US District Judge Matthew F. Kennelly has set June 5, 2017, for the start of first of six AbbVie bellwether trials in MDL 2545, in the Testosterone Replacement Therapy Products Liability Litigation in the Northern District of Illinois.
Discovery deadlines start in September for more than 5,500 cases currently pending. All the actions involve plaintiffs (or their survivors) who used one or more testosterone replacement therapies and contend that their (or their decedent’s) use of the drugs caused their injuries, which include:
- heart attack
- deep vein thrombosis
- pulmonary embolism
On January 31, 2014, the U.S. Food and Drug Administration announced that it was “investigating the risk of stroke, heart attack, and death in men taking FDA-approved testosterone products.” Plaintiffs filed the actions in the wake of this announcement.
In March 2015, the FDA issued a safety communication, cautioning men against taking testosterone products for low testosterone levels associated with aging. The agency also required companies manufacturing these drugs to change their labels to clarify the appropriate usages for their products. Manufacturers were also required to add warnings about the risks of heart attack and stroke associated with taking these drugs.
All testosterone replacement therapy actions share factual questions about general causation and the background science regarding the role of testosterone in the aging body, as well as involve common regulatory issues in light of the FDA’s announcement and subsequent actions, if any.
The hormone has been used off-label to treat a range of symptoms such as loss of energy, decreased muscle mass and reduced libido.
The defendants include:
- AbbVie Inc. and Abbott Laboratories Inc. (collectively Abbot)
- Eli Lilly and Co. and Lilly USA LLC
- Endo Pharmaceuticals
- Actavis, Inc.
- Auxilium Pharmaceuticals, Inc.
- Pfizer, Inc.
All of these cases involve Androgel, a testosterone drug manufactured by AbbVie.
The first case, which is slated to begin July 2017, was filed by Jeffrey Konrad. Konrad claims he suffered a myocardial infarction after taking Androgel. The order of the remaining cases will be determined at a later date. Once these trials are completed, Judge Kennelly is expected to select a second group of bellwether trials that will include Axiron, Testim, Androderm and other testosterone products.