Claims Against Generic Sulindac Maker Federally Preempted, Calif. Federal Judge Rules

SAN JOSE, Calif. — Failure-to-warn claims brought against the maker of sulindac are federally preempted by the Food and Drug Administration’s prohibition on changes to generic drug labels, a California federal judge has ruled.

On Oct. 18, Judge Ronald M. Whyte of the U.S. District Court for the Northern District of California dismissed the plaintiff’s complaint against Mutual Pharmaceutical Co. with prejudice, finding the claims are barred pursuant to PLIVA v. Mensing and Mutual Pharmaceutical Co. v. Bartlett.

On Jan. 17, Josie Ko, acting pro se, filed a form complaint in the Santa Clara County (Calif.) Superior Court, alleging she …