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The treatment of low testosterone (also known as hypogonadism or Low-T) in men has increased significantly since the year 2000. However, with the growth of such testosterone replacement therapy, there has also been an increase in the number of studies that have shown a link to various medical problems, such as the increased risk of heart attacks, strokes and other potentially deadly outcomes.
As a result, the FDA has issued several statements on the use of testosterone therapy, and a number of lawsuits have been filed claiming that treatments to combat low testosterone have resulted in harm to the patient or even fatalities.
FDA Investigates Testosterone Treatments
Although the FDA has not issued any recalls of testosterone due to the possibly dangerous nature of various treatments, early in 2014 the agency published an alert stating that it was going to begin investigating the potentially adverse outcomes of testosterone supplements. Specifically, the FDA denied any conclusions related to increased probability of heart attacks, strokes or death in men undergoing testosterone replacement therapy. However, the agency said that would analyze data from multiple studies and monitor side effects of testosterone treatments as reported through its MedWatch program. The FDA also advised patients and physicians to understand both the risks and the benefits of drugs and supplements before beginning any treatment. 1
In June 2014, the FDA announced that it manufacturers of testosterone would be required to add a warning label to their products indicating the possible formation of blood clots in patients’ veins. The agency stressed that this requirement was unrelated to the separate investigation into the other health problems that may be associated with testosterone use. 2
The FDA has scheduled a multi-committee meeting for mid-September 2014 related to a new oral testosterone tablet. 3
Testosterone Lawsuits and MDL
Because of the large number of cases related to testosterone products, and the even larger number of potential future case that could expand into the thousands, the United States Judicial Panel on Multidistrict Litigation has created MDL No. 2545 to handle actions related to testosterone products.
As a result of the potentially dangerous consequences of taking various low-testosterone treatments — which are available as topical gels, transdermal patches, buccal systems, subcutaneous pellets and injections — a significant number of lawsuits have been filed against manufacturers of testosterone products.
Because of the large number of cases related to testosterone products, and the even larger number of potential future case that could expand into the thousands, the United States Judicial Panel on Multidistrict Litigation has created MDL No. 2545 to handle actions related to testosterone products. In the original order, the panel noted its hesitancy to encompass an entire industry with a broad range of products under a single MDL. However, the panel members acknowledged that even among different products and across competing companies, many of the claims associated with the testosterone cases have common discovery, and thus are suitable for MDL status.
At the time of the original order on June 6, 2014, forty-five cases across four districts were pending. Since then, additional cases have been added. 4
Testosterone Manufacturers Facing Lawsuits
The following table lists companies that have faced lawsuits related to their testosterone treatments, along with the names of some commonly known testosterone products they have developed. Other companies also may have faced litigation for their testosterone products.
|AbbVie Inc./Abbott Laboratories Inc.||AndroGel|
|Eli Lilly and Co./Lilly USA LLC||Axiron|
|Endo Pharmaceuticals||Aveed, Delatestryl, Fortesta|
|Actavis, Inc.||ANDA, LibiGel, Testosterone Enanthate Injection USP, Testosterone Cypionate Injection USP, AndroDerm|
|Auxilium Pharmaceuticals, Inc.||Testim, Testosterone Gel CIII, Testopel, Striant|
|Pfizer, Inc./Pharmacia & Upjohn Co.||Depo-Testosteroneh, Depo-Testadiol|
- U.S. Food and Drug Administration. FDA Drug Safety Communication: FDA evaluating risk of stroke, heart attack and death with FDA-approved testosterone products. (Jan. 31, 2014). Accessed July 28, 2014.
- U.S. Food and Drug Safety Administration. FDA adding general warning to testosterone products about potential for venous blood clots. (June 19, 2014). Accessed July 31, 2014.
- U.S. Food and Drug Administration. September 18, 2014: Joint Meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee Meeting Announcement. (July 22, 2014). Accessed July 31, 2014.
- U.S. Judicial Panel on Multidistrict Litigation, In Re: AndroGel Products Liability Litigation – Transfer Order. MDL No. 2545. (June 6, 2014). Accessed July 31, 2014.