Case Title: Howard v. Zimmer, Inc.

Citation: 

Docket Number: 110857

State: oklahoma

Court: Oklahoma Supreme Court

Date: 2013-03-19T00:00:00Z

Document:
HOWARD v. ZIMMER, INC.2013 OK 17Case Number: 110857Decided: 03/19/2013THE SUPREME COURT OF THE STATE OF OKLAHOMA
NOTICE: THIS OPINION HAS NOT BEEN RELEASED FOR PUBLICATION IN 
THE PERMANENT LAW REPORTS. UNTIL RELEASED, IT IS SUBJECT TO REVISION OR 
WITHDRAWAL. 

BRIAN C. HOWARD, M.D.; SUZANNE HOWARD, 
Plaintiffs/Appellants,v.ZIMMER, INC., 
Defendant/Appellee,andSULZER ORTHOPEDICS, INC.; SULZER MEDICA USA 
HOLDING CO.; SULZER MEDICA USA, INC., Defendants.
Certified Question of Lawfrom the United States Court of 
Appealsfor the Tenth Circuit.
¶0 The United States Court of Appeals for the Tenth Circuit certified a 
single question under the Revised Uniform Certified Questions of Law Act, 
20 O.S. 2011 §1601, et seq. Having 
reformulated the inquiry, we address a single first impression question:
"Whether 21 U.S.C. §337 of the Federal Food, Drug, and Cosmetic Act (FDCA), 
21 U.S.C. §301 et seq., providing that all violations of the Act shall be 
prosecuted in the name of the United States, prohibits Oklahoma from recognizing 
a claim for negligence per se based on violation of a federal regulation under 
the Medical Device Amendments (MDA) to the FDCA?"
We answer the single reformulated first impression question, "no."
CERTIFIED QUESTION ANSWERED.
Timothy G. Best, Matthew B. Free, BEST & SHARP, Tulsa, Oklahoma, for 
Plaintiffs/Appellants.Michael F. Smith, Thomas Steichen, McAffee & Taft, 
Tulsa, Oklahoma, for Defendant/Appellee.David W. Brooks, William F. 
Northrip, Shook, Hardy & Bacon L.L.P., Kansas City, Missouri
WATT, J.:
¶1 The United States Court of Appeals for the Tenth Circuit (Tenth Circuit) 
certified a single question of first impression to this Court under the Revised 
Uniform 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. 3372 of the Federal Food, Drug, and Cosmetic Act (FDCA), 21 
U.S.C. §301 et seq., providing that all violations of the Act shall be 
prosecuted in the name of the United States, prohibits Oklahoma from recognizing 
a claim for negligence per 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 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 individualsto maintain a 
parallel claim for negligence per sebased on violation of a federal 
regulationwhose enforcement lies with a governmental entity.
¶11 a) Federal regulations may form the basisof 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 lawproviding 
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 sebased 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.
COLBERT, C.J., REIF, V.C.J., KAUGER, WATT, EDMONDSON, COMBS, JJ. - CONCUR
WINCHESTER, TAYLOR, GURICH, JJ. - DISSENT 
FOOTNOTES
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(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?"
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. 
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 S.C. 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 C.F.R. §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 C.F.R. §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, ¶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.S. 2011, Ch. 5, App. 1; 20 O.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.3d 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 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 . . ." 
27 Title 15 O.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 21 C.F.R. §820.70(h), see note 4, supra. 
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 21 C.F.R. §820.70(h), see note 4, supra. 
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 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.]; 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 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. 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 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, ¶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 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. 
FOOTNOTES
1 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 the Sixth Circuit has already decided that the negligence per se 
claim is not preempted and that decision remains the settled law of the case. 

