HOWARD v. ZIMMER, INC.HOWARD v. ZIMMER, INC.
¶0 The United States Court of Appeals for the Tenth Circuit certified a single question under the Revised Uniform Certified Questions of Law Act,
“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 Certification of Questions of Law Act,
“Whether
21 U.S.C. 337 2 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 se3 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 FACTS5 AND 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 sеttlement 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 mаnufacturing 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
¶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,
REGULATORY BACKGROUND
¶8 The Federal Food, Drug, and Cosmetic Act (FDCA),
¶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.13 Title
¶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 sе 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 ordinary care there are also duties imposed by statute, and that if they found that a person violated any one of the following statutes or federal regulations, and that the violation was the direct cause of the injury, then such violation in and of itself would make such person negligent. ... [Bold added. Italics in original.]
The instruction given in the cause contained references to federal motor carrier safety regulations. In Covel, we determined that there was no prejudicial misstatement of law and no fundamental error in the instructions given on negligence per se. Such a position was adopted as early as 1984 in Woodis v. OG&E Co., 1985 OK 62, 704 P.2d 483 when the Court determined that violation of a national safety electric code constituted negligence per se.
¶15 We have long recognized that validly promulgated and executed regulations have the full force and effect of law19 as do administrative rules which are binding expressions of lawmaking powers.20 These rules and regulations, enacted by administrative agencies and boards pursuant to the powers delegated to them, are highly material and relevant to the issue of the applicable standard of care and its alleged breach.21
¶16 The Court of Civil Appeals has held in three cases that federal regulations would not support a claim for negligence per se. In Claborn v. Plains Cotton Cooperative Ass‘n, 2009 OK CIV APP 39, 211 P.3d 915, the appellate court held that the cooperative could not be held negligent per se for a violation of the Occupational Safety and Health Administration (OSHA) regulation where the relationship of employee/employer did not exist with the plaintiff. It did so on grounds that the plain language of OSHA regulations at issue directed employers to act in certain ways to protect employees. Similar reasoning was in the works in Rosson v. Coburn, 1994 OK CIV APP 25, 876 P.2d 731 wherein the Court of Civil Appeals refused to acknowledge a claim based on negligence per se when a physician allegedly violated Medicaid statutes by receiving Medicaid funding for performing a sterilization procedure on an underage female. In that instance, it was determined that the Medicaid statutes did not afford protection to individuals but merely established a national policy prohibiting sterilization of those under the age of twenty-one (21) years. In Christian v. First Capital Bank, 2006 OK CIV APP 128, 147 P.3d 908, the appellate court determined that a federal regulation regarding interest on agricultural loans did not provide customers with a cause of action against their bank.
¶18 b) The 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.
¶19 Sulzer arguеs that because the FDCA regulations relating to medical devices do not contain a provision allowing private individuals to bring tort claims for their enforcement, they cannot support a negligence per se claim. The manufacturer insists that recognizing such a claim would be contrary to expressed legislative intent providing that “all such proceedings for the enforcement, or to restrain violations ... shall be by and in the name of the United States.” [Emphasis supplied.]23 We agree that, pursuant to Oklahoma jurisprudence, the mandatory language24 of the statute requires that all actions for enforcement be maintained by the federal government.25 On first blush it would appear that Sulzer‘s arguments have merit. Nevertheless, Howard‘s assertion that the lack of a provision allowing private enforcement is irrelevant to his negligence per se claim arising from the alleged violation of the GMP warrants a closer look. The patient contends that he does not seek to enforce the federal statute but to base his theory of recovery on Sulzer‘s failure to follow the federal regulation requiring the removal of manufacturing materials from his knеe implant prior to its having been placed in his body. We find the patient‘s contentions persuasive.
