Background

• Howard, M.D. sues Sulzer for a failed knee implant allegedly contaminated with oil residue in violation of FDA regulations under the Medical Device Amendments (MDA).
• Federal court preemption was resolved to move forward; the case involves Oklahoma negligence per se based on violation of a federal regulation.
• FDCA/MDA framework classifies devices; Class III devices require PMA and GMPs, including removal of manufacturing materials under 21 C.F.R. § 820.70(h).
• Oklahoma permits private negligence per se claims based on federal regulations if the claim parallels federal requirements and the plaintiff belongs to the protected class.
• Tenth Circuit certified a first-impression question: whether Oklahoma recognizes a negligence per se claim based on a federal regulation despite lack of private enforcement rights in the FDCA/regulations.
• The Oklahoma Supreme Court answered the certified question in the negative, holding that the private right exists and the claim can proceed as a parallel negligence per se claim, subject to causation and damages proof.

Issues

Key Cases Cited

• Covel v. Rodriguez, 272 P.3d 705 (2012 OK 5) (certified question; negligence per se under federal regs depending on class and injury)
• Woodis v. Oklahoma Gas & Electric Co., 704 P.2d 483 (1985 OK 62) (negligence per se based on regulatory violation; statute/order context)
• Holbert v. Echeverria, 744 P.2d 960 (1987 OK 99) (three-factor test for implied private rights of action under regulatory schemes)
• Walls v. American Tobacco Co., 11 P.3d 626 (2000 OK 66) (private damages action under consumer protection acts where enforcement is government-led)
• Riegel v. Medtronic, Inc., 552 U.S. 312 (2008) (FDA regulations may parallel state duties; damages remedy not precluded)
• Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996) (parallel claims based on federal requirements allowed; damages not precluded)
• Bausch v. Stryker Corp., 630 F.3d 546 (2010) (seventh circuit; FDCA preemption not broad; private parallel actions possible)