In recent years, testosterone replacement therapy (TRT) drugs have been at the center of many legal battles. Thousands of people sued drug companies, saying these products caused serious health problems like heart attacks, strokes, and other heart-related issues. These lawsuits also said that drug makers used improper marketing to convince men they had something called “Low T.”
More than 25,000 lawsuits were once active against major drugmakers like AbbVie Inc., Eli Lilly & Co., Pfizer Inc., and Endo International. They were grouped together in a multidistrict litigation (MDL) called “MDL-2545 IN RE: Testosterone Replacement Therapy Products Liability Litigation,” led by U.S. District Judge Matthew F. Kennelly in the Northern District of Illinois.
By October 2022, almost all these lawsuits had been settled or dismissed, leaving only 5 cases in Illinois federal court. This shows how most people’s claims were resolved over about eight years (2014–2022).
Core Allegations Against Manufacturers
The U.S. Food and Drug Administration (FDA) had approved testosterone drugs to treat hypogonadism, a condition where men have clinically low testosterone levels. However, many lawsuits claimed the companies marketed these drugs for off-label uses (not officially approved), pushing the idea of “Low T.”
According to these court papers, drugmakers used ads that linked normal aging symptoms (tiredness, lower sex drive, mood changes) with “low testosterone.”
The lawsuits say companies:
- Failed to warn people about serious heart risks.
- Pushed products beyond what the FDA allowed.
- Used deceptive ads that focused on benefits but hid risks.
- Created “disease awareness” campaigns to make men think they had “Low T.”
Products and Manufacturers in the Lawsuits
Although AndroGel by AbbVie got the most attention, many other products faced lawsuits too. Here is a list of the main testosterone products involved:
| Brand | Manufacturer(s) |
|---|---|
| AndroGel | AbbVie Inc.; Abbott Laboratories Inc.; AbbVie Products; Unimed; Solvay; Besins Inc.; Besins S.A. |
| Depo-Testosterone | Pfizer Inc.; Pharmacia & Upjohn Inc. |
| Foresta | Endo Pharmaceuticals |
| Delatestryl | Endo Pharmaceuticals |
| Testim | Auxilium Pharmaceuticals Inc.; GlaxoSmithKline; Endo Pharmaceuticals |
| Testopel | Auxilium Pharmaceuticals Inc.; Endo Pharmaceuticals |
| Striant | Auxilium Pharmaceuticals Inc.; Endo Pharmaceuticals |
| Androderm | Allergan; Actavis Inc.; Actavis Pharma Inc.; ALU; and Anda, Inc. |
AndroGel is a man-made testosterone gel that you put on your skin. It releases testosterone over 24 hours. Because it was so popular, AndroGel was at the heart of many lawsuits and large jury verdicts.
Health Risks and Scientific Evidence: Key Research Findings
Several studies pointed to heart risks tied to these drugs:
- A study by the National Cancer Institute showed older men (over 65) and younger men with heart disease doubled their chances of having a heart attack within three months of starting TRT, compared to the year before treatment. When they looked at men who used erectile dysfunction (ED) drugs like Viagra, those men did not have the same heart attack jump.
- Another study in the Journal of the American Medical Association reported that older men on TRT had a 29% increase in strokes, heart attacks, or death.
- A separate federally funded study was ended early after noticing more heart attacks and heart problems among men taking testosterone.
Alleged Health Risks
Lawsuits said testosterone could cause:
- Heart attacks (myocardial infarction)
- Strokes
- Blood clots (like pulmonary embolism or deep vein thrombosis)
- Congestive heart failure
- Sudden death (rarely)
The suits claimed drugmakers knew or should have known about these dangers but did not properly warn patients or doctors.
Major Verdicts and Settlements
AndroGel Verdicts and Settlement
Because AndroGel was so widely used, AbbVie faced the largest number of cases and some huge jury verdicts:
- One jury told AbbVie to pay $150 million in punitive damages in 2017.
- Another jury verdict reached $140 million, totaling $290 million from two trials.