¶20 We refused to recognize a private right of action for the prosecution of a consumer protection claim in Holbert v. Echeverria, 1987 OK 99, 744 P.2d 960. In so doing, the Court was particularly impressed with the legislative language placing the power to seek redress of the Oklahoma Consumer Protection Act (Consumer Protection Act),
¶21 We took a second look at the Consumer Protection Act in Walls v. American Tobacco Co., 2000 OK 66, 11 P.3d 626 when smokers attempted to sue cigarette manufactures for civil penalties under subsection C of
¶22 In State of Oklahoma ex rel. Oklahoma Bar Ass‘n v. Mothershed, 2011 OK 84, ¶80, 264 P.3d 1197, we refused to allow an individual to proceed in a common-law version of qui tam action to compel the prosecution of alleged professional misconduct and an investigation of the Bar Association. In so doing, the Court relied upon Bass Angler Sportsman Soc. v. United States Steel Corp., 324 F.Supp. 412 (S.D.Ala. 1971), aff‘d, 447 F.2d 1304 (5th Cir. 1971) quoting the principle that:
[E]ven where some statutory language seems to grant a private right of action, if the same or a related statute also clearly places enforcement in the hands of governmental authorities the right of action is exclusively vested in such governmental authority. [Emphasis provided.]
¶23 The cases discussed herein are not the only causes in which we have determined that where a statute expressly places the right of prosecution in a public entity, there can be no intent to create a private right of aсtion.28 Nevertheless, in each of these cases, the plaintiff sought to obtain recovery through enforcement of the particular regulatory scheme.
¶24 The language of
¶26 The situation described in Medtronic as a “parallel claim” which should be allowed to proceed is precisely the situation presented here.30 Howard does not seek, in filing his action based on negligence per se, to hold Sulzer to some new or higher requirement not anticipated by federal law. Rather, the patient‘s claim is based on allegations that the manufacturer did not follow the GMP requiring the removal or limiting of manufacturing materials to the extent the material would not adversely affect the device‘s quality.31
¶27 The United States Court of Appeals for the Sixth Circuit (Sixth Circuit) would have allowed the patient‘s suit to proceed. In an unpublished opinion, it held that Howard‘s negligence per se claim was not preempted by the amendments to the FDCA.32 Other courts have taken similar stances allowing private tort claims alleging FDCA violations to proceed. In Alen v. Delchamps, Inc., 724 So.2d 1065 (Ala. 1993), the court agreed that there is no private cause of аction for civil damages under the FDCA. However, it concluded that the plaintiffs were not suing directly under the FDCA or its accompanying regulations. Rather, the court perceived that the plaintiffs relied on the regulations to establish a duty or standard of care. Therefore, the Alabama court determined that summary judgment could not be supported on the basis that the FDCA provided no private cause of action for damages.
¶28 The Seventh Circuit Court of Appeals held that, to the degree tort claims could be construed to allege that a defendant failed to meet the standards set forth in the government‘s approval process, the claims were not pre-empted. It reasoned that a state judgment premised on the truth of the allegations, set up no requirement different from or in addition to those established by the FDCA.33
¶29 Although the federal court found a lack of evidence to support a prima facie case for the patients’ claims in Valente v. Sofamore, SNC, 48 F.Supp.2d 862 (E.D.Wis. 1999), it analyzed the claim of negligence per se in light of the Supreme Court‘s decision in Medtronic v. Lohr, 518 U.S. 476, 116 S.Ct. 2240, 135 L.Ed.2d 700 (1966). Lohr held that a claim that the defendants violаted FDCA regulations was not preempted by the MDA. In its analysis, the federal court quoted the Supreme Court‘s reasoning that “the presence of a damages remedy does not amount to the additional or different ‘requirement’ that is necessary under the statute; rather, it merely provides another reason for manufacturers to comply with existing ‘requirements’ under federal law.” The Valente court concluded that Congress intended to impose liability on FDCA violators through state common law claims when such claims parallel federal requirements as in an action for negligence per se. Furthermore, relying on the Supreme Court‘s pronouncements in Lohr, the federal court noted that Congress clearly intended that the MDA was enacted to protect the safety of those who use medical devices, inferring intent that the statute be used as a basis for civil liability under state common law. Finally, the federal court opined that, if causation could be shown, a negligence per se claim would lie against the defendants.
¶30 There is no unanimity in the courts which hаve addressed the issue of whether negligence per se claims should be allowed to proceed under the FDCA. This is demonstrated by the federal district court‘s ruling herein in which the Northern District determined that we would not acknowledge Howard‘s negligence per se claim because he was not a member of the class intended to be protected by the federal regulations.34 While a substantial number of jurisdictions allow claims based on the violation of federal requirements denoted as “parallel claims,”35 others determine that even those claims are preempted.36 Nevertheless, even courts recognizing that no private cause of action for civil damages exists under the FDCA, allow private actions where parties rely on the regulations themselves to establish a duty or standard of care.37
RESPONSE TO DISSENT
¶32 The dissent begins by doing what it criticizes the majority for having done: crafting the question certified to answer the issues it perceives will reach the result it prefers.
