pharmaceutical company has paid in each case.. Bloomberg reviewed 562 complaints alleging the patch caused deep-vein thrombosis - blood clots in the legs and pulmonary embolisms – blood clots in the lungs. The complaints also blame Ortho Evra for the deaths of 20 women, Bloomberg wrote. Complaints filed on behalf of 4,000 women in state and federal courts claim the company hid or altered data about the risks of high levels of estrogen released by Ortho Evra. Janet Abaray, an attorney for the plaintiffs, is helping lead the litigation before U.S. District Judge David Katz in Toledo, Ohio where 1,330 patch cases have been combined into a class-action suit. Abaray said in an April 17 court document that, “Several hundred individual cases” had been settled by March 31 and “there have been a significant number that have settled since then.” Attorneys requesting anonymity and who are familiar with the litigation told Bloomberg that J&J typically settles the death cases for more than $1M, deep-vein thrombosis cases for $125,000 to $175,000 and pulmonary embolisms for $140,000 to 300,000. The amounts vary according to each woman’s circumstances.

Posted by Seth A. Katz at 09:37 AM | Permalink | Comments (0) | TrackBacks (0)

A medical malpractice complaint filed in Sioux Falls, South Dakota seeks to challenge the constitutionality of the state’s cap on non-economic damages. Non-economic damages such as pain and suffering, as well as disability and disfigurement are limited to $500,000. There is no limit to the amount of economic damages including loss of wages and medical bills. However, that will not help a baby girl who suffered severe brain damage because of the negligence by a Sioux Falls hospital. “The goal basically is to make sure my family is OK and my daughter is OK,” said Louis Martin, the father of the brain damaged one-year-old Aspen Martin. Scott Hoy, the Sioux Falls lawyer representing the Martins, said the cap is unconstitutional in part because it protects health care providers as a special class of people. For instance, there is no limit to the civil damages that a victim can seek in a car accident, for example. “The Legislature is not to make laws that are for a specific association or for specific individuals,” Hoy said. Aspen Martin’s brain damage was caused by a feeding device that was incorrectly placed in her abdominal cavity instead of her stomach. When Aspen underwent a procedure requiring barium, she was poisoned leading to severe brain damage because of the incorrect placement. Michael Myers, a University of South Dakota law professor and former hospital executive, said the Martin complaint could present a valid challenge to the law. “The Martin case puts forth circumstances of such profound injury as to challenge the fairness of a cap,” he said.

Posted by Scott J. Eldredge at 10:01 PM | Permalink | Comments (0) | TrackBacks (0)

A potentially deadly crash could have been avoided had a pharmacy filled a prescription correctly. On March 20 Nesta DeRoy drove into an eight-by-ten foot plate-glass window. She had lost consciousness for 15 minutes. Two weeks prior to her accident she was complaining to friends, family and her doctor about feeling unwell and groggy. In early March, DeRoy went to a pharmacy to refill her prescription for blood-pressure medication. What was filled was two weeks worth of a sedative. Not only was the medication wrong, but it was filled with four times the strength commonly prescribed to people suffering anxiety and seizure disorders of which DeRoy did not suffer. She had unknowingly been given Clonazepam in place of her blood-pressure medication hydrochlorothiazide (HCTZ). Clonazepam works by slowing the activity of the central nervous system. Those prescribed the drug are advised not to engage in activities requiring mental alertness, judgment and physical coordination, such as driving. When she finally complained to the pharmacy about the error they offered her an insulting deal to pay her expenses as well as $2,000. The College of Pharmacists of British Columbia says it gets an average of 86 complaints a year over medication errors.

Posted by David P. Hersh at 08:57 AM | Permalink | Comments (0) | TrackBacks (0)

Deep brain stimulation is already used to treat Parkinson’s disease and is now being tested in patients with traumatic brain injuries as well as a number of other medical and emotional problems. “I believe this field is where heart pacemaker devices were 25 to 30 years ago. Brain pacemakers are going to have a significant impact on the treatment for a number of neurological and behavioral conditions,” said Dr. Ali Rezai, director of the Cleveland Clinic's Center for Neurological Restoration. Researchers are using new brain maps generated by sophisticated imaging technologies such as functional MRIs and PET scans. By recording activity in both sick and healthy people, scientists are learning how brain circuits work and discovering where significant breakdowns seem to occur. In a successful effort, a year ago researchers in New York and New Jersey reported that a minimally conscious man in a nursing home who appeared unaware of his surroundings began speaking single words and responding to people after treatment with deep brain stimulation occurred. Dr. Nicholas Schiff, a neurologist at Weill Cornell Medical College believes the procedure may have activated neural circuits that were intact but impaired after an assault disabled the 38-year-old man. His team has received approval from the Food and Drug Administration to study 11 additional patients with traumatic brain injury.

