796 F. Supp. 2d 1305
N.D. Okla.2011Background
- Plaintiffs allege defects in the Sulzer Natural Knee II Tibial Baseplate (NK-II) implanted in Howard in 2000.
- Allegations focus on residue from a manufacturing process change that allegedly impeded bonding and caused inflammation.
- MDL proceedings in the Northern District of Ohio settled many claims; Howard’s device was not in the designated affected lot.
- The Sixth Circuit reversed a district court on preemption, holding GMP regulations could support a negligence per se claim.
- This court previously granted summary judgment rejecting the negligence per se claim; on remand, it again grants summary judgment.
- Defendants argue the Federal MDA preempts state-law negligence per se claims; plaintiffs contend Oklahoma would recognize such a claim.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether Oklahoma recognizes negligence per se based on FDA regulations | Howard alleges GMP violations create duty under FDCA. | Oklahoma does not recognize such claims; FDCA lacks private right of action and preemption applies. | Not recognized as a private action; summary judgment granted. |
| Whether the GMP at issue creates a private standard of care under Oklahoma law | § 820.70(h) requires actual removal of manufacturing material. | PMA process suffices; GMPs are not independent duties. | GMPs do not create an independent, private duty under Oklahoma law. |
| Whether FDCA provides a private right of action for negligence per se claims | FDCA regulations can support state-law negligence per se. | FDCA lacks a private cause of action; claims preempted unless fitting under Riegel. | FDCA lacks private action; per se claim not viable. |
| Whether the negligence per se claim is barred by express or implied preemption | Sixth Circuit found GMP enforceable; not preempted. | Riegel preemption applies to state claims that conflict with federal requirements. | Court declines full preemption; nonetheless, no viable Oklahoma negligence per se claim remains. |
Key Cases Cited
- Riegel v. Medtronic, 552 U.S. 312 (U.S. 2008) (FDA preemption framework for device-mandated requirements)
- Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341 (U.S. 2001) (private enforcement of FDCA preemption implications)
- Riley v. Cordis Corp., 625 F. Supp. 2d 769 (D. Minn. 2009) (limits private actions premised on FDA regulation violations)
- Rimbert v. Eli Lilly and Co., 577 F. Supp. 2d 1174 (D.N.M. 2008) (FDCA regulation-based negligence per se under preemption analysis)
- Cottrell, Ltd. v. Biotrol International, Inc., 191 F.3d 1248 (10th Cir. 1999) (FDCA regulation interpretation issues in per se claims)
- Rosson v. Coburn, 876 P.2d 731 (Okla. Civ. App. 1994) (Oklahoma rejection of per se claim based on Medicaid statute)