Federal Law Preempts Failure-To-Warn, Design Defect Claims Against Generic Lovenox Maker, Ky. Judge Rules

PADUCAH, Ky. — Failure-to-warn and design defect claims brought against the maker of a generic anti-coagulant drug are preempted because they seek to impose the duty to change the drug’s label or composition, which generic drug makers are prohibited from doing, a Kentucky federal judge has ruled.

On Sept. 18, Senior Judge Thomas B. Russell of the U.S. District Court for the Western District of Kentucky dismissed the plaintiff’s entire complaint against Sandoz Inc. in connection with its generic Lovenox (enoxaparin sodium).

Cindy Mitchell sued Sandoz, alleging that after taking the company’s enoxaparin sodium shots from February 2013 through September …