Androgel Wrongful Death Lawsuit Filed Against AbbVie

AbbVie faces another wrongful death lawsuit, which alleges that side effects of AndroGel testosterone caused a Florida man to suffer a fatal heart attack.

The complaint (PDF) was filed by Fronita Collins in the U.S. District Court for the Northern District of Illinois on April 22, where it will be consolidated with more than 1,300 similar cases filed on behalf of men who suffered heart attacks, strokes or blood clots following use of a testosterone replacement therapy medication.

All of the testosterone lawsuits present similar claims, alleging that AbbVie and other drug makers failed to adequately warn about the cardiovascular risks associated with use of the medications.

Collins indicates that her husband began using AndroGel in January 2012, and suffered an acute heart attack in April 2013, which caused ultimately resulted in his death.

The complaint presents claims against AbbVie for designing a defective drug, failure to warn, negligence, negligent misrepresentation, breach of warranty, fraud, redhibition, violation of consumer protection laws, and unjust enrichment. The lawsuit seeks both compensatory and punitive damages.

Androgel and Other Testosterone Litigation

Since June 2013, all Androgel lawsuits, Testim lawsuits, Axiron lawsuits, Androderm lawsuits and other claims involving injuries allegedly caused by side effects of testosterone replacement therapy have been consolidated in the federal court system as part of an MDL, or multidistrict litigation.

Regardless of which low T drug is involved in the case, lawsuits have been centralized before U.S. District Judge Matthew Kennelly in the Northern District of Illinois 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.

Most of the lawsuits involve heart attacks or wrongful deaths from Androgel, which has been the most widely used testosterone replacement drug on the market.

As part of the coordinated proceedings in the MDL, 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.

Testosterone Heart Attack and Death Risk

The testosterone litigation has emerged over the past few years, 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 (JAMA) 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.

In March, 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.