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Pfizer Unit Hid Prempro’s Health Risks, Lawyer Says

A Pfizer Inc. unit failed to properly warn doctors and consumers that its Prempro menopause drug could cause breast cancer, a lawyer for an Arkansas woman who developed the disease told jurors.

Officials of Pfizer’s Wyeth subsidiary knew women like Margaret Wilson were at risk for the disease by taking the hormone-replacement drug and kept quiet to pump up sales, Chris Kirchmer, a lawyer for Wilson, told a federal court jury in Little Rock, Arkansas.

After studies showed the risks of Prempro, “they never once changed their warnings,” Kirchmer said today in opening statements in the trial of Wilson’s lawsuit over the drug. “The evidence will show you that they did not act responsibly.”

More than 6 million women took the menopause drugs to treat symptoms such as hot flashes and mood swings before a 2002 study highlighted their links to cancer. Wyeth’s sales of the medicines, which are still on the market, topped $2 billion before the Women’s Health Initiative, a National Institutes of Health-sponsored study, concluded they posed an increased risk of cancer.

Until 1995, many menopausal women combined Premarin, Wyeth’s estrogen-based drug, with Upjohn’s progestin-laden Provera, to relieve their symptoms. Wyeth later combined the two hormones in its Prempro pill.

Safety Label

Wyeth officials contend they provided adequate warnings about Prempro’s cancer risks on the drug’s safety label. Wilson’s lawyers won’t be able to show the pills caused her cancer, said Lyn Pruitt, a lawyer for the company, in her opening statement.

“Mrs. Wilson would have gotten breast cancer whether she took Prempro or not,” said Pruitt of Mitchell Williams Selig Gates & Woodyard in Little Rock. “Prempro didn’t cause it and nobody knows what caused it.”

Pruitt said Wilson had other possible risk factors for cancer. They included her age, weight and menopause as well as having a daughter who died of breast cancer, Pruitt said.

Wyeth has lost seven of the 12 Prempro cases decided by juries since trials began in 2006. The drugmaker got some of those verdicts thrown out after trial or had the awards reduced.

Pfizer also has won dismissals of more than 3,000 cases before trial, according to court filings. Pfizer, the world’s largest drugmaker, completed its $68 billion purchase of Wyeth last year.

Wilson, a 68-year-old bank teller from Trumann, Arkansas, took the drug for six years before being diagnosed with breast cancer in 2002, according to court filings.

‘Corporate Responsibility’

“It is a case about the breast cancer that they caused,” Kirchmer said. “It is a case about corporate responsibility.”

The first witness, Donald Austin, an epidemiologist from the University of Oregon, testified that Prempro causes breast cancer. He said that after the release of the Women’s Health Initiative study, use of Prempro dropped “precipitously” because of concerns over breast cancer.

Wyeth attorney David Dukes asked Austin whether the “vast majority” of women taking hormone replacement therapy drugs don’t get breast cancer. Austin replied that they didn’t.

Austin also acknowledged there are other risk factors for breast cancer, including age, obesity, breast density and having a “first-degree relative,” such as a daughter, who had breast cancer.

8,000 Cases

U.S. District Judge William Wilson, who is presiding over the case, is overseeing more than 8,000 cases over the drugs that have been consolidated in his court for pre-trial information exchanges and some early trials. The plaintiff in the current trial isn’t related to the judge.

Wyeth officials have faced repeated criticism over the marketing of their menopause drugs, including allegations that the company paid for ghostwritten articles in medical journals that overstated the effectiveness of the medicines.

The case is Wilson v. Wyeth, MDL 03-cv-1507-WRW, U.S. District Court, Eastern District of Arkansas (Little Rock).

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