¶33 More exploration is required of the dissent‘s insistence that the purpose of the federal regulation at issue here is merely a “record keeping” function and asserts that the regulation is too “vague” to serve as a basis for a negligence per se claim. When faced with arguments similar to those championed by the dissent as to the purpose of the Medical Devices Act, the Seventh Circuit Court of Appeals relied on the Sixth Circuit‘s rejection of such an argument in this very case.41 In Bausch v. Stryker Corp., 630 F.3d 546 (7th Cir. 2010), the appellate court stated in pertinent part:
Like the Sixth Circuit in Howard, we do not see a sound legal basis for defendants’ proposal to distinguish between general requirements and “concrete, device-specific” requirements. ... [F]edеral law is clear: for manufacturers of Class III medical devices, the Quality System Regulations and Current Good Manufacturing Practices adopted by the FDA under its delegated regulatory authority are legally binding requirements ... “The failure to comply with any applicable provision in this part [of the regulations] renders a device adulterated under section 501(h) of the act. Such a device, as well as any person responsible for the failure to comply, is subject to regulatory action. ...” [Emphasis supplied.]
Defendants’ proposed distinction between concrete, product-specific requirements and more general requirements would also leave injured patients without any remedy for a wide range of harmful violations of federal law. The FDA regulations contain many requirements that are not concrete or product-specific, yet which are obviously vital to producing safe and effective medical devices. For example, the regulations require each manufacturer to “establish and maintain prоcedures to prevent contamination of equipment or product by substances that could reasonably be expected to have an adverse effect on product quality,”
21 C.F.R. §820.70(e) , and to “establish and maintain procedures for the use and removal” of manufacturing material (such as lubricants or abrasives, or cleaning and disinfectant agents) “to ensure that it is removed or limited to an amount that does not adversely affect the device‘s quality.”21 C.F.R. §820.70(h) . If a patient were harmed by an implanted hip replacement system that was contaminated, for example, by a production worker‘s blood or mucus or by a lubricant or abrasive that caused an infection after implantation, that contamination would present a substantial claim for violating requirements that are not “concrete” and “product-specific,” yet which surely are essential for the manufacture of safe and effective medical devices for implantation in the human body. [Emphasis provided.]
¶34 Most concerning is that the dissent seeks to be the “fact finder,” a function which lies at the trial level and not with this Court. It would determine that Howard‘s reliance on the federal regulation is too tenuous to convince a reasonable person that the manufacturer‘s failure to properly follow the federal regulation at issue caused his injury. This is not the role of an appellate court. Even recognizing that there is a possibility that a jury deciding the common law claim might apply requirements more stringently than the FDA intended, the Seventh Circuit refused to engage in a question that it found to present a “slippery slope” of whether a distinction could be drawn under the federal regulation between “concrete” and “product-specific requirements.” Instead, it left those fact issues where we have done, in the realm of the fact-finder who will determine whether there was a violation which would support an award, something upon which we expressly refuse to comment or speculate.
CONCLUSION
¶35 Our determination that Howard should be allowed to utilize a negligence per se claim based upon violatiоn of the federal regulation does not guarantee recovery of damages. Instead, we emphasize that negligence per se does not equate to liability per se. Simply because the law may presume negligence from a person‘s violation of the federal regulation does not mean that the law presumes that such negligence was the proximate cause of the harm inflicted.42 Here, to prevail on a claim for negligence per se, the patient must not only demonstrate violation of the regulation but also that the violation caused his injury along with the extent to which the injury may support an award of damages.43
COLBERT, C.J., REIF, V.C.J., KAUGER, WATT, EDMONDSON, COMBS, JJ. - CONCUR
WINCHESTER, TAYLOR, GURICH, JJ. - DISSENT
FOOTNOTES
For the purposes of this section, the district court issuing an injunction shall retain jurisdiction, and in such cases, the Attorney General, acting in the name of the state, or a district attorney may petition for recovery of civil penalties.”
28 See, Walker v. Chouteau Lime Co., Inc., 1993 OK 35, 849 P.2d 1085 [No private cause of action against insurer who violates provisions of Unfair Claim Settlement Practices Act where the power to regulate was expressly given to the Insurance Commissioner.].
