Makers of generic testosterone supplements hope a 2011 U.S. Supreme Court decision is their ticket out of the testosterone multidistrict litigation pending in a Chicago federal court.

These generic drug manufacturers seek to shield themselves from liability under Pliva v. Mensing, in which the U.S. Supreme Court held that federal drug labeling laws preempt application of state tort laws. For makers of generic drugs, Pliva means they can avoid liability under state tort law as long as their labeling matches the FDA-required labeling for the name brand drug that their generic drug copies.

Plaintiffs’ attorneys are concerned that Pliva could eliminate many types of tort claims common to many pharmaceutical products liability lawsuits, especially failure to warn. The generic drug manufacturers in the testosterone product lawsuits argue that under Pliva all claims against them should be dismissed.

Testosterone Side Effects

Testosterone replacement therapy brings with it the threat of certain side effects, particularly affecting the cardiovascular and circulatory systems. Studies have found links between testosterone replacement and stroke, heart attack, pulmonary embolism, and deep vein thrombosis. Plaintiffs in the testosterone products lawsuits allege that the manufacturers failed to properly warn them of the risks of testosterone side effects.

Some plaintiffs are also bringing claims over alleged improper marketing campaign by Abbott and AbbVie. They allege those defendants promoted AndroGel for off-label use as a lifestyle drug.

In 2012, Abbott deployed a marketing campaign representing that symptoms such as decreased libido, depressed mood, or low energy could be associated with low testosterone, or “Low T.” The campaign encouraged consumers to ask their doctor about using AndroGel to treat those symptoms.

However, all of these symptoms tend to appear as part of the normal aging process, and testosterone itself naturally decreases with age. And the FDA has never approved AndroGel as a treatment for naturally-occurring decreases in testosterone.

The testosterone multidistrict litigation, or MDL, formally began in June 2014 when the federal Judicial Panel on Multidistrict Litigation ordered 45 lawsuits to be consolidated in the U.S. District Court for the Northern District of Illinois to be overseen by U.S. District Judge Matthew Kennelly. The federal court system frequently consolidates products liability lawsuits with common questions of fact into an MDL for the sake of efficient and consistent determination of relevant issues.

That initial group of testosterone lawsuits was filed against Abbott Laboratories and its affiliate AbbVie over their brand-name testosterone products AndroGel and AndroDerm. Since then, new plaintiffs have added their claims over both generic products and name-brands, and the number of federal testosterone product lawsuits has grown from a few dozen to over 1,500. Those involved say there could be several thousand more lawsuits filed.

The court plans to conduct a handful of bellwether trials on select cases to flesh out the major issues in ways that may apply to all other lawsuits. The court plans to conduct the first group of such trials between October 2016 and April 2017 addressing claims over Androgel. A separate set of trials over other testosterone products is planned for 2017.

The Testosterone MDL is In re: Testosterone Replacement Therapy Products Liability Litigation, MDL No. 2545, in the U.S. District Court for the Northern District of Illinois.