Following Suit: Testosterone Lawsuit Update

Increasingly, testosterone therapy manufacturers are facing lawsuits after men who were prescribed AndroGel, Testim, Dep-Testosterone, Fortesta, Striant, Axiron and other “low-t” treatments suffered life-threatening testosterone side effects such as stroke and heart attack.

Testosterone lawsuits allege that manufacturers of testosterone therapies failed to warn patients about the risk of heart attack, stroke, pulmonary embolism and other serious side effects on their products’ labeling or advertising materials. As well, claimants who were prescribed testosterone treatment for low libido, fatigue and other symptoms normally associated with aging, allege that the testosterone manufacturers engaged in “disease mongering” to increase sales.

Recent testosterone studies

A study titled “Testosterone Therapy and Myocardial Infarction” (January 2014) published by the Public Library of Science in conjunction with the University of Florida and the National Cancer Institute shows an association between testosterone therapy (TT) and cardiovascular disease. The researchers also noted that testosterone therapy is increasing despite the fact that in older men, and in younger men with pre-existing diagnosed heart disease, the risk of myocardial infarction shortly after they begin testosterone therapy is substantially increased.

Another study published in JAMA (Journal of the American Medical Association, November 2013) also concluded cardiovascular risk with testosterone therapy. Researchers said the study warranted cautious testosterone prescribing and additional investigation. (See JAMA video.)

Testosterone litigation update

AndroGel

AndroGel, which is made by AbbieVie, a subsidiary of Abbott Laboratories, makes up about 80 percent of the testosterone therapy or replacement market. It is currently the main product being investigated.

Shortly after an FDA notice on January 31, 2014 alerted the public of its “Low T” treatment safety review, four testosterone lawsuits against AndroGel were filed in the U.S. District Court, Northern District of Illinois on behalf of men who allegedly experienced strokes, heart attacks, heart failure and other complications stemming from use of the medications.

On February 10, 2014, a fifth case was filed against AndroGel. The plaintiff claims the testosterone drug caused him to suffer pulmonary embolism, deep vein thrombosis and other serious cardiovascular injuries. And one month later a man who had a stroke in 2011 joined other plaintiffs in an AndroGel lawsuit filed in the Northern District of Illinois.

Testim

Testim, manufactured by Auxilium Pharmaceuticals, is facing two lawsuits (along with co-defendant GlaxoSmithKline) in the Court of Common Pleas of Philadelphia County. Plaintiff Robert Olivetti of Scranton claims that his use of Testim and AndroGel led to a testosterone heart attack he suffered in 2012, which required heart bypass surgery due to using both drugs. Olivetti et al v. Auxilium Pharmaceuticals Inc. et al, Case No. 140303508.

The second lawsuit filed by plaintiffs Edwin and Eileen Rios in April 2014 alleges that “defendants, jointly or individually, represented to the public at large and to the medical profession, through word, actions and deeds, including extensive direct-to-consumer advertising and physician-detailing, that Testim was safe and effective for its intended use.” Edwin Rios allegedly suffered a testosterone heart attack in 2013. Rios et al v. Auxilium Pharmaceuticals Inc. et al, Case No. 140302537.

Another Testim lawsuit was filed April 10, 2014, in U.S. District Court for the Eastern District of Louisiana. A Jefferson Parish man claims he suffered multiple strokes caused by AndroGel and Testim testosterone therapy (case no.2-14-cv-00839). The complaint accuses AndroGel’s AbbVie Inc. and Abbott Laboratories and Testim’s Auxilium Pharmaceuticals, Inc. of misrepresenting their products as safe, easy to use and free from serious side effects.

Court documents state the plaintiff believed he had low testosterone symptoms based on the defendants' advertisements. He was prescribed AndroGel and Testim at the age of 63 and took the topical gel treatments from 2006 until 2014. The Testim lawsuit claims he had no cardiac problems prior to taking the testosterone treatment. Further, if he had known about the potential risks associated with the therapy, as reported by the FDA Safety Announcement, he would not have suffered serious testosterone side effects.

Testosterone multidistrict litigation (MDL)

On March 28, 2014, a motion was filed to combine more than three dozen pending federal lawsuits filed against the manufacturers of AndroGel. Plaintiffs asked the Judicial Panel on Multidistrict Litigation (JPML) to centralize all the cases to the U.S. District Court in Illinois. US District Judge Matthew Kennelly will preside over those consolidated pretrial proceedings.

Court records show that all 38 men involved in the possible MDL claim suffered “stroke, heart attack, pulmonary embolism, deep vein thrombosis or thromboembolic event” after taking AndroGel to treat Low T. They also claim the drugmakers failed to provide sufficient warnings about heart risks from using the prescription product. (In Re: AndroGel Product Liability Litigation, MDL Docket No. 36.)

The MDL panel is scheduled to discuss the motion on May 29, 2014. The panel has been asked to combine all testosterone product litigation into one MDL, which would include AndroGel, Testim and Eli Lilly’s Axiron.