In a new testosterone product lawsuit, a husband and wife from Kentucky claim his heart attack resulted from his Depo testosterone injections.

Plaintiffs Tony and Kristi S. are suing over alleged Depo testosterone side effects that Tony says he suffered. Tony says he started using Depo testosterone in August 2008 and kept using it into October 2013.

He says he had a heart attack during that time, which was treated with a stent placement. Tony now argues that his myocardial infarction was attributable to his Depo testosterone injections.

Kristi, Tony’s wife, is bringing her own claim for loss of consortium. Loss of consortium is a type of claim that the spouse of a harmed person can bring to seek compensation for the harm done to their marital relationship.

The Testosterone Product MDL

Tony and Kristi’s testosterone product lawsuit is part of the multidistrict litigation, or MDL, going on over Depo testosterone side effects and those of other testosterone products. The MDL now contains almost 3,500 separate lawsuits from plaintiffs alleging

Defendants in the MDL are the manufacturers of several different testosterone products, including Androderm, AndroGel, Axiron, and Testim, as well as Depo testosterone injections.

Plaintiffs in these are generally men who suffered potentially deadly cardiovascular Depo testosterone side effects or those of other testosterone drugs. These plaintiffs say they suffered heart attacks, stroke, pulmonary embolism, or deep vein thrombosis, all allegedly due to the testosterone products they had used.

In January 2014, the FDA began to give the issue a close look. It announced then that it was reviewing the safety and effectiveness information regarding testosterone products and their cardiovascular side effects.

The agency followed up in March 2015 by ordering the manufacturers of testosterone products to update their warning labels to address the risk of heart attack and stroke associated with those products.

The FDA also said it was aware that some physicians were prescribing testosterone off-label as a treatment for symptoms that were not associated with any actual disease but were merely the natural consequences of aging. Testosterone products have not been evaluated for safety and effectiveness within that application, the agency said.

So far, the FDA has approved these products only for the treatment of testosterone deficiency associated with male hypogonadism, caused by certain disorders of the testicles, pituitary gland, or brain.

In the testosterone MDL, plaintiffs argue that the manufacturers of these products knew about the cardiovascular risks but deliberately concealed that information from physicians and their patients. They say what warnings the companies did provide were inadequate to put patients on notice of the real risks.

They also accuse these companies of promoting testosterone products to treat the normal symptoms of aging, as noted in the FDA’s announcement.

In December 2015, the court announced a schedule for the first few testosterone lawsuits in the MDL that will go to trial. Trials are planned to begin in April 2017 and run through the following November. The cases to be tried will be selected from a list of 32 claims previously chosen by the parties.

The Depo-Testosterone Lawsuit is Case No. 1:15-CV-09831 and is filed within the larger Testosterone Products MDL No. 2545,  in the U.S. District Court for the District of Northern Illinois.