Shire Asks 11th Cir. to Reconsider Reinstatement of Colitis Drug Action, Says Claims Preempted

ATLANTA — Shire has asked the 11th Circuit U.S. Court of Appeals to reconsider its reinstatement of a lawsuit in which a man alleged the company’s colitis drug Lialda caused him to develop kidney failure, arguing that it could not unilaterally change the “Highlights” section of the label to add the plaintiff’s proposed testing schedule.

In a Nov. 28 petition for panel rehearing or rehearing en banc, Shire argues that the “Highlights” section cannot be amended by a Changes Being Effected supplement.

Professional golf coach Mark Blackburn was prescribed Lialda, a delayed release mesalamine tablet, in November 2013 to treat …