A select group of the nearly 6,000 cases pending in the Testosterone Replacement Therapy Products Liability Litigation are nearing completion of the discovery process and are preparing for trial. Starting last month and extending into this month, the parties will depose the expert witnesses retained by both the Plaintiffs and Defendants. As part of the expert discovery process, U.S. District Judge Matthew Kennelly, the Illinois federal judge overseeing the multidistrict litigation (MDL), denied a motion by AbbVie Inc., the manufacturer of Androgel, to strike certain medical and scientific articles from the report of Dr. B. Bud Gerstman, a professor at San Jose State University.
Dr. Gerstman is an expert for the Plaintiffs’ Steering Committee (PSC). He wrote his original report in October and expanded his December report to include additional medical articles following the production of AbbVie’s expert reports. Judge Kennelly entered his notice the day before Dr. Gerstman’s deposition and held the articles are admissible in court and “properly part of a rebuttal report.”
AbbVie, maker of the top-selling brand AndroGel, is the first Defendant scheduled for bellwether trials in the MDL. The first trial is currently for June 2017. Plaintiffs argue Defendants failed to adequately warn consumers about the risks of stroke, deep vein thrombosis, pulmonary embolism and cardiovascular injury associated with testosterone therapy while improperly marketing their drugs as a remedy for age-related conditions rebranded as “Low T.” The testosterone lawsuits were consolidated for the purpose of general pretrial discovery.
In March 2015, The U.S. Food and Drug Administration (FDA) cautioned consumers that prescription testosterone products are approved only for men who have low testosterone levels caused by certain medical conditions. The FDA made clear that the benefit and safety of these drugs, including Androgel, Testim, Axiron, Fortesta, and Androderm, have not been established for the treatment of low testosterone levels due to aging, or “Low T,” even if a man’s symptoms seem related to low testosterone.
The FDA required all testosterone replacement manufacturers to change their labeling to clarify the approved uses of these medications. The FDA also required new warnings about a possible increased risk of heart attacks and strokes in patients taking testosterone. Finally, the FDA required manufacturers of approved testosterone products to conduct a well-designed clinical trial to more clearly address the question of whether an increased risk of heart attack or stroke exists among users of these products.
Source: Law 360
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