Pfizer Wins Big Prempro Case In New Jersey

Pfizer Wins Big Prempro Case In New Jersey

October 3rd, 2011 // 2:39 pm @

A New Jersey appeals court late last week ruled that Pfizer cannot be sued by two women who argued that the drugmaker’s hormone replacement therapies caused their breast cancer. The decision upheld a ruling back in 2008 (back story) and, significantly, places a question mark over the fate of more than 150 similar lawsuits that are currently filed in the state.

At issue is whether Pfizer – or more specifically, its Wyeth and Upjohn subsidiaries that were acquired over the past decade – provided adequate warnings of the risk of breast cancer. The decision is a needed win for the drugmaker, which earlier this year set aside nearly $800 million to cover the costs of litigating an estimated 8,000 such cases in federal and state courts around the country (see here).

So far, Pfizer has won about half of the Prempro cases that were decided by juries since trials began five years ago. However, Pfizer has succeeded in having some verdicts tossed after a trial or had awards reduced. Some verdicts, meanwhile, were settled and some are on appeal. Pfizer also won dismissals of more than 3,000 cases before these went to trial.

But the latest ruling surprised the attorney for the two women. “If you happen to be a woman in New Jersey, you don’t get your day in court,’’ Esther Berezofsky, who represents most of the New Jersey women suing Pfizer, tells The Star-Ledger of New Jersey, which first reported the decision. Acknowledging she was “stunned” by the ruling, Berezofsky immediately asked the state Supreme Court to review the case. “We really didn’t want to waste any time. We feel these women have waited long enough. Far too long,’’ she says.

In reaching its decision, the all-female appeals panel concluded there was no evidence the drugmaker misled doctors or patients about the risks associated with Premarin, Prempro and Provera. Writing for the court, Judge Edith Payne said the lower court ruling was “well supported by the evidence and legally unassailable’’ (read the ruling here).

In the initial 2008 decision, state Superior Court Judge Jamie Happas ruled that the plaintiffs failed to provide the specific type of evidence necessary to overcome state law that presumes FDA-approved labeling on the three drugs was adequate. And what is that? “The presumption of an adequate warning based on compliance with FDA regulations will be deemed rebutted only if the following proof is presented: deliberate concealment or nondisclosure of after-acquired knowledge of harmful effects or manipulation of the post-market regulatory process,” according to the 2008 ruling (see here).

Pfizer released a statement to the paper saying the case should decide the fate of the others in New Jersey. “Today’s Appellate Division decision affirming summary judgment is an important victory,’’ said Amy Schulman, executive vice president and general counsel for Pfizer. “The decision was based on a thorough and detailed review of the record and supports our consistent position that these medicines have always carried accurate, science-based, FDA-approved warnings for physicians and patients.’’

However, Berezofsky tells the paper that the court should have conducted its own analysis of the case rather than rely heavily on what Happas wrote in 2008. “It’s hard to fathom why, after three-and-a-half years, there was no independent analysis by the court on the lower court’s opinion,’’ says Berezofsky, who represented the two plaintiffs in this case, Loretta DeBoard and Dora Bailey.

Source: Pharmalot


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