Pliva, Inc. v. Mensing

Gladys Mensing and Julie Demahy (plaintiffs) sued generic manufacturers of metoclopramide, including Pliva, Inc. (defendant), claiming inadequate warning labels caused their tardive dyskinesia, a serious movement disorder. Under the Hatch-Waxman Amendments, a generic manufacturer must use the same label as its brand-name equivalent and has an ongoing duty to match any label change the brand-name maker makes, rather than independently strengthening its own warning. The Fifth and Eighth Circuits held federal law did not preempt the plaintiffs' state tort claims, reasoning the FDA's changes-being-effected process let manufacturers update labels without prior approval.