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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