29
30 See, Medtronic, Inc. v. Lohr, see note 10, supra, providing that nothing denies states the right to provide a traditional damages remedy for violations of common-law duties when those duties parallel federal requirements. In Bates v. Dow Agrosciences LLC, 544 U.S. 431, 125 S.Ct. 1788, 161 L.Ed.2d 678 (2005), the Supreme Court explained that a state cause of action that seeks to enforce a federal requirement does not impose a requirement that is different from, or in addition to, requirements under federal law. See also, Bausch v. Stryker Corp., 630 F.3d 546 (7th Cir. 2010), cert. denied, ___ U.S. ___, 132 S.Ct. 498, 181 L.Ed.2d (2011) [FDCA did not preempt tort claims against medical device manufacturer because state tort duty breached was parallel to FDA regulations promulgated under the Act.].
31 Title
32 Howard v. Sulzer Orthopedics, Inc., see note 9, supra.
33 Mitchell v. Collagen Corp., 146 F.3d 902 (7th Cir. 1997).
34 Howard v. Sulzer Orthopedics, Inc., 796 F.Supp.2d 1305 (N.D.Okla. 2011).
35 Stengal v. Medtronic, Inc., ___ F.3d ___, 2013 WL 106144 (9th Cir. 2013) [MDA did not preempt failure to warn claim]; Bass v. Stryker Corp., 669 F.3d 501 (5th Cir. 2012) [MDA preempted negligence claims to extent they were premised on failure to warn, but negligent manufacturing claims survived.]; Hughes v. Boston Scientific Corp., 631 F.3d 762 (5th Cir. 2011) [Invoking negligence per claim to support state negligence claim parallel to federal requirements is not expressly or impliedly preempted.]; Bausch v. Stryker Corp., see note 30, supra [Patient‘s claims alleging that the medical device was “adulterated” were not impliedly preеmpted by MDA.); Ellis v. C.R. Bard, Inc., 311 F.3d 1272 (11th Cir. 2002) [Presuming Georgia law permits a claim for negligence per se for violation of the FDCA.]; Gomez v. Saint Jude Medical Daig Div. Inc., 442 F.3d 919 (5th Cir. 2006) [Claims not preempted to extent patient alleged that device was defectively manufactured because it did not comply with FDA-approved specifications.]; Talley v. Danek Med., Inc., 179 F.3d 154 (4th Cir. 1999) [In cause were negligence per se based on violation of the FDCA, liability in tort differs in that plaintiff must still show how statute dictates standard of care and prove other elements of negligence.]; White v. Stryker Corp., 818 F.Supp.2d 1032 (W.D. Ky. 2011) [MDA does not preempt state-law claims premised on violation of FDA regulations.]; Orthopedic Equip. Co. v. Eutsler, 276 F.2d 455, 79 A.L.R.2d 390 (4th Cir. 1960) [Misbranding of surgical nail could be negligence per se under FDA statute prohibiting “misbranding.“]; Rollins v. St. Jude Medical, 583 F.Supp.2d 790 (WD. La. 2008) [State was not preempted from providing a damages remedy for claims premised on violation of FDA regulations.]; Prohaska v. Sofamor, S.N.C., 138 F.Supp.2d 422 (W.D.N.Y. 2001) [ Cause of action exists under negligence per se when the underlying claim is for misbranding or otherwise illegally omitting product warnings required by FDCA.]; Valente v. Sofamor, S.N.C., 48 F.Supp.2d 862 (E.D.Wis. 1999) [Would allow negligence per se claim if had evidential support of causation as negligence per se based on violation of FDCA regulation parallels federal requirements.]; Wutzke v. Schwaegler, 86 Wash.App. 898, 940 P.2d 1386 (1997), review denied, 134 Wash.2d 1003, 953 P.2d 96 (1998) [PMA process established by FDCA did not establish additional or different requirements specific to medical devices, and thus were not preempted under MDA.]; Montoya v. Mentor Corp., 122 NM 2, 919 P.2d 410 [MDA to FDCA did not preempt common-law products liability claim against manufacturer where product was class III device.]. See also, Gelber v. Stryker Corp., 788 F.Supp.2d 145 (S.D.N.Y. 2011) [Manufacturing defect claims were not prohibited by MDA where allegations included claim that hip replacement had excessive levels of manufacturing residue left on device but did not allow plaintiff‘s negligence claim to proceed.]; D. Frank-Jackson, “The Medical Device Federal Preemption Trilogy: Salvaging Due Process for Injured Patients,” 35 S.IllU.L.J. 453 (2011) [Emphasizing that the failure to recognize a cause of action for individuals injured by Class III medical devices is “to blatantly ignore over a century of well-settled tort and procedural law precedence in favor of denying due process to those injured by hazardous devices.“]; Federal Pre-emption of State Common-law Products Liability Claims Pertaining to Drugs, Medical Devices, and Other Health-Related Items, 98 A.L.R.Fed. 124 (1990).
