Hormone Suits Face Hurdle as Drugs Keep FDA Backing
The bad news came on July 9, 2002: Scientists had abruptly halted a major study of hormone-replacement drugs for menopausal women after finding links to breast cancer and blood clots.
Santa Monica gynecologist Karen Blanchard remembers that summer as “horrible. We received at least 20 calls a day from hysterically upset patients, and many, many women stopped taking hormones.”
Next, following a now-familiar pattern, came the lawyers. Over the last three years, some 3,600 cases have been filed against Wyeth, Upjohn, Pfizer Inc. and other companies over estrogen drugs women took to ease menopausal symptoms.
But somewhere along the line, this controversy departed from the usual script: The hormone medication -- unlike other drugs that have inspired waves of litigation, such as Wyeth’s “fen-phen” and Merck & Co.'s Vioxx -- is still on the market. It’s still approved by the Food and Drug Administration as safe and effective.
And although sales have declined dramatically since 2002, doctors wrote more than 40 million prescriptions for the pills last year alone. Many women consider them a godsend.
This creates a challenge for the plaintiffs’ lawyers.
The fact that the hormone medication is still on the market “implies that it must be pretty safe,” and this probably will help drug-company lawyers appeal to jurors, said Robert MacCoun, a professor at UC Berkeley’s law school.
The availability means that plaintiffs’ attorneys “have to tell a more complicated story of why regulators haven’t done their job.”
Plaintiffs’ attorneys contend that none of this changes the link between hormone pills and serious health concerns.
“The scientific evidence is substantial and it indicates that hormone replacement therapy causes breast cancer,” Sherman Oaks lawyer Howard Snyder said.
Juries also will recognize that many plaintiffs have been left emotionally scarred, Snyder said. “There’s a lengthy period when you’re in the dark about whether you’ll live or die. It’s a very difficult road for these women and for their families.”
Trial for the first plaintiffs in federal court could get underway in July. Lawyers on both sides expect that the jury verdicts or settlements in those cases could set benchmarks for the other pending hormone-replacement cases.
Most of the 3,000 suits filed in federal District Courts around the country have been collected before U.S. District Judge William Wilson Jr. in Little Rock, Ark., for pretrial discovery. Several hundred other hormone cases are before state court judges in New Jersey, where Wyeth is headquartered, and in Pennsylvania.
Investors do not appear worried about how hormone suits will affect the drug companies.
“I don’t see this litigation as anywhere near as big as fen-phen or Vioxx,” said Jason Napodano, a senior analyst at Zach’s Investment Research. “This is just part of doing business in the pharmaceutical market.”
For half a century, hormone pills were fixtures in medicine cabinets of women of a certain age. Tens of millions of American women have taken some form of the estrogen-progestin mix to temper the drenching night sweats, insomnia, heavy bleeding and other bedeviling symptoms of menopause.
Women often stayed on the regimen for years, convinced by their doctors -- and a steady barrage of ads -- that the pills also would ward off wrinkles, brittle bones, heart disease and other ravages of age.
Marketed as Premarin, Prempro and Provera, hormone-therapy drugs were so widely prescribed that they long ranked among the top-selling pharmaceuticals -- until the 2002 study.
Drug makers contend that the study was flawed because so many of the women were in their 60s or 70s, or they were smokers or had high blood pressure or other risk factors for cancer and vascular disease.
Wyeth’s senior corporate counsel, Mark Lynch, also said that doctors and patients had been warned about the breast cancer link. “That information had been on the Prempro label since 1995,” he said.
Santa Monica plaintiffs’ lawyer Gary M. Paul disagrees. “No one had ever indicated either to the doctors or to the women how much of an increase there was for breast cancer from using this medication,” he said.
Regardless, news of the study was enough to persuade thousands of women to stop taking the drugs.
One was Fran Yeoman of Pacific Palisades. The retired bookkeeper, 67, took the drugs for eight years to cope with insomnia and occasional hot flashes and said they were “wonderful.”
Yeoman swallowed her last pill in July 2002 when she had to temporarily stop all medications before hip replacement surgery.
Days after her surgery came news of the study linking the hormone drugs to health problems. “I called my gynecologist and told her I didn’t want to go back on it.”
Later that year Yeoman learned she had breast cancer, and she has since sued several drug companies.
After a lumpectomy and radiation treatment, Yeoman says she is “perfectly fine,” but she recalls that the diagnosis “absolutely floored” her. “I never smoked, don’t drink coffee and I haven’t had red meat in 22 years.”
Many women, however, were not as alarmed by the 2002 study.
Ellen Goldstein, for example, checked with her gynecologist after the study’s findings were released to discuss the risks and has seen her regularly since then. Each time, Goldstein said, the two women have agreed that she should stay on the medication.
“I don’t feel I’m putting myself in any danger whatsoever,” said Goldstein, a 56-year-old government relations executive in Washington. “I don’t lose a wink of sleep.”
She remains on a lower-dose formulation of the drug, which Wyeth began marketing in June 2003, and calls it “incredibly helpful.”
Like many women in their 50s, Goldstein concluded that the 2002 study results did not apply to her because she was younger than most of the patients in the trial.
Indeed, for younger women, “the jury’s still out, frankly, on whether hormone therapy has the risks that are being described,” said Phyllis Greenberger, president of the Society for Women’s Health Research, a Washington-based group advocating for more clinical studies of women’s health concerns.
This uncertainty about the 2002 study, however, has not ended the bad news for hormone pill makers. Later studies have linked the drugs to higher risks for dementia and stroke.
Attitudes also are changing toward menopause, which many now consider a normal life stage not generally needing treatment.
The result has been a steady slide in the number of women taking estrogen or estrogen-progestin drugs. Nearly 25 million prescriptions were written during the first eight months of 2005, according to IMS Health Inc., a pharmaceutical information company. More than 45 million were written during the same period before the 2002 study ended.
But the gloomy sales news for pharmaceutical makers may not necessarily translate to courtroom victories for Yeoman and other plaintiffs. Experts say the drugs’ continued use by some women creates a problem for lawyers who represent the breast cancer plaintiffs.
“The easiest cases for plaintiffs are ones in which the product never should have been marketed because it was too dangerous from the get-go,” said Stephen Sugarman, who studies product liability at UC Berkeley’s law school.
Given the large number of women still taking hormones, Sugarman believes that plaintiffs’ lawyers must convince juries that drug companies knew the drugs were riskier for some women than for others but didn’t tell doctors.
They also will have to show that their clients fit the profile of women especially at risk, he said. That burden makes these cases more difficult, “but definitely not insurmountable for the plaintiffs,” he said.
For that reason, plaintiffs’ attorneys say they are carefully screening the medical records of potential plaintiffs before filing cases. Often they look for women who developed certain kinds of cancer tumors and have no family history of the disease.
“Science indicates you need to have certain kinds of markers in the tumor to have a legitimate case,” said Paul, the Santa Monica plaintiffs’ attorney.
At least partly mitigating the murkiness of the scientific evidence is what John C. Coffee, a professor at Columbia Law School who studies mass litigation, called “the human heartthrob evidence.”
Jurors might look at cancer patients, he said, “and think, shall we leave them nothing or can we look at this deep-pocket company?”