A New Jersey state court judge granted summary judgment against the claims made by a woman who claims Wyeth's Prempro and Premarin, and Pfizer's Provera, caused her breast cancer. Her lawsuit, which charged the drugmakers failed to adequately warn against the risks associated with their meds, is the first in dozens of such cases and the outcome may call those into question.
In a 52-page decision, Superior Court Judge Jamie Happas ruled that Dora Bailey failed to provide the specific type of evidence necessary to overcome state law that presumes FDA-approved labeling on the three drugs was adequate.
Happas wrote 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." As the Drug and Device Law blog notes, to overcome this presumption, a plaintiff must show substantial evidence, not merely rely on expert testimony.
And so because Bailey was unable to refute the presumption of adequacy about the labeling, Happas granted summary judgment on claims under the state's Product Liability Act. As a result, Bailey's other claims - fraud, misrepresentation, and consumer fraud - were subsumed and no longer exist as separate bases of liability, the Drug and Device Law blog also points out. The judge dismissed a second case on the same grounds. READER NOTE: We learned of this very late in the day and so are unable to obtain comment right now from Bailey's attorneys. When we do, will update accordingly.
UPDATE: On Monday, Wyeth issued this statement.
Hat tip to Drug and Device Law