Court Decision Threatens New Jersey Prempro Breast Cancer Litigation

About 150 hormone replacement therapy (HRT) lawsuits pending in New Jersey state court may be in jeopardy after an appeals court upheld the dismissal of claims that the manufacturers of Prempro, Provera and Premarin failed to adequately warn consumers about the risk of breast cancer and misled federal regulators. 

A panel of New Jersey appellate court judges maintained the dismissal of a Prempro breast cancer lawsuit brought by two women; Loretta DeBoard and Dora Bailey.

Although, the decision could impact similar cases pending in New Jersey state court, it will have no impact on lawsuits over the HRT medications outside the state, where thousands of other cases are pending.

Attorneys for the plaintiffs have indicated that they will appeal the decision to the state supreme court.

The lawsuit, filed against Pfizer’s Wyeth and UpJohn subsidiaries, was originally dismissed by Superior Court Judge Jamie Happas in 2008. Happas ruled that the plaintiffs failed to present sufficient evidence that the companies hid data from the FDA showing that they knew HRT caused breast cancer and also failed to prove that the companies did not properly comply with labeling requirements for the drugs. The appeals court said Happas’ decision was “supported by the evidence and legally unassailable”.

The decision comes several months after a U.S. Supreme Court decision in June that upheld a Prempro lawsuit verdict that awarded $58 million to three women in Nevada, who raised similar allegations. 

Prempro contains a combination of the drugs Provera and Premarin, to artificially boost hormone levels in women undergoing menopause due to surgery or in postmenopausal women. Known as hormone replacement therapy, or HRT, the drugs are designed to provide relief from symptoms such as hot flashes, irregular menstruation or weight gain.

About 10,000 Prempro lawsuits have been filed against Pfizer’s subsidiaries, all involving similar allegations that the drug makers failed to adequately research the side effects of Prempro or warn that the medication may increase the risk of breast cancer.

Most of the complaints were filed after a 2002 study by the National Institutes of Health found that women receiving hormone replacement therapy (HRT) were at a higher risk of breast cancer, strokes and heart attacks. By that time, Prempro and other HRT drugs had been used by more than 6 million women.

A number of Prempro trials have resulted in multi-million dollar compensatory awards against the drug maker and even larger punitive damage awards after juries determined that Wyeth intentionally hid the risk of breast cancer from Prempro.

Pfizer has previously indicated that Prempro settlements have been reached in roughly one-third of the claims brought on behalf of women diagnosed with breast cancer. Another 3,000 of the cases have been dismissed. However, the company continues to battle the Prempro breast cancer litigation in a number of state and federal courts.