Testosterone replacement therapy users have been filing product liability lawsuits against testosterone product manufacturers at increasing rates, taking issue with certain low-t drugs such as AndroGel, Androderm, Axiron, and Testim.

There are currently about 2,000 low testosterone lawsuits still pending in the U.S. District Court, Northern District of Illinois. Most of these are filed against AbbVie and Abbott Laboratories, the manufacturers of AndroGel.

The first round of testosterone product trials involve only AndroGel lawsuits. These lawsuits are considered bellwether trials, or typically representative cases of the majority that the court and the various parties use in order to give a good indication of the likely results of future related trials.

Low-T Drug Makers Want Cases Dismissed

AbbVie, a division of Abbott Laboratories, is looking to have many of these testosterone product lawsuits dismissed. The manufacturers filed a motion stating that the plaintiffs’ fact sheet for the first round of trials was incomplete, missing information such as physician and pharmacy names.

AbbVie further stated that the authorizations which would allow them to collect any additional medical records were left incomplete. AbbVie used this incomplete fact sheet to warn plaintiffs to either provide the missing information before the hearing on Aug. 14, or they would ask the Court to dismiss these cases with prejudice.

Plaintiffs respond, however, that AbbVie is likely using the incomplete fact sheet as an excuse to undermine the process of the testosterone bellwether trials rather than to actually gather necessary information.

About AndroGel

AndroGel was created, developed, and marketed by AbbVie and Abbott Laboratories. It was approved by the United States Food and Drug Administration (FDA) in 2000 to treat low testosterone (hypogonadism) which sometimes occurs as a result of various underlying medical conditions.

AndroGel is the most popular of available prescription testosterone therapy drugs. AndroGel accounts for at least three quarters of the market for prescription low-t drugs, and their ad campaign made $1.4 billion in sales during 2013.

FDA Issues Testosterone Product Warning

In January 2014, the FDA launched an investigation into FDA-approved prescription testosterone gels, patches, creams, and injections, later issuing a safety warning that stated such testosterone products should be approved only for those men who have low testosterone levels due to certain medical conditions.

This announcement was issued in March 2015 after substantial research and investigation. The FDA stated that the safety of testosterone medications, as well as the benefits, have not been established with regards to the treatment of testosterone levels due to aging.

After the investigation, the FDA further required testosterone manufacturers such as AbbVie to update the labels on their products to fully and adequately warn consumers of the potential risk of heart attack or stroke in patients.

Testosterone Product Lawsuits

Many testosterone replacement therapy product lawsuits allege such complications as heart attack, stroke, and in some cases, death. Plaintiffs in these low-t drug lawsuits claim that manufacturers of testosterone products failed to disclose the potential risks linked with their drugs, despite the FDA’s conclusions after their investigation and the subsequent warnings.

If you or someone you know has taken low testosterone treatment and feel you were not adequately warned about the potential risks, you may be able to join a testosterone product lawsuit.