Howard v. Zimmer, Inc.

2013 OK 17, 299 P.3d 463, 2013 WL 1130759, 2013 Okla. LEXIS 19

• Court: Supreme Court of Oklahoma
• Decided: March 19, 2013
• Docket: No. 110,857
• Status: Published

Opinions

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 Certifica- § tion of Questions of Law Act, 20 0.S8.2011 1601, et seq. We are not asked whether the negligence claim is preempted by federal law as the Tenth Cireuit 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. 387² 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 FACTS ⁵ AND PROCEDURAL BACKGROUND

12 The plaintiff/appellant, Brian C. Howard, M.D. (Howard/patient), received a knee replacement manufactured by the defendant, Sulzer Orthopedics, Inc. (Sul-zer/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.

13 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 eases 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-Mar-ket 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 Iubri-cating 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.

15 The Howards appealed the dismissal of their negligence per se claim to the Sixth Cireuit They argued that 21 CER. § 820.70(b),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.

T6 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.

17 The Howards appealed to the United States Court of Appeals for the Tenth Circuit (Tenth Cireuit). 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.S8.2011 §§ 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

18 The Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. § 801 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. § 860e et seq.¹⁰The 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

T 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

1 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.

112 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.

118 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 negli-genee 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. Italies 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.

1 15 We have long recognized that validly promulgated and executed regulations have the full force and effect of law ¹⁹ 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, Rosson, 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 distinet 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.

119 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 language ²⁴ 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 negli-genee 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.

120 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 ©.8.2011 § 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

122 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 gui 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:

[Even 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.]

T 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.

1 24 The language of 21 U.S.C. § 887 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.EF.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.

125 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.

T 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 de-viee's quality.³¹

127 The United States Court of Appeals for the Sixth Cireuit (Sixth Cireuit) 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 Allen v. Delchamps, Inc., 624 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.

1 28 The Seventh Cireuit 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

129 Although the federal court found a lack of evidence to support a prima facie case for the patients' claims in Valente v. Sofamor, 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. 470, 116 S.Ct. 2240, 135 L.Ed.2d 700 (1996). 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.

130 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

181 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

382 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.

133 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.... [Fljlederal 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(b). 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 Iubri-cant 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 Cireuit 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

135 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 lability 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.

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

1 . As originally certified, the question provides:

"Does Oklahoma recognize a claim for negligence per se based on an alleged violation of 21 C.F.R. § 820.70(b), 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?"

Certification of Question of State Law, filed on July 9, 2012, providing in pertinent part at p. 7: "... [Wle 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.

2 . Title 21 U.S.C. § 337 providing in pertinent part:

"(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.

3 . 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. Busby v. Quail Creek Golf & Country Club, 1994 OK 63, ¶ 6, 885 P.2d 1326. 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. Lockhart v. Loosen, 1997 OK 103, ¶ 9, 943 P.2d 1074; Hamilton v. Allen, 1993 OK 46, ¶ 9, 852 P.2d 697; Ohio Cas. Ins. Co. v. Todd, 1991 OK 54, ¶ 8, 813 P.2d 508. 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 proved. In re: Orthopedic Bone Screw Products Liability Litigation, see note 36, infra; In re TMI, 67 F.3d 1103 (3rd Cir.1995), cert. denied, 516 U.S. 1154, 116 1034, 134 L.Ed.2d 111 (1996). 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. Jones v. Oklahoma Natural Gas Co., 1994 OK 89, ¶¶ 17-18, 894 P.2d 415. See also, Busby v. Quail Creek Golf & Country Club, this note, supra.

4 . The federal regulation at issue is 21 CFR. § 820.70(h) providing:

"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."

5 . In answering a certified question, the Court does not presume facts outside those offered by the certification order. In re Harris, 2002 OK 35, ¶ 4, 49 P.3d 710; Jones v. University of Central Oklahoma, 1995 OK 138, ¶ 5, 910 P.2d 987. Although we will neither add nor delete such facts, we may consider uncontested facts supported by the record. McQueen, Rains & Tresch, LLP v. CITGO Petroleum Corp., 2008 OK 66, fn. 4, 195 P.3d 35; In re Harris, this note, supra.

6 . We refer to "Sulzer" as the manufacturer, as did the federal court, because that name had been utilized throughout the litigation. The parties are aware that Zimmer, Inc., is the proper defendant/appellee in the cause. Certification of Question of Law, filed with this Court on July 9, 2012.

7 . See generally, 21 CFR. § 820.

8 . 21 C.F.R. § 820.70(h), see note 4, supra.