2 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. 
3 See, e.g., Cornwell v. Union Pacific 
R.R., 2010 WL 3521668 (determining whether Cornwell was negligent per se for 
failing to follow 47 O.S. 
11-701(A)); Akin v. Mo. Pacific R.R. Co., 1998 OK 102, 977 P.2d 1040 (discussing the duty of a motorist 
approaching a grade crossing under 47 O.S. 1991 § 11-701(a)(1)); Lockhart 
v. Loosen, 1997 OK 
103; 943 P.2d 1074 (finding a third party could not assert negligence per se based on 
violation of 63 O.S. 1991 § 
1-519); Jones v. Okla. Natural Gas Co., 1994 OK 89, 894 P.2d 415 (holding that the question of negligence 
per se under 63 O.S. 1981 § 
142.1 et seq., The Underground Facilities Damage Prevention Act, was a 
question of fact for the jury); Busby v. Quail Creek Golf and Country 
Club, 1994 OK 
63, 885 P.2d 1326 (determining that violation of 37 O.S. 1991 § 241 could satisfy the 
negligence per se factors but that under proper facts a jury could find the 
violation excusable); Hamilton v. Allen, 1993 OK 46, 852 P.2d 697 (finding driver of vehicle was negligent 
per se under 47 O.S. 
11-701(a)(1) and (2) for failing to stop, look, and listen); Athey v. 
Bingham, 1991 OK 
82, 823 P.2d 347 (giving an instruction on unavoidable accident under 47 O.S. 1981 § 11-310(a) and 
47 O.S. 1981 § 
11-801(a) and (d) held not to be reversible error); Ohio Cas. Ins. Co. 
v. Todd, 1991 OK 
54, 813 P.2d 508 (finding a violation of 37 O.S. 1981 § 537(A)(2) did not amount 
to negligence per se under the facts); Hampton By and Through Hampton v. 
Hammons, 1987 OK 
77, 743 P.2d 1053 (finding material questions of fact on the issue of negligence per se 
under a Tulsa city ordinance); Boyles v. Okla. Natural Gas Co., 
1980 OK 163, 619 P.2d 613 (finding that Plaintiff was within the 
class meant to be protected by the city ordinance concerned with injuries 
occasioned by gas explosions).
4 49 C.F.R. §§ 383.1; 383.113; 391.11; 391.31; 392.7.
5 47 O.S. §§ 11-311; 11-801(B)(2); 
47 O.S. 2004 § 6-101. In Covel, in 
evaluating the jury instructions as a whole to determine whether there 
was reversible error, this Court held that there was no prejudicial misstatement 
of the law and no fundamental error in the instructions given on negligence per 
se. 2012 OK 
5, 
¶ 26, 272 P.3d 705, 716. 
6 See also Myers v. Mo. Pacific R.R. 
Co., 2002 OK 
60, ¶ 30, 52 P.3d 1014, 1029, where the Plaintiff challenged the trial court's refusal to 
instruct the jury on negligence per se in relation to the railroad's failure to 
comply with two statutes requiring a railroad to erect suitable signs of caution 
and requiring a railroad to maintain its crossings in good condition. This Court 
found the trial court's refusal to instruct on negligence per se correct. We 
found that the first statute would have placed before the jury an issue 
preempted by the Federal Railroad Safety Act and that the second statute was not 
relevant to the case. Id. Even though the Federal Railroad Safety Act was 
brought up in the case, the actual instruction requested was based on Title 66 
of the Oklahoma statutes. Id. n.56, 52 P.3d  at 1029, n.56.
7 Howard v. Sulzer Orthopedics, Inc., 382 F.App'x 
436, 440 (6th Cir. 2010). The Sixth Circuit, in both the majority opinion and 
the dissenting opinion, went beyond the text of the statute and looked to FDA 
guidance documents to determine the meaning of the regulation. 
8 Brief in Chief of Appellants Brian C. Howard, M.D., and 
Suzanne Howard, at 11. 
9 Food and Drug Admin., OMB No. 0910-0073, Supporting 
Statement for Medical Devices: Current Good Manufacturing Practice (CGMP), 
Quality System (Q/S) Regulation, at 1, (updated as of Apr. 27, 2007) (emphasis 
added) http://www.fda.gov/OHRMS/DOCKETS/98fr/04n-0034-ss00001.pdf.
The description of information collection requirements for 21 C.F.R. § 
820.70(h) is listed as follows:
"21 CFR 820.70(h)-Recordkeeping 
Manufacturers shall establish and maintain procedures for using and removing 
adverse manufacturing materials." 
Id.
10 The Plaintiff has pointed to nothing in his four 
appendices that would indicate that this GMP was meant to protect a certain 
class of individuals or a certain type of injury.