Miller Ex Rel. Estate of Kelly v. Mylan Inc.

The Majority finds that there remains a factual determination as to whether the fentanyl patch is a “combination product” under the Food, Drug, and Cosmetic Act. I disagree with the Majority’s interpretation of the Michigan immunity statute and would instead hold that Mylan’s Fentanyl Transdermal System is a “drug” under 21 U.S.C. § 321(g)(1) and therefore Mylan is immune from suit under Michigan law. I respectfully dissent.

Determining whether the Mylan Fenta-nyl Transdermal System should be considered a “drug,” a “device,” or “combination product” requires first looking at the definition of…