Howard v. Zimmer, Inc.

• Decision Date: 19 March 2013
• Docket Number: No. 110,857.,110,857.
• Citation: 299 P.3d 463
• Parties: Brian C. HOWARD, M.D.; Suzanne Howard, Plaintiffs/Appellants, v. ZIMMER, INC., Defendant/Appellee, and Sulzer Orthopedics, Inc.; Sulzer Medica USA Holding Co.; Sulzer Medica USA, Inc., Defendants.
• Court: Oklahoma Supreme Court

299 P.3d 463

Brian C. HOWARD, M.D.; Suzanne Howard, Plaintiffs/Appellants,

v.ZIMMER, INC., Defendant/Appellee,andSulzer Orthopedics, Inc.; Sulzer Medica USA Holding Co.; Sulzer Medica USA, Inc., Defendants.

No. 110,857.

Supreme Court of Oklahoma.

March 19, 2013.

Certified Question of Law from the United States Court of Appeals for the Tenth Circuit.

¶ 0 The United States Court of Appeals for the Tenth Circuit certified a single question under the Revised Uniform Certified Questions of Law Act, 20 O.S.2011 § 1601, et seq. Having reformulated the inquiry, we address a single first impression 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 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?”

We answer the single reformulated first impression question, “no.”

CERTIFIED QUESTION ANSWERED.

Timothy G. Best, Matthew B. Free, BEST & SHARP, Tulsa, Oklahoma, for Plaintiffs/Appellants.

Michael F. Smith, Thomas Steichen, McAffee & Taft, Tulsa, Oklahoma, for Defendant/Appellee.

David W. Brooks, William F. Northrip, Shook, Hardy & Bacon L.L.P., Kansas City, Missouri.

WATT, J.:

¶ 1 The United States Court of Appeals for the Tenth Circuit (Tenth Circuit) certified a single question of first impression to this Court under the Revised Uniform Certificationof Questions of Law Act, 20 O.S.2011 § 1601, et seq. We are not asked whether the negligence claim is preempted by federal law as the Tenth Circuit has resolved that preemption analysis has no place in the cause. Rather, we were requested to address a related, first impression question.¹ The reformulated, first impression question we address is dispositive. It asks:

“Whether 21 U.S.C. 337² 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 ³ based on violation of a federal regulation under the Medical Device Amendments (MDA) to the FDCA?” ⁴

The question is answered in the negative.

CERTIFIED FACTS ⁵AND PROCEDURAL BACKGROUND

¶ 2 The plaintiff/appellant, Brian C. Howard, M.D. (Howard/patient), received a knee replacement manufactured by the defendant, Sulzer Orthopedics, Inc. (Sulzer/manufacturer).⁶ 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.

¶ 3 The long and tortured litigation trail began in this case in 2002 in the Northern District of Oklahoma. However, because the Howards' complaint was one of many concerning Sulzer implants, the Judicial Panel on Multi–District Litigation consolidated the cases in the Northern District of Ohio. Sulzer entered into a settlement agreement with patients receiving implants the manufacturer identified as having undergone a cleaning process which left lubricating machine oil on the implants. However, Howard's case was excluded from the settlement because his device was not in the lot Sulzer identified as being cleaned inappropriately.

¶ 4 Initially, the Ohio district court refused to dismiss Howard's negligence per se claim. Thereafter, Sulzer filed a summary judgment motion alleging that the negligence claim was preempted based on the implant's Pre–Market Approval (PMA) application. A PMA prescribes the manufacturer's obligations in manufacturing and distributing the device. Sulzer contended that Howard's device met all the prescribed standards. Nevertheless, Howard argued that the PMA also required Sulzer to follow the more general Good Manufacturing Practices (GMPs) incorporated in the PMA. GMPs are FDCA regulations based upon manufacturing standards that apply to all FDCA-regulated medical devices. ⁷ Among other things, they require a process to remove manufacturing materials like lubricating oil. The district court disagreed. It granted Sulzer summary judgment on grounds that Howard's claims were preempted and denied a motion to transfer the cause back to the Northern District of Oklahoma.

