A Florida couple is adding their testosterone lawsuit to the multidistrict litigation over the side effects associated with testosterone replacement therapy.

Plaintiffs Marcy and Robert W. allege that Robert began using testosterone products – specifically, AndroGel and Axiron – in June 2009. He kept using them until August 2012, when he suffered a cerebrovascular accident, commonly known as a stroke.

The resulting brain damage left Robert in a wheelchair for 14 months, the testosterone lawsuit says. His stroke had left him with not just physical impairment but also brain damage and memory loss. The plaintiffs allege Robert was forced into early retirement from his family business, losing substantial amounts of income.

Marcy, Robert’s wife, is bringing her own claim for loss of consortium. Loss of consortium is a type of claim that a relative (often the spouse) of an injured person can bring based on the effect that injury has on their relationship. A successful loss of consortium claim can yield compensation for the loss of companionship, emotional support, sexual relations, and possibly other losses, depending on the jurisdiction.

The Testosterone Lawsuit is Case no. 1:16-CV-02488, filed in the U.S. District Court for the Northern District of Illinois.

The Testosterone Lawsuit MDL

This testosterone lawsuit is one of over 1,000 similar cases combined into a single multidistrict litigation, or MDL, under the supervision of U.S. District Judge Matthew F. Kennelly. These cases have been consolidated so that discovery and other pretrial proceedings can be conducted more efficiently.

Plaintiffs in these testosterone lawsuits claim they suffered unexpected side effects after using testosterone products like Androgel and Axiron. Many of these plaintiffs suffered cardiovascular conditions like heart attack or stroke – potentially leading to brain damage, as in Robert’s case.

Plaintiffs typically claim that manufacturers like AbbVie or Eli Lilly failed to properly warn them of the possibility of cardiovascular side effects associated with testosterone products.

The plaintiffs also allege some manufacturers over-promoted their testosterone replacement products as treatments for a condition they called “Low T” — a term that refers not to any actual medical condition but only to the normal symptoms of the decline in testosterone that naturally occurs with age.

The FDA has approved testosterone products for the treatment of hypogonadism associated with certain medical conditions. But the agency has not evaluated the products safety or effectiveness when applied to a normal decrease in testosterone.

Promoting testosterone products for a use other than those approved by the FDA runs afoul of the laws governing pharmaceutical advertising, the plaintiffs say.

Preemption Dismissal Reversed

Plaintiffs bringing a testosterone lawsuit based on generic testosterone products won a minor victory in 2016 by getting Judge Kennelly to reverse his previous dismissal of some of their claims. Judge Kennelly had dismissed their entire fourteen-claim lawsuit as being preempted by federal law.

On reconsideration, Judge Kennelly reinstated seven of those claims – the ones that relied on allegations of fraudulent off-label marketing. The other seven claims, which mostly brought allegations of defective design and failure to warn, remain dismissed.

The testosterone products MDL is pending under MDL no. 2545, also in the federal court for the Northern District of Illinois.