- At least one verdict was later reduced after part of it was overturned.
By September 2018, AbbVie agreed to settle 4,200 AndroGel lawsuits (though the amount was not made public). Later, in June 2019, AbbVie’s settlement for AndroGel was said to be $775 million in total—one of the bigger drug-related settlements ever.
Other Manufacturer Settlements
- Eli Lilly settled about 400 Axiron lawsuits in 2017.
- Endo International and GlaxoSmithKline settled around 1,300 cases for about $200 million.
Depo-Testosterone Case Dismissals
Over 1,000 lawsuits targeting Pfizer’s Depo-Testosterone were dismissed in 2015 by Judge Kennelly and later upheld by an appeals court in February 2018. Pfizer always said those claims had no merit and stuck by its product.
FDA Label Changes (March 2025)
The FDA has continued to watch testosterone drugs and made new label changes in March 2025, especially after data from the phase 4 TRAVERSE trial and postmarket ABPM (ambulatory blood pressure monitoring) studies. Major updates include:
- New warning about increased blood pressure.
- Removal of the black box warning about heart attack and stroke risk, based on fresh trial results.
- Removal of the warning that men with heart disease are at higher risk of major adverse heart events (MACE).
These changes are very different from the FDA’s old stance in 2014 and 2015, when they warned about serious heart risks linked to testosterone.
Industry Response
Shalin Shah, CEO of Marius Pharmaceuticals, said the old black box warning frightened people away from a treatment that might help their health. He believes removing the warning will let doctors and patients talk about the true benefits and risks of testosterone.
Additional Legal Background (Cases and Claims)
Testosterone replacement therapy (TRT) drugs have been sued over claims of heart attacks, strokes, and other problems. These cases went to MDL proceedings in the Northern District of Illinois under “In re: Testosterone Replacement Therapy Products Liability Litigation” (MDL 2545). People said the companies failed to warn patients about dangers, breaking state product-liability laws. (See Guilbeau v. Pfizer Inc., 880 F.3d 304, Med. Mut. of Ohio v. Abbvie Inc. (In re Testosterone Replacement Therapy Prods. Liab. Litig. Coordinated Pretrial Proceedings), 159 F. Supp. 3d 898, In re Testosterone Replacement Therapy Prods. Liab. Litig., 136 F. Supp. 3d 968.)
In one well-known case, a court threw out failure-to-warn claims against the maker of Depo-T, saying it was federally preempted (the company couldn’t change its label on its own). The appeals court agreed (Guilbeau v. Pfizer Inc., 880 F.3d 304).
Many claims involved fraudulent marketing—drug makers were accused of unbranded ads pushing the idea of “Low T” and making it seem super common. This allegedly caused economic harm to health insurance groups (Med. Mut. of Ohio v. Abbvie Inc., 159 F. Supp. 3d 898).
In antitrust news, AbbVie Inc. and its partners were found guilty of filing “sham patent lawsuits” to block cheaper versions of AndroGel. They had to pay $448 million (see FTC v. AbbVie Inc., 976 F.3d 327, and “AbbVie, Besins Owe $448M In FTC Androgel Antitrust Case”).
Overall, these cases show many legal challenges for TRT makers, touching on product liability, marketing, and antitrust. The outcomes matter for drug companies and for patients alike, reminding everyone of the need for clear warnings and honest marketing.
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The testosterone replacement therapy litigation has been one of the biggest and most complicated mass tort cases in recent years. Starting with 25,000+ lawsuits and now down to only a handful left in federal court, it has changed how drug companies market and warn about testosterone treatments.
AbbVie alone paid $775 million to resolve many claims. The lawsuits brought huge attention to how drug companies advertise off-label uses and how they handle patient safety.
The FDA’s newer label changes mark a new chapter in the TRT story, reducing some heart warnings but keeping notices about high blood pressure. Because science keeps changing, doctors and patients must stay informed, use TRT only for correct medical reasons, and keep an eye out for side effects.
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