Drug Makers Move to Dismiss Class Action Lawsuit Over Testosterone Drugs

The manufacturers of various different testosterone replacement therapy drugs sold throughout the U.S. have filed a motion to dismiss a class action lawsuit brought by a health insurer, which alleges that the pharmaceutical companies fraudulently marketed their products for “off-label” conditions.

Medical Mutual of Ohio (MMO) is pursuing a testosterone drug class action lawsuit against nearly every drug maker who has sold a treatment for low testosterone over the past 15 years, pursuing claims for illegal marketing of testosterone replacement therapy for medical conditions that have not been approved as safe and effective by the FDA. The insurer is also asserting claims under the federal Racketeer Influence and Corrupt organizations (RICO) Act, state statutes, and the common law.

In a joint motion to dismiss (PDF) filed July 31, AbbVie, Abbott Laboratories, GlaxoSmithKline, Auxilium, Actavis, Watson Pharmaceuticals, Endo Pharmaceuticals and other drug companies argue that the class action complaint has no legal basis.

The makers of popular medications like Androgel, Testim, Axiron and others point out that a number of similar third-party payor lawsuits filed in recent years over alleged off-label marketing have been dismissed at the pleading stage. In addition, those prior claims have involved lawsuits against one manufacturer over one drug, as opposed to an industry-wide fraud action, for which the drug makers maintain there is no precedent.

“MMO is seeking to stretch RICO’s private right of action to regulate the practices of an entire industry,” the companies claim. “Yet, RICO was not enacted to provide a sophisticated insurance company with industry-wide regulatory powers.”

The class action lawsuit against testosterone replacement therapy makers reflects a belief among numerous critics that the entire “low T” drug industry has been manufactured by aggressive marketing that encouraged use of the medications among men without any real medical need.

Instead of promoting their medications for treatment of low testosterone caused by a medical condition, such as hypogonadism, television advertisements and other promotions have encouraged men to seek medical treatment for a “condition known as low T” if they experience any number of symptoms associated with natural drops in testosterone levels as all men age, such as decreased energy levels, reduced strength and diminished sex drive.

Testosterone Litigation

The class action lawsuit filed by MMO is part of the consolidated testosterone drug litigation, which is centralized for pretrial proceedings before U.S. District Judge Matthew Kennelly in the Northern District of Illinois to reduce duplicative discovery into common issues, avoid conflicting pretrial rulings and to serve the convenience of the parties, witnesses and the courts.

Most of the complaints have been brought on behalf of men who suffered a heart attack, stroke, deep vein thrombosis, pulmonary embolism or other injury, alleging that the drug makers failed to provide adequate warnings about the potential side effects of testosterone replacement therapy.

There are currently more than 2,000 Androgel lawsuits, Testim lawsuits, Axiron lawsuits and other low testosterone drug lawsuits pending before Judge Kennelly in a federal multidistrict litigation (MDL).

As part of the coordinated discovery and pretrial proceedings, a small group of Androgel cases are being prepared for early trial dates next year, since AbbVie’s low testosterone drug is the most widely used product involved in the litigation. A series of six Androgel trials have been scheduled to help gauge how juries may respond to certain evidence and testimony that is likely to be repeated throughout other cases.

Individual trial dates for the three thromboembolism cases have been scheduled to begin October 31, 2016, December 5, 2016 and January 9, 2017. The three cases involving cardiovascular injuries are scheduled to begin on February 13, 2017, March 20, 2017 and April 24, 2017.

While the outcomes of these early trial dates are not binding on other cases, they may influence eventual testosterone drug settlement negotiations. Following the bellwether process, if the drug manufacturers fail to resolve large numbers of cases, they may face hundreds of individual trial dates for low testosterone drug lawsuits spread throughout the country.