Court Restores $28 Million Punitives Award in HRT Case

The Ruling

The panel of the Superior Court said that in the case of Kendall v. Wyeth, the punitive damages award of $28 million was in a 4.44:1 ratio to the compensatory damages award of $6.3 million. “A 4.44:1 ratio between punitive and compensatory damages satisfies due process,” Judge Ford Elliott wrote for the Superior Court in an unpublished decision.

But the court rejected the punitive damages award of $75 million in Barton v. Wyeth, which in contrast was about 20 times the compensatory damages award of $3.75 million. In a footnote in the Barton opinion, Ford Elliott explained that Donna Kendall, unlike Connie J. Barton, had “suffered unusually devastating physical and emotional injuries, including a double mastectomy, serious complications from reconstructive surgery, and a 75 percent chance of recurrence” of her breast cancer.

The Superior Court's remittitur of Barton's award results in a 2:1 ratio between punitive and compensatory damages, Ford Elliott said. The panel applied Illinois law in both cases.

Illinois Law

Under Illinois law, punitive damages are reviewed in the context of the “'nature and enormity of the wrong, the financial status of the defendant and the defendant's potential liability,'” Ford Elliott said. The judge also opined that “it is true, as Barton argued in the lower court, that the jury's award of $75 million in punitive damages represents just .39 of 1 percent of Wyeth's overall net worth. However, it is equally true that due to thousands of lawsuits filed across the country by plaintiffs who allegedly contracted breast cancer as the result of ingesting Wyeth's HRT drugs including Prempro, Wyeth faces an enormous potential liability for its conduct. This factor clearly militates in favor of remittitur. If Wyeth were to face punitive damages in the range of $75 million in every case in which the plaintiff prevails, it would soon be driven into bankruptcy.”

Punitive Damages

The evidence in support of punitive damages, Ford Elliott said in Kendall, included that “Wyeth sought to actively suppress information, instructing its sales representative not to discuss the matter with physicians, and sponsoring ghostwritten articles denying any causative link between Premarin/Prempro and breast cancer. … Wyeth's overarching concern was profit, with the stated goal of having a majority of women in the world taking its products for the rest of their lives, in spite of the known risks.”

The evidence in support of punitive damages regarding Upjohn, Ford Elliott said in Kendall, included that “the FDA repeatedly denied Upjohn's applications for approval of Provera in combination with exogenous estrogens, citing a lack of sufficient studies and data. Despite this, Upjohn chose not to study Provera in combination with estrogen but continued to promote the use of Provera in combination with estrogens … sending advertisements directly to physicians. Although physicians were free to prescribe E+P, it was an off-label use and Upjohn was forbidden from promoting or advertising for it.”

Philadelphia Common Pleas Court Senior Judge Norman Ackerman remitted the Barton award to $10.6 million. Philadelphia Common Pleas Court Senior Judge Victor J. DiNubile Jr. remitted the punitive damages award to $1 million in Kendall.

Wyeth and Upjohn each argued that jurors should have been instructed that plaintiffs had the burden of showing that their physicians would have made different prescribing decisions based on the drugs' warnings, Ford Elliott said. But the judge said that, under Illinois law, the learned intermediary doctrine does not apply if a doctor was insufficiently warned.

Howard Bashman, a Willow Grove, PA, solo practitioner who is appellate counsel for Kendall, said one thing that was important about the decision was its rejection of the argument that because the HRT drugs were approved by the federal Food and Drug Administration and had been subject to some study, punitive damages should be rejected as a matter of law. The state Supreme Court has granted allocatur in Daniel v. Wyeth on the question of whether punitive damages should be disallowed under Pennsylvania law when the FDA approved a prescription drug, the drug's warning label and the testing behind the drug.

Amaris Elliott-Engel can be contacted at 215-557-2354 or [email protected]. This article also appeared in The Legal Intelligencer, an ALM sister publication of this newsletter.

The Pennsylvania Superior Court has restored the $28 million in punitive damages a Philadelphia jury awarded to an Illinois plaintiff who said drugmakers Wyeth and Pharmacia & Upjohn Inc. failed to warn her doctor of the risks of breast cancer from using hormonal drugs, which are often prescribe to ease women's menopausal symptoms. The trial judge had reduced the punitive damages award to $1 million.

