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.1 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).

FACTUAL AND PROCEDURAL BACKGROUND

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.

THE CERTIFIED QUESTION

Through a convoluted procedural history not relevant to our inquiry, the following question of first impression was certified to the Oklahoma Supreme Court by the Court of Appeals for the Tenth Circuit:

“Whether 21 U.S.C. § 337 of the Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C § 301 et seq., providing 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?”

2013 WL 1130759 at *1.

THE OKLAHOMA SUPREME COURT’S ANSWER AND ANALYSIS

The Oklahoma Supreme Court “answered in the negative,” drawing “the distinction between attempting to enforce a federal regulation,” which would be prohibited, and “allowing a parallel claim for negligence per se bottomed on violation of the regulation.” Id. at *1,*7 (emphasis added). The Howard court based this decision on its understanding of “parallel claims” and the negligence per se doctrine, which it reasoned allows a plaintiff “to substitute statutory standards for parallel common law, reasonable care duties,” so long as the general negligence per se standard is met (i.e., the injury was caused by the violation, the injury was the type of injury intended to be prevented by the statute or regulation, and the injured party was a member of the class intended to be protected by the statute or regulation). Id. at *3. This much of the Howard decision is easily understood. 2

Howard becomes more complicated, however, during the court’s discussion of whether the FDCA provision providing that enforcement proceedings “shall be by and in the name of the United States” prohibits Howard from moving forward with his negligence per se claim. Sulzer argued that allowing the negligence per se claim would be contrary to the expressed legislative intent that enforcement actions be brought only by the United States. Id. at *4. Howard, on the other hand, argued that he did not seek to enforce the federal statute, “but to base his theory of recovery on Sulzer’s failure to follow the federal regulation.” Id. The court found the distinction persuasive, ultimately holding that allowing Howard’s negligence per se claim did not amount to allowing private “enforcement” of the federal regulation. Id. at *7.

In coming to its conclusion, the Howard court relied heavily on the U.S. Supreme Court’s decision in Riegel, stating that Riegel “blessed” its holding because there “the Supreme Court [] acknowledged that the Medical Device Amendments to the FDCA . . . would not prevent a state from providing a damages remedy for claims premised on violation of FDCA regulations.” Id. at *6. In actuality, the Court in Riegel declined to address “parallel claims” because it found those issues were not before it. Riegel, 552 U.S. at 330 (“Although [plaintiffs] now argue that their lawsuit raises parallel claims. . . . We decline to address that argument in the first instance.”).

Finally, and most striking about the Howard decision, is the Oklahoma Supreme Court’s lack of explanation as to just how its holding actually fits within the U.S. Supreme Court’s preemption jurisprudence. Specifically, we find it difficult to distinguish Howard’s negligence per se principle from Buckman’s holding that claims which exist “solely by virtue” of FDCA violation are preempted. Buckman, 531 U.S. at 353. It seems that, in Howard, the plaintiff would be unable to establish liability without the existence of the federal enactment—which is exactly the type of claim that we understand Buckman to preempt. Howard may be just another decision in the recent line of cases confusing (at best) and chipping away at (at worst) Buckman-style preemption. See Stengel v. Medtronic, Inc., ---F.3d---, 2013 WL 106144, 13 C.D.O.S. 365 (9th Cir. 2013) (no preemption for parallel claim based on the MDA); see also Hughes v. Boston Sci. Corp., 631 F.3d 762 (5th Cir. 2011); Bausch v. Stryker Corp., 630 F.3d 546 (7th Cir. 2010) cert. denied 132 S. Ct. 498 (2011).

CONCLUSION

The Howard decision complicates an increasingly gray area of products liability law. Manufacturers should be prepared. This decision allows plaintiffs to bring state-law negligence claims based solely on federal standards. Even though Buckman rejected the notion that “any violation of the FDCA will support a state-law claim,” Howard directly suggests otherwise—at least for cases in Oklahoma. The decision will likely aid plaintiffs in overcoming summary dismissal, and may result in new cases brought against manufacturers asserting negligence per se based on violations of the FDCA, despite the FDCA’s provision providing that enforcement actions can only be prosecuted by the United States.