Low T Drug Lawsuits Centralized as One MDL in Illinois Federal Court

A panel of federal judges has ordered all product liability lawsuits filed in U.S. District Courts nationwide involving injuries associated with the use of any testosterone replacement therapy (TRT) will be centralized before one judge in the Northern District of Illinois as part of an MDL, or multidistrict litigation.

Following oral arguments late last month, the U.S. Judicial Panel on Multidistrict Litigation (JPML) issued an order (PDF) today, which transfers cases involving any “Low T” drugs to U.S. District Judge Matthew F. Kennelly for coordinated handling during pretrial proceedings.

The ruling affects at least 45 lawsuits filed against the makers of AndroGel, Axiron, Testim, Foresta, AndroDerm and Depo-Testosterone. However, any future cases filed involving any testosterone gel, cream, injectiom or other prescription treatment will also be transferred to the MDL.

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Since all of the low T drug lawsuits involve common allegations that the medications caused plaintiffs suffer heart attacks, strokes, blood clots and other cardiovascular injuries, the Panel decided to centralize the entire litigation to reduce the risk of duplicative discovery, avoid conflicting rulings from different judges and to serve the convenience of the parties, witnesses and the courts.

Industry-Wide Consolidation

While most of the complaints filed so far have involved problems associated with the use of AndroGel, which is the most widely used testosterone treatment, a number of the lawsuits have been filed against the makers of competing low T drugs, including Axiron, Testim, AndroDerm, Depo-Testosterone and others.

The panel of judges heard various proposals regarding how the mounting lawsuits over low T drugs should be managed during a hearing on May 29.While some plaintiffs and many of the defendants called for all of the testosterone cases to be centralized as part of one proceeding, other proposals called for only AndroGel lawsuits or cases involving testosterone gels to be included in the MDL.

“We are typically hesitant to centralize litigation on an industry-wide basis,” the panel of federal judges wrote in the order issued June 6. “In these circumstances, however, we think it is the best solution. Plaintiffs suggest that related cases will number in the thousands. Significantly, in the actions and potential tag-along actions already filed, a number of plaintiffs used more than one testosterone replacement therapy.”

The Panel noted that all of the lawsuits involve common factual questions regarding general causation and the background science regarding the role of testosterone in the aging body.

Common regulatory issues will also impact all of the different medications, according to the Panel, as most of the lawsuits have been filed in the wake of an FDA announcement issued on January 31, which indicated that the agency was reviewing the risk of stroke, heart attack and death among men taking any FDA-approved testosterone drugs.

The FDA investigation was launched following several studies published in recent months involving the link between low T 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.

As product liability lawyers continue to review and file new cases over the coming months and years, it is ultimately expected that several thousand cases will be included in the Low T drug litigation.


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