Howard v. Zimmer, Inc.
711 F.3d 1148
10th Cir.2012Background
- Dr. Brian Howard received a Sulzer knee implant that failed to bond to bone, allegedly due to Sulzer’s negligent manufacturing leaving oily residue.
- The Howards filed state-law and federal claims in 2002; the matter was later consolidated in MDL proceedings in the Northern District of Ohio.
- The Ohio court granted summary judgment that claims were expressly preempted by the Medical Device Amendments (MDA) to the FDCA.
- The Howards argued negligence per se based on FDA GMP 21 C.F.R. § 820.70(h), claiming actual removal of oil was required.
- The Sixth Circuit held the negligence per se claim was not preempted, but did not address implied preemption Buckman issues, and remanded to Oklahoma district court.
- The Oklahoma district court predicted Oklahoma law would not recognize such a negligence per se claim and dismissed the remaining claim, leading to this appeal and eventual certification.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether Oklahoma recognizes negligence per se based on a federal regulation | Howard last name; GMP violation supports negligence per se | Sulzer last name; regulation does not create duty or is preempted | Oklahoma law is unclear; certification sought to resolve |
| Whether lack of a private right of action affects a negligence per se claim under Oklahoma law | Howard argues enactment may permit | Sulzer argues lack of private action forecloses claim | Ambiguity remains; certification to Oklahoma Supreme Court deemed warranted |
| Whether 21 C.F.R. § 820.70(h) provides an objective standard for negligence per se | Regulation imposes duty to remove oil; supports per se | Ambiguity and sufficiency of standard questioned | Regulatory ambiguity exists; Oklahoma Supreme Court guidance needed |
Key Cases Cited
- Riegel v. Medtronic, Inc., 552 U.S. 312 (2008) (preemption under MDA applies to state tort claims depending on the statute)
- Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001) (implied preemption under FDCA for fraud-on-the-FDA claims)
- Guidry v. Sheet Metal Workers Int’l Ass’n, Local No. 9, 10 F.3d 700 (10th Cir. 1993) (law-of-the-case and implied issues when necessary)
- Chambers v. St. Mary’s School, 82 Ohio St.3d 563 (1998) (negligence per se based on administrative rule examination varies by jurisdiction)
- Corel v. Rodriguez, 272 P.3d 705 (Okla.2012) (Oklahoma recognition of negligence per se based on federal regulation)
- Rosson v. Coburn, 876 P.2d 731 (Okla.Civ.App.1994) (private-right-of-action factor in Oklahoma’s negligence-per-se analysis)
- Athey v. Bingham, 823 P.2d 347 (Okla.1991) (ambiguity standard for negligence-per-se instruction when no objective standard)