Prempro Hormone Replacement Therapy Lawsuit Award Upheld on Appeal

A $58 million award against Pfizer’s Wyeth unit in a Prempro lawsuit has been upheld by the Nevada Supreme Court, which stated in its opinion that it was clear the drug makers knew and tried to suppress information on hormone replacement therapy’s (HRT) links to breast cancer. 

The unanimous court ruling (pdf), issued on November 24, affirms a 2007 verdict in favor of three women: Pamela Forrester, Arlene Rowatt and Jeraldine Scofield. Forrester and Rowatt have since died.

Justice Michael Cherry wrote in the opinion that while the lower court did err in a couple places, none of them led to any harm during the case and did not justify overturning the verdict. In addition, Cherry wrote that it was clear Wyeth knew about HRT’s connection to breast cancer for years and tried to downplay it as much as possible, giving sufficient reason for the large punitive damage penalties against the company.

“Internal Wyeth documents show that it responded to studies suggesting a possible breast cancer risk by downplaying the risk through public relations campaigns and its sales representatives’ interactions with physicians,” Cherry wrote. “Wyeth also created an internal task force to counteract such findings.”

Prempro is a hormone replacement therapy (HRT) that contains a combination of the drugs Provera and Premarin. The drug was originally developed by Wyeth, which was acquired by Pfizer last year. HRTs use hormones and progestins to artificially boost hormone levels in women undergoing menopause due to surgery or in postmenopausal women, to provide relief from symptoms such as hot flashes, irregular menstruation or weight gain.

In 2002 the National Institutes of Health released the results of studies that found women receiving HRT were at higher risk of breast cancer, strokes and heart attacks. The studies, part of the Women’s Health Initiative, sparked most of the Prempro hormone replacement therapy lawsuits currently pending throughout the country.

Cherry notes that in 1992, an FDA advisory committee decided there was insufficient data to determine whether progestin and estrogen combined increased breast cancer risk. Internal documents from Wyeth at the time show that the company celebrated its efforts to influence that conclusion.

There are now about 9,000 lawsuits over Prempro hormone replacement therapy pending against Pfizer’s Wyeth unit by women who claim that they developed breast cancer from the medication. Wyeth has lost five of the last seven cases that have gone to trial, resulting in tens of millions of dollars in compensatory and punitive damages. The punitive damages have been awarded by juries who saw Wyeth’s behavior as reckless disregard for the risk of injury to consumers.