36 In re: Medtronic, Inc., Sprint Fidelis Leads Products Liability Litigation, 623 F.3d 1200 (8th Cir. 2010) [MDA preempted patients’ failure to warn, defective design, manufacturing defect, and breach of express warranty claims.]; Cupek v. Medtronic, Inc., 405 F.3d 421 (6th Cir. 2005), cert. denied, 546 U.S. 935, 126 S.Ct. 420, 163 L.Ed.2d 320 (2005) [Negligence per se claim due to failure to comply with FDCA preempted.]; Kemp v. Medtronic, Inc., 231 F.3d 216 (6th Cir. 2000) [Negligence per se claims preempted under MDA.]; In re: Orthopedic Bone Screw Products Liability Litigation, 193 F.3d 781 (3rd Cir. 1999) [Allowing negligence per se action to go forward would undermine legislation indicating no private right of action should exist.]; Gross v. Stryker Corp., 858 F.Supp.2d 466 (W.D.Penn. 2012) [Complaint failed to state parallel claim for negligence so as to avoid preemption.]; In re Trasylol Products Liability Litigation, 763 F.Supp.2d 1312 (S.D.Fla. 2010) [Recognizing that mere congressional intent to preclude a private right of action would not necessarily indicate that Congress intended to preclude a state remedy under theory of negligence per se.]; Ilarraza v. Medtronic, Inc., 677 F.Supp.2d 582 (E.D.N.Y. 2009) [Patient‘s claim of manufacturing defect of pain relief device preempted by MDA to FDCA.]; Kapps v. Biosense Webster, Inc., 813 F.Supp.2d 1128 (D.Minn. 2011) [Negligence per se cannot be based on violation of the FDCA.]; Moore v. Sulzer Orthopedics, 337 F.Supp.2d 1002 (2004) [MDA to the FDCA preempted plaintiff‘s action.]; Blinn v. Smith & Nephew Richards, Inc., 55 F.Supp.2d 1353 (M.D.Fla. 1999) [No private cause of action for violations of FDCA.]; Mitaro v. Medtronic, Inc., 23 Misc.3d 1122(A), 886 N.Y.S.2d 71 (2009), aff‘d, 900 N.Y.Supp.2d 899, 73 A.D.3d 1142 (2010) [Negligence per se claim preempted under statute providing that all proceedings to enforce or to restrain violations of the FDCA are brought by the Unitеd States.]; Osburn v. Danek Medical, Inc., 135 N.C.App. 234, 520 S.E.2d 88 (1999), review denied, 351 N.C. 359, 542 S.E.2d 215 (2000), aff‘d, 352 N.C. 143, 530 S.E.2d 54 (2000) [Violation of FDA regulation or requirements does not create private right of action.]; Friedlander v. HMS-PEP Products, Inc., 226 Ga.App. 123, 485 S.E.2nd 240 (1997) [All proceedings for enforcement must be brought by United States.]. See also, In re: Sulzer Orthopedics, 335 F.Supp.2d 830 (N.D. Ohio 2004) [Elements of fraud claims insufficient to proceed under Oklahoma law.]; J. Beck and J. Valentine, “Challenging the Viability of FDCA-Based Causes of Action in the Tort Context: The Orthopedic Bone Screw Experience,” 55 Food & Drug L.J. 389 (2000).
37 Allen v. Delchamps, Inc., 624 S.2d 1065 (Ala. 1993); Grove Fresh Distributors, Inc. v. Flavor Fresh Foods, Inc., 720 F.Supp. 714 (N.D.Ill. 1989).
