Pennsylvania high court upholds $8.6 million verdict in HRT breast cancer lawsuit over Prempro

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by Michael Heygood

Arkansas resident Mary Daniel sued Wyeth in 2004 alleging the company’s drug Prempro had caused her breast cancer. In 1999, Daniel’s doctor, John Haggard, M.D., prescribed for her a hormone therapy drug, Prempro, manufactured by Wyeth. Daniel alleged that she continued to ingest Prempro until August 9, 2001, at which time she was diagnosed with breast cancer (moderately differentiated invasive ductal carcinoma, extending to one margin) and had to undergo surgery and chemotherapy as a result. Daniel asserted claims against Wyeth for negligence, breach of express warranty, and fraud, and her husband asserted a claim for loss of consortium.

After a four-week trial in 2007, the jury awarded the Daniel and her husband $1,681,650 in compensatory damages ($1,000,000 to Daniel, $500,000 to Daniel, Sr., and $181,650 in delay damages). The trial court summarized the jury’s findings as follows:

The jury concluded that Wyeth negligently failed to provide proper warnings regarding the risks of breast cancer to [Daniel’s] prescribing physician during the time that she took Prempro. The jury further concluded that Wyeth’s negligence was a cause of her physician’s decision to prescribe Prempro to her, and that Prempro was a factual cause of her injury, specifically breast cancer or its growth. Additionally, the jury found that Wyeth’s conduct was sufficient to award punitive damages to [the Daniels].

However, the trial court agreed with Wyeth’s argument that punitive damages should not be awarded. When the Daniels indicated that they intended to appeal this ruling, the trial court conducted a brief jury trial with the same jury so that the court of appeals would not have to remand the case for re-trial in the event of a reversal as to punitive damages. The parties presented additional evidence, including information regarding Wyeth’s net worth, and the jury returned an award of $8.6 million for punitive damages. The trial court then formally struck the award of punitive damages in accordance with its prior ruling. Later, the trial court granted Wyeth’s request for a new trial, based on its argument that one of the plaintiff’s experts had supposedly recanted his testimony following the trial.

The Daniels appealed. The Superior Court of Pennsylvania reversed the trial court and reinstated the verdict of the jury. Daniel v. Wyeth Pharmaceuticals, Inc., 15 A.3d 909 (Pa.Super. 2011). The court of appeals held that Wyeth failed to demonstrate that new trial was warranted on the ground of after-discovered evidence and that matters such as causation, the adequacy of warnings, and whether the manufacturer’s conduct was intentional were all questions for the jury. As to punitive damages in particular, the Superior Court determined that sufficient evidence existed for the jury to conclude that Wyeth had failed to thoroughly test the drug’s breast cancer risks, thus engaging in “outrageous conduct” that merited punitive damages.

Wyeth petitioned the Pennsylvania Supreme Court to review the case. In December of 2011, the court accepted the appeal, limited to a single issue:

Whether the Superior Court erred in reversing the trial court’s grant of JNOV for Wyeth on [Respondents’] punitive damages claim under Pennsylvania law, where (a) the FDA extensively reviewed and approved the prescription drug at issue, the sufficiency of the testing for that drug, and the drug’s label warnings of the risk of breast cancer, (b) there was no evidence that Wyeth concealed information from or misled the FDA or knew that the risk of breast cancer was greater than disclosed in its warnings, and (c) the drug was extensively tested and studied by Wyeth and independent researchers?

Now, more than a year after hearing oral argument in the case, the Pennsylvania Supreme Court has decided it will not review the case. Wyeth’s appeal has been “dismissed as having been improvidently granted.”

As a result, the judgment of the Superior Court remains. In other words, the jury’s verdict as to both compensatory and punitive damages is reinstated.

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