636 F.3d 935
8th Cir.2011Background
- KV manufactured Metoprolol Succinate ER in Missouri and sold it nationwide; Lefaivre, RI resident, purchased it in Rhode Island.
- FDA filed a complaint against KV on March 2, 2009 alleging non-compliance with FDA cGMP standards under the FDCA.
- Consent Decree of Permanent Injunction was entered March 6, 2009; KV admitted no specific admission of claims.
- KV stipulates the drug as sold was adulterated and misbranded under federal law; recalls and destruction of adulterated stock followed.
- Lefaivre sues for implied warranty of merchantability and Missouri MMPA violations, seeking damages tied to value difference between compliant and adulterated drug.
- District court held claim preempted by federal law; this court reverses, holding no implied preemption.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether FDCA preempts Lefaivre’s state claims | Lefaivre argues Wyeth rejects broad preemption | KV urges field/conflict preemption under Buckman | Not impliedly preempted; remand for merits |
| Whether field preemption applies to FDCA claims | State law complements FDA regulation | FDCA occupies field of drug regulation | Field preemption not applicable |
| Whether conflict preemption applies (impossibility/obstacle) | KV cannot comply with both regimes | State law obstructs federal objectives | Conflict preemption rejected; state law queries allowed |
| Whether Buckman forecloses state claims here | Buckman not controlling because claims aren’t fraud-on-FDA | Buckman controls field preemption | Buckman does not bar these state claims |
Key Cases Cited
- Wyeth v. Levine, 555 U.S. 555 (Supreme Court 2009) (FDCA not preempting state-law failure-to-warn claims in Wyeth)
- Buckman Co. v. Plaintiffs' Legal Committee, 531 U.S. 341 (Supreme Court 2001) (fraud-on-the-FDA claims impliedly pre-empted; field preemption analysis)
- Riegel v. Medtronic, Inc., 552 U.S. 312 (Supreme Court 2008) (express preemption for medical devices; conflicts with state tort claims)
- Medtronic, Inc. v. Lohr, 518 U.S. 470 (Supreme Court 1996) (FDA regulation and state tort claims interplay; not decisive here)
- Bonito Boats, Inc. v. Thunder Craft Boats, Inc., 489 U.S. 141 (Supreme Court 1989) (presumption against preemption; tolerance of state-law remedies)
- In re Aurora Dairy Corp. Organic Milk Mktg. & Sales Practices Litig., 621 F.3d 781 (8th Cir. 2010) (presumption against preemption; statutory purpose relevant)
- Wis. Cent. v. Mortier, 501 U.S. 597 (U.S. 1991) (conflict preemption framework; impossibility vs. obstacle)
- Buckman Co. v. Plaintiffs' Legal Committee, 531 U.S. 341 (Supreme Court 2001) (fraud-on-the-FDA claims implicate federal scheme; field preemption)