Brain Injury Journey: Hope, Help, Healing
I just received the premier issue of “Brain Injury Journey, Hope, Help, Healing, a magazine for the brain injury community published by Lash and Associates Publishing/Training Inc.
The United States Department of Justice is Concerned with Plavix®
The United States Department of Justice (“DOJ”) is concerned that the dangers of Plavix® were not properly identified by its manufacturers Sanofi-Aventis and Bristol-Myers Squibb. The DOJ is concerned that the manufacturers failed to disclose certain information in hopes of misleading consumers about the safety of the drug. Studies show that certain individuals have a difficult time metabolizing Plavix®. The DOJ was troubled with the warning and “is investigating disclosures to the FDA regarding the variability of response to Plavix” according to Sanofi. This is not the first time Sanofi and Bristol-Myers have been questioned about their Plavix® disclosures. The FDA inquired into the drug’s safety back in 2003. A warning was added to the box to flag the differences in Plavix®,effectiveness back in 2010.
If you feel you have experienced any side-effects from taking Plavix®, you can contact Stark & Stark and speak to one of the Mass Tort/Pharmaceutical Litigation attorneys, free of charge, who can help assess any claims that you might have against the Plavix® manufacturers.
Bayer Sets Aside $1 Billion to Settle Yaz Cases
Yasmin and its sister drug Yaz were introduced in the market over ten years ago. The drugs, made by Bayer, achieved $1.47 billion in sales during 2010 alone. The drug sold well, but proved to have devastating side effects that sometimes proved fatal.
Litigation commenced many years ago and many cases have settled. However, Bayer recently announced it had reached agreements to pay $1 billion in settlements to 4,800 women in the United States who say there were harmed by taking Yasmin or Yaz. These settlements are only applicable to blood clot injuries.
If you have suffered a heart attack, stroke, deep vein thrombosis or pulmonary embolism while taking YAZ® or Yasmin®, contact Stark & Stark and speak to one of the Mass Tort/Pharmaceutical Litigation attorneys, free of charge, to help you assess any claims that you might have against the YAZ® or Yasmin® manufacturers.
Good Old Days
I previously commented on an article authored by Grant Iverson, Ph.D. discussing the concept of “Good Old Days Bias” in which patients remember being healthier prior to their sustaining their traumatic injury.
Topamax Mass Tort Filed in Philadelphia County
According to a February 28, 2013 lawsuit filed in Philadelphia, Pennsylvania, an Indiana woman has alleged that her child was born with a cleft palate as a result of her ingestion of Topamax during pregnancy. Topamax, manufactured by New Jersey based Ortho-McNeil-Janssen Pharmaceuticals, is prescribed to treat epilepsy in adults and children.
The lawsuit alleges multiple counts including design defect, failure to warn, negligence, negligent design, fraud, misrepresentation and breach of express and implied warranties. The lawsuit is part of the consolidated mass tort action currently underway in Philadelphia. To date, the manufacturer has paid $75 million to the United States Department of Justice and other plaintiffs for violations of the federal False Claims Act for improper marketing, promotion and sale of Topamax.
Trials are currently set for some of the Philadelphia Topamax cases starting in July 2013.
Diffusion Tensor Imaging Used to Diagnose White Matter Damage After TBI and to Predict Neuropsychological Outcome in Individual Patients
A new paper published in the Annals of Neurology by trained pattern classifiers discriminated between patients with microbleeds and age-match controls with a high degree of accuracy, and outperformed other methods. “Individual prediction of white matter injury following traumatic brain injury,” Hellyer PJ, Leech R, Ham TE, Bonnelle V and Sharp DJ, Ann Neurol 2013.
Risk for Addiction-Related Disorders Following Mild Traumatic Brain Injury
This month’s issue of the American Journal of Psychiatry, the Aflagship@ journal of the American Psychiatric Association, includes a study entitled ARisk for Addiction-Related Disorders Following Mild Traumatic Brain Injury in a Large Cohort of Active-Duty U.S. Airmen,@ Miller SC, Baktash SH, Webb TS, Whitehead CR, Maynard C, Wells TS, Otte CN and Gore RK, Am J Psychiatry Miller, et al.; (2013).
Binder, Rohling and Larrabee Meta-Analytic Review Criticized Again
Neuro law attorneys are very familiar with the meta-analytic review of neurological studies that was authored by Binder, Rohling and Larrabee (Binder 1997). It is a study that is often cited by defense attorneys to support the myth that recovery after mild traumatic brain injury (mTBI) occurs within the first three months, with any subsequent changes in performance being of limited statistical and clinical significance.
First Trial in DePuy Hip Recall Litigation Begins
As we have previously reported, in August 2010, DePuy Orthopaedics recalled all of its ASR products after reports surfaced alleging a higher than normal failure rate for their metal-on-metal hip implant devices. The recall encompassed about 93,000 devices in the United States, which has prompted the filing of approximately 10,000 lawsuits since 2010.
The first trial in the DePuy ASR lawsuits began at the end of January 2013 in Los Angeles, California. The New York Times reports that DePuy Company Compliance Manager Jimmy Smith testified that DePuy had taken “inappropriate” steps to identify and eliminate risks in the design of its ASR product. According to a Bloomberg report, Smith told a California jury that DePuy used irrelevant testing procedures to determine the safety and effectiveness of the ASR product. Smith also told the jury that DePuy’s design analysis group fell short in 13 areas and “didn’t predict the levels of excessive wear and the loosening that have been identified.” When asked why DePuy cut corners when analyzing the safety of its product Smith testified it “would have been too expensive” to provide more comprehensive trial tests for the product.
If you have had a hip replacement, which used the DePuy ASR or DePuy Pinnacle devices, you can contact Stark & Stark and speak to one of the Mass Tort attorneys, free of charge, who can help assess any claims that you might have against the DePuy manufacturers.
Patients Taking Pradaxa at 33% Higher Risk
According to recent reports, patients that are taking the anti-clotting drug Pradaxa have a 33% higher risk of heart attack or severe symptoms of heart disease than patients taking Warfarin. The finding, from Cleveland Clinic researchers Ken Uchino, MD, and Adrian V. Hernandez, MD, PhD, is based on data from seven clinical trials that enrolled 30,514 patients. “The risk of [heart attack] or acute coronary syndrome is increased with [Pradaxa] compared with various control treatments, which include adjusted-dose Warfarin, [Lovenox], or placebo,” Uchino and Hernandez concluded. Acute coronary syndrome — acute symptoms of serious heart disease — is usually caused by the rupture of a plaque in a heart artery. In an editorial accompanying the study in the Jan. 9 issue of Archives of Internal Medicine, journal editor Rita Redberg, MD, noted that this is not the first safety warning issued for Pradaxa.
If you or a loved one has experienced serious side effects after taking Pradaxa, you can contact Stark & Stark and speak to one of the Mass Tort attorneys, free of charge, who can help assess any claims that you might have against Boehringer Ingelheim Pharmaceuticals, Inc.