An Allegheny County judge has ruled that the "different manufacturers exception" to 21 U.S.C. Section 355(j)(2)(A)(v), which permits a generic drugmaker’s warning label to deviate from the brand-name manufacturer’s label in certain respects, does not allow generic manufacturers to include warnings that are not also disclosed on the brand-name equivalent’s label.
In Krelic v. Mutual Pharmaceuticals, Allegheny County Court of Common Pleas Senior Judge R. Stanton Wettick Jr. granted defendant Mutual Pharmaceuticals’ motion to dismiss the plaintiffs’ failure-to-warn claims on the grounds that the claims were pre-empted by federal law.
