Wesley Davis, from New York filed a stroke product liability lawsuit against Actavis and Watson. Davis alleged that the side effects of the testosterone patch AndroDerm caused him to suffer a serious stroke. Furthermore, Davis claimed that the drug manufacturers failed to warn men about the potential risks associated with use of testosterone replacement therapy (TRT).
What is Androderm?
AndroDerm patch is a low testosterone drug approved by the FDA in 1995 for treatment of low testosterone caused by a medical condition, called hypogonadism. The testosterone replacement therapy medication is delivered in permeable skin patches.
Sales for AndroDerm exceeded $87 million in 2011, making it one of the best selling testosterone drugs in America. Testosterone replacement therapy medication sales now exceed $2 billion per year.
Davis states that AndroDerm was doctor prescribed for low testosterone symptoms. In 2011, Davis was hit hard with a significant stroke, which has left him with serious injuries and medical expenses.
Davis points to the aggressive direct-to-consumer advertising by Actavis and Watson, which cajoled men to seek testosterone medical treatment for normal symptoms associated with aging.
Testosterone Stroke, Heart and Blood Clot Risks
Many injured men have filed AndroDerm, AndroGel, Testim and Axiron lawsuits. The men allege that the drug manufacturers failed to adequately warn about the risk of heart attacks, strokes, blood clots (deep vein thrombosis and pulmonary embolism) and death associated with the use of testosterone therapy.
Nationwide Testosterone Lawsuit Claims Increasing
The majority of the lawsuits involve personal injuries associated with AndroGel usage. Androgel is a testosterone gel spray manufactured and sold by AbbVie.
Last month, plaintiffs filed a centralization of all AndroGel lawsuits before one U.S. District Judge, as part of an MDL or Multidistrict Litigation. This month, a second motion was filed, requesting all testosterone drug lawsuits to be centralized as part of one consolidated proceeding during pretrial litigation. MDL consolidation and centralization is common in mass tort pharmaceutical litigation, to reduce discovery, and avoid conflicting rulings from different judges.
The U.S. Judicial Panel on Multidistrict Litigation (JPML), which oversees MDL consolidations, has set a hearing over the AndroGel consolidation motion for May 29.
Low Testosterone Medical Studies
In January 2014, according to a study published in the medical journal PLOSOne, low testosterone treatments may double the risk of heart attack for younger men with heart disease and men over the age of 65.
According to a November 2013 study published in the Journal of the American Medical Association, side effects of testosterone may increase the risk of heart attacks, strokes, and death among older men with certain pre-existing heart problems.
FDA Launches Investigation
The FDA launched a safety review of AndroGel and other testosterone replacement therapy on January 31.