Howard v. Zimmer: Negligence Per Se Based on Violations of the FDCA—Blurring the Line Between Parallel Claims and Preemption

Last week in Howard v. Zimmer, — P.3d —, 2013 WL 1130759 (Okla. 2013), the Oklahoma Supreme Court held that a plaintiff can assert a negligence per se claim against a medical device manufacturer based on the manufacturer’s violation of federal regulations, even where the federal regulations provide that their enforcement must be prosecuted by the United States. Though Howard’s holding is broad and somewhat novel in medical device and pharmaceutical litigation, it comports with a long line of cases recognizing that negligence per se claims may be based on federal safety regulations. More interesting is how the Howard decision fits within the preemption framework outlined by the U.S. Supreme Court in Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001) and Riegel v. Medtronic, Inc., 552 U.S. 312 (2008).


The plaintiff, Brian C. Howard, M.D., received a knee-replacement implant manufactured by the defendant, Sulzer Orthopedics, Inc. The implant failed and had to be removed, allegedly because it did not bond to Howard’s bone due to Sulzer’s failure to remove an oily residue that, according to Howard, was left on the implant in violation of the Good Manufacturing Practices (“GMP”) regulations incorporated into the federal Food Drug and Cosmetic Act (“FDCA”). See 21 C.F.R. § 820.70(h). The GMP regulations require medical device manufacturers to establish procedures for removing or limiting manufacturing materials from medical devices to the extent the manufacturing materials adversely affect the device’s quality. Id. Howard alleged that Sulzer’s violation of the GMP regulations constituted negligence per se.

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