Howard v. Zimmer, Inc.

Plaintiff-Appellant Brian C. Howard, M.D. received a knee replacement manufactured by Defendant Sulzer Orthopedics, Inc. The implant failed and had to be removed allegedly because it did not bond to Howard's bone. Howard asserted that the implant was unsuccessful because Sulzer left oily residue on the implant in violation of federal regulations. The United States Court of Appeals for the Tenth Circuit certified a single question to the Oklahoma Supreme Court. The Court in turn reformulated the question as one of first impression: "[w]hether 21 U.S.C. 337 of the Federal Food, Drug, and Cosmetic Act (FDCA), [which provides] that all violations of the Act shall be prosecuted in the name of the United States, prohibits Oklahoma from recognizing a claim for negligence per se based on violation of a federal regulation under the Medical Device Amendments (MDA) to the FDCA?" Howard asserted that Oklahoma law would allow a claim for negligence per se to proceed based on the violation of a federal regulation, and that such a position was supported by a recent opinion promulgated by the Oklahoma Court. Sulzer argued that federal regulations are not the type of law which should give rise to negligence per se claims. The manufacturer also insisted that recognizing such a claim would contravene legislative intent where no clear standard of conduct is outlined. The Oklahoma Supreme Court was not persuaded by Sulzer's arguments and answered the single reformulated first impression question, "no." View "Howard v. Zimmer, Inc." on Justia Law