Wyeth Loses Prempro Trial, Ordered to Pay $1.5 Million in Damages

A state jury in Philadelphia on Monday found Wyeth's hormone replacement therapy (HRT) Prempro was responsible for a woman's breast cancer and ordered the U.S. drugmaker to pay $1.5 million in compensatory damages, a court official said.

The jury found that Wyeth was negligent in failing to provide adequate warnings about the breast cancer risk associated with Prempro.

The jury is expected to return on Tuesday to decide punitive damages after also finding that Wyeth's conduct was "malicious, wanton, willful or oppressive or showed reckless indifference to the interest of others" in its failure to provide proper warnings about its HRT drugs, taken by millions of women to treat symptoms of menopause.

Wyeth is facing about 5,000 product liability lawsuits involving its hormone replacement drugs.

"Wyeth protected their bottom dollar instead of protecting the patients," Zoe Littlepage, attorney for plaintiff Mary Daniel, said in a statement.

Daniel, 60, of Hot Springs, Arkansas, began taking Prempro in late 1999, and was diagnosed with breast cancer in July 2001. She underwent two surgeries as well as chemotherapy and radiotherapy for the cancer.

Seven of eight jurors who agreed to the verdict, as required by Pennsylvania law, awarded $1 million to Daniel and $500,000 to her husband. They deliberated for two days following the three-week trial.

Linda Bannister, an analyst at Edward Jones, said Prempro is a minor cloud hanging over the company, with Wyeth's risk limited by the fact that the drug remained on sale. "It's not a situation like Vioxx or fen-phen," she said, referring to the 2004 withdrawal of Merck's arthritis drug Vioxx, and the 1997 recall of two Wyeth drugs used in the fen-phen diet cocktail.

Wyeth has taken more that $21 billion in charges related to fen-phen settlements and litigation.

"If the U.S. Food and Drug Administration advises that a product be removed from the market, a company's (financial) risk is significant," Bannister said, because the product is deemed very defective or potentially harmful.

During the trial before Judge Myrna Field of the Philadelphia Court of Common Pleas, attorneys for Daniel argued that Wyeth was negligent in the testing, manufacture and marketing of Prempro.

Littlepage said Wyeth knew for decades of the cancer risk associated with post-menopausal drugs but failed to conduct studies to quantify the risk.

Attorneys for Wyeth argued that the company had clearly warned users that there was a slightly increased risk of breast cancer from taking Prempro, which was first marketed in 1995 and is still on the market today.

A Wyeth spokesman declined to comment on the verdict.

This was the third Prempro lawsuit to reach a jury verdict. The first, heard in Arkansas last summer, resulted in a win for Wyeth. The drugmaker lost a Prempro trial in Philadelphia last October, but that verdict was thrown out by the judge amid allegations of juror misconduct. That case will be retried.