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Pa. High Court Reconsiders, Won’t Disturb $8.6M Prempro Punitive Damages Award

PHILADELPHIA — (Mealey’s) The Pennsylvania Supreme Court on Dec. 16 let stand an $8.6 million punitive damages verdict in a Prempro hormone replacement therapy case after dismissing the appeal as improvidently granted (Mary Daniel, et al. v. Wyeth Pharmaceuticals, Inc., et al., Nos. 63 EAP 2011 and 64 EAP 2011, Pa. Sup.). 

In 2007, a jury in the Philadelphia County Common Pleas Court found in favor of Mary Daniel, who claimed that she developed moderately differentiated invasive ductal breast cancer from taking Prempro hormone replacement therapy from 1999 to 2001.  The trial court granted a motion by defendant Wyeth (now Pfizer Inc.) for a new trial on liability issues and judgment notwithstanding the verdict (JNOV) on punitive damages. 

Daniel appealed, and in February 2011, a panel of the Pennsylvania Superior Court reinstated the $1.68 million compensatory and $8.6 million punitive damages verdicts.  Wyeth petitioned the state Supreme Court for review, and in December 2011, the state high court declined to review the compensatory verdict but agreed to hear the appeal of the punitives verdict. 

FDA Defenses On Appeal 

The Supreme Court said it would limit Wyeth’s appeal to the issues of whether the Superior Court erred in reversing JNOV on the punitive damages claim under Pennsylvania law where: 

•           “[T]he Food and Drug Administration has 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.” 

•           “[T]here 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.”

 •           “[T]he drug was extensively tested and studied by Wyeth and independent researchers.” 

Both sides were supported by amicus curiae briefs, Wyeth by the Pharmaceutical Research and Manufacturers of America (PhRMA) and the Product Liability Advisory Council (PLAC) and Daniels by the Pennsylvania Association for Justice. 

The Supreme Court heard arguments in September 2012. 


Wyeth/Pfizer are represented by Robert C. Heim and Judy L. Leone of Dechert in Philadelphia and Sheila L. Birnbaum of Skadden Arps in New York. 

Daniel is represented by Esther Berezofsky, Samuel Abloeser, Mark R. Cuker and Michael J. Quirk of Williams Cuker Berezofsky in Philadelphia and Howard J. Bashman of Willow Grove, Pa. 

PhRMA is represented by Neal K. Katyal, Lindsay Dobrynski Breedlove, Melissa B. Kimmel and Mit Spears of Hogan Lovells in Washington, D.C.  PLAC is represented by Robert B. Murphy of Dykema Gossett in Washington. 

The Pennsylvania Association for Justice is represented by George G. Rassias of Schmidt, Kirifides & Fridkin in Media, Pa., and Andre Mura of the Center for Constitutional Litigation in Washington.

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