A group of bellwether cases selected from the nearly six thousand cases pending in In re Testosterone Replacement Therapy Products Liability Litigation have completed discovery and are preparing for trial. The testosterone lawsuits were consolidated for the purpose of general pretrial discovery.

In early 2015, the U.S. Food and Drug Administration (FDA) cautioned consumers that prescription testosterone products are only approved for men who have low testosterone levels due to 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.”

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 mandated 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 drugs.

Additionally, a recent study rebutted health benefit claims for off-label testosterone use. The study systematically reviewed 156 randomized, relevant controlled trials published from January 1950 to April 2016 comparing testosterone therapy benefits to a placebo in men with low testosterone. The study found that testosterone therapy “did not show consistent benefit for cardiovascular risk, sexual function, mood and behavior, or cognition.” Ultimately, the study showed that testosterone supplementation provided no consistent clinical benefits and that a placebo was equally as effective.

The first “Low-T” bellwether trial against AbbVie, Inc., manufacturer of the testosterone replacement product Androgel, is set for jury selection on June 5, 2017, in Chicago in the United States District Court for the Northern District of Illinois. Plaintiffs contended that the 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.”

In April 2017, the court received a final round of briefs addressing several key issues in the bellwether cases, including motions for summary judgment, Daubert challenges against Plaintiff and Defense experts as well as certain medical and causation issues. At press time, the Court had not ruled on these issues, but is expected to do so very soon.

However, in an April 11, 2017 order, the Court denied AbbVie’s request for either a Lone Pine order or a modification of the initial discovery process. A Lone Pine order requires a Plaintiff to preemptively serve a certification from a treating physician or medical expert attesting to and supporting an opinion that the Plaintiff has suffered an injury caused by the Defendant’s product and to do so before the case-specific discovery process is completed.

In denying AbbVie’s motion without prejudice, the Court held that “imposing an expert-certification requirement on the MDL as a whole is premature at this point.” The Court did determine that it may revisit this issue after ruling on “the pending summary judgment motions (or, perhaps, after one or two bellwether trials, which are set for June and July 2017).”

If you need more information on this litigation, contact Jenna Fulk, a lawyer in our firm’s Mass Torts Section, at 800-898-2034 or by email at Jenna.Fulk@beasleyallen.com.

Source: Law 360; Treatment of Men for “Low Testosterone”: A Systematic Review, Samantha Huo, PLOS One, 9/21/16



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