9 . Howard v. Sulzer Orthopedics, Inc., 382 Fed.Appx. 436 (6th Cir.2010).

10 . Riegel v. Medtronic, Inc., 552 U.S. 312, 128 S.Ct. 999, 169 L.Ed.2d 892 (2008); Medtronic, Inc. v. Lohr, 518 U.S. 470, 116 S.Ct. 2240, 135 L.Ed.2d 700 (1996).

11 . Buckman Co. v. Plaintiffs' Legal Committee, 531 U.S. 341, 121 S.Ct. 1012, 148 L.Ed.2d 854.

12 . Riegel v. Medtronic, Inc., see note 10, supra.

13 . Howard v. Sulzer Orthopedics, Inc., see note 9, infra.

14 . Title 21 C.F.R. § 820.70(h), see note 4, supra.

15 . Busby v. Quail Creek Golf & Country Club, 1994 OK. 63, ¶ 6, 885 P.2d 1326.

16 . Lockhart v. Loosen, 1997 OK 103, ¶ 9, 943 P.2d 1074; Hamilton v. Allen, 1993 OK 46, ¶ 9, 852 P.2d 697; Ohio Cas. Ins. Co. v. Todd, 1991 OK 54, ¶ 9, 813 P.2d 508.

17 . In re: Orthopedic Bone Screw Products Liability Litigation, see note 36, infra; In re TMI, 67 F.3d 1103 (3dCir.1995).

18 . Jones v. Oklahoma Natural Gas Co., 1994 OK 89, ¶ 0, 894 P.2d 415. See also, Busby v. Quail Creek Golf & Country Club, see note 15, supra.

19 . Hoar v. Aetna Casualty & Surety Co., 1998 OK 95, 11 12, 968 P.2d 1219.

20 . McClure v. ConocoPhillips Co., 2006 OK 42, ¶ 17, 142 P.3d 390; Cox v. Dawson, 1996 OK 11, ¶ 18, 911 P.2d 272.

21 . Johnson v. Hillcrest Health Center, Inc., 2003 OK 16, ¶ 14, 70 P.3d 811.

22 . Opinions released for publication by order of the Court of Civil Appeals are persuasive only and lack precedential effect. Rule 1.200, Supreme Court Rules, 12 O.$.2011, Ch. 5, App. 1; 20 0.S.2011 §§ 30.5 and 30.14.

23 . Title 21 U.S.C. § 337, see note 2, supra.

24 . It is correct that the word "shall" is ordinarily interpreted as implying a command or mandate and that "may" generally denotes permissive or discretional authority, we have held that a directory rather than mandatory construction may be given to the work "shall" upon a finding of strongly persuasive contrary legislative intent. State ex rel. Oklahoma Bar Ass'n. v. Mothershed, 2011 OK 84, ¶ 62, 264 P.3d 1197; Woods Development Co. v. Meurer Abstract & Title Co., 1985 OK 106, ¶ 11, 712 P.2d 30.

25 . We note that in Walls v. American Tobacco Co., 2000 OK 66, 11 P.3d 626 we determined that as long as the Oklahoma Consumer Protection Act contained no private right of action and a provision providing that the Attorney General, acting in the name of the state, or the district attorney had the authority to sue for a monetary award, individual plaintiffs could not maintain an action to recover.

26 . Title 15 O.S. Supp.1988 § 761.1(A) providing in pertinent part:

''The commission of any act or practice declared to be a violation of the Consumer Protection Act shall render the violator Hable 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 ..."

27 . Title 15 0.S. Supp.1994 § 761.1(C) providing:

"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 Protection 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. 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 687 (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 346 (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

32 . Howard v. Sulzer Orthopedics, Inc., see note 9, supra.

33 . Mitchell v. Collagen Corp., 126 F.3d 902 (7th Cir.1997).

34 . Howard v. Sulzer Orthopedics, Inc., 796 F.Supp.2d 1305 (N.D.Okla.2011).

35 . Stengel v. Medtronic, Inc., 704 F.3d 1224 (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 preempted 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.J; 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 (W.D.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 N.M. 2, 919 P.2d 410 [MDA to FDCA did not preempt common-law products lability 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.IIIU.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.Pa.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.S.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 United 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.2d 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 So.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, 125, supra.

40 . See, 129, supra.

41 . Bausch v. Stryker Corp., 630 F.3d 546 (7th Cir.2010) providing in pertinent part:

"... The Sixth Circuit has rejected this approach. See Howard, 382 Fed.Appx. at 440 (reversing summary 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, 129, supra.