Countless men are suing AbbVie, the maker of the popular testosterone therapy product AndroGel, and the numbers continue to flood in. There doesn’t seem to be an end in sight as the total number of testosterone lawsuits filed is now over 2,700 and still growing.
Claims have been filed against seven manufacturers of “Low T” products. The U.S. District Court for the Northern District of Illinois has chosen AbbVie to defend in the first multidistrict litigation (MDL) testosterone lawsuit to go to trial.
Earlier this year, AbbVie expressed dissatisfaction with the federal court’s bellwether trial selection process and pressured the court to ensure fairness of the process by allowing the company to be actively involved in selecting the first cases to go to trial, rather than leaving it up to the lawyers. Some of the plaintiff’s lawyers have accused AbbVie of undue influence over the bellwether process.
The testosterone MDL bellwether trials will be categorized into two groups: those pertaining to blood clotting conditions, such as deep vein thrombrosis; and those pertaining to heart attack. The lawyers for AbbVie selected 16 plaintiffs to represent the class of men suing for each type of alleged side effect.
12 bellwether cases are scheduled for later in 2016. The first 6 cases will start in October 2016 and involve men alleging “thromboembolic” injuries and the latter 6 will involve men who suffered from a heart attack or stroke. Bellwether cases will also be selected for the other testosterone makers that are being sued, but those cases will not start until the second half of 2017.
Ron Johnson, co-lead counsel on the testosterone cases, stated that he “imagine(s) we’re not quite to the halfway point in terms of the number of suits we’re going to see ultimately filed in this case.” Johnson believes that the bellwether cases need to represent men of different ages from different time periods to test the adequacy of the product warnings at all stages. “We want a guy who’s under 65 and we want a guy who’s over 65, because the best literature on the heart attacks says if you’re over 65 your risk is doubled.”
In March, the U.S. Food and Drug Administration (FDA) mandated that all testosterone replacement manufacturers revise the product labels to accurately detail the proper use of the hormone and to include cardiovascular risks. The FDA is also enforcing clinical trials to be performed by the companies to further define the risks.
Regardless of how all of this plays out, the allegations against testosterone has already taken a toll on AbbVie’s AndroGel. In the first half of this year, which the company reported on July 24, sales of the product dropped nearly 32% year-over-year to $323 million. Sales fell again in the third quarter, yet AbbVie’s other franchises are helping to soften the financial woes by driving up total sales 26% and earnings up 27%.