Ketek Lawsuit Alleges Sordid History of Pre-Approval Drug Study

NASHVILLE, Tenn. - A lawsuit filed recently by a woman who says she suffered liver damage as a result of taking the antibiotic Ketek alleges that a study designed to test the safety of the drug before its introduction to U.S. markets was tainted with fraud. Hawkins v. Sanofi-Aventis U.S. Inc., et al., No. 06-1146 (M.D. Tenn.).

Kim Hawkins says in a complaint filed Nov. 29 in the U.S. District Court for the Middle District of Tennessee that prior to receiving approval to market Ketek, manufacturer Sanofi-Aventis enlisted the participation of several physicians who failed to accurately report adverse events …