STORY FROM: Drugs & Medical Devices

Lialda Kidney Damage Lawsuit to Proceed Against Shire in Alabama Federal Court

BIRMINGHAM, Ala. — State law claims accusing the maker of Lialda of failing to recommend monthly testing of kidney function are not preempted because there is evidence that the label could have been changed without FDA approval, an Alabama federal judge has ruled.

On May 8, Judge R. David Proctor of the U.S. District Court for the Northern District of Alabama said the plaintiff plausibly pled the existence of “newly acquired information” that would have allowed Shire US Inc. to make the label change via the Changes Being Effected regulation.

However, the judge dismissed the plaintiff’s breach of express warranty ...

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