Testosterone Medication Lawsuits Continue to Move Forward As Number of Cases Grow

There are currently more than 2,700 testosterone lawsuits moving forward through the federal court system, each involving claims by men who allege that the popular hormone replacement medicines caused them to suffer a heart attack, stroke, pulmonary embolism, deep vein thrombosis or other injury.

Since June 2014, all complaints filed throughout the federal court system over the alleged side effects of testosterone medications have been centralized for coordinated pretrial proceedings before U.S. District Judge Matthew Kennelly in the Northern District of Illinois, as part of an MDL or multidistrict litigation.

Given the similar claims raised in the lawsuits, the cases are consolidated for discovery, pretrial motions and a series of “bellwether” trials that are expected to begin next year to help the parties gauge how juries may respond to certain evidence and testimony that is likely to be repeated throughout the litigation.

Following a status conference last week, Judge Kennelly issued a case management order (PDF) on October 21, calling for the makers of Androgel, which is the most widely used testosterone medicine, to produce certain documents that include safety information on other testosterone products, even if they were never commercialized. The order also calls on AbbVie to provide reports for any clinical trials it conducted on other testosterone medications.

As a growing number of Androgel lawsuits, Testim lawsuits, Axiron lawsuits and other complaints are filed against the manufacturers of different testosterone drugs, Judge Kennelly issued a separate case management order (PDF) this week, updating the process for plaintiffs to request a waiver of service of process for new complaints filed.

According to the latest case list (PDF) released by the U.S. JPML, there are now at least 2,708 complaints centralized before Judge Kennelly. However, as testosterone injury lawyers continue to review and file complaints on behalf of men who have experienced problems, the size of the litigation is expected to grow further in the coming months and years.

Concerns Over Safety of Testosterone Medicines

The testosterone litigation has emerged since the FDA warned in early 2014 that it was investigating a potential reviewing the cardiovascular risks among men taking any of the approved medications marketed for treatment of low testosterone.

The FDA review was launched after several studies published identified a link between low 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.

As part of the coordinated proceedings before Judge Kennelly, it is expected that a series of six Androgel trials will go before juries between October 2016 and April 2017, to help the parties gauge how juries may respond to certain evidence and testimony that is likely to be repeated throughout the litigation. After those trials against AbbVie, it is expected that a second series of bellwether trials will be scheduled involving individuals who used other testosterone replacement therapy products.

While the outcomes of these trials will not be binding on other cases in litigation, they will be closely watched by lawyers involved in the lawsuits, and may influence eventual testosterone medicine settlements for men who have suffered cardiovascular injuries, blood clots or other side effects.