Posted by Kerry N. Jardine at 07:52 PM | Permalink | Comments (0) | TrackBacks (0)

Research is finding that mild traumatic brain injuries (MTBIs), or concussions, are much more common than previously thought in children. A mild traumatic brain injury can result from a direct or indirect blow to the head and from an impact somewhere else on the body where the impelling force is transmitted to the head, such as in a sudden stop. It is now estimated that more than 1 million children a year experience an MTBI, and some studies suggest that number may actually be closer to 3 million to 5 million children a year. In the United States these injuries are responsible for 2,700 deaths a year, 37,000 hospitalizations, 435,000 emergency room visits, and more than 125,000 visits to the pediatrician. Concussions occur when the cerebrospinal fluid surrounding the brain is insufficient in cushioning the brain during an impact. As a result, the brain can slam against the interior of the skull. Symptoms of a mild traumatic brain injury include changes in physical, cognitive and emotional functioning. Physical symptoms express themselves as loss of consciousness, headaches, ringing in the ears, slurred speech, fatigue, dizziness, light sensitivity, nausea/vomiting, problems balancing and visual impairment (blurred or double vision). Disturbance in cognitive functioning such as memory loss, trouble focusing and feeling “foggy” can occur as a result of a MTBI. Recent research has highlighted the emotional difficulties faced that present themselves as irritability, sadness, anxiety and increased emotional sensitivity. In adults who have suffered a number of MTBIs there was a strong correlation between the brain injuries and chronic depression which has presented itself as suicidal tendencies. With all the information that research has found on concussions and traumatic brain injuries it is imperative to seek medical help to prevent further brain injury and dysfunction. Rest is necessary for in all cases.

Posted by Kerry N. Jardine at 07:18 AM | Permalink | Comments (0) | TrackBacks (0)

Minnesota resident Leticia Harnung led a motivated, successful life as a finance director for a congressman. She thrived on multi-tasking, financial calculations and political networking. That all changed five months ago when she was thrown from a jet ski and hit her head while on vacation in Florida. She flew home the next day, but had a bad headache. As days went by her headache cart wheeled into incoherency. Harnung’s MRI scans were sent to Dr. Gaylan Rockswold who is a chief of Neurosurgery. Rockswold concluded her brain injury was not visible and in fact said that usually is the case in the majority of concussions. Sometimes the only way a brain injury can be diagnosed is by its symptoms: personality changes, cognitive dysfunction, memory loss, loss of balance, dizziness, etc. Pat Maraciniak said the Brain Injury Association of Minnesota offers a host of resources to help brain injury victims and their families get the help and support they need. “They go home not realizing the impact a brain injury has on them and how life-changing and life-altering it is,” said Marciniak. “So they can understand what's going on. Their symptoms are explained, they're identified. They're told what they can expect,” he said. “With family, with work, with school it helps enormously. The patient feeling reassured they are not going crazy.” Rockswold said follow-up care is critical for the best chances of recovery. One of Harnung’s current challenges is constant migraines which her doctor is trying to help control. New research has found that the brain can heal itself and rewire pathways that were lost in the injury. Which gives Leticia Harnung and her family hope, but they wish more people understood how serious a concussion, known as a mild traumatic brain injury, can be.

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

Another lawsuit has been filed against the manufacturers of the gadolinium contrasting dye Omniscan on behalf of a 38-year-old Georgia man who contracted the disease Nephrogenic Systemic Fibrosis. General Electric Company’s Omniscan is a dye used to better define soft tissue in MRIs. The lawsuit includes GE’s subsidiaries GE Healthcare Inc., GE Healthcare Medical Diagnostics, GE Healthcare AS and Novation LLC. Nephrogenic Systemic Fibrosis is a condition that affects patients with kidney dysfunction who have been exposed to gadolinium dye. It is debilitating, progressive and can be fatal. The lawsuit alleges that Omniscan is defective, and that the defendants failed to adequately test Omniscan and failed to warn patients about its potential to cause NSF. Finally in September 2007, the Food & Drug Administration asked the manufacturers of gadolinium contrast dyes to add a “black box” warning, the most severe, to the product labels about its association with NSF. The FDA also warned that patients with kidney disease should avoid gadolinium contrast agents. NSF is a devastating condition characterized by high blood pressure, burning, itching, swelling and hardening of the skin. Other symptoms include eye discoloration, red or dark patches on the skin, pain deep in the hip bones or ribs and muscle weakness. NSF can progress to the point of causing severe stiffness in joints. There is no known cure for NSF, however an experimental treatment called extracorporeal photopheresis has shown progress in three known cases of NSF. Extracorporeal photopheresis 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

