AndroDerm Lawsuit Filed Over Stroke on Testosterone Patch

A New York man has filed a product liability lawsuit against Actavis and Watson, claiming that side effects of the testosterone patch AndroDerm caused him to suffer a massive stroke and alleging that the drug makers failed to adequately warn men about the potential risks associated with use of testosterone replacement therapy (TRT).  

The complaint (PDF) was filed by by Wesley Davis and his wife, Betty, in the U.S. District Court for the District of Nevada on April 18, joining a growing number of testosterone therapy lawsuit filed against manufacturers of different treatments.

AndroDerm patch is one of the earlier low testosterone drugs approved in the U.S., which was introduced in 1995 for treatment of low testosterone caused by a medical condition, such as hypogonadism. The medication is delivered in 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.

According to allegations raised in Davis’s lawsuit, AndroDerm was prescribed by his doctor in response to the “woes of aging he was feeling,” which he felt may be attributed to low testosterone. Davis claims that AndroDerm caused him to suffer a massive stroke in April 2011, which has left him with permanent injuries and huge medical expenses.

The lawsuit blames, in part, the advertising push by Actavis and Watson, which urged men to seek out blood tests for low testosterone if they found themselves feeling depressed, irritable, having diminished sexual desire and other symptoms generally synonymous with aging. The drug makers’ website, direct-to-consumer marketing, and marketing tactics of similar products, say that men can get a “simple blood test” to determine whether they suffer from low testosterone, which they call “low T.”

Testosterone Stroke, Heart Risks

The complaint is one of a growing number of AndroDerm lawsuits, AndroGel lawsuits, Testim lawsuits and Axiron lawsuits that have been brought in recent months by men throughout the United States, all involving similar allegations that the drug makers failed to adequately warn about the risk of heart attacks, strokes, blood clots and death associated with the use of testosterone patches, gels, injections and other treatments.

Concerns about the link between heart problems and testosterone drugs has increased over the past year, after a series of studies 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.

Testosterone Lawsuits Growing

Most of the lawsuits filed to date have involved injuries associated with the use of AndroGel, which is a testosterone gel spray manufactured and sold by AbbVie. However, a growing number of other cases are being filed by men like Davis, who suffered injuries following use of the patch or other gel treatments.

In late March, a group of plaintiffs filed a motion to centralize all AndroGel lawsuits before one U.S. District Judge, as part of an MDL or Multidistrict Litigation. However, earlier this month, a second motion was filed calling for all testosterone drug lawsuits to be centralized as part of one consolidated proceeding during pretrial litigation, to reduce duplicative discovery into common issues in the cases, avoid conflicting rulings from different judges and to serve the convenience of the parties, witnesses and the courts.

The U.S. Judicial Panel on Multidistrict Litigation (JPML), which oversees MDL consolidations, has set a hearing to listen to oral arguments over the AndroGel consolidation motion for May 29. It has also set a deadline of April 25 for the makers of various testosterone products to file a consolidated response to the motion.