HOWARD v. USA USA (2013)

¶ 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, 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. 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 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 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 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.¹³ Title 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 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.

¶ 17 Claborn, Rossen, and Christian do not bear the imprimatur of this Court. At best, they are of only persuasive value.²² Each of the opinions appears to be factually distinct from this cause. Nevertheless, to the extent that any or all of these opinions conflict with our holding herein that violation of a federal regulatory scheme will support a claim of negligence per se, they are expressly overruled.

¶ 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 argues 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 knee 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), 15 O.S.2011 § 751, et. seq., in the hands of the Attorney General or a district attorney. Subsequently, the Legislature amended subsection A of § 761.1 to give a private right of action for damages to aggrieved consumers.²⁶

¶ 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 § 761.1, amended in 1994, providing for the collection of civil penalties of not more than ten thousand dollars ($10,000.00) per violation of the consumer protection act. The Court took the position that the smokers could not collect the penalties for violation provided therein because of the express legislative language of the section. It provided that “[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 the district attorney may petition for the recovery of civil penalties.”²⁷

¶ 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 action.²⁸ Nevertheless, in each of these cases, the plaintiff sought to obtain recovery through enforcement of the particular regulatory scheme.

¶ 24 The language of 21 U.S.C. § 337 provides that all actions to enforce violations of the FDCA “shall be by and in the name of the United States.” There is little question that, under this Court's jurisprudence, Howard would have no authority to bring an enforcement action based on the violation of a federal regulation promulgated under the FDCA. Nevertheless, while Howard seeks to show violation of 21 C.F.R. § 820.70(h),²⁹ i.e. requiring removal of manufacturing materials from his implant, he does not claim that he should be entitled to bring a private action under the FDCA.

¶ 25 The United States Supreme Court determined in Riegel v. Medtronic, Inc., 552 U.S. 312, 128 S.Ct. 999, 169 L.Ed.2d 892 (2008), that the MDA would pre-empt a jury determination that the FDA-approved labeling for a pacemaker violated a state common-law requirement for additional warnings. It did so based on grounds that such a requirement would be “different from, or in addition to” the federal requirements imposed for medical device labeling. However, the Supreme Court also acknowledged that the Medical Device Amendments to the FDCA, allowing for such preemption, would not prevent a state from providing a damages remedy for claims premised on violation of FDCA regulations. The high court did so in recognition that such state duties parallel, rather than add to, federal requirements.

¶ 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 action 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 violated 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 have 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

¶ 31 We align ourselves with those jurisdictions which would allow a negligence per se claim to proceed.³⁸ This Court acknowledges the distinction between attempting to enforce a federal regulation and allowing a parallel claim for negligence per se bottomed on violation of the regulation. Such claims have been blessed by the United States Supreme Court in Riegel v. Medtronic, Inc.³⁹ and Medtronic v. Lohr⁴⁰ distinguishing between attempts to enforce a federal regulation and reliance on the violation of such rules to bring a parallel claim.

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]ederal 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 procedures 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 violation 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

CERTIFIED QUESTION ANSWERED.

¶ 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 21 C.F.R. § 820.70(h) too ambiguous, under Oklahoma law, to support a claim for negligence per se? See Certification of Question of State Law, at 7–9 (July 3, 2012).

¶ 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 21 C.F.R. § 820.70(h) regardless of whether the Medical Device Amendments to the Food, Drug, and Cosmetic Act allow for a private right of action. Therefore, I must respectfully dissent from today's decision.¹

¶ 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 was 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, 21 C.F.R. § 820.70(h) is ambiguous because it isn't clear from the text of the regulation whether it “requires compliance with a validated cleaning process, or whether it also requires a specific result: namely, actual removal” of the machine oil.⁷ Even though the Sixth Circuit held that the regulation required Sulzer to actually remove the excess machine oil, the regulation does not impose sufficient objective standards to allow the negligence per se claim to go forward under Oklahoma law. This issue must be decided before analyzing whether the Plaintiff is within the class of persons meant to be protected by the regulation. In my view, the majority has not addressed this issue and the Tenth Circuit is free to address the issue when the case goes back.

¶ 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, apparently 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 21 C.F.R. § 820.70(h), and the GMP's generally, appears to be “recordkeeping.” The Supporting Statement for Medical Devices: Current Good Manufacturing Practice, found on the FDA website, states as its justification: “The Food and Drug Administration (FDA) is requesting extension of approval for information collection requirements in 21 CFR Part 820.”⁹ Rather than giving the Plaintiff a free pass on this issue, he should, on remand from the Tenth Circuit, be required to present some evidence or authority to the trial court that 21 C.F.R. § 820.70(h) was intended to protect a certain class of individuals of which he is included and that the regulation was intended to prevent a certain type of injury .¹⁰

¶ 6 The holding in today's case is not limited to negligence per se claims based on the particular regulation at issue, 21 C.F.R. § 820.70(h). It is not even limited to negligence per claims based on federal regulations under the Food, Drug, and Cosmetic Act. Rather, today's holding is so broadly worded that it allows a plaintiff to allege negligence per se based on a violation of any federal regulation. With the thousands of federal regulations from the various federal agencies, an overly broad holding will inevitably lead to unanticipated results. The holding in this case should be limited to the facts disclosed. I respectfully dissent.

WATT, J.

COLBERT, C.J., REIF, V.C.J., KAUGER, WATT, EDMONDSON, COMBS, JJ., concur. WINCHESTER, TAYLOR, GURICH, JJ., dissent.