Posted by Peter W. Burg at 07:38 AM | Permalink | Comments (0) | TrackBacks (0)

The Oregon Health & Science University has settled six medical malpractice cases for $38.5 million said U.S. District Judge Michael Hogan. The settlements will average more than $6 million per claimant which is well above the $2 million Oregon statewide liability cap on medical malpractice suits. The settlements were made after the Oregon Supreme Court lifted the cap on liability claims. The settlement included $9.3 million to be awarded the family of Jordaan Clarke who suffered permanent brain damage because of a medical mistake at OHSU. It was the Clarke lawsuit that challenged the $200,000 liability cap that protected the hospital from paying large malpractice claims. The insurance company, Washington Casualty that covered OHSU will cover $21.35 million of the settlement costs. Scott Gallant, of the Oregon Medical Association is concerned. He said that since these suits were settled far above the statewide liability cap, the future of the $2 million cap looks unstable as the decision of the cap comes before the next state legislature for ratification. A gag-order was put in place by Judge Michael Hogan on all parties in the suits so it may be sometime before the details of the settlement will be forthwith.

Posted by Scott J. Eldredge at 09:33 PM | Permalink | Comments (0) | TrackBacks (0)

In 2002, hospitals in the University of Michigan health system started encouraging doctors to apologize for their mistakes. Malpractice lawsuits subsequently dropped from 262 filed in 2001 to an average of 130 a year. British Columbia passed an Apology Act in 2006 as well. The Act allows an individual or organization to express sympathy, regret or remorse by saying “I’m sorry,” and even to admit culpability, but the apology cannot be used against them when deciding fault or liability in a lawsuit. The Act further states that saying “sorry” cannot void or cancel out an insurance policy (some policies stipulate that an apology will make the policy void). In a report by Susan Alter for the Law Commission of Canada it was concluded that, “for a victim, an apology is often considered to be the key that will unlock the door to healing.” According to the American Bar Association Journal, 30% of all plaintiffs would not have sued if an apology had been made. Studies have shown that an apology can have a powerful effect and can help to resolve disputes. For patients, apologizing reduces the risk of medical malpractice lawsuits being filed against doctors. B.C.’s attorney general voiced concern saying that:

- Public confidence in the courts could be affected if a person who admits they're to blame in an apology is later found not liable;

- Insincere and strategic apologies could be encouraged;

- Apologies might create an emotional vulnerability in some plaintiffs, who may accept settlements that are inappropriately low.

Regardless, an apology goes a long way in helping a victim heal. Some wrongs can only be righted with an apology. And it enables those to take responsibility for their actions while possibly derailing legal action against them.

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

In a surprising move the Texas Hospital Association and the Texas Medical Association are asking the Texas Supreme Court to decide whether the law capping damages to victims of medical malpractice is constitutional. Questions have arisen about whether the cap violates people’s rights to equal protection, due process and jury trials, among other constitutional provisions. “We have to be certain that the cap is constitutional, and the only body that can tell us that in Texas is the Supreme Court,” said Austin attorney Mike Hull, who launched the call. Critics argue that the consequence could limit future challenges in state courts and feel that the tactic is intended to prevent a future case that would make a stronger challenge as well as the concern that making a direct appeal to the Supreme Court with this case violates Texas rules. “This is another way to put more nails in the coffins of people who are dying because of medical malpractice,” said Mark Werbner, a Dallas plaintiffs’ attorney. Critics further say the cap has limited patients’ with little income rights to seek compensation after suffering life-threatening injuries at the hands of a doctor and establishment. “If you have economic damages, a corporate CEO, a doctor or a lawyer probably can still get to court,” said Alex Winslow, executive director of Texas Watch, a consumer advocacy group in Austin. “Stay-at-home moms, retirees, a child, elderly people, chances are you won’t.” The poor, he said, are disproportionately affected because they depend more on non-economic damages. With the awards capped, patients cannot recover enough to pay for the cost of such lawsuits. As an example, single mom Vicki Rohall had a hysterectomy and a surgical instrument was left inside her body. She later went into septic shock and a coma. Although she had insurance, it didn’t cover all the costs, and she said she was left with $100,000 or more of hospital bills to correct the surgical errors. Rohall has an attorney, but the cost of filing a lawsuit on her behalf is cost prohibitive because of the cap. On the surface the move by the Texas Hospital Association and the Texas Medical Association sounds good, but what do they have to gain by the Supreme Court’s decision and will the Supreme Court even hear their arguments?

