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From Products Liability Law Daily, October 6, 2017

AbbVie hit with another huge AndroGel® verdict

By Georgia D. Koutouzos, J.D.

In the second bellwether lawsuit involving the prescription testosterone-replacement medication AndroGel®, an Illinois federal jury has awarded a heart-attack patient $140,000 in compensatory damages and $140 million in punitive damages after finding the manufacturers liable for negligence and misrepresentation. Another jury in a similar suit had socked the drug makers with a $150-million punitive damages award in late July (Konrad v. AbbVie, Inc., October 5, 2017, Kennelly, M.).

A man who had used AndroGel for symptoms that he and his physician attributed to low testosterone suffered a myocardial infarction and had to undergo emergency medical treatment, including the placement of a cardiac stent. Arguing that he would not have used the drug had he and his doctors known the true risks associated with the use of testosterone-replacement medications, the patient filed suit against the product’s manufacturers, AbbVie, Inc. and Abbott Laboratories, Inc., asserting claims for strict products liability (failure to warn and design defect), negligence, breach of implied and express warranties, fraud, negligent misrepresentation, and design defect. The suit also included a loss-of-consortium claim on behalf of his spouse.

Claims. According to the plaintiffs’ complaint, AndroGel’s manufacturers misrepresented that their product was a safe and effective treatment for hypogonadism and a condition they referred to as "low testosterone" or "low T," when in fact the drug causes serious medical problems. The companies engaged in aggressive, award-winning direct-to-consumer and physician marketing and advertising campaigns for the topical medication as well as an aggressive unbranded "disease awareness" campaign to alert men that they might be suffering from "low T" even though the condition is not a disease recognized by the medical community and the U.S. Food and Drug Administration has not approved any testosterone-replacement therapy drug as a treatment for it.

AndroGel was defective due to inadequate warnings or instructions because the drug makers knew or should have known that their product created significant risks of serious bodily harm to consumers, and yet they failed to adequately warn consumers and/or their health care providers that the drug could cause heart attacks, strokes, pulmonary embolism, cardiovascular events, and blood clots. The companies also failed to adequately warn that patients who use AndroGel must have their hematocrit and estradiol levels frequently monitored in order to prevent the abovementioned conditions.

In addition, the manufacturers had a duty of care when it undertook to provide comprehensive medical information to consumers and patients concerning "Low T" as a medical diagnostic entity, and the companies negligently and carelessly disregarded the applicable regulations/industry standards regarding the prohibition against off-label marketing, misbranding, and label expansion. As a result, millions of men—including the patient—were prescribed AndroGel unnecessarily and were needlessly exposed to serious health risks for which there were no or inadequate warnings.

Furthermore, the drug makers deceived physicians by explicitly or implicitly claiming that the treatment of "Low T" was an FDA-approved clinical indication for use of AndroGel, when in fact it was an "off-label" indication for clinical use. In essence, the drug contained a defective condition because the design was defective and unsafe in that it could cause serious injuries and death as the result of the formation of blood clots and adverse cardiovascular events. The design defect made the drug unreasonably dangerous, yet the companies knowingly introduced the drug into the market, the complaint contended.

Verdict. The case went to trial and the court entered judgment in favor of the drug companies on the strict liability claim and in favor of the patient on the claims of negligence, intentional misrepresentation, and misrepresentation by concealment. The jury awarded compensatory damages totaling $140,000 and punitive damages in the amount of $140,000,000.

The case is No. 15 C 966.

Attorneys: Christopher A. Seeger (Seeger Weiss LLP) for Jeffrey Konrad and Jana Konrad. Michelle H. Yeary (Dechert LLP) for AbbVie, Inc. and Abbott Laboratories, Inc.

Companies: AbbVie, Inc.; Abbott Laboratories, Inc.

MainStory: TopStory JuryVerdictsNewsStory DamagesNews DesignManufacturingNews WarningsNews DrugsNews IllinoisNews

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