Testosterone Replacement Therapy Prods. Liab. Litig. Coordination Pretrial Proceedings v. Abbvie
| Decision Date | 22 December 2017 |
| Docket Number | MDL No. 2545,Case No. 14 C 1748 |
| Parties | In re: Testosterone Replacement Therapy Products Liability Litigation Coordination Pretrial Proceedings (This document applies to Mitchell v. AbbVie, Case No. 14 C 9178) |
| Court | U.S. District Court — Northern District of Illinois |
(Memorandum Opinion and Order on post-trial motions in Mitchell v. AbbVie, No. 14 C 9178)
Plaintiff Jesse Mitchell's case was the first "bellwether" case to be tried to a jury verdict in this multidistrict litigation (MDL) proceeding. Plaintiffs in the proceeding allege that defendants, manufacturers of testosterone replacement therapy (TRT) drug products, have misleadingly marketed their drugs. According to plaintiffs, although TRT products are considered safe and effective for the treatment of "classical hypogonadism" (low testosterone levels in the blood and associated signs and symptoms resulting from certain recognized medical conditions), defendants have falsely represented in their marketing and promotional materials that TRT is safe and effective for the treatment of age-related hypogonadism (low testosterone levels in the blood and associated signs and symptoms resulting from the normal male aging process). Plaintiffs also assert that defendants failed to provide adequate warnings about the risk that using TRT could increase venous thromboembolisms (blood-clotting injuries in the veins) and cardiovascular injuries like heart attacks and strokes. At trial, Mitchell presented evidence in support of his contentions that AndroGel, a TRT drug manufactured by defendants AbbVie Inc. and Abbott Laboratories (collectively, AbbVie), caused him to suffer a heart attack and that he would not having taken AndroGel but for AbbVie's misleading marketing of the drug and failure to provide an adequate warning label.
Mitchell, an Oregon resident, asserted three claims against AbbVie under Oregon law: strict liability, negligence, and fraudulent misrepresentation. After deliberating for several hours following a 13-day trial, the jury returned a split verdict. On the strict liability and negligence claims, the elements of which Mitchell was required to prove by a preponderance of the evidence, the jury found in favor of AbbVie. On the fraudulent misrepresentation claim, the elements of which Mitchell was required to prove by clear and convincing evidence, the jury found in favor of Mitchell. But despite finding in Mitchell's favor on the fraudulent misrepresentation claim, the jury awarded him zero dollars in compensatory damages. And despite awarding zero dollars in compensatory damages, the jury awarded $150 million in punitive damages.
In their post-trial motions, both parties challenge aspects of the jury's verdict, though neither side takes issue with the jury's findings on the strict liability and negligence claims. AbbVie contends that it is entitled to judgement as a matter of law on the fraudulent misrepresentation claim, both because the evidence at trial was insufficient to support a finding of liability against AbbVie and because the jury's finding of zero compensatory damages means that Mitchell failed to prove an essential element of the claim. AbbVie also maintains that the punitive damages award should be vacated, both because it was not supported by the evidence at trial and because punitive damages may not be awarded in the absence of compensatory damages. Mitchell, for his part, argues that the evidence at trial supports the jury's liability verdicton the fraudulent misrepresentation claim and its award of punitive damages. He contends, however, that the award of zero compensatory damages is contrary to the weight of the evidence presented at trial, and he urges the Court either to amend the judgment and award Mitchell the undisputed amount he paid in medical bills or to hold a new trial solely on the issue of compensatory damages. Neither party contends that the jury's verdict is internally inconsistent, but the Court noted this point when it first reviewed the parties' motions and asked them to address it in their response and reply briefs. For the reasons discussed below, the parties' attempts to reconcile the jury's findings are unconvincing. Because the Court concludes that the jury's findings are logically incompatible, the Court vacates the jury's verdict on the fraudulent misrepresentation claim and the compensatory and punitive damages awards and orders a new trial on that claim.