Posted by Scott J. Eldredge at 07:29 PM | Permalink | Comments (0) | TrackBacks (0)

A Northlake, Illinois woman agreed to a $5.5 million settlement with doctors and the hospital where her child was delivered. In March 2002 she was admitted to Westlake Hospital and given a drug to induce her contractions. Her infant’s heart rate started to drop. The first doctor attempted to deliver the baby, but failed. A second doctor elected to perform a Caesarean section, but by the time the baby boy was delivered he had been deprived of oxygen long enough to cause severe brain damage. The $5.5 million settlement will go toward the lifetime of medical care the mother faces in raising her child.

Posted by Scott J. Eldredge at 07:27 AM | Permalink | Comments (0) | TrackBacks (0)

A 25 year old woman in Oklahoma City believes she suffered a stroke caused by the Ortho Evra Birth Control Patch. At the time she was a restaurant manager and working the day she believes she suffered the stroke. She remembers she started to feel shaky and dizzy. When she answered the phone incoherent words came out in slurred speech. As with most young women who use the patch, she was perfectly healthy with no history of family health problems. After her stroke she researched the side effects and found that stroke was one of them. She had no idea how dangerous it could be and said she didn’t remember her doctor telling her of the possible dangers when she was prescribed it. More than likely her doctor gave the usual speech on possible, but improbable side effects of birth control use. Not the increased risk with the patch at 3 times the dosage of hormones compared to birth control pills.

Posted by Seth A. Katz at 09:23 PM | Permalink | Comments (0) | TrackBacks (0)

A New York mother started using the Ortho Evra patch in March 2005. In January 2007 she suffered an aneurysm. Before her aneurysm, she was fit and exercised regularly and had no blood pressure problems. Two months prior she started having headaches daily. She awoke from a coma in the hospital three months later. Her doctor told her never to use the Ortho Evra patch again. According to the website HealthLink, “Brain aneurysms can occur in anyone, at any age. They are more common in adults than in children and slightly more common in women than in men…Some investigators have speculated that oral contraceptives may increase the risk of developing aneurysms.” If that is the case how much more does the patch increase risk since it dispenses 60% more hormones into the bloodstream.

Posted by Seth A. Katz at 09:22 PM | Permalink | Comments (0) | TrackBacks (0)

In response to rising concerns about food safety in the United States, The Government Accountability Office recently reported, “While the FDA has considered fresh produce safety a priority for many years, resource constraints and other work -- including counterterrorism efforts and unplanned events such as food borne illness outbreaks -- have caused FDA to delay key produce safety activities.” The U.S. Food and Drug Administration has been preparing for a biological attack. The repeated outbreaks of food poisoning have interfered with their efforts to improve food safety as well. What is frightening is the FDA is unclear on what it plans to do to plug up the holes. The “FDA has no formal program devoted exclusively to fresh produce and has not consistently and reliably tracked its fresh produce spending.” The fresh produce industry indicated it would welcome stronger regulation especially after outbreaks of Salmonella found in peppers from Mexico that sickened 1,400 people from April to August of this year and an E. coli epidemic in 2006, traced to California spinach that killed three. In response to the report the FDA said it is meeting with officials in Canada and Mexico, will add 327 state contract food inspections in 2009 and has approved the use of radiation to disinfect fresh spinach and lettuce. The GAO further reported that the FDA has limited resources saying, “FDA's intervention efforts have also been limited. Specifically, domestic fresh produce firms were inspected infrequently. Furthermore, FDA examined less than 1 percent of the 7.6 million fresh produce lines imported from fiscal years 2002 through 2007,” In defense the FDA is taking further steps to keep food safe and has proposed changes in its Food Protection Plan that could significantly improve its ability to oversee fresh produce. The U.S. Centers for Disease Control and Prevention estimates that each year 76 million people get some kind of food borne illness, 300,000 are hospitalized and 5,000 die.

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

While riding his bike an Omaha, NE father and husband suffered an epileptic seizure. When his head hit the pavement he suffered a traumatic brain injury, ultimately losing two-thirds of the left hemisphere of his brain. He was not wearing a helmet at the time. He underwent intensive therapy at a rehabilitation center, but his doctor said his memory, judgment and reasoning are still lacking. The man says he feels fantastic and looks forward to returning to work and driving again. However, his wife and doctor disagree. A psychologist said brain injury patients often experience denial about their injury and how it will affect their life. Although the goal of rehabilitation is to help brain injury patients return to some level of independence, unfortunately it isn’t always successful. Many state brain injury associations have resources available to the families and victims of a traumatic brain injury. The Brain Injury Association of America is an excellent place to start looking for options.

Posted by Kerry N. Jardine at 07:16 AM | Permalink | Comments (0) | TrackBacks (0)