Testosterone Replacement Therapy Lawsuits

Testosterone replacement therapy (TRT) is used to treated male hypogonadism (otherwise known as low T or low testosterone). Some of the TRT products used to treat the condition have been subject to recent controversy, with patients filing lawsuits against the manufacturers alleging that they were at increased risk of heart attack, stroke, blood clots, deep vein thrombosis (DVT), pulmonary embolism, and even death. To date, around 6,000 cases are pending multidistrict litigation.

The lawsuits allege that the manufacturers of these products:

• Exaggerated their benefits
• Understated and omitted, or failed to adequately warn patients and doctors about, the risks associated with the products and the necessary monitoring that was required to ensure patient safety
• Engaged in aggressive marketing and advertising campaigns both direct to consumer and physicians
• Engaged in aggressive unbranded disease awareness campaigns to alert men that they may be suffering from low T
• Have engaged in “disease-mongering” in order to increase sales for these products when they may not be medically indicated
• Made false representations about the safety and efficacy of TRT products

In fact, the FDA has not approved any TRT product as a treatment for low T. Actually, many in the medical community do not recognize low T as a disease, but rather as a normal result of the aging process.

Anyone who used TRT products and suffered adverse effects may be able to file suit. Surviving spouses and relatives of patients who took TRT and suffered sudden death may also be able to claim.

Lawsuits have been filed against the manufacturers of at least nine TRT products, including:

• AndroGel (AbbVie Inc.; Abbott Laboratories Inc.; AbbVie Products; Unimed; Solvay; Besins Inc.; Besins S.A.)
• Axiron (Eli Lilly and Company, Lilly USA)
• Fortesta (Endo Pharmaceuticals)
• Testim (Auxilium Pharmaceuticals Inc.; GlaxoSmithKline; Endo Pharmaceuticals)
• Testopel and Striant (Auxilium Pharmaceuticals Inc.; Endo Pharmaceuticals)
• Androderm (Actavis Inc., Actavis Pharma Inc., ALU, and Anda, Inc.)

TRT Litigation

Early in 2014, the FDA issued warnings about the severe risks associated with TRT.

Later in 2014, the lawsuits have been consolidated into a multidistrict litigation (MDL) in November 2015. MDL involves consolidating cases with similar legal issues to one court, where a judge familiar with the technical details of the case can rule on the them. Lawsuits from four districts were transferred to the Northern District of Illinois, where District Judge Matthew F. Kennelly will preside over the MDL (no. 2545).

To date, more than 7,500 lawsuits have been filed against TRT manufacturers, but only a few have gone to trial in the bellwether phase. Bellwether trials, otherwise known as test trials, assist both legal parties to determine the strength of their case. The result could impact how other cases within the MDL proceed.

The first bellwether trial ended in a mistrial when an attorney was taken ill; in the second,  AbbVie was ordered to pay $150 million to a man who used Androgel and had a heart attack (later thrown out by an Illinois judge in December 2017); and the third resulted in AbbVie being ordered to pay $140 million to another man who used AndroGel and had a heart attack. In one case, a jury ruled in favor of Endo International. The final case commenced January 2018.

Auxilium Pharmaceuticals and Eli Lilly and Company have reached hundreds of settlements.