38 This Court has adopted a three-part test for determining whether a private right of action may be implied from a regulatory statute. Pursuant to our opinion in Holbert v. Echeverria, 1987 OK 99, 744 P.2d 960, the factors to be considered are whether: 1) the plaintiff is one of the class for whose especial benefit the statute was enacted; 2) there is some explicit or implicit legislative intent suggesting the desire to create a private remedy and not to deny one; and 3) implying a remedy for the plaintiff would be consistent with the underlying purposes of the legislative scheme. The opinions cited in fn. 36, supra, demonstrate that the federal regulation herein meets all three of Holbert‘s requirements.
39 See, ¶25, supra.
40 See, ¶29, supra.
41 Bausch v. Stryker Corp., 630 F.3d 646 (7th Cir. 2010) providing in pertinent part:
“. . . The Sixth Circuit has rejected this approach. See Howard, 382 Fed.Appx. At 440 (reversing summаry judgment on preemption grounds, concluding that the Current Good Manufacturing Practices are ‘not so vague as to be incapable of enforcement.‘). . . .”
42 Graham v. American Cyanamid Co., 350 F.3d 496 (6th Cir. 2003), cert. denied, 541 U.S. 990, 124 S.Ct. 2040, 158 L.Ed.2d 495 (2004).
43 Ohio Casualty Ins. Co. v. Todd, 1991 OK 54, ¶9, 813 P.2d 508; Hampton v. Hammons, 1987 OK 77, ¶12, 743 P.2d 1053. It has previously been determined that patients such as Howard were intended to be protected by the GMP at issue here. See, ¶29, supra.
GURICH, J., with whom WINCHESTER, J. joins, dissenting:
¶1 The Tenth Circuit certified the following question to this Court:
Does Oklahoma recognize a claim for negligence per se based on an alleged violation of
21 C.F.R. § 820.70(h) , a federal regulation promulgated pursuant to the Medical Device Amendments to the Food, Drug, and Cosmetic Act, even though those enactments do not allow private rights of action?
In explaining its reasons for certifying this question, the Tenth Circuit pointed to three areas where Oklahoma law appears to be ambiguous: 1) Does Oklahoma law allow a claim for negligence per se based on an alleged violation of a federal regulation rather than a statute? 2) Does Oklahoma law bar a claim for negligence per se when the statute in question lacks a private right of action? and 3) Is
¶2 My interpretation of the certified question and my understanding of the issues presented by the Tenth Circuit leads me to the conclusion that Oklahoma law does not recognize a claim for negligence per se based on an alleged violation of
¶3 The Defendant correctly points out that this Court has never allowed a negligence per se claim to go forward solely on an alleged violation of a federal regulation.2 That‘s because this Court‘s negligence per se case law has developed primarily around violations of Oklahoma state statutes and municipal ordinances.3 The Plaintiff relies on Covel v. Rodriguez, 2012 OK 5, 272 P.3d 705, and Woodis v. Oklahoma Gas and Electric Co., 1985 OK 62, 704 P.2d 483, to support his position that this Court has allowed negligence per se claims to go forward based on alleged violations of federal regulations. They do not. In Covel, the negligence per se claim wаs based on alleged violations of regulations under the Federal Motor Carrier Safety Administration4 and violations of the Oklahoma statutes addressing licensing standards and qualifications for commercial drivers.5 In Woodis, although the negligence per se claim was premised on a violation of the National Electrical Safety Code, the National Electrical Safety Code was adopted by the Oklahoma Corporation Commission by order. Woodis, 1985 OK 62, ¶ 16, 704 P.2d 483, 486 (citing Rotramel v. Public Service Co., 1975 OK 91, ¶ 5, 546 P.2d 1015, 1017). As such, noncompliance with the code was actually a violation of an order of the Oklahoma Corporation Commission, not a federal regulation.6
¶4 I cannot join today‘s opinion because the holding is too broad. In my view, any expansion of the law in this area should be done narrowly and on a case-by-case basis and only when the Plaintiff can prove that he or she is within the class meant to be protected by the regulation and that his or her injury was meant to be prevented by the regulation. The facts of today‘s case certainly do not warrant an expansion of our negligence per se law. First, for a negligence per se instruction to be proper under Oklahoma law, the terms of a statute must impose objective standards. See Athey, 1991 OK 82, ¶ 8, 823 P.2d at 349. As the Sixth Circuit recognized,
¶5 Additionally, without any citation to authority or to the record, the Plaintiff asserts that “[t]he purpose of this requirement was to protect individuals who receive Sulzer‘s implants and was designed to prevent the very risks that occurred in this case--damage caused to Dr. Howard because of Sulzer‘s failure to remove such substances.”8 The majority, in footnote 43, appаrently agrees with the Plaintiff‘s broad, general assertions and finds that “patients such as Howard were intended to be protected by the GMP at issue here.” The primary purpose of
¶6 The holding in today‘s case is not limited to negligence per se claims based on the particular regulation at issue,
FOOTNOTES
Notes
“Does Oklahoma recognize a claim for negligence per se based on an alleged violation of
Certification of Question of State Law, filed on July 9, 2012, providing in pertinent part at p. 7:
“... [W]e conclude that the law of the case prevents us from reconsidering the implied-preemption question. ... Having resolved that preemption analysis no longer has any place in this case, we turn to Oklahoma state law. ...”
