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Hormone Suits Face Hurdle as Drugs Keep FDA Backing

A study linking the menopausal aids to health risks has led to 3,600 suits. But the pills' continued sale may add to the burden of proof.

November 07, 2005|Molly Selvin | Times Staff Writer

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.

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