Pharmaceutical

First testosterone trial scheduled for June 2017

Low T1 First testosterone trial scheduled for June 2017The first trial in a multi district litigation (MDL) in Northern District of Illinois involving hundreds of cases alleging cardiovascular risks with testosterone replacement therapies is scheduled for June 2017, and will serve as a bellwether that could encourage settlement negotiations with the other lawsuits.

The Konrad case will serve as the first bellwether. Seven others have also been selected but the dates for those are yet to be determined. All of the bellwether cases involve AbbVie’s AndroGel topical testosterone treatment, which is the best-selling testosterone therapy on the market.

The litigation against AbbVie and manufacturers of other testosterone treatments allege the companies failed to warn the public about life-threatening risks of heart attacks, strokes, and blood clots associated with its products. The lawsuits also accuse the drug makers of luring men who didn’t even need the hormone to ask their doctors for it through their aggressive marketing campaigns that promised increased sex drive, weight loss, and improved mood with treatment.

Testosterone replacement therapy is intended for men with diagnosed hypogonadism, a condition in which the testes do not produce enough of the male hormone resulting in infertility issues and decreased muscle mass. The lawsuits allege that drug makers’ advertisements resulted in billions of dollars in testosterone treatment sales from doctors overprescribing the medications without knowledge of the risks.

However, studies began to emerge linking testosterone treatments to heart attacks, strokes and blood clots.

In March 2015, following a safety review, the Food and Drug Administration (FDA) issued a Drug Safety Communication cautioning against the use of testosterone products for low testosterone due to aging, and required drug makers to add warnings to the safety labels of their testosterone products warning of the increased risk of heart attacks and strokes.

Sources:
US District Court
FDA