Testosterone Drug Makers Split Over Motion for One MDL for All Lawsuits

While the makers of most testosterone replacement drugs have filed a response supporting the creation of one federal multidistrict litigation (MDL) for all testosterone lawsuits, at least one manufacturer is opposing efforts to centralize cases involving various different products before one judge.

There are currently more than 74 product liability lawsuits filed throughout the federal court system on behalf of men who allegedly suffered a heart attack, stroke, blood clot or other injury caused by side effects of low testosterone drugs.

While most of the cases involve the use of Androgel, which accounts for about 60% of the market for testosterone replacement therapy, other cases have been filed against the makers of AndroDerm, Testim, Axiron, Foresta, Depo-Testosterone and other low T drugs.

Last month, a motion was filed a plaintiff with the U.S. Judicial Panel on Multidistrict Litigation (JPML), seeking to centralize all federal AndroGel lawsuits before one judge for coordinated handling during pretrial proceedings. Another group of plaintiffs filed a second motion, seeking to consolidate all testosterone drug lawsuits as part of one MDL, regardless of which specific medications were used.

In a response (PDF) filed by Auxilium Pharmaceuticals, Inc. on April 25, the maker of Testim and Testopel opposed an industry-wide MDL. Auxilium indicates that it has only been named in seven federal cases, arguing that given the small number of cases, an MDL for lawsuits involving all testosterone drugs is not warranted.

However, in a joint response (PDF) filed on behalf of other testosterone drug makers, including AbbVie, Inc., Abbott Laboratories, Eli Lilly and Co., Lilly USA, LLC and Endo Pharmaceuticals, Inc., the manufacturers indicate that they support centralization of all pending testosterone replacement therapy lawsuits before the same judge.

These other drug makers point out that many of the cases involve men who used several different testosterone drugs, which they argue is strong justification for the creation of one industry-wide MDL,

“If only the AndroGel cases are centralized, the co-Defendants who were also sued in some of those cases would find themselves litigating in both the AndroGel MDL and in the courts that have non-AndroGel cases,” wrote the drug makers in their response filed April 25. “The benefits and efficiencies of an MDL would be lost for those Defendants and plaintiffs in those cases.”

Testosterone Drug Lawsuits

Centralizing federal cases before one judge in complex pharmaceutical litigation is common when a large number of lawsuits are filed over the same or similar medications. As a result of common questions of law and fact likely to be presented throughout the lawsuits, coordinated pretrial proceedings are designed to help reduce duplicative discovery, avoid conflicting rulings from different judges and generally serve the convenience of the parties, witnesses and the courts.

All of the lawsuits filed to date involve nearly identical allegations against the different manufacturers of testosterone drugs, claiming that inadequate warnings were provided for users and the medical community about the risk of cardiovascular problems.

The complaints come following a series of studies published in recent months that identified a link between testosterone drugs and heart attacks.

In November 2013, a study published in the Journal of the American Medical Association suggested side effects of testosterone may increase the risk of heart attacks, strokes, and death among older men with certain pre-existing heart problems.

This research was followed by a study published by the medical journal PLOSOne in January 2014, which found that low testosterone 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 AndroGel and other testosterone replacement therapy on January 31, leading to multiple media reports about the potential risk and lawyers advertising for potential claims.

The complaints involve allegations that the manufacturers essentially created the “disease” of low testosterone among men, blaming everything from fatigue to grumpiness on “Low T.” However, originally, the testosterone drugs were approved by the FDA to treat medically discernable low testosterone levels caused by a medical condition, such as hypogonadism. The condition was at first estimated to affect only about a million men in the U.S., but now the pharmaceutical industry estimates a 20 million man market for testosterone drugs.

As testosterone injury lawyers continue to review and file new lawsuits for men throughout the United States, it is ultimately expected that several thousand complaints will be filed in state and federal courts nationwide.

The U.S. JPML is scheduled to hear oral arguments on the motions to establish a testosterone MDL on May 29, at an upcoming hearing in Chicago, Illinois.

Even if the testosterone litigation is centralized before one judge for pretrial proceedings, each case will remain an individual lawsuit. Following discovery into common issues and a series of bellwether trials likely to be scheduled in the MDL, if the drug makers fail to reach testosterone settlement agreements to resolve a large number of cases, individual claims may ultimately be remanded back to the U.S. District Courts throughout the country where they were originally filed for separate trials.