Pfizer Unit Failed to Warn of HRT Risk, Jury Says

posted on:
May 16, 2007

author:
Staff

A Pfizer Inc. 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.

“We believe the jury’s decision with respect to Wyeth is consistent with the evidence presented and the scientific knowledge concerning hormone therapy,” Chris Garland, a Wyeth spokesman, said.

Simon’s claims were 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 Corp.

Pfizer’s lawyers said they’d 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 lawyer representing Upjohn, said in an interview after the verdict. “We believe we acted responsibly in regard to this product.”

Hot Flashes

Simon is among as many as 6 million women who took the pills to treat menopause symptoms such as hot flashes and mood swings before a 2002 study highlighted their links to cancer.

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.

The company recognized the association “long before the WHI study” and noted it on labels, Garland said in March.

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 Morris told jurors. She stopped taking hormone-replacement drugs after being diagnosed with breast cancer in 2002, he said.

`Wishy-Washy’ Warnings

Jim Morris, Simon’s lawyer, argued during the month-long trial that neither Wyeth nor Upjohn properly warned Simon that she risked breast cancer by taking the menopause treatments.

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 U.S. Food and Drug Administration to insure doctors had accurate information about the treatments.

In their verdict, jurors concluded that Upjohn’s Provera was a cause of Simon’s cancer and the company provided “inadequate warnings” about its health risks. They cleared Wyeth’s drugs of playing any role in Simon’s cancer and found the company properly warned of its risks.

“I think it’s a good verdict and it confirms what we thought all along,” Morris said in an interview after jurors reached their decision.

Other Awards

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.

Shares of Madison, New Jersey-based Wyeth rose 38 cents to $55.67 in New York Stock Exchange composite trading today. The company’s shares have risen 13 percent over the last year. Pfizer’s shares, which have risen 9 percent over the same period,fell 13 cents to $27.10.

Wyeth officials said in January that sales of its hormone- replacement drugs climbed to more than $1 billion in 2006. Sales topped $2 billion, making them Wyeth’s best-selling products, before the Women’s Health Initiative study.

Free Legal Consultation
At Beasley Allen, there is never a fee for legal services, unless we collect for you. Contact us today by filling out a brief questionnaire, or by calling our toll free number, 1-800-898-2034, for a free, no-cost no-obligation evaluation of your case.
back to top