The deceased plaintiff in a lawsuit alleging a Wyeth-made hormone replacement therapy drug caused her death from breast cancer has a surviving identical twin who has not had breast cancer.
Both the plaintiffs and the defense attorneys sought to leverage to their advantage the fact that Cheryl Foust's twin sister, Carol, was present and in good health in a Philadelphia Common Pleas courtroom Wednesday. Opening arguments were held in Foust v. Wyeth. Senior Judge Esther R. Sylvester is presiding over the trial.
Plaintiffs attorney James A. Morris Jr. told the jury that Carol Foust, the plaintiff's twin sister, took different hormone replacement therapy drugs than his deceased client did. Carol, with the same DNA as her late sister, was tested for the gene that indicates an increased risk of breast cancer, said Morris, of the Morris Law Firm, which has offices in Philadelphia and Austin, Texas. The test came back negative, he said.
Foust took Prempro, Wyeth's drug combining estrogen-progestin, a synthetic form of progesterone, for four years, Morris said. Foust's widower, Stephen Foust, is also a plaintiff in the case.
One of the main aspects of the plaintiffs' theory is that postmenopausal women with already-damaged breast cells have the growth of their damaged cells fueled into malignant breast cancer by taking hormone replacement therapy drugs. Morris argued that postmenopausal women have their estrogen and progesterone hormonal levels go down dramatically, and that it is only due to the ingestion of a drug like Prempro that Foust's breast cells with receptors for estrogen and progesterone turned into cancer. Foust, of Abington, Ind., died at 56 after her breast cancer metastasized, Morris said.
Defense counsel Beth A. Wilkinson said that 99.62 percent of women who take HRT drugs do not get breast cancer. She said that the living proof of the fact that the vast majority of women who have ingested HRT drugs do not get breast cancer is Cheryl Foust's twin. The studies warning of an increased risk of breast cancer from taking HRT did not pinpoint Prempro but referred to all HRT drugs, including the drugs Carol Foust took, said Wilkinson, of Paul Weiss Rifkind Wharton & Garrison's Washington, D.C., office.
There are about 1,500 HRT cases pending in Philadelphia's mass torts program, the Complex Litigation Center. Other HRT cases have resulted in large plaintiffs' verdicts, including a $79 million verdict in October and a $34 million verdict in November.
Another key aspect of the plaintiffs' theory is that Wyeth "controlled the paradigm" in the medical community's perception of whether the risks of Prempro outweighed the benefits. Morris said Wyeth, now owned by Pfizer, marketed the drug as potentially beneficial for reducing cardiovascular disease in women, and company officials were resistant to studying the breast cancer risk more in-depth because of the potential detrimental market impacts on drug sales, Morris said.
Morris also argued that the federal government's drug regulatory body, the Food and Drug Administration, is understaffed and not robust enough to keep drug companies accountable to adequately warn prescribing medical professionals and their patients.
Hormone replacement therapy received notorious publicity in 2002 when a government-funded study, the Women's Health Initiative, was discontinued because of an increased risk of breast cancer and because the risks of the hormones outweighed the benefits, according to court papers.
If the true context of the drug's benefits and risks had been provided to Foust's treating nurse practitioners, including on the drug label, then Foust would not have used Prempro, Morris argued. "And she wouldn't have died," he said.
"Had Cheryl had different information at that first visit [at which she was prescribed Prempro] ... her whole treatment might have been different," Morris said.
Wilkinson said during her opening that the plaintiffs procured a couple of damning documents during discovery that show that some Wyeth employees or contractors discussed downplaying the risks of breast cancer. But Wilkinson said any workplace has good and bad things written during its operation, and that the company was able to pair its for-profit purpose with a good motive to benefit patients.
Wilkinson asked the jury to rise above "demonizing" Wyeth, and she countered Morris' theme by stating sardonically how easy it was to inspire "anger at a big pharmaceutical company."
"Wow. That's a big shock. That's a hard thing to do," Wilkinson said.
Wilkinson said the jurors must answer three questions: whether Foust's three treating nurse practitioners were adequately warned by Wyeth about the risk of breast cancer from Prempro; whether Foust's nurse practitioners discussed the risks of Prempro with her; and whether the breast cancer risk was widely discussed in the scientific community, public health officials and the media.
Wilkinson showed the jury a 1990s article from Time magazine and a 1995 broadcast with NBC news anchorman Tom Brokaw that stated the downside of taking HRT to treat symptoms of menopause was a higher risk of breast cancer. Wilkinson also told the jury that most of the time doctors are not able to tell their patients the underlying causes for breast cancer, as well as most other types of cancer.
Wilkinson showed the jury depositions from a couple of Foust's treating nurse practitioners in which they said they were aware of the risks of breast cancer from HRT before the WHI study was published.
The defense attorney also sought to personalize Wyeth by saying that she represented the "people of Wyeth" and by introducing the jury to Dr. Ginger Constantine, a Wyeth employee who was in charge of women's health issues.
While the defense is going to argue that there is not a known cause of breast cancer, Prempro caused 200,000 excess breast cancers, Morris claimed to the jury.
"That's the Rose Bowl filled twice with women with breast cancer," Morris said.
Plaintiffs co-counsel are Gregory L. Laker and Jeff Gibson of Cohen & Malad of Indianapolis.
Defense co-counsel is F. Lane Heard III of Williams & Connolly's Washington, D.C., office.
Another hormone replacement therapy trial, Singleton v. Wyeth , started in front of Judge Mark I. Bernstein last week.