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Rick Shapiro
| Shapiro, Appleton & Washburn

A federal jury in Chicago awarded a man who suffered a heart attack while using the testosterone replacement product AndroGel $150 million in punitive damages. With their July 24, 2017, decision, jurors found that AndroGel’s maker, AbbVie, misrepresented the risks of using the product. While this particular award is unlikely to survive an appeal, it sets an example for thousands of similar lawsuits brought by former AndroGel users.

Jurors Found a Failure to Warn

A summary of the claims and defenses in Mitchell v AbbVie Inc. prepared by the U.S. District Court for the Northern District of Illinois, which heard the arguments, states that the plaintiff began using AndroGel in January 2008 after being diagnosed with hypogonadism. The extremely low levels of testosterone produced by that condition resulted in symptoms that included depression, fatigue, lethargy, muscle aches and insomnia.

Mitchell stopped applying AndroGel when he went to the hospital in cardiac arrest and was subsequently diagnosed with coronary artery disease (CAD). In its defense, AbbVie pointed to the plaintiff’s CAD, obesity, high blood pressure, high cholesterol, history of smoking and family history of heart disease.

That defense partially convinced the jurors in Chicago that Mitchell might have suffered a heart attack regardless of his use of the testosterone supplement made by AbbVie. At the same time, members of the jury determined that the drug maker did not do enough to warn users like Michell about the heart risks of AndroGel.

A recent update to the product’s FDA-approved label states, “Some postmarketing studies have shown an increased risk of myocardial infarction and stroke associated with use of testosterone replacement therapy.” Another warning relates to the occurrence of a life-threatening blood clotting problem called deep vein thrombosis that can cause strokes.

This information was not shared with AndroGel users during the years that Mitchell used the product. Numerous lawsuits currently in progress present claims that the drug maker knew AndroGel could raise heart attack risks by as much as 30 percent but kept the information hidden.

AbbVie Facing Accusations of Making Fraudulent Misrepresentations

Claims of fraudulent misrepresentation are central to many civil lawsuits involving dangerous drugs. Pharmaceutical manufacturers have a high legal duty to warn patients of potentially dangerous adverse effects. Failing to meet that duty makes a company like AbbVie liable for paying compensation and damages to people who suffer from undisclosed or underemphasized side effects.

According to a legal dictionary maintained by the Legal Information Institute at Cornell University, judges and juries must answer six questions to find for a plaintiff who brings a fraudulent misrepresentation case:


  1. Did the defendant make a representation?
  2. Was the representation false?
  3. Did the defendant know that the representation was false at the time, or did the defendant make the statement recklessly without knowing whether it was true?
  4. Was the fraudulent misrepresentation made with the intention of having the plaintiff rely on it?
  5. Did the plaintiff did rely on the fraudulent misrepresentation?
  6. Did the plaintiff suffer harm as a result of the fraudulent misrepresentation?
  7. The $150 million punitive damage award in Mitchell v. AbbVie Inc. will almost definitely be overturned when the company appeals it because the trial jury answered only a few of these questions affirmatively. However, AndroGel lawsuits brought by plaintiffs who used the product to treat Low-T could succeed.

FDA has approved AndroGel only as a treatment for hypogonadism, not the normal decline in testosterone men experience as they age. Despite this AndroGel heavily marketed AndroGel as a Low-T treatment for several years. That fell into a legal gray area because doctors can prescribe any FDA-approved therapy for any condition and AbbVie scripted its ads very carefully to avoid making specific medical claims. Nonetheless, since the product was being used in ways that health professionals call “off label,” AbbVie had a special duty to protect patients through education and warnings. Also, not all plaintiffs would present with the CAD risks that Mitchell did.

My Virginia dangerous drug law firm colleagues and I thank the plaintiffs’ attorneys who helped Mitchell. A press release lists the lawyers as Troy Rafferty of Levin Papantonio, lead, David Buchanan of Seeger Weiss, Bill Robins of Robins Cloud, Stephanie O’Connor of Douglas & London, and David Diamond of Goldberg & Osborne.

Pharmaceutical companies must be held accountable for ignoring or covering up their drug’s risks and for overselling products’ benefits.


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