Patients filed testosterone lawsuits claiming the manufacturer failed to warn them of severe side effects like blood clots, stroke, pulmonary embolism, heart disease and prostate cancer. Manufacturers faced more than 7,800 lawsuits, paying $200 million in settlements thus far, with thousands more pending.
Why Are People Filing Testosterone Lawsuits?
Thousands of men have filed testosterone lawsuits against manufacturers like AbbVie, Allergan, and Endo Pharmaceuticals because of harmful side effects. Lawsuit claims against testosterone replacement therapy (TRT) products - which are often prescribed to treat low testosterone levels ("Low-T") in men - include an increased risk of blood clots, stroke, pulmonary embolism, heart disease, and prostate cancer, among other potentially deadly complications.
The claims range from design defects and failure to warn about the potentially dangerous complications testosterone could cause, to negligence and breach of warranty, both express and implied. Other claims include false marketing efforts, such as marketing testosterone treatments for off-label uses not approved by the U.S. Food and Drug Administration (FDA). Specific claims were made in each individual lawsuit, as various people have experienced different problems with testosterone therapy.
Testosterone Products and Companies Being Sued
AndroGel testosterone lawsuits have been extremely high-profile, given the large number of cases filed against AbbVie Inc., a division of Abbott Laboratories. However, a number of other products and companies have also found themselves at the heart of legal claims. Companies like Endo Pharmaceuticals, GlaxoSmithKline, Actavis, and Eli Lilly and Company have all been named as defendants in these suits. Some of the TRT products under litigation are no longer available on the market.
Companies & Products Named in Testosterone Lawsuits
|AbbVie (Abbott Industries)||AndroGel|
|Eli Lilly and Company||Axiron|
|Endo Pharmaceuticals / Auxilium||
Testosterone Class Actions and MDLs
While testosterone lawsuits have been filed in many states, most of those lawsuits were transferred to the U.S. District Court in the District of Northern Illinois to participate in multidistrict litigation (MDL) proceedings. The MDL process lets plaintiffs file individual lawsuits, allowing them to seek damages related to their personal experience.
MDL No. 2545 In re: Testosterone Replacement Therapy Products Liability Litigation is overseen by Judge Matthew F. Kennelly. The first lawsuits were filed in 2014, and bellwether trials began in late 2017 and early 2018. Several bellwether trials were completed in 2018, and most cases have been thrown out or settled since then. The remaining cases have announced plans to settle but have not yet reached a final agreement.
Testosterone Lawsuit Settlement Amounts and Verdicts
In May 2018, a court rendered the first testosterone-related verdict in an Androgel lawsuit. In that trial, the federal jury ordered AbbVie to pay $3.2 million to a Chicago man who suffered a heart attack after using the testosterone replacement therapy. A separate jury had previously awarded the same defendant, Jesse Mitchell, more than $150 million in punitive and compensatory damages, but that initial verdict was overturned and the case was sent back for a second trial.
To date, major TRT companies have agreed to settlements as follows:
- Pfizer: In 2015, a federal judge granted Pfizer's motion for dismissal of the 1,000 cases filed against them. Their version of testosterone was a generic, meaning federal law prohibited them from making any changes to the drug label and warnings. As such, the court found that they could not be held liable for failure to warn.
- Eli Lilly: In December 2017, Eli Lilly announced a global settlement to resolve all testosterone cases against it worldwide, before its first case had gone to trial.
- Auxilium, Endo & GlaxoSmithKline: In February 2018, Auxilium Pharmaceuticals, Endo Pharmaceuticals and GlaxoSmithKline announced a settlement to resolve outstanding testosterone lawsuits against them.
- Endo Pharmaceuticals: In June 2018, Endo announced a master settlement agreement in their testosterone cases. Though they did not publicly disclose the total amount, they did increase their legal reserves to $200 million to cover the agreement.
- Actavis Inc.: In July 2018, Actavis reached a settlement for lawsuits related to their testosterone drug Androderm but did not disclose the total amount.
- Abbvie Inc.: In September 2018, the last of the large TRT manufacturers announced a master settlement in the remaining testosterone lawsuits. Judge Kelly executed a stay of proceedings for all Abbvie testosterone lawsuits to allow involved parties to focus on finalizing the settlement agreement, though it had not been finalized as of early 2019.
Since legal proceedings began, many of the manufacturers facing litigation have added additional warnings to their drug labels. Abbvie, for instance, lists an increased risk of heart attack, pulmonary embolism, and stroke on its new AndroGel label. It is unlikely that new lawsuits will be filed over the side effects now listed on TRT drug labels.