Yet another appellate court has condemned drug-maker Wyeth Pharmaceuticals for its conduct in failing to study and failing to warn about the breast cancer risk associated with its hormone therapy drugs.
In two hormone therapy breast cancer cases, Barton v. Wyeth and Kendall v. Wyeth, the Pennsylvania Superior Court has issued decisions that affirm each plaintiff’s jury verdict and reinstate a measure of the punitive damages awards that had been reduced by the trial judges after the verdicts. The cases involve two Illinois women, Connie Barton and Donna Kendall, who claimed that their use of combination hormone replacement therapy (estrogen and progestin therapy, or “E+P”) was a cause of their hormone-positive breast cancers. The cases were tried separately in late 2009 in the Philadelphia Court of Common Pleas.
In Barton, the sole defendant was Wyeth Pharmaceuticals, and the trial was “reverse-bifurcated,” with the jury considering medical causation and compensatory damages in Phase I, liability in Phase II, and punitive damages in Phase III. After Phase I, the jury found that E+P was a cause of Ms. Barton’s breast cancer and awarded $3.7 million in compensatory damages. After Phase II, the jury found that Wyeth had failed to study and failed to warn about the breast cancer risk and that its conduct in ignoring the risk was outrageous and reprehensible. The jury then awarded $75 million in punitive damages in Phase III.
In Kendall, the plaintiff brought suit against both Wyeth and Pharmacia & Upjohn, making the same claim: that E+P caused her breast cancer and that Wyeth and P&U failed to study and warn about the risk. After a five-week trial, with PBM attorney Tobi Millrood serving as lead trial counsel for the plaintiff, the jury awarded Mrs. Kendall $6.3 million in compensatory damages and $28 million in punitive damages – $16 million assessed against Wyeth and $12 million against Upjohn.
In both cases, the drug companies sought J.N.O.V. (judgment non obstante veredicto) – that is, dismissal of the verdicts – on a variety of grounds. Although both trial judges refused to undo the verdicts, they reduced the punitive awards significantly. The trial judge in Barton cut the punitive damages award from $75 million to $5.6 million, and the trial judge in Kendall cut the award from $28 million to just $1 million. In both cases, all of the parties sought appeals to the Pennsylvania Superior Court. Wyeth and Upjohn claimed that the verdicts should be thrown out altogether, raising a number of arguments, including challenges to the admission of certain evidence and the viability of certain expert testimony. Ms. Barton and Mrs. Kendall each appealed only one issue: whether the trial judge in each case was correct in reducing the punitive damages awards. The cases proceeding separately on appeal, with separate briefing, although the same Superior Court panel heard consolidated oral argument on the cases.
In separate opinions, issued earlier this week, the Superior Court panel denied all of the drug companies’ challenges to the verdicts. The Superior Court was resolute in rejecting the drug companies’ arguments that their conduct was not punishable at all. In Barton, the court explained:
Wyeth contends that there was insufficient evidence for the jury to find willful and wanton misconduct. We disagree.
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The jury considered Wyeth’s “revolution” in marketing a drug that it knew was not sufficiently tested. The jury heard of Wyeth’s manipulation of medical literature and its effect on the medical standard of care. The jury pondered over Wyeth’s numerous decisions to ignore studies, extinguish dissenting science, and thumb its nose at the FDA. Finally, the jury saw evidence that Wyeth promoted the drug for extensive, non-authorized, wholly fabricated, and even detrimental off-label uses.
Barton, Slip Op. at *28. Similarly, in Kendall, the court echoed its condemnation of Wyeth’s conduct and also discussed co-defendant Upjohn at length:
Upjohn argues that the jury could not impose punitive damages for failing to discover an unknown risk. However, the record reflects that Upjohn was willfully ignorant of the increased risk of breast cancer from long-term use of Provera in conjunction with exogenous estrogen. As Kendall argues, there were numerous “red flags,” not least of which was the Degge Group’s review and explicit recommendation for further study, which Upjohn consciously ignored. Indeed, there was evidence of a possibility of increased risk as early as the 1960s. Yet, inexplicably, Upjohn did not conduct any studies to evaluate a breast cancer risk despite the ability to do so. … This was sufficient for the jury to find that Upjohn was grossly negligent and acted with wanton disregard for users of its products including Kendall. Upjohn’s disingenuous claim that it was unaware of any increased risk does not shield it from liability.
Kendall v. Wyeth, Slip Op. at *15.
But the Superior Court went further than simply affirming the jury verdicts. In both cases, the appellate court reinstated some measure of the punitive damages awards that had been previously reduced. In Kendall, the court reinstated the entirety of the jury’s $28 million punitive damages award, while in Barton, the court reinstated the punitive award to $7.49 million. Explaining its rationale for the divergent punitive damages awards and why they are not inconsistent under the circumstances, the Barton court clarified:
We recognize that in a similar case argued before the same panel, Kendall v. Wyeth, et al., we reinstated a punitive award with a ratio of 4.44:1, or more than four times compensatory damages. In that case, we concluded that the trial court abused its discretion in granting the defendants’ motion for remittitur and reducing the amount of punitive damages to only $1 million, measured against compensatory damages of $6.3 million. We emphasized in Kendall that while perhaps close to the line, single-digit multipliers, particularly in the 4:1 range, can usually survive constitutional scrutiny. … In Kendall, we found that the jury’s original punitive damages award of $28 million did not offend federal due process guarantees. It should also be noted that the plaintiff in that case suffered unusually devastating physical and emotional injuries, including a double mastectomy, serious complications from reconstructive surgery, and a 75% chance of recurrence. Indeed, had the trial court in this case elected, in its discretion, to remit damages in an amount greater than a 2:1 ratio, we would have no hesitancy in affirming that judgment; however, we discern no inherent inconsistency between the case sub judice and Kendall, where the jury’s initial award of $75 million in punitive damages here was plainly excessive.
Barton v. Wyeth, Slip op. at *45, n.5.
The Superior Court has relinquished jurisdiction, but the drug companies retain the right to seek reconsideration and seek further appellate review.