11th Cir. Refuses to Reconsider Revival of Lialda Kidney Failure Lawsuit

ATLANTA — The 11th Circuit U.S. Court of Appeals has refused to reconsider its reinstatement of a lawsuit in which a man alleged Shire’s colitis drug Lialda caused him to develop kidney failure, letting stand a panel’s ruling that the label’s warnings can be amended by a Changes Being Effected supplement.

On Jan. 6, the appellate court rejected Shire’s argument that it would have been required to seek the FDA’s prior approval to make such a label change; therefore, under U.S. Supreme Court case law, Blackburn’s claim is preempted by federal law.

Professional golf coach Mark Blackburn was prescribed Lialda, …