As the drug injury lawsuits against testosterone product makers continue to mount, AndroGel manufacturer AbbVie is raising questions about the fairness of the process used to choose bellwether cases.

The testosterone bellwether trials are set to begin in October 2016. The presiding judge instructed lawyers representing the defendant, AbbVie, and attorneys for the plaintiffs, the men who have sued the company over the dangerous side effects of the low testosterone product, to pick 32 representative cases for potential trial.

AbbVie is not happy with this arrangement, however, and in an August filing the company requested that the court take an active role in selecting the 32 representative AndroGel cases.

AbbVie argued that allowing the lawyers to pick “their favorite” cases “frustrates rather than facilitates sound pretrial case management.” AbbVie argued that in order to ensure the fairness of the bellwether process, the court should select the first cases.

Overview of Testosterone Product Lawsuits

Lawsuits against AbbVie and other low-t drug makers allege that the testosterone product makers endangered healthy men by marketing the testosterone products to treat sexual dysfunction, age-related fatigue and other symptoms that go beyond what the FDA has approved the product to treat.

The FDA has approved testosterone therapy to treat hypogonadism, a serious hormonal decline caused by disease or injury, not simply age-related low testosterone.

The companies are accused of popularizing the term “Low T” to describe the symptoms the products were marketed to treat. The plaintiffs allege that taking testosterone caused them to suffer heart attacks, strokes and other debilitating testosterone side effects.

AbbVie is among seven named testosterone product makers that plaintiffs have sued, and is the first of the seven scheduled for trial. AbbVie’s low-t drug, AndroGel, is by far the most popular testosterone product, dominating about 65 percent of a $2 billion dollar market annually.

The Androgel testosterone product lawsuits claim that AbbVie used several aggressive direct-to-consumer marketing tactics to promote AndroGel, specifically targeting healthy aging men by advertising a cure-all for what is considered the normal aging process.

Testosterone Bellwether Trials

Since June 2014, all federal testosterone drug injury and product liability lawsuits have been consolidated as part of a multidistrict litigation (MDL), with the cases centralized before U.S. District Judge Matthew Kennelly in the Northern District of Illinois.

MDL consolidation is common in pharmaceutical and medical device litigation, and helps to streamline and fast track the trial process.

The early bellwether cases are to be divided into two categories: those involving blood clots from testosterone therapy, such as thromboembolism and deep vein thrombosis injuries, and testosterone heart attack claims. By March 1, 2016, The court expects to choose three thromboembolism cases and three heart attack cases to go to trial.

A second group of testosterone bellwether trials are expected, involving lawsuits pending against other manufacturers. Those trials would likely not begin until the second half of 2017.