An Illinois federal court jury on Oct. 5 awarded Plaintiff Jeffrey Konrad more than $140 million. Mr. Konrad was prescribed AndroGel in May 2010 after complaining to his primary care physician of fatigue and low energy after seeing advertisements on television. Two months later, he suffered a heart attack while using the drug. Mr. Konrad subsequently sued AbbVie, the maker of AndroGel, claiming that AbbVie failed to warn the drug was linked to an increased risk of adverse cardiovascular effects. The company also falsely marketed the drug as a treatment for age-related low testosterone, when the drug had never been approved for this purpose.

AndroGel and testosterone replacement products are generally prescribed for men with low levels of testosterone due to injury or disease, a condition called hypogonadism. However, AbbVie promoted its testosterone gel directly to men like Mr. Konrad through direct-to-consumer advertising by fabricating a condition called “Low T” to treat symptoms such as low libido, weight gain and muscle loss. Studies have linked testosterone replacement therapy to an increased risk of heart attacks, strokes, blood clots and death, especially in older men.

In early 2015, the U.S. Food and Drug Administration (FDA) warned 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.

The jury verdict in the Konrad case included $140,000 in compensatory damages and $140 million in punitive damages. Lawyers from Seeger Weiss, Levin Papantonio, and Robbins Cloud were leads in the Konrad case. Matt Teague and Jessica Taylor, lawyers from our firm, assisted in this trial. The case is Konrad v. AbbVie Inc. (case number 1:15-cv-00966). The MDL is In re: Testosterone Replacement Therapy Products Liability Litigation, (case number 1:14-cv-01748) both cases are in the U.S. District Court for the Northern District of Illinois.

The win in this case is the second Plaintiff victory in the multidistrict litigation (MDL) involving a number of testosterone treatment manufacturers. The first verdict also involved AbbVie, and ended in a $150 million verdict for the Plaintiff punitive damages. Jurors there also held the company liable for aggressive marketing for unapproved uses.

The MDL dates back to 2014 and names drug companies such as AbbVie, Besins, Eli Lily and GlaxoSmithKline, and includes products AndroGel, Testim and Axiron, among others. The lawsuits were consolidated in the U.S. District Court for Northern Illinois in Chicago under U.S. District Judge Matthew F. Kennelly. About 6,000 cases are now pending in the MDL, 4,200 of which name AbbVie’s top selling AndroGel.

Beasley Allen lawyer Matt Teague is handling testosterone replacement therapy litigation for the firm, and he serves on the Plaintiffs Steering Committee for the MDL. For more information, call 800-898-2034 or email Matt.Teague@beasleyallen.com.

Source: Law360



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