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The makers of the Androderm patch face a wrongful death lawsuit brought by the family of a Virginia man, alleging that inadequate warnings were provided about the risk of heart attacks, strokes and blood clots associated with the popular testosterone replacement therapy.
The complaint (PDF) was filed by the family of Alvin Harris in the U.S. District Court for the District of Utah on August 1, naming Actavis Pharma, formerly Watson Pharmaceuticals, Inc., Watson Laboratories, Inc. and Anda, Inc. as defendants.
Harris used the Androderm testosterone patch from October 2005 to February 2008, and again from July 2008 to May 2012. He was diagnosed with deep vein thrombosis in October 2011 and suffered strokes in June and July 2012, which ultimately led to his death August 3, 2012.
The family alleges that the injuries were caused by side effects the testosterone patch, indicating that Harris had no history of blood clots or strokes before using AndroDerm.
According to claims raised in the lawsuit, the Androderm makers engaged in aggressive direct-to-consumer marketing for the testosterone patch, which led to millions of men asking their doctors for the prescription medication when they were not actually suffering from low testosterone, but rather simply experiencing the natural effects of aging.
“Defendants’ marketing campaign encouraged men to discuss testosterone replacement therapy with their doctors and consumers and their physicians relied on Defedants’ promises of safety, effectiveness and east of use,” the lawsuit states. “Although prescription testosterone replacement therapy has been available for years, millions of men who had never been prescribed testosterone flocked to their doctors and pharmacies.”
Testosterone Health Concerns
Androderm patch is one of the earlier testosterone drugs approved in the U.S., which was introduced in 1995 for treatment of “low T” caused by a medical condition, such as hypogonadism. The medication is provided through a patch, which delivers the drug through the skin on the arms, back, stomach or thighs.
In 2011, sales for Androderm exceeded $87 million, making it one of the biggest selling testosterone drugs in the U.S. Together with other testosterone replacement medications, which include AndroGel, Axiron, Testim and others, global sales now exceed $2 billion per year.
The complaint is one of a growing number of Androderm patch lawsuits brought in recent months by men throughout the United States, all involving similar allegations that inadequate warnings were provided about the risk of heart attacks, strokes, blood clots and death. Nearly identical allegations have also been raised in AndroGel lawsuits, Testim lawsuits and Axiron lawsuits, filed over popular testosterone gel products.
Concerns about the link between heart problems and testosterone drugs has increased in recent months, after a series of studies were published that suggested that the drug makers may have aggressively promoted the medications without adequately researching the cardiovascular risks.
In November 2013, a study published in JAMA suggested that side effects of low T drugs may increase the risk of heart attacks, strokes, and death among older men with certain pre-existing heart problems.
That research was followed by a study published in the medical journal PLOSOne in January 2014, which found that low T treatments may double the risk of heart attack for younger men with heart disease and men over the age of 65, regardless of their prior heart conditions.
In response to the findings, the FDA launched a safety review of all testosterone replacement therapy on January 31, leading to multiple media reports about the potential risk and lawyers advertising for potential claims. An FDA advisory panel is scheduled to meet next month to evaluate the potential testosterone drug risks and determine what regulatory actions may be necessary to protect the public.
Amid the growing number of product liability lawsuits filed over testosterone replacement therapy, the U.S. Judicial Panel on Multidistrict Litigation (JPML) established coordinated pretrial proceedings in June 2014, consolidating all low T drug lawsuits filed throughout the federal court system as part of a multidistrict litigation (MDL). The litigation has been centralized before U.S. District Judge Matthew F. Kennelly in the Eastern District of Illinois, regardless of which testosterone drug was used by the plaintiff.
As of July 15, at least 156 product liability lawsuits have been centralized before Judge Kennelly. However, as testosterone injury lawyers continue to review and file additional cases, it is ultimately expected that several thousand complaints will be filed against various manufacturers.
The Harris complaint involves claims for failure to warn, negligence, breach of warranty, fraud, negligent misrepresentation, and wrongful death, seeking both compensatory and punitive damages. Although the case was filed in the District of Utah, it is likely to be transferred into the testosterone MDL for coordinated pretrial proceedings.