¶ 5 The Howards appealed the dismissal of their negligence per se claim to the Sixth Circuit. They argued that 21 C.F.R. § 820.70(h),⁸ providing for the removal or limiting of manufacturing material to ensure a medical device's quality would not be affected, established a GMP requiring the removal of all manufacturing oil from the knee implant. Sulzer argued that the negligence per se claim was preempted, because the GMP only required that a process be in place to remove the oil, not that the oil actually be removed from the implant. Alternatively, the manufacturer insisted that any claim relying exclusively on violation of the FDCA or MDA to establish a breach of duty was impliedly preempted. In an unpublished opinion,⁹ the Sixth Circuit held that the negligence per se claim for good manufacturing practices violations was not preempted. It determined that the GMPs required Sulzer to actually remove the machine oil from the implant rather than to merely have a process for removal in place.

¶ 6 On remand, the cause was transferred back to the Northern District of Oklahoma where Sulzer renewed its motion for summary judgment. The manufacturer argued that the non-preempted claim for negligence per se was not cognizable under Oklahoma state law. The district court agreed, dismissing the cause.

¶ 7 The Howards appealed to the United States Court of Appeals for the Tenth Circuit (Tenth Circuit). The Tenth Circuit certified a single question of first impression to this Court on July 9, 2012 pursuant to the Revised Uniform Certification of Questions of Law Act, 20 O.S.2011 §§ 1601, et seq. We set a briefing cycle which was concluded with the filing of the patient's response brief on August 3, 2012.

REGULATORY BACKGROUND

¶ 8 The Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. § 301 et seq., requires Federal Drug Administration (FDA) approval for the introduction of new drugs into the market. The introduction of new medical devices into the stream of commerce is governed by the Medical Device Amendments of 1976(MDA), 21 U.S.C. § 360c et seq.¹⁰ The MDA was enacted to provide for the safety and effectiveness of medical devices intended for human use. It covers three classes of medical devices. Class I devices are those that present no unreasonable risk of illness or injury and therefore require only general manufacturing controls. Class II devices are those possessing a greater potential of dangerousness and thus warrant more stringent controls. Class III devises, such as knee replacements, present a potential for unreasonable risk of illness or injury and incur the FDA's strictest regulation.¹¹

¶ 9 Class III devices must complete a thorough review process before they may be marketed. Pre–Market Approval (PMA) applications must be submitted and approved before medical devices may be distributed. A PMA prescribes the manufacturer's obligations in manufacturing and distributing the device. It is focused on safety, requiring that a device be made with almost no deviations from the specifications in its approval application.¹² Good Manufacturing Practices (GMPs) may be incorporated in the PMA. These practices are FDA regulations based upon manufacturing standards that apply to all FDA-regulated medical devices.¹³Title 21 C.F.R. 820.70(h) is the GMP at issue in this cause. It requires manufacturers to establish procedures for removing or limiting manufacturing materials from medical devices to the extent that the material adversely affects the device's quality.¹⁴

¶ 10 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.

¶ 11 a) Federal regulations may form the basis of a negligence per se claim under Oklahoma law.

¶ 12 Howard asserts that Oklahoma law will allow a claim for negligence per se to proceed based on the violation of a federal regulation. The patient contends that such a position is supported by a recent opinion promulgated by this Court. Sulzer argues that federal regulations are not the type of law which should give rise to negligence per se claims. The manufacturer also insists that recognizing such a claim would contravene legislative intent where no clear standard of conduct is outlined. We are not persuaded by Sulzer's arguments.

¶ 13 The negligence per se doctrine is employed to substitute statutory standards for parallel common law, reasonable care duties. When courts adopt statutory standards for causes of action for negligence, the statute's violation constitutes negligence per se.¹⁵ To establish negligence per se, the plaintiff must demonstrate the claimed injury was caused by the violation, and was of the type intended to be prevented by the statute. Finally, the injured party must be one of the class intended to be protected by the statute.¹⁶ Liability per se enables plaintiffs to establish as a matter of law that the defendant's conduct constituted a breach of duty in a negligence action, so that only causation and damages need be proven.¹⁷ The question of whether a causal connection exists between the violation of the regulation here and Sulzer's actions and whether those violations were negligence per se, is for the trier of fact.¹⁸

¶ 14 Approximately six months before the instant question was certified to this Court, we issued an opinion in Covel v. Rodriguez, 2012 OK 5, 272 P.3d 705. One of the issues presented in Covel was whether the negligence per se instruction should have been given. The instruction provided that:

... [I]n addition to the duty to exercise...