Judge Says HRT Labels Presumed Adequate Under New Jersey Law

NEW BRUNSWICK, N.J. - A New Jersey judge has awarded summary judgment to defendants in two hormone replacement therapy cases after determining that the plaintiffs failed to provide evidence to rebut the assumption that the warning labels on three FDA-approved HRT drugs were adequate. Bailey v. Wyeth Inc., et al., No. MID-L-0999-06 MT (N.J. Super. Ct., Middlesex Cty.).

Judge Jamie D. Happas of the Middlesex County Superior Court said in a July 11 ruling that the FDA has been actively involved in the labeling and monitoring of Premarin, Provera and Prempro for decades, and made deliberate and informed decisions about …