Wyeth Loses $1.5 Million in First Plaintiff Victory of 5,000 Product Liability Lawsuits Against Its Hormone Replacement Drugs


A Philadelphia jury dealt drug manufacturer Wyeth its first official loss with the third verdict among about 5,000 pending product liability lawsuits over the company's hormone replacement drugs. The jury determined that the drug Prempro caused a woman's breast cancer, and awarded the Arkansas woman and her husband $1.5 million.

Mary Daniel of Hot Springs, Arkansas claimed that she developed breast cancer after using Prempro, a combination of estrogen and progestin that treats symptoms of menopause. Daniel used Prempro every other day for 16 months to relieve hot flashes and was later diagnosed with breast cancer in July 2001. After undergoing radiation and chemotherapy treatments, she is now cancer free.

Daniel's personal injury attorney alleged that Wyeth knew of the links between breast cancer and Prempro but failed to conduct in-depth studies to quantify the risk, and ultimately put profits ahead of safety. According to an Associated Press story, Wyeth netted $2 billion a year with Prempro and its other hormone replacement drug Premarin. The drugs were once taken by millions of women after menopause, but many stopped using these allegedly defective drugs after a 2002 Women's Health Initiative study detailed such increased risk factors.

Wyeth claimed during the personal injury case that the company had clearly warned users of the increased risk of breast cancer with using Prempro since first marketing the drug in 1995. They denied any malice and then tried to tie Daniel's breast cancer with other risk factors, including her family's history of the illness and the density of her breasts.

The jury disagreed, finding Wyeth negligent in failing to provide adequate warnings about the risks of Prempro potentially leading to breast cancer. Seven of the eight jurors agreed, as required by Pennsylvania law, and the jury awarded Mary Daniel $1 million and her husband Tom $500,000.

According to a Reuters story, the jury found Wyeth's conduct to be "malicious, wanton, willful or oppressive" and to show "reckless indifference to the interests of others." The jury is also expected to return and decide punitive damages against Wyeth, which had avoided such outcomes in the prior two personal injury verdicts regarding its hormone replacement drugs.

During September 2006, a Federal jury rejected similar claims by another Arkansas woman that Prempro caused her breast cancer and Wyeth acted negligently. Linda Reeves' claim was struck down by the Wyeth argument that Prempro was the only drug at the time to treat her osteoporosis, and that the company had warned Reeves and her doctor of the risk. Reeves admitted that she did not read the warnings on the Prempro product label but rather relied on the guidance of her doctor.

A month after this decision, a Philadelphia jury originally ruled in favor of a 66-year-old woman in a Prempro product liability lawsuit against Wyeth, but the verdict was struck down a week later when a judge in a Pennsylvania state court declared a mistrial. After using Prempro for five years, Jennie Nelson also developed breast cancer. The Philadelphia jury agreed with her claim that Prempro was the cause and awarded her the same compensatory damages as Mary Daniel. The drug company filed a motion and was granted a mistrial. The Pennsylvania judge did not give a reason for the mistrial, and all records in the case were sealed.

While the recent Wyeth product liability verdict is a big win for the involved plaintiffs, it also brings even more interest to the large number of pending cases against the drug maker in connection with its hormone replacement drugs.

These Prempro product liability cases against Wyeth are just one example of the recent wave of cases alleging that drug manufacturers have been less than fully honest about disclosing problems that may result when taking their drugs, but ultimately reveal the sad truth in some cases. Some drug manufacturers have been blinded by profits rather than meeting the best interests of the public, and the results have led to serious problems. Whether it's a recent New York Times story reporting that Eli Whitney urged employees to be quiet about studies finding that its Zyprexa drug increased the risk of diabetes or any other similar situation, such action needs to stop in order to better serve all parties involved.

The Food and Drug Administration (FDA) this week announced new plans for tightening up the science and the exchange of information surrounding drug and medical device risks.

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