Low Testosterone Drug Litigation Moves Through Early Stages

The U.S. District Judge presiding over all federal Androgel lawsuits, Testim lawsuits, Axiron lawsuits and other claims involving side effects of low testosterone treatments, met with attorneys for both sides this week to map out the process for moving the cases forward during the early stages of the litigation.

Since June, all low testosterone drug lawsuits filed in U.S. District Courts throughout the country have been consolidated as part of a federal multidistrict litigation (MDL), which is centralized before U.S. District Judge Matthew F. Kennelly in the Eastern District of Illinois.

All of the complaints involves similar allegations that plaintiffs suffered a heart attack, stroke, deep vein thrombosis, pulmonary embolism or other serious injury after using a prescription medication for low testosterone levels.

According to an update (PDF) released by the U.S. Judicial Panel on Multidistrict Litigation (JPML) on September 15, there are already 201 cases consolidated before Judge Kennelly in the MDL, which includes claims involving all testosterone drugs, regardless of the specific medication or manufacturer involved.

Centralization of the cases before one judge for coordinated pretrial proceedings is designed to reduce duplicative discovery into common issues across hundreds of claims, to avoid conflicting rulings from different courts and to serve the convenience of witnesses, parties and the courts.

As part of the early organization for the litigation, the parties met with Judge Kennelly on September 23.

According to minutes (PDF) released by the Court Clerk, the parties advised Judge Kennelly that they are hopeful of reaching a mutual agreement regarding the form for a plaintiffs’ fact sheet to facilitate exchange of information about each specific case, and for a document preservation order.

The parties were directed to submit a proposed order, indicating that if agreements are not reached, the matters will be addressed at the next status conference scheduled for October 24. Future case management conferences are also set for December 8 and January 12, 2015.

Low T Drug Lawsuits

The low testosterone drug litigation remains in the very early stages, with nearly all of the cases filed over the past nine months, following the publication of a series of studies and an FDA investigation launched into the link between testosterone drugs and heart risks.

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.

The FDA launched its own testosterone investigation shortly afterwards. indicating that the agency is reviewing the cardiovascular risks among men taking any approved testosterone drugs.

Earlier this month, the agency convened two advisory committees to evaluate the testosterone drug heart risks. The panels voted 20-to-1 to recommend that drug manufacturers be forced to conduct clinical trials, at the risk of civil penalties, to determine the heart attack risks of testosterone drugs.

The panels also called for label changes that would help reduce testosterone drug use by men suffering from age-related low T levels and would return the drug’s focus on men with hypogonadism caused by injury or disease affecting the testicles or certain parts of the brain.

As testosterone drug lawyers continue to review and file new cases, it is ultimately expected that several thousand lawsuits will be filed by individuals throughout the country.

Judge Kennelly will likely establish a “bellwether” plan as part of the testosterone MDL, where a small group of cases will be selected for early trial dates.

While the outcomes of these cases are not binding in other lawsuits, they are typically used to help the parties gauge how juries may respond to evidence and testimony that may be repeated throughout the litigation. The process may also influence eventual testosterone settlement negotiations with the various manufacturers.