The U.S. Food and Drug Administration (FDA) is requiring manufacturers to include a general warning in the drug labeling of all approved testosterone products about the risk of blood clots in the veins. Blood clots in the veins, also known as venous thromboembolism (VTE), include deep vein thrombosis (DVT) and pulmonary embolism (PE). The risk of venous blood clots is already included in the labeling of testosterone products as a possible consequence of polycythemia, an abnormal increase in the number of red blood cells that sometimes occurs with testosterone treatment. Because there have been postmarket reports of venous blood clots unrelated to polycythemia, FDA is requiring a change to drug labeling of all testosterone products to provide a more general warning regarding venous blood clots and to ensure this risk is described consistently in the labeling of all approved testosterone products.
un 19, 2014, 3:54pm MST Updated: Jun 20, 2014, 7:33am MST
General Motors (GM) has recalled 1,367,146 vehicles: the 2005-2007 Chevrolet Cobalt, the 2007 Pontiac G5, the 2003-2007 Saturn Ion, the 2006-2007 Chevrolet HHR, the 2006-2007 Pontiac Solstice and the 2007 Saturn Sky vehicles due to a faulty ignition switch. The defect allows the key to unintentionally slip from the "run" to "off" or "accessory" position while the vehicle is being operated. This problem can occur especially when using heavy key rings, and causes the ignition to turn off and stall while in motion. The stalled engine can turn off power steering and power brakes, making the vehicle difficult to control and creating a hazardous emergency situation. Additionally, with the loss of power, the air bag system is disabled and rendered useless in an ensuing crash. There have been reported to be at least 34 collisions, resulting in 12 fatalaties, caused by this defective product. As part of the recall, GM dealers will be replacing ignition switches and recommend taking non-essential items off key rings until the ignition switch has been replaced.
Endo International PLC agreed to pay $830 Million to settle about 20,000 lawsuits filed by women who say they were injured by transvaginal mesh devices. While not admitting fault, the company said the settlement will cover a substantial majority of the mesh litigation brought against its American Medical Systems subsidiary. This settlement is in addition to the $54.5 Million Endo agreed to pay last year to settle an undisclosed number of TVM cases.
Phoenix personal injury attorney Stephen I. Leshner has been selected to the 2014 Arizona Super Lawyers list, for the seventh consecutive year. Each year, no more than five percent of the lawyers in the state are selected by the research team at Super Lawyers to receive this honor. Super Lawyers, a Thomson Reuters business, is a rating service of outstanding lawyers from more than 70 practice areas who have attained a high degree of peer recognition and professional achievement. The annual selections are made using a patented multiphase process that includes a statewide survey of lawyers, an independent research evaluation of candidates and peer reviews by practice area. The result is a credible, comprehensive and diverse listing of exceptional attorneys. The Super Lawyers lists are published nationwide in Super Lawyers Magazines and in leading city and regional magazines and newspapers across the country. Super Lawyers Magazines also feature editorial profiles of attorneys who embody excellence in the practice of law. For more information about Super Lawyers, visit SuperLawyers.com.
Endo Health Solutions Inc., the parent company of American Medical Systems, Inc., (AMS) is under investigation relating to its pelvic mesh products. The company has received subpoenas from a number of states in the investigation. Endo revealed this information in a SEC filing last month that warned investors that the "strain of pelvic mesh litigation" threatens its unit's women's health business. AMS is facing thousands of lawsuits in multi-district litigations over the products, and said in the filing that the company is now facing investigation by a number of states, and is cooperating with the investigation.
In the just published "Showtime", a book about the Los Angeles Lakers of the 1980's, by best-selling author Jeff Pearlman, I was interviewed about a case I handled a long time ago. While all my cases are important to me and my clients, this case received a disproportionate amount of publicity, if only because of the identity of the Defendant. As reported in the book:
Biomet has agreed to pay a base rate of $200,000 each to hundreds of people who received artificial hips that were later replaced, which depending on individual circumstances, can be adjusted upward or downward.
Transvaginal Mesh (TVM): The first bellwhether trial in the MDL against Johnson & Johnson (Ethicon) began on February 10, 2014. The first bellwhether trial against American Medical Systems (AMS) in the MDL is scheduled for April 17, 2014. Stephen I. Leshner, P.C. has a number of TVM clients with complaints filed in the MDL against these Defendants, and others, and we are anxiously awaiting the results of these trials.
An op-ed piece in titled "Don't Ask Your Doctor About Low-T" in today's New York Times discusses the link between prescription drugs for low testosterone and heart attack in otherwise healthy men. See the link to the article below. If you or someone close to you has suffered a heart attack or other serious cardiac event after taking a prescription drug for low testosterone, please call Phoenix Arizona accident injury product liability attorney Stephen I. Leshner for a free consultation.