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Wyeth Prempro ruling upheld

A US court has upheld a previous ruling that Wyeth must pay $57.6m compensation to hormone-replacement therapy patients diagnosed with breast cancer

The Supreme Court of Nevada has upheld an earlier district court ruling that Wyeth, which was recently acquired by Pfizer, must pay a total of $57.6m in compensation to three hormone-replacement therapy patients who filed lawsuits in 2004 after being diagnosed with breast cancer. 

A spokesman for Pfizer said the company is considering further appealing the ruling.

The plaintiffs in the lawsuit were long-term users of Wyeth's estrogen-progestin combination hormone replacement therapy, marketed as Prempro. Their lawsuit was one of thousands filed after a 2002 study sponsored by the US National Institutes of Health (NIH) showed a marked increase in the risk of breast cancer with the therapy, which is used to treat hot flashes and other symptoms of menopause.

Wyeth appealed the Nevada district court ruling, arguing that the company's compliance with federal regulations should shield it from having to pay punitive damages. The company also maintained that the amount of the award was excessive and that the plaintiffs' claims were not supported by substantial evidence.

However, the state supreme court determined that "substantial evidence supports the jury's conclusion that Wyeth acted with malice,” according to a copy of the ruling. The ruling upholds the earlier conclusions that Wyeth did not perform sufficient testing on the breast cancer link and did not offer strong enough cautions on the products' labelling to accurately reflect the data that did exist.

"The evidence shows that while the words 'breast cancer' appear ten times in the Prempro label, in many instances the term appeared in reassuring statements,” the Supreme Court ruling states.

"For instance, the warning stated that the relationship between progestin and breast cancer is unknown, that the majority of studies show no increase in breast cancer risk, and that the rate of breast cancer that showed up in Wyeth's human study did 'not exceed that expected in the general population.'" 

These warnings were not a sufficient response to scientific data that confirmed an increased risk in breast cancer with prolonged use, according to the ruling.

The ruling also points to Wyeth's marketing and communications strategies as elements of the company's wrongdoing. "Over the years, Wyeth organised task forces to contain any negative publicity about hormone therapy and breast cancer,”"it states. "Wyeth's strategy to undermine scientific studies linking an increased risk of breast cancer to estrogen-progestin hormone therapy included ghostwriting multiple articles."

26th November 2010

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