The US District Court for the Northern District of Illinois selected two cases as Lilly Bellwether Trial cases in In re Testosterone Replacement Therapy Product Liability Litigation, MDL 2545.
There are 6,090 lawsuits over testosterone replacement treatments against Eli Lilly and other drug companies before US District Judge Matthew F. Kennelly in the multidistrict litigation docket. Lilly makes Axiron testosterone topical solution.
The cases set for trial are:
- Plaintiff Tracy Garner who suffered a myocardial infarction, Case No 1:15-cv-02045
- Plaintiff John Debroka, Jr., who suffered a deep vein thrombosis, Case No. 1:15-cv-09246
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 proper 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 about 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.