Trials to Begin Over Wyeth Menopause Drug

Pharmaceuticals maker Wyeth, still resolving legal claims over a deadly diet drug, now faces lawsuits alleging that its menopause treatments can cause breast cancer.

The first of more than 5,000 suits over Wyeth’s hormone replacement drugs goes to trial today in federal court in Little Rock, Ark. The second is scheduled to begin in September in state court in Philadelphia.

The plaintiffs will argue that Wyeth misled them through deceptive marketing about the risks of Prempro, a pill containing the hormones estrogen and progestin. As many as 6 million women were taking Prempro to treat menopause symptoms such as hot flashes and mood swings before the product was linked to the cancer in a 2002 study.

“Doctors and women were led to believe that this drug was the fountain of youth,” said Tobias Millrood, a partner at Schiffrin & Barroway in Radnor, Pa.

“Post-menopausal women were preyed upon by Wyeth,” Millrood said May 2 before a judge imposed a gag order on participants in the case. Millrood’s law firm represents 1,000 of the 6,000 women suing Wyeth.

Wyeth’s lawyers insisted the company conducted extensive safety tests on the drugs and marketed them properly. The Madison, N.J.-based drug maker has vowed to fight each case.

The new round of lawsuits may cost Wyeth “in the billions of dollars,” Millrood said. The costs will come on top of the more than $21 billion Wyeth has paid in settlements and legal fees related to claims that the now-withdrawn diet combination fen-phen caused heart and lung damage.

Wyeth’s stock market value fell more than 55%, or $48 billion, in three months after a 2002 U.S. government study showed that women taking hormone replacement drugs like Prempro had a higher risk of breast cancer.

The stock has since regained about half the decline. This year, Wyeth shares are up 3%, underperforming a 7.5% gain in the 14-member Standard & Poor’s 500 pharmaceutical index. The shares fell 19 cents to $47.26 on Friday.

The Prempro suits include cases in federal court in Arkansas and state courts nationwide, Wyeth spokesman Chris Garland said. Some of the suits also involve Wyeth’s Premarin, an estrogen-only pill that was taken in combination with progestin. Wyeth hasn’t said whether it would fund a reserve for legal costs.

Some suits were expanded to include other manufacturers of hormone replacement therapy drugs, including Pfizer Inc., Bristol-Myers Squibb Co. and Barr Pharmaceuticals Inc., based on court filings. Pfizer spokesman Bryant Haskins and Bristol-Myers spokesman Jeff MacDonald declined to comment. Barr spokeswoman Carol Cox called the cases “without merit” and said they may not involve Barr products.

Among the first cases to go to court will be that of a 67-year-old Ohio woman who allegedly contracted breast cancer and needed a double mastectomy after taking Wyeth’s Prempro for six years, attorney Millrood said. Plaintiffs are asking to be reimbursed for years of medical treatment, breast cancer surgery, lost wages and pain and suffering, he said. In some cases users died of breast cancer.

The lawsuits started after a study sponsored by the National Institutes of Health found that women getting a combination of estrogen and progestin as found in Prempro had a 24% higher risk of invasive breast cancer. In an average year, that would mean an additional eight cases for every 10,000 women, according to the NIH’s website.

Prempro sales plummeted 82% following the NIH report, according to data provider Verispan, based in Yardley, Pa.

Wyeth conducted more than 300 studies in which women were given mammograms and monitored for breast cancer risk, said Heidi Hubbard, an outside attorney representing Wyeth.

“The risk is actually lower than the risk of getting a brain hemorrhage from aspirin,” Hubbard said in a phone interview. Studies showed that Prempro increased a 50-year-old woman’s risk of developing breast cancer over 10 years to 2.48% from 2%, she said.

Lawyers for users of the hormone-replacement drugs are likely to focus on claims that Wyeth inappropriately promoted the products and failed to properly warn women of their risk, said Dan Cahoy, an assistant professor of business law at Penn State University, who isn’t involved in the litigation.

Wyeth spent $34.8 million in 2000 advertising Prempro as a treatment for post-menopausal women, according to Nielsen Monitor-Plus. The promotions used celebrities to warn of the consequences of not taking Prempro during menopause.

Wyeth said it would be hard for plaintiffs to prove that any one case of breast cancer was caused by its products. People suing Merck & Co. have similarly found it difficult to show that the painkiller Vioxx caused their heart attacks. Merck withdrew the product in 2004, after a company study linked Vioxx to an elevated risk of heart attacks and strokes.

Lawyers pressing claims over Prempro and Premarin may benefit from years of adverse publicity over Wyeth’s handling of fen-phen. Wyeth withdrew the medicines, sold as Pondimin and Redux, in 1997 after researchers found they damaged some users’ hearts and left others with an often fatal lung disorder.

Wyeth has faced more than 175,000 fen-phen claims since withdrawing the drugs, plaintiffs’ lawyers say. Over the last nine years, the company has settled many of the claims without forcing former users to file suit, said Charles Parker, a Houston lawyer who represented fen-phen claimants who have settled their cases.

“I think because of all the attention paid to fen-phen, juries are certainly more willing to question drug makers’ actions than they were nine or 10 years ago,” Parker said. “This could hurt Wyeth in these Prempro and Premarin cases.”

Wyeth’s lawyers contend that the litigation over the hormone-replacement drugs involves a much smaller number of suits than were filed by former fen-phen users.