In a companion opinion, the same Superior Court panel reduced the $75 million in punitive damages awarded to another Illinois plaintiff who also alleged Wyeth failed to warn prescribing physicians of the substantially increased risk of breast cancer from using estrogen- and progesterone-related hormone-replacement therapy drugs.

The trial judge had remitted the punitive damages award in that case to $5.62 million, but the Superior Court remitted the punitive damages award to $7.49 million. Wyeth was found 60% liable for the plaintiff's injuries and Upjohn was found 40% liable for the plaintiff's injuries. Wyeth and Upjohn are now both subsidiaries of Pfizer.

The Ruling

The panel of the Superior Court said that in the case of Kendall v. Wyeth, the punitive damages award of $28 million was in a 4.44:1 ratio to the compensatory damages award of $6.3 million. “A 4.44:1 ratio between punitive and compensatory damages satisfies due process,” Judge Ford Elliott wrote for the Superior Court in an unpublished decision.

But the court rejected the punitive damages award of $75 million in Barton v. Wyeth, which in contrast was about 20 times the compensatory damages award of $3.75 million. In a footnote in the Barton opinion, Ford Elliott explained that Donna Kendall, unlike Connie J. Barton, had “suffered unusually devastating physical and emotional injuries, including a double mastectomy, serious complications from reconstructive surgery, and a 75 percent chance of recurrence” of her breast cancer.

The Superior Court's remittitur of Barton's award results in a 2:1 ratio between punitive and compensatory damages, Ford Elliott said. The panel applied Illinois law in both cases.

Illinois Law

Under Illinois law, punitive damages are reviewed in the context of the “'nature and enormity of the wrong, the financial status of the defendant and the defendant's potential liability,'” Ford Elliott said. The judge also opined that “it is true, as Barton argued in the lower court, that the jury's award of $75 million in punitive damages represents just .39 of 1 percent of Wyeth's overall net worth. However, it is equally true that due to thousands of lawsuits filed across the country by plaintiffs who allegedly contracted breast cancer as the result of ingesting Wyeth's HRT drugs including Prempro, Wyeth faces an enormous potential liability for its conduct. This factor clearly militates in favor of remittitur. If Wyeth were to face punitive damages in the range of $75 million in every case in which the plaintiff prevails, it would soon be driven into bankruptcy.”

Punitive Damages

The evidence in support of punitive damages, Ford Elliott said in Kendall, included that “Wyeth sought to actively suppress information, instructing its sales representative not to discuss the matter with physicians, and sponsoring ghostwritten articles denying any causative link between Premarin/Prempro and breast cancer. … Wyeth's overarching concern was profit, with the stated goal of having a majority of women in the world taking its products for the rest of their lives, in spite of the known risks.”

The evidence in support of punitive damages regarding Upjohn, Ford Elliott said in Kendall, included that “the FDA repeatedly denied Upjohn's applications for approval of Provera in combination with exogenous estrogens, citing a lack of sufficient studies and data. Despite this, Upjohn chose not to study Provera in combination with estrogen but continued to promote the use of Provera in combination with estrogens … sending advertisements directly to physicians. Although physicians were free to prescribe E+P, it was an off-label use and Upjohn was forbidden from promoting or advertising for it.”

Philadelphia Common Pleas Court Senior Judge Norman Ackerman remitted the Barton award to $10.6 million. Philadelphia Common Pleas Court Senior Judge Victor J. DiNubile Jr. remitted the punitive damages award to $1 million in Kendall.

Wyeth and Upjohn each argued that jurors should have been instructed that plaintiffs had the burden of showing that their physicians would have made different prescribing decisions based on the drugs' warnings, Ford Elliott said. But the judge said that, under Illinois law, the learned intermediary doctrine does not apply if a doctor was insufficiently warned.

Howard Bashman, a Willow Grove, PA, solo practitioner who is appellate counsel for Kendall, said one thing that was important about the decision was its rejection of the argument that because the HRT drugs were approved by the federal Food and Drug Administration and had been subject to some study, punitive damages should be rejected as a matter of law. The state Supreme Court has granted allocatur in Daniel v. Wyeth on the question of whether punitive damages should be disallowed under Pennsylvania law when the FDA approved a prescription drug, the drug's warning label and the testing behind the drug.

Amaris Elliott-Engel can be contacted at 215-557-2354 or [email protected]. This article also appeared in The Legal Intelligencer, an ALM sister publication of this newsletter.