The state Superior Court upheld a judgment Friday in a Philadelphia hormone-replacement therapy case in which $4.4 million in compensatory damages was awarded and in which $6 million in punitive damages was awarded.

Amaris Elliott-Engel

2012-07-23 12:00:00 AM

The state Superior Court upheld a judgment Friday in a Philadelphia hormone-replacement therapy case in which $4.4 million in compensatory damages was awarded and in which $6 million in punitive damages was awarded.

Judge Jacqueline O. Shogan wrote the unpublished opinion on behalf of Judge David N. Wecht and Senior Judge James J. Fitzgerald III.

Wyeth Inc., now owned by Pfizer, argued that the judgment in favor of Alabama plaintiffs Audrey and Charles Singleton should be reversed because of “‘extensive prejudicial evidence of marketing and other conduct by Wyeth that had no connection to the decision by Ms. Singleton’s physician [Dr. James Donald] to prescribe Prempro to her.'”

But Shogan said that “while Dr. Donald testified that he did not prescribe HRT drugs to Singleton based on Wyeth’s direct marketing, the representations made by Wyeth’s salespeople, his belief that HRT drugs had off-label benefits that led to it being prescribed, and the medical literature and ghost written reviews created at Wyeth’s behest were all directly related to Wyeth’s promotion of Prempro. Dr. Donald concluded that, had he known the dangers, he would not have prescribed Prempro. As such, there was reliance on Wyeth’s promotion of Prempro, both directly and indirectly, and Wyeth’s claim that the trial court violated Alabama and Pennsylvania law by imputing a fraud on the market theory is meritless.”

The marketing evidence also was relevant to illustrate the wantonness of Wyeth’s conduct, the panel said.

The Singletons successfully argued to the jury that Wyeth failed to adequately warn of the risk of breast cancer from ingesting its hormone-replacement therapy.

Wyeth also argued that one of the plaintiffs’ experts used unscientific methodology.

The Superior Court said that the differential diagnosis used by breast surgeon Dr. Elizabeth Naftalis to determine a causal relationship between HRT and breast cancer was a methodology generally accepted in the scientific community and that her testimony withstood Frye and Daubert challenges not just in Philadelphia but in other courts.

“The question as to the conclusion reached and whether it is believed by the jury is a question of the weight of the evidence and not its admissibility,” Shogan said.

The panel also upheld Philadelphia Court of Common Pleas Mark I. Bernstein’s instructions on the adequacy of the warning about Prempro’s risks and upheld Bernstein’s instruction on proximate cause.

For example, Wyeth wanted the trial court to tell the jury regarding proximate cause that, even if the jury found that Wyeth failed to adequately warn Singleton’s prescribing physician, that it should issue a defense verdict if it found that Donald did not rely upon the label.

But Shogan said that proposed charge would have been an inaccurate statement of the law.

Wyeth also argued that under Alabama’s punitive damages standards that such damages were not appropriate for a drug with labeling approved by the federal Food and Drug Administration and for which there was no evidence that Wyeth misled the FDA.

Wyeth also argued that the punitive damages award should be remitted to no more than the compensatory damages award.

But the panel said that it had to apply Pennsylvania law regarding punitive damages.

“Wyeth’s concerted effort to misdirect physicians from the dangers of Prempro illustrates the consciousness that its conduct was not at all reasonable, and the jury exercised its discretion in awarding punitive damages,” Shogan said.

“We are very pleased for Audrey Singleton,” plaintiffs’ counsel Esther Berezofsky of Williams Cuker Berezofsky said in a statement. “This ruling leaves little question of the sufficiency of the evidence to show that HRT causes breast cancer, that Wyeth failed to conduct appropriate studies that would have alerted women and their physicians to the significant risk of breast cancer. Instead Wyeth conducted a publicity campaign designed to dismiss and distract the medical community from recognizing this risk.”

Defense counsel Robert C. Heim of Dechert said when reached late Friday that he could not provide a comment without having a chance to review the opinion immediately.

Amaris Elliott-Engel can be contacted at 215-557-2354 or aelliott-engel@alm.com. Follow her on Twitter @AmarisTLI.

( Copies of the 59-page opinion in Singleton v. Wyeth, PICS No. 12-1356, are available from The Legal Intelligencer. Please call the Pennsylvania Instant Case Service at 800-276-PICS to order or for information. ) •