A lawsuit filed in Miami-Dade county in July of 2002 was certified as a class action in February of 2005. The suit seeks court-supervised, company-paid medical monitoring for 300,000 Florida women who took the hormone-replacement drug Prempro.

A study released by the Women’s Health Initiative in 2002 found that Prempro, a hormone-replacement therapy drug containing conjugated estrogen plus progestrin, was statistically associated with a 41% increase in strokes, a 29% increase in heart attacks, a 100% increase in blood clots, a 22% increase in total cardiovascular disease, and a 26% increase in breast cancer among 16,000 clinical study trial participants.

After the study results were published, prescriptions for the drug dropped over 75%. Prempro is still on the market, but the FDA mandated warnings that doctors notify patients of the increased risks of the dangerous side effects found in this study prior to recommending the drug.

The Florida suit alleges negligence on the part of Wyeth, Inc., for failing to provide consumers with adequate warning of the drug’s potential effects and for continuing to market and distribute it after the study’s release. Without monitoring, which would include MRI tests, CT scans, and biopsies, nearly 9,000 of the 300,000 women who took the drug may develop otherwise preventable illnesses in the next decade as a result of taking Prempro.

The lawsuit was certified as a class action by Judge Lawrence Schwartz of Miami-Dade County. Wyeth is appealing the decision. Wyeth contends the findings of the study do not justify the patient’s demands for monitoring.

Source: Dan Lynch, “Wyeth Fights Class Status for Prempro Suit in Miami,” Daily Business Review, March 24, 2005.