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Testosterone MDL Expands, Parties Working on Bellwether Trial Selection

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The U.S. Judicial Panel on Multidistrict Litigation (JPML) centralized all federal testosterone replacement therapy lawsuits in the Northern District of Illinois in June 2014. District Judge Matthew Kennelly was appointed to oversee the proceedings.

Today, there are about 1,100 cases pending in the MDL, with over 700 involving claims against AbbVie, the manufacturers of AndroGel. Plaintiffs involved in litigation have similar claims about testosterone replacement drugs, stating that after taking them, they suffered some sort of cardiovascular event, including heart attacks and strokes.

They add that the manufacturers didn’t do enough to warn doctors and the public about the potential risks, and that their advertisements for the products way overstated the benefits while concealing the potential side effects.

Will the Date of the First Testosterone Bellwether Trial be Postponed?

In a motion filed by the defendant on February 18, 2015, AbbVie requested the court set a new, later deadline on plaintiff fact sheets (PFSs), since delays have resulted in less than 10 percent of cases with sufficient sheets available for medical record collection and review. They also requested that each plaintiff have 60 days to provide a completed PFS to the defendants.

As the number of cases in the MDL continues to increase, the previous dates for the bellwether trials may be pushed back. They were initially scheduled to begin in October 2016. AbbVie and plaintiffs were originally ordered to come up with a list of potential cases by July 2015, with bellwether discovery to begin November 1, 2015, but with the delays in gathering PFSs and the expansion of the litigation, that date may no longer be feasible.

A case management conference for the MDL took place on February 20, 2015, during which the parties were scheduled to discuss important developments, including the motion filed by AbbVie.

Other Defendants On a Separate, Later Bellwether Track

AbbVie isn’t the only defendant in the testosterone MDL, but because they are named in the majority of cases, they will be the ones involved in the bellwether trials. Other products named in other cases include Axiron, Testim, AndroDerm, Depo-Testosterone, Delatestryl, and Fortesta.

For these other products, Judge Kennelly has established a second bellwether track scheduled to begin in mid-2017. Early trials can help gauge how juries will react to the evidence, and can sometimes set the stage for settlement negotiations. If the parties do succeed in eventually negotiating settlements, it can help to facilitate a faster resolution, as it cuts down on the need for additional trials.

FDA Warns of Testosterone Risks

Testosterone replacement therapy lawsuits increased after a January 2014 announcement by the FDA. In a safety communication, the administration stated it was investigating the risk of stroke, heart attack, and death in men taking testosterone products. They decided to undertake the investigation after two scientific studies found a link between the drugs and risk of cardiovascular problems.

In September 2014, an FDA advisory panel voted to change the labeling for testosterone drugs, with the goal of alerting consumers to the risks, and of reducing the amount of prescriptions written for “lifestyle” symptoms like fatigue and low libido, rather than for the FDA-approved diagnosis of hypogonadism caused by a medical condition.