Neither party challenges the jury's verdicts on the strict liability or negligence claims, so for the purposes of this ruling, the Court focuses on the evidence presented in support of the fraudulent misrepresentation claim. At trial, Mitchell presented testimony from AbbVie employees and documentary exhibits of promotional materials tending to show that AbbVie marketed AndroGel for the treatment of age-related hypogonadism despite its knowledge that the drug had not been proven both safe and effective for that use. The evidence indicated that AbbVie sought to expand the market for AndroGel by directly communicating to physicians—through direct sales calls and face-to-face visits, distribution of physician treatment guidelines, and hiring of keyopinion leaders—that TRT was safe and effective for the treatment of age-related hypogonadism.
Mitchell also presented evidence showing that his own prescribing physician, Dr. Gordon Canzler, had been visited by AbbVie sales representatives on over 100 occasions and had received promotional materials touting TRT's safety and its effectiveness in treating age-related hypogonadism. Notes from sales calls to Dr. Canzler from AbbVie representatives indicated that Dr. Canzler was receptive to AbbVie's message, and Dr. Canzler testified that he considers sales representatives to be a valuable resource. As AbbVie notes, though, Dr. Canzler also testified that he based his particular prescribing decisions for individual patients on a combination of factors, including his own experience with a particular medication, rather than something a sales representative would have told him. For his part, Mitchell emphasizes that Dr. Canzler's testimony about his understanding of AndroGel's purported benefits echoes the representations in AbbVie's marketing that TRT is effective at improving stamina, strength, energy, and libido.
AbbVie denies that its marketing materials gave Dr. Canzler or Mitchell a false impression about AndroGel's risks or benefits, and AbbVie emphasizes Dr. Canzler's testimony that he told patients that TRT use presented a risk of heart attack. Dr. Canzler also testified, however, that at the time he prescribed AndroGel for Mitchell, he would not have mentioned testosterone as being a special risk factor for heart attack or stroke. And Mitchell himself testified that he had an expectation that AndroGel had been proven safe and effective for the treatment of his condition and that Dr. Canzler never warned him of the risk that AndroGel could cause him to suffer a heart attack.According to Mitchell's testimony, he would not have taken AndroGel had he been aware that it could cause heart attacks.
To prove that AndroGel is generally capable of causing heart attacks and that it caused his own heart attack, Mitchell relied at trial on the expert testimony of Dr. Hossein Ardehali, a cardiologist at Northwestern Memorial Hospital in Chicago. Dr. Ardehali acknowledged that Mitchell's medical history revealed a number of risk factors for heart attack, apart from TRT use, including a 34-year history of smoking, high blood pressure, high cholesterol, high triglycerides, obesity, lack of exercise, and a family history of heart disease. And he conceded that those risk factors would be sufficient to cause Mitchell to suffer a heart attack even if he had never taken AndroGel. But Dr. Ardehali maintained that AndroGel was the cause of the heart attack Mitchell actually suffered. Specifically, he testified that the type of blood clot that caused the heart attack would be unlikely to occur in patients as young as Mitchell, and he opined that AndroGel likely worked synergistically with Mitchell's other preexisting risk factors to produce the blood clot that caused the heart attack.
There was no dispute between the parties at trial that the medical bills associated with Mitchell's heart attack amounted to $136,408. Mitchell also testified that the heart attack caused severe physical pain and put him out of work for three months and that his absence from work generated anxiety about his financial situation. According to Dr. Ardehali, Mitchell's heart attack has increased his risk of suffering a future heart attack, and Mitchell testified that this increased risk has been an additional source of anxiety.
The Court instructed the jury on the elements Mitchell was required to prove inorder for the jury to find in his favor on claims for strict liability, negligence, and fraudulent misrepresentation. The instruction for the fraudulent misrepresentation claim told the jury that it could find in Mitchell's favor only if he proved each of five elements by clear and convincing evidence: (1) "AbbVie made a false representation regarding a material matter[;]" (2) "AbbVie knew that the representation was false or made the representation recklessly, without knowing if it was true or false[;]" (3) AbbVie knew that it was misleading Mr. Mitchell and/or his physician, or recklessly disregarded whether it was misleading Mr. Mitchell and/or his physician[;]" (4) Mir. Mitchell and/or his physician reasonably relied on the representation[;]" and (5) "Mr. Mitchell was damaged as a direct result of his and/or his physician's reliance on the representation." Jury Instructions at 16. The next page of the jury instructions was titled "Causation" and stated that "[e]ach of Mr. Mitchell's claims...
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