Medical Device and Medicines

MEDICAL DEVICES AND MEDICINES BEING INVESTIGATED

Lidocaine Viscous: The FDA has issued a warning that this product should NOT be used to treat children with teething pain. This medication is sold under the brand name XYLOCAINE made by AstraZeneca. Use of this medication could result in seizures, severe brain injury and heart problems in children.

Metal-On-Metal Hip Implants: The FDA has reported over 16,800 adverse events associated with metal-on-metal hip implants from 2000 – 2011. We are currently investigating all metal-on-metal (“MOM”) hip implant failure cases, including those involving the DePuy ASR, Pinnacle, Wright Conserve Plus, Zimmer Durom Cup and Biomet Magnum MOM Implants. A well-functioning hip implant should last longer than a decade, and it is not uncommon for them to last 15-20 years or more. Many MOM hips must be revised in five years or less.

Actos & Bladder Cancer: The FDA has updated drug labels for Actos, usually prescribed to treat Type 2 diabetes, to state that the use of the drug for more than one year may be associated with an increased risk of bladder cancer. The FDA issued a warning for Actos in June 2011. We are working with other attorneys to investigate whether a diagnosis of bladder cancer where the patient used Actos for more than one year.

Pradaxa: Pradaxa (dabigatran etexilate) is a prescription medication manufacture by Boehringer Ingelheim that was approved by the FDA in October 2010 for the prevention of stroke and blood clots in patients with abnormal heart rhythm (atrial fibrillation). In December 2011, the FDA issued a safety announcement that it is evaluating post-marketing reports of serious bleeding events in patients taking Pradaxa, including reports that bleeding is occurring more commonly than would be expected. Bellas & Wachowski is working with other attorneys to investigate cases involving serious hemorrhages or death in patients who were taking Pradaxa.

Avandia and possible Cardiac Risks: Since May, 2007, significant concerns have emerged regarding a number of potentially adverse side effects of the drug Avandia. Avandia (which is commonly known as Rosiglitazone) is a drug manufactured by GlaxoSmithKlein. It was approved by the FDA in 1999 for treatment of Type 2 diabetes. During the past year the drug has been under very close scrutiny by the FDA because of reports of increased of congestive heart failure, increased hear attacks, bone fractures, liver failure, vision loss and premature death and, in some cases, death. The concern has come about because in May, 2007, the President of the American College of Cardiology, Dr. Steven Nissen, published a report that indicated that those taking Avandia had a 43% higher risk of heart attacks and a 64% risk of dying from heart disease. In November, 2007, the FDA ordered a "Black-box Warning" on all of the Avandia packaging to warn of increased risk of heart attacks and heart-related problems. Recent information provided to the U.S. Senate Finance committee indicated that GlaxoSmithKlein was aware of the cardiac risks of Avandia for years before those risks became public. Significantly, the Senate Finance committee alleged that instead of warning patients about these risks, GlaxoSmithKlein "intimidated independent physicians, focused on strategies to minimize findings that rosiglitazone may increase cardiovascular risk, and sought ways to downplay findings at the rival drug ACTOS might reduce cardiovascular risk. . ." If you or a loved one has been taking Avandia, you should consult with an attorney regarding your rights to pursue claims arising out of problems suffered while taking Avandia. This office is available to consult with you if you have been taking Avandia.

CONTACT US: FOR MORE INFORMATION ABOUT THESE PRODUCTS AND OTHERS, CONTACT PETER WACHOWSKI (peter@bellas-wachowski.com or 847.823.9030 Ext: 214).