Testosterone Lawsuits: The Hits Just Keep On Coming

Chicago, ILThe march through the courts with regard to testosterone side effects continues, while the US Food and Drug Administration (FDA) issued an order granting a manufacturer of a generic testosterone gel a therapeutic equivalency to a non-generic product already on the market.

With regard to the latter, Perrigo Co. had put the wheels in motion for a lawsuit against the federal drug regulator over the issue. Perrigo manufacturers a generic that mirrors AndroGel, a popular testosterone supplement manufactured by AbbVie. Specifically, Perrigo had sought a declaratory judgment that the FDA’s alleged failure to publish constituted an agency action that “unlawfully held and unreasonably delayed.”

However, the legal challenge was withdrawn when the FDA issued an order in response to citizen petitions. Individual patients as well as health plans prefer generics over the more expensive brand-name products. It is unclear whether the FDA was responding solely to citizen petitions or if the regulator was attempting to diffuse the legal challenge brought by Perrigo.

Nonetheless, the FDA issued its order July 24, holding that “the Perrigo topical testosterone gel product and AndroGel 1 percent can be expected to have the same clinical effect and safety profile when administered to patients under the conditions specified in the labeling,” the FDA said.

Will increased availability of testosterone generics foster a heightened demand and use for testosterone gel products? And if this is the case, will we be seeing more lawsuits alleging serious testosterone side effects?

Two recent lawsuits allege just that, with one plaintiff suffering a testosterone stroke. Another was felled in a testosterone death.

With the latter, court documents show that David R. Young employed the use of brand-name AndroGel until April 21, 2012, when he died from a sudden testosterone heart attack. A side effect of testosterone is an over-production of red blood cells, which can lead to thickening of the blood and blood clots. In their testosterone lawsuit, brought by Young’s widow Lesa M. Young on behalf of her late husband’s estate (Cook County Circuit Court Case No. 2014L004407), the deceased had no history of heart problems, cardiovascular issues or experience with blood clotting prior to his use of testosterone gel.

Another testosterone lawsuit (Cook County Circuit Court Case No. 2014L005860) was filed June 3 of this year, alleging testosterone stroke. Plaintiff Richard A. Martin cited product liability in his action against AbbVie Inc. In court records, Martin claims he suffered a stroke January 11 of this year following use of AndroGel. He accuses the manufacturer of failure to warn, negligence and breach of implied warranty - as well as other claims.