Androgel Lawsuit Filed By Man Who Suffered Heart Attack, Stroke and Deep Vein Thrombosis

A Virginia man is among the latest to file a product liability lawsuit against the makers of AndroGel, indicating that side effects of the testosterone treatment caused him to suffer three serious cardiovascular events, including a heart attack, deep vein thrombosis (DVT) and stroke. 

The complaint (PDF) was filed in the U.S. District Court for the Northern District of Illinois on March 12, by Everett Mitchell and his wife, Kaye, alleging that AbbVie ailed to adequately warn men and the medical community about the risks associated with use of their popular testosterone gel.

Mitchell, 79, indicates that he began using AndroGel in 2007 and had no prior history of blood clots or heart problems. While using the testosterone gel, Mitchell suffered a heart attack in January 2010, and then had a deep vein thrombosis and stroke in March 2013.

The lawsuit claims that all three problems were caused by to AndroGel, indicating that he continues to suffer from cardiovascular impairment, loss of enjoyment of life, physical and mental trauma, economic loss, loss of earnings, medical expenses and must have regular medical monitoring due to his injuries.

Androgel Litigation

The case will join hundreds of similar Androgel lawsuits pending in the Northern District of Illinois, where centralized proceedings have been established for all lawsuits over testosterone drugs.

While most of the cases involve use of Androgel, which is the most popular drug of the class, claims involving Testim, Axiron, AndroDerm and other “low T” products are also included in the litigation.

Since June 2014, complaints filed throughout the federal court system have been centralized before U.S. District Judge Matthew Kennelly in the Northern District of Illinois as part of a multidistrict litigation, or MDL. Regardless of which drug is involved in the case, the lawsuits have been centralized to reduce duplicative discovery into common issues, avoid conflicting pretrial rulings in similar cases and to serve the convenience of witnesses, parties and the courts.

As part of the coordinated proceedings, a small group of Androgel lawsuits are being prepared for early trial dates, which are expected to begin in October 2016. Judge Kennelly recently approved criteria for generic depositions of witnesses that apply to all cases, and the parties are working on search term criteria in the AbbVie cases that would successfully identify all relevant company documents on the development and marketing of the drug.

The parties are scheduled to meet with Judge Kennelly for a status hearing on March 20.

Testosterone Heart Concerns

The testosterone litigation has emerged over the past year, following publication of two studies that raised concerns about the increased risk of heart attacks, strokes and sudden death following use of the products.

In November 2013, a study published in the Journal of the American Medical Association suggested side effects of testosterone may increase the risk of heart attacks, strokes, and death among older men with certain pre-existing heart problems.

This research was followed by a study published by the medical journal PLOSOne in January 2014, which found that low testosterone treatments may double the risk of heart attack for younger men with heart disease and men over the age of 65, regardless of their prior heart conditions.

Amid concerns that testosterone drugs have grown from a niche treatment into a $2 billion industry, following aggressive marketing that has promoted the drugs for age-related drops in testosterone levels, the FDA launched its own investigation into the safety of the drugs last year.

Earlier this month, the FDA issued a testosterone drug safety communication, warning that the agency had concluded that there is evidence of a possible link between testosterone drugs and heart problems. The agency is requiring new label warnings on all testosterone drugs and has ordered testosterone drug manufacturers to conduct new clinical trials into the side effects of testosterone medications and their effects on men’s cardiovascular system.