                                                                             FILED
                                                                 United States Court of Appeals
                                      PUBLISH                            Tenth Circuit

                      UNITED STATES COURT OF APPEALS                     May 29, 2013

                                                                     Elisabeth A. Shumaker
                                 TENTH CIRCUIT                           Clerk of Court



 BRIAN C. HOWARD, M.D.; SUZANNE
 HOWARD,

       Plaintiffs–Appellants,

 v.

 ZIMMER, INC.,

       Defendant–Appellee.                                 No. 11-5109

 and

 SULZER ORTHOPEDICS, INC.;
 SULZER MEDICA USA HOLDING
 CO.; SULZER MEDICA USA, INC.,

       Defendants.




                     Appeal from the United States District Court
                       for the Northern District of Oklahoma
                       (D.C. No. 4:02-CV-00564-CVE-FHM)


Matthew B. Free (Timothy G. Best with him on the briefs), Best & Sharp, Tulsa,
Oklahoma, for the Plaintiffs-Appellants.

William F. Northrip (David W. Brooks with him on the briefs), Shook, Hardy & Bacon,
LLP, Kansas City, Missouri, for the Defendants-Appellees.
Before LUCERO, McKAY, and GORSUCH, Circuit Judges.


LUCERO, Circuit Judge.


       This case is before us for further consideration following receipt from the

Oklahoma Supreme Court of the answer to our question, which was certified to them on

July 3, 2012.

       After Dr. Brian Howard received a knee implant manufactured by Sulzer

Orthopedics, Inc. (“Sulzer”) that failed to bond properly, Howard and his wife filed suit

against Sulzer alleging negligence per se. Howard v. Zimmer, 711 F.3d 1148, 1149-50

(10th Cir. 2012). Following the completion of earlier consolidated litigation, the district

court dismissed the Howards’ negligence per se claim, predicting that it would not be

cognizable under Oklahoma state law. Id. at 1151. On July 3, 2012, we stayed the

Howards’ appeal pending resolution of a question of state law certified to the Oklahoma

Supreme Court. Id. at 1153. That question has been answered, and we now reverse the

district court’s grant of summary judgment and remand for further proceedings.

       The relevant factual background and procedural history of this case is thoroughly

presented in our prior order, id. at 1150-51, and need not be repeated here. After we

resolved the only other issue on appeal, concerning implied preemption, we certified to

the Oklahoma Supreme Court the following question:

       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
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       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 v. Zimmer, No. 110,857, 2013 WL 1130759, at *1 (Okla. Mar. 19, 2013)

(footnotes omitted).

       This question has now been answered in the negative by the Oklahoma Supreme

Court. It held that “Oklahoma law allows private individuals to maintain a parallel claim

for negligence per se based on violation of a federal regulation whose enforcement lies

with a governmental entity.” Id. at *2. The court further concluded that “[t]he existence

of a provision in federal law providing that all enforcement proceedings ‘shall be by and

in the name of the United States’ does not prohibit a state law claim for negligence per se

based on violation of the federal regulation.” Id. at *4. Noting that Howard does not

claim he should be entitled to bring a private action under the FDCA, but rather brings a

state claim based on duties that “parallel, rather than add to, federal requirements,” id. at

*6, the court determined that Howard’s negligence per se claim should be allowed to

proceed, id. at *8.

       In light of this conclusive determination of state law, the district court’s dismissal

of the Howards’ negligence per se claim cannot stand. We therefore REVERSE and

REMAND the case to the district court for further proceedings consistent with this

opinion.



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