Even if the preemption issue were before us, we likely would have taken the same position as that of Sixth Circuit, i.e. the Howards’ claim would be allowed to go forward. The negligence per se claim is based on allegations that Sulzer did not clean the implant in accordance with the federal regulatory requirements. The United States Supreme Court has made it clear that state requirements are pre-empted only to the extent that they are different from, or in addition to the requirements imposed by federal law. States are not prevented from providing a damages remedy for claims premised on a violation of federal regulations. Riegel v. Medtronic, Inc., see note 10, infra; Medtronic v. Lohr, see note 10, infra.
I see no reason to rely on cases such as Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), Mitchell v. Collagen Corp., 126 F.3d 902 (7th Cir. 1997), and Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), all of which are preemption cases that are not dispositive of the issue presented. Everyone agrees that thе Sixth Circuit has already decided that the negligence per se claim is not preempted and that decision remains the settled law of the case.”(a) Except as provided in subsection (b) of this section, all such proceedings for the enforcement, or to restrain violations, of this chapter shall be by and in the name of the United States. ...”
Subsection (b) allows states to bring actions in their own names for civil enforcement of the statute in certain instances.
The Court of Civil Appeals in two different cases implied that a federal regulation could provide the basis for a negligence per se claim. However, in both of those cases, the COCA found that the Plaintiffs did not fall within the class of persons meant to be protected by the regulations. As such, the negligence per se theories could not go forward. See Claborn v. Plains Cotton Co-Op Ass‘n, 2009 OK CIV APP 39, ¶ 9, 211 P.3d 915, 919 (holding that because the plain language of the OSHA regulations at issue directed employers to act in certain ways to protect employees, the trial judge properly rejected the instruction because in that case, the Plaintiff was not an employee of the Defendant); Rosson v. Coburn, 1994 OK CIV APP 25, ¶ 28, 876 P.2d 731, 736 (rejecting a negligence per se argument based on violation of the Social Security Act and its implementing regulations because the purpose of the statutes and regulations was not to afford protection to any individuals). While these cases tend to support the majority‘s holding, the opinion overrules these cases to the extent they are inconsistent.“Manufacturing material. Where a manufacturing material could reasonably be expected to have an adverse effect on product quality, the manufacturer shall establish and maintain procedures for the use and removal of such manufacturing material to ensure that it is removed or limited to an amount that does not adversely affect the device‘s quality. The removal or reduction of such manufacturing material shall be documented.”
The description of information collection requirements for
“21 CFR 820.70(h)-Recordkeeping
Manufacturers shall establish and maintain procedures for using and removing adverse manufacturing materials.”
Id.“The commission of any act or practice declared to be a violation of the Consumer Protection Act shall render the violator liable to the aggrieved consumer for the payment of actual damages sustained by the consumer and costs of litigation including reasonable attorney‘s fees, and the aggrieved consumer shall have a private right of action for damages ...”
“Any person who is found to be in violation of the Oklahoma Consumer Protection Act in a civil action or who willfully violates the terms of any injunction or court order issued pursuant to the Consumer Proteсtion Act shall forfeit and pay a civil penalty of not more than Ten Thousand Dollars ($10,000.00) per violation, in addition to other penalties that may be imposed by the court, as the court shall deem necessary and proper.”