Androgel Class Action Lawsuit Filed Against AbbVie, Abbott in Canada

Abbott Laboratories and AbbVie face a new class action lawsuit over Androgel in Canada, raising allegations similar to those brought in dozens of cases filed in the United States over side effects of testosterone therapy.

The case was filed late last month on behalf of all Androgel users in Canada, indicating that the drug makers withheld warnings about the risk of heart attacks, strokes and other injuries associated with the popular testosterone gel.

The Androgel class action indicates that instead of properly disclosing important safety information to Canadians, the pharmaceutical companies aggressively marketed the drug and mislead the public about the extent of men who may require prescription treatments for low testosterone to maximize profits.

According to a press release issued by the law firms that filed the case, it is believed to be the first lawsuit brought in Canada over problems with testosterone replacement therapy. However, a similar class action was filed in Canada this month over Delatestryl testosterone injections.

Androgel Heart Risks

AbbVie and Abbott face a number of similar Androgel lawsuits in the United States, which have been brought on behalf of individuals nationwide who suffered a heart attack, stroke, deep vein thrombosis (DVT), pulmonary embolism or sudden death after using the treatment to combat symptoms associated with drops in testosterone levels.

On July 15, Health Canada, that nation’s medical device and drug agency, warned that country’s residents that the side effects of Androgel and other similar drugs can increase the risk of cardiovascular problems, indicating that there is a “growing body of evidence” linking testosterone and heart risks.

Data reviewed by the agency showed that many of the men who began having cardiovascular problems after using the drugs had those issues dissipate when they stopped using testosterone. The issues then often returned when they began using it again, which provides strong evidence of a causal link. The determination and new label changes in Canada came after a safety review of all testosterone adverse event reports and medical literature.

In the United States, the FDA announced a similar investigation into the potential risk testosterone heart problems in January 2014, following a series of studies published late last year and early this year that raised concerns about the safety of the medication.

A study published by the Journal of the American Medical Association (JAMA) in November 2013 found that side effects of low testosterone drugs were associated with increased rates of heart attacks, strokes, and death among veterans with pre-existing heart conditions.

That research was followed by a larger study published in the medical journal PLOSOne in January 2014, which involved a review of data on more than 55,000 men who received an initial prescription for testosterone and compared them to men who received a first prescription for an erectile dysfunction drug. The study found that low T treatments may double the risk of heart attack for younger men with pre-existing heart disease, and for men over the age of 65, regardless of their prior heart conditions.

While testosterone litigation is just getting underway in Canada, in the U.S, more than 150 lawsuits over Androgel and other drugs have been centralized in a multidistrict litigation (MDL) in U.S. District Court for the Northern District of Illinois, where the cases will be managed during pretrial proceedings in a manner similar to an Androgel class action. However, each claim remains an individual lawsuit where the plaintiff must establish that their injury was caused by a failure to warn about the risks associated with the medication.