Pfizer’s Pharmacia & Upjohn unit failed to properly warn a New Jersey woman about the cancer risk of its hormone-replacement drug Provera and should pay $1.5 million in damages, jurors said in the first trial over the menopause treatment.

A Philadelphia jury deliberated more than six hours today before finding Pharmacia & Upjohn didn’t adequately warn women about Provera’s breast cancer risk. Jurors also ruled that Wyeth did properly warn of the risks of its hormone drugs Premarin and Prempro. It was Wyeth’s third win in six trials over the drugs.

Merle Simon’s claims are the first to go to trial over Provera against the unit of New York-based Pfizer, the world’s largest drugmaker. The drug, on the market since 1959, was developed by Upjohn, which Pfizer acquired in 2003 along with Pharmacia. Pfizer’s lawyers say they will appeal the Philadelphia Court of Common Pleas jury’s decision.

“We don’t believe the verdict is supported by the evidence or medical science,” Jim Pagliaro, a Pfizer lawyer, tells Bloomberg News. “We believe we acted responsibly in regard to this product.”

Simon’s lawsuit was one of at least 5,000 pending against Wyeth over its hormone-replacement drugs, including Prempro and Premarin. Simon is among up to 6 million women who took the pills to treat menopause symptoms such as hot flashes and mood swings before a 2002 study highlighted links to cancer. Pfizer hasn’t disclosed how many Provera cases it faces.

The Women’s Health Initiative study, sponsored by the U.S. National Institutes of Health, concluded women who took a combination of estrogen and progestin, as found in Prempro, had a 24 percent higher risk than others of getting invasive breast cancer.

Until 1996, many menopausal women combined Premarin, which contained estrogen, with Provera, which contains progestin, to relieve their symptoms. In 1996, Wyeth combined the two substances in its Prempro pill.

Simon took the Premarin-Provera combination starting in 1992 and switched to Prempro in 1996, her lawyer told jurors. She stopped taking hormone-replacement drugs after being diagnosed with breast cancer in 2002, said Jim Morris, Simon’s lawyer, who argued that neither company properly warned of breast cancer risks.

Wyeth offered only “wishy-washy” warnings about possible breast cancer while Upjohn’s only warning was that a test on beagles showed some of the dogs did develop the disease. The companies countered that breast-cancer risks associated with their drugs were well known and they included warnings in their labels approved by the FDA to insure doctors had accurate information about the treatments.

Simon’s case is the first hormone-replacement suit to come to trial since February, when another Common Pleas Court jury in Philadelphia ordered Wyeth to pay $3 million in damages to an Ohio woman and her husband who claimed Prempro helped cause her breast cancer.

An earlier jury had awarded the couple $1.5 million on their claims. A judge threw out that verdict because of a juror’s misconduct. Wyeth is appealing the February verdict.

A separate Philadelphia jury ruled in January that an Arkansas woman and her husband were entitled to $1.5 million in damages over her claims that Prempro use caused her breast cancer. Wyeth also is appealing that verdict.

Further reading…
Bloomberg News;
Wyeth statement;
Pfizer statement.[tags]Hormone Replacement Therapy, Pfizer, Pharmacia & Upjohn, Prempro, Provera, Wyeth[/tags]