After an hour of deliberation Friday and four weeks of trial, a Philadelphia jury will continue its work today in a lawsuit over whether drugmaker Wyeth's hormonal drug caused an Alabama plaintiff's breast cancer.
The verdict in Singleton v. Wyeth will either continue or disrupt the run of jury verdicts in favor of plaintiffs in Philadelphia hormone-replacement therapy cases. There are 1,500 HRT mass tort cases pending in Philadelphia Common Pleas Court.
Judge Mark I. Bernstein has been presiding over the trial. Plaintiffs Audrey and Charles Singleton, of Chatom, Ala., allege that Audrey Singleton's breast cancer was caused by her use of Wyeth-made Prempro for six years before her diagnosis with breast cancer in January 2004.
Zoe Littlepage of Littlepage Booth in Houston and Samuel Abloeser of Williams Cuker Berezofsky in Philadelphia, among others, represent the Singletons. Heidi Hubbard of Williams & Connolly in Washington, D.C., and David Dukes of Nelson Mullins Riley & Scarborough of Columbia, S.C., among others, represent Wyeth, now owned by Pfizer.
Last fall, a jury awarded $75 million in punitive damages and $3.7 million in compensatory damages to the plaintiffs in Barton v. Wyeth. The total Barton award now stands at $10.6 million after a judicial remittitur. Also last fall, a jury awarded $28 million in punitive damages and $6 million in compensatory damages against Wyeth and Pharmacia & Upjohn in Kendall v. Wyeth.
Three other Philadelphia verdicts in favor of plaintiffs in the HRT litigation were overturned by trial judges and now are on appeal.
During her closing arguments, Littlepage said that Singleton was among the minority of women who become estrogen-deficient after menopause. Singleton's cancer was estrogen-receptor-positive breast cancer that needed hormones in order to grow, and she got those hormones by taking Prempro, she said. Hubbard said women who have never taken a Prempro pill get the same type of ductal, hormone-receptor-positive breast cancer that Singleton did.
Littlepage said defendant Wyeth was allegedly negligent in "experimenting" on "grandmothers" because of its failure to adequately warn doctors and patients of the increased risk of breast cancer from using its hormone replacement therapy drugs, including the combination estrogen-progestin Prempro drug.
Littlepage said Wyeth had no incentive to study any possible breast cancer risk from its HRT drugs because the drugs had made the company a lot of money for decades, and Wyeth lost a lot of money when one of its past products was found to be a cause of cancer in women's wombs.
A reasonable drugmaker, Littlepage said, would have conducted studies to see if there was a greater risk of breast cancer from Prempro. And a reasonable drugmaker, Littlepage said, would have not developed marketing strategies to counteract studies done by others that showed a link between use of HRT and breast cancer. She noted that Wyeth's own documents obtained during discovery talked about ways to "dismiss," "distract," "downplay," "contain," "neutralize," "manage" and "overshadow" scientific studies finding a risk of breast cancer from using Prempro.
Among the evidence showed to the jury was an internal letter from Charles H. Payne, a Wyeth manager in Alabama, who wrote that "'the desire for increased sales has overruled our company's ethical responsibility to promote our products safely."'
Hubbard said that when Payne's allegations were raised, Wyeth conducted an investigation and took action regarding its personnel.
Hubbard also said in her closing that every company has employees who write "stupid" things. But she questioned if any of those documents linked up to Singleton's and her doctor's decision-making.
Hubbard tried to narrow the jury's focus on what Singleton's doctor, Dr. Steven Donald, did, and what information Singleton and her doctor actually received. Hubbard also noted that Singleton did not go to get mammograms from 1997 to 2004, so there is no evidence from mammograms to know what might have caused her breast cancer.
In order to have drugs like antibiotics, patients must make the choice to take the drugs for the benefits the drugs provide -- after weighing the risks of taking the drugs, Hubbard said.
Prempro and similar hormonal drugs are the single best federal Food and Drug Administration-approved drugs for treating severe menopausal symptoms like vaginal dryness, hot flashes and severe fatigue like Singleton had, Hubbard argued.
"Patient health care is about choice," Hubbard said. "It's also about responsibility. It's not a one-party responsibility. It's not a two-party responsibility. It's a three-party responsibility" of the doctors, patients and drug manufacturers.
Littlepage said in her closing that, while Wyeth says that the use of its HRT requires a benefit-risk analysis by its users and the doctors prescribing drugs to patients, Wyeth's customers and prescribing doctors can't make the right decisions without truthful information.
Wyeth "contaminated" multiple sources of information for doctors about Prempro, she said, with the false message that adding progestin with estrogen in a drug to treat menopausal symptoms in women was not known to increase breast cancer.
But there were contraindications that this information was incorrect, which is why Wyeth's actions were negligent, and worse wanton and deserving of punitive damages, Littlepage said.