Sherry Walker v. Medtronic, Incorporated
2012 U.S. App. LEXIS 1334
4th Cir.2012Background
- Walker appeals district court ruling that her common law tort claims against Medtronic are preempted by the MDA as interpreted by Riegel.
- The SynchroMed EL programmable pump is a Class III device approved via PMA in 1988 with supplements in 1994 and 1999.
- FDA approval did not impose a formal performance standard; the plus/minus 15% flow specification appeared in labeling and PMA materials, not as a formal standard.
- Walker's husband died in 2005 from hydromorphone overdose; pump allegedly overinfused according to expert analysis.
- Walker filed a diversity suit in 2007 alleging negligence, strict liability, and breach of warranty against Medtronic.
- Discovery showed the particular pump was designed, manufactured, and sold in compliance with its PMA terms, including the 15% specification.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether Walker's claims are preempted by the MDA under Riegel. | Walker argues claims parallel federal requirements by alleging failure to operate per PMA. | Medtronic contends PMA controls and the 15% spec is not an ongoing requirement; claims exceed FDA-approved standards. | Preempted; claims do not parallel federal requirements. |
| Whether the 15% delivery accuracy is a formal performance standard. | 15% spec is a binding, ongoing requirement under PMA. | Not a formal performance standard; PMA approved device without such standard. | Not a formal performance standard; preemption applies. |
| Whether summary judgment was proper given discovery showing PMA compliance. | Discovery supports parallelism; factual dispute about device operation. | Compliance with PMA negates parallel claims. | Summary judgment proper; Walker's claims preempted. |
Key Cases Cited
- Riegel v. Medtronic, Inc., 552 U.S. 312 (U.S. 2008) (PMAs establish federal requirements; parallel claims may exist only if they mirror federal rules)
- Medtronic, Inc. v. Lohr, 518 U.S. 470 (U.S. 1996) (Parallel claims doctrine; FDA regulation framework)
- Kemp v. Medtronic, Inc., 231 F.3d 216 (6th Cir. 2000) (PMAs establish federal requirements; device-specific standards)