LeFaivre v. KV Pharmaceutical Co.
2011 WL 722404
8th Cir.2011Background
- KV manufactured Metoprolol Succinate ER in Missouri for national markets; Lefaivre, Rhode Island resident, purchased it at Rhode Island retail pharmacies.
- FDA filed a complaint against KV on March 2, 2009 alleging noncompliance with FDA cGMP requirements under FDCA; KV and FDA entered a Consent Decree on March 6, 2009.
- Consent Decree admitted adulteration/misbranding of drugs but KV did not admit or deny the FDA's claims; KV recalled stock and destroyed adulterated drugs.
- Lefaivre asserted breach of implied warranty of merchantability and Missouri Merchantsability Practices Act (MMPA) claims based on cGMP violations and adulteration.
- District court held Lefaivre’s state-law claims preempted as impliedly preempted by the FDCA due to dependency on federal regulations; court remanded for further proceedings.
- On appeal, Lefaivre argued preemption was not warranted and Wyeth v. Levine supports state-law claims; KV argued the FDCA preempts private actions; court reversed and remanded.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Is Lefaivre’s claim impliedly preempted by the FDCA? | Lefaivre argues Wyeth supports state-law claims; Buckman does not apply. | KV contends FDCA preempts private actions as it regulates drug compliance. | Not impliedly preempted; state-law claims permitted. |
| Does Buckman govern and preempt these claims? | Buckman does not apply to consumer-focused state-law claims here. | Buckman controls fraud-on-the-FDA claims; it forecloses private actions. | Buckman does not control; claims not fraud-on-the-FDA. |
| Does field preemption apply to these drug-regulation claims? | FDCA does not occupy the field; state-law aids enforcement. | FDCA and regulations occupy field of drug regulation. | Field preemption does not apply. |
| Do Wyeth and related cases require federal preemption of these claims? | Wyeth suggests no preemption for warning-related state-law claims. | Wyeth supports preemption where federal regime occupies regulatory field. | Wyeth does not compel preemption in this case. |
Key Cases Cited
- Wyeth v. Levine, 555 U.S. 555 (U.S. 2009) (FDCA does not preempt state-law failure-to-warn claims for drugs)
- Buckman Co. v. Plaintiffs' Legal Committee, 531 U.S. 341 (U.S. 2001) (fraud-on-the-FDA claims pre-empted; field preemption not favored)
- Riegel v. Medtronic, Inc., 552 U.S. 312 (U.S. 2008) (express preemption for medical devices; not directly controlling here)
- In re Aurora Dairy Corp. Organic Milk Mktg. & Sales Practices Litig., 621 F.3d 781 (8th Cir. 2010) (presumption against preemption; field of regulation relevance)
- Wyeth v. Levine (cited within opinion), 129 S. Ct. 1187 (U.S. 2009) (discusses history of FDA regulation and state-law complements)
- Medtronic, Inc. v. Lohr, 518 U.S. 470 (U.S. 1996) (context for state-law remedies in parallel with federal regimes)