Increasing Testosterone Therapy Litigation

Use of testosterone therapy has increased fivefold from 2000-2011. More than 5 million men were prescribed testosterone therapy in 2011. Those who have experienced injuries have filed lawsuits against multiple manufacturers of testosterone drugs as Androgel, Testim and Axiron. Those injured claim that they were not properly warned of the potential risks associated with testosterone therapy.

Thousands of men have experienced undisclosed side effects resulting from their use of testosterone that was prescribed to them. Two studies that investigated the effects of testosterone therapy indicated an increased risk of myocardial infarction (heart attack) associated with testosterone therapy in men. Other studies showed that testosterone therapy was related to adverse heart conditions such as ischemic stroke, heart attacks, and even death.

As a result of these studies, on January 31, 2014, the U.S. Food and Drug Administration issued a safety announcement surrounding potential risks associated with testosterone therapy. They announced that further investigation would follow.

On June 20, 2014, the FDA issued a post-market update of the approved uses of testosterone therapy drugs. This update approved testosterone therapy drugs for men who suffer from specific medical conditions which limit the amount of testosterone produced naturally These conditions include failure of testicles to produce testosterone due to genetic problems or chemotherapy, and hypothalamus and pituitary issue that control the production of testosterone by the testicles. The FDA explicitly rejected the use of testosterone for all other low testosterone related conditions.

The plaintiffs in the recently filed action allege that the manufacturers understated the risks associated with testosterone use; and used misleading marketing tactics. On February 4, 2014, the first testosterone therapy lawsuit was filed in the US District Court for the Northern District of Illinois Eastern Division. By June 2014 the U.S. Judicial Panel on Multidistrict Litigation (JPML) created a multidistrict litigation for testosterone litigation which affected at least 45 current lawsuits. Any subsequent cases involving testosterone therapy, not manufacturer specific, will be transferred to the multidistrict litigation.

Coordinated pretrial hearings have begun in the Northern District of Illinois with Judge Matthew F. Kennelly presiding. Discovery has begun and any documents that could reveal trade secrets will be sealed to protect the manufacturers. While there are currently over 200 cases that are part of the MDL, it is speculated that considerably more testosterone lawsuits will arise.

Parties on both sides are proposing strikingly different timelines for the trials. Those representing the plaintiffs have proposed June 2016. In the interest of judicial efficiency, expenses, and time, plaintiffs are encouraging Judge Kennelly to defer to their less length timeline so that unnecessary delays and burdens are not experienced.

Attorneys for the drug manufacturers would like to delay the prosecution of these cases until late 2017. They suggest that there is insufficient scientific evidence that can causally link testosterone and adverse heart complications. Because of this, they are requesting that Judge Kennelly address this causation issue first.

There will likely be a group of cases selected for a bellwether trial to assess how juries may respond to certain evidence and what testimony is likely to be offered. These outcomes are not binding on the other cases, but they may assist in future settlements. Discovery for the bellwether cases is expected to begin in April 2015.

Alexandra Bhatti, student intern Jacoby & Meyers, LLC.