23 Hormone Replacement Therapy Breast Cancer Lawsuits Dismissed

A New York judge has dismissed 23 hormone replacement therapy lawsuits filed by women diagnosed with breast cancer, saying that the risk of developing breast cancer from the drugs was well known and that the plaintiffs failed to file their lawsuits within the three-year statute of limitations in New York.

The ruling, issued December 14 by New York State Supreme Court Judge Martin Shulman, granted a motion made by attorneys for Pfizer to dismiss the 23 lawsuits brought by women who alleged problems with hormone replacement therapy (HRT) drugs Prempro, Premarin and Provera. The drugs were developed by Wyeth, which was recently acquired by Pfizer. Teva Pharmaceuticals was also a defendant in the cases.

Hormone replacement therapy involves the use of 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 hormone replacement therapy breast cancer lawsuits currently pending throughout the country.

In an order issued earlier this week, Judge Shulman said that the debate over HRT health problems has not yet been settled, but noted that “the potential risk of contracting breast cancer from taking HRT medication was well known at all times out there in the stream of public information.” Shulman determined that the evidence presented by plaintiffs did not contain evidence of fraud or misrepresentation which would have allowed the filings to go forward despite being filed after the state’s three year statute of limitations.

There are currently about 9,000 Prempro lawsuits pending against Pfizer’s Wyeth subsidiary. All of the lawsuits claim that the company failed to adequately warn about the risk of invasive breast cancer from the HRT drugs and that they intentionally hid the cancer risk from women. As a result of Wyeth’s conduct, Pfizer has been hit with several large punitive damage awards.

In two Prempro lawsuits that went to trial in recent months in Philadelphia, juries awarded a combined $103 million in punitive damages to two women who established that Wyeth purposefully hid the risks of breast cancer.

In November, a federal appeals court in St. Louis determined that Wyeth’s actions at attempting to downplay cancer concerns was enough to be presented to a jury as evidence of the need of punitive damages in a case that has already resulted in compensatory damages of $3.75 million.

A New York Times investigation involving recently released documents, discovered a number of instances which appear to show that the drug maker intentionally worked to downplay known cancer risks in the medical community. The newspaper highlighted uncovered documents by Wyeth employees. In one case an employee wrote “Dismiss/distract” on a report about breast cancer risks and HRT.

The New York Times investigation also raises questions about whether the drug manufacturers falsely pumped up the health benefits of HRT to increase sales.

Pfizer has released statements in the wake of the Times piece calling it unfair, saying reporters cherry-picked data. The company also noted that the HRT drugs have long carried label warnings regarding the risk of breast cancer.