On January 3, 2012, the Superior Court of Pennsylvania released two extremely important opinions in the Hormone Therapy Replacement drug cases. The first case is Kendall v. Wyeth Pharmaceuticals, Inc., and the second is Barton v. Wyeth Pharmaceuticals, Inc. In each case, the Court affirmed punitive damage awards involving Wyeth, Pharmacia & Upjohn, Inc. Wyeth was a Defendant in both cases with Upjohn only being a Defendant in the Kendall case. The claims against both Wyeth and Upjohn were based on the conduct of each Defendant in the sale of their drugs promoted for the treatment of menopausal symptoms. The Plaintiff in each case contended that the drugs caused breast cancer and that the Defendants failed to provide adequate warnings concerning the breast cancer risks of the drugs.
Examining the evidence supporting a punitive damage award against Wyeth, the Court concluded that the evidence demonstrated that Wyeth, as early as the 1970s, knew of a link between its drug, Premarin, and breast cancer, but failed to warn physicians or pursue definitive studies about the risk. Additionally, the Court concluded that the evidence demonstrated that Wyeth:
• actively sought to suppress information about the risk of breast cancer associated with Premarin/Prempro;
• promoted the drugs for unapproved off-label uses; and
• that the drug company’s primary motivation was profit.
The Court held that Wyeth’s conduct was sufficient to support a claim that Wyeth acted with a wanton disregard for the rights of others under Illinois law. The Court rejected Wyeth’s arguments that compliance with FDA regulations prohibited the imposition of punitive damages and evidence of Wyeth’s marketing conduct should not have been admitted at trial.
Examining the evidence supporting a punitive damage award against Upjohn, the Court concluded that Upjohn was on notice that its drug, Provera, caused mammary cancer in rats as early as 1961 and exacerbated breast cancer in humans as early as 1963. The Court noted that Upjohn did not study the risk of breast cancer despite actively promoting Provera to be used with exogenous estrogens for the treatment of menopausal symptoms, a use that was not approved by the FDA. In fact, the FDA repeatedly denied Upjohn’s requests for such a use due to the lack of sufficient studies.
The Court rejected Upjohn’s argument that punitive damages were not warranted for an “unknown” risk of breast cancer associated with Provera because Upjohn stuck its head in the sand and failed to conduct studies to explore a possible risk between Provera and breast cancer. That failure was despite Upjohn conducting studies on potential benefits of Provera, including osteoporosis.
Additionally, Upjohn did not include any warning about the possible risk of breast cancer in humans in the Provera label. The Court held that the evidence was sufficient to support a claim that Upjohn acted with wanton disregard for the users of Provera. The Court also rejected Upjohn’s arguments concerning compliance with FDA regulations and admission of Upjohn’s marketing materials.
In Kendall, the Court affirmed a compensatory award of $6.3 million and reinstated a $28 million dollar punitive damage award against Wyeth ($16 million) and Upjohn ($12 million). The Court reversed the trial court’s remittitur of the punitive damages award.
In Barton, the Court affirmed a compensatory award of $3,746,344.97 and modified the trial court’s remittitur of the punitive damage award by increasing the punitive damage award to $7,492,689.94. That was a 2:1 ratio of punitive damages to compensatory damages. These two appellate court decisions are very important and told the story of how truly bad these companies have been. I believe the well-written opinions have to be considered good news for Plaintiffs in other cases and very bad news for the Defendant companies.
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