6th Cir. Asks Trial Court to Determine Whether Mylan Fentanyl Patch is ‘Drug’ or ‘Combination Product’

DETROIT — A 6th Circuit U.S. Court of Appeals majority has reversed dismissal and remanded a Mylan fentanyl patch case for a determination of whether the patch is a “drug,” “device” or “combination product” under federal law.

In a Jan. 21 opinion, the majority explained that if the patch is considered a “drug” approved by the Food and Drug Administration, Mylan would be shielded from liability. If the patch is better defined as a "combination product," Mylan is not immune from suit in Michigan, the majority noted.

Beth Ann Miller sued Mylan Inc., Mylan Pharmaceuticals Inc. and Mylan Technologies …