741 F.3d 674
6th Cir.2014Background
- Kelly died from a fentanyl patch-themed overdose; estate sues the patch’s manufacturer in Michigan state-law claims (strict products liability, negligence, misrepresentation, fraud, warranty, and CPAct).
- District court dismissed all claims as immunized under Mich. Comp. Laws § 600.2946(5) governing drug manufacturers; the court treated the patch as a “drug.”
- Issue on appeal is whether the fentanyl patch is a “drug” or a “combination product” under federal regulation, affecting immunity under Michigan law.
- Michigan defines “drug” by federal law (21 U.S.C. § 321(g)(1)); the district court did not account for the 1990 combination-product framework.
- Legislation creates three product categories (drug, device, combination product); the district court’s binary view is incomplete; remand to determine if the patch is a combination product.
- The case also addresses how FDA labeling and agency designations should influence state-law immunities.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Is the fentanyl patch a drug or a combination product under federal law? | Kelly's estate argues the patch may be a combination product and not immune. | Mylan argues the FDA treated the patch as a drug; immunity should apply if it is a drug. | Remand to determine the proper designation (drug vs. combination product). |
| Does Michigan immunity apply if the product is a combination product rather than a drug? | If a combination product, immunity may not apply. | If the product is a drug, immunity applies; the question is proper designation. | Remand needed to classify the patch under FDA rules before immunity ruling. |
| Should FDA labeling/designation control the determination of immune status under Michigan law? | FDA designation should be given deference and not overridden by state-law immunities. | State-law immunity centers on federal definitions; FDA’s primary jurisdiction should control. | Remand to allow FDA-based designation to govern immunity outcome. |
Key Cases Cited
- United States v. Generix Drug Corp., 460 U.S. 453 (1983) (drug vs. device classification context under FDA regime)
- K Mart Corp. v. Cartier, Inc., 486 U.S. 281 (1988) (statutory interpretation requires reading the statute as a whole)
- Tellabs, Inc. v. Makor Issues & Rights, Ltd., 551 U.S. 308 (2007) (court may consider documents incorporated by reference in pleadings on a motion to dismiss)
- Badaracco v. Comm'r, 464 U.S. 386 (1984) (statutory derogations must be narrowly construed)
- Greenberg v. Life Insurance Co. of Virginia, 177 F.3d 507 (6th Cir. 1999) (principle of treating referenced documents at motion-to-dismiss stage with caution)
- Wyeth v. Levine, 555 U.S. 555 (2009) (FDA labeling and drug regulation framework relevance to preemption/labeling)
- Weinberger v. Hynson, Westcott & Dunning, Inc., 412 U.S. 609 (1973) (FDA primary jurisdiction over drug designation)
- Bower v. Johnson & Johnson, 795 F. Supp. 2d 672 (N.D. Ohio 2011) (district court on FDA-regulated patch immunity context)