Court Opinion

ID: 5158427
Source: CourtListenerOpinion
Date Created: 2022-01-02 02:28:50.561+00
Date Added: 2024-06-11T08:25:30.538497
License: Public Domain

GURICH, J.,
with whom WINCHESTER, J. joins, dissenting.
11 The Tenth Circuit certified the following question to this Court:
Does Oklahoma recognize a claim for negli-genee per se based on an alleged violation of 21 C.EF.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 38) Is 21 C.E.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 8, 2012).
T2 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 Cos*475metic 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 regulation2 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 negli-genee 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 Administration 4 and violations of the Oklahoma statutes addressing licensing standards and qualifications for commercial drivers5 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 488, 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 *476regulation.6
T4 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 negli-genee 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.
15 Additionally, without any citation to authority or to the record, the Plaintiff asserts that "[the purpose of this requirement was to protect individuals who receive Sul-zer'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 48, 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
*477T 6 The holding in today's case is not limited to negligence per se claims based on the particular regulation at issue, 21 CER. § 820.70(h). It is not even limited to negli-genee 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.

. I see no reason to rely on cases such as Riegel v. Medtronic, Inc., 552 U.S. 312, 128 S.Ct. 999, 169 L.Ed.2d 892 (2008), Mitchell v. Collagen Corp., 126 F.3d 902 (7th Cir.1997), and Medtronic, Inc. v. Lohr, 518 U.S. 470, 116 S.Ct. 2240, 135 L.Ed.2d 700 (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.

. 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.

. See, eg., 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 0.$.1991 § 1-519); Jones v. Okla. Natural Gas Co., 1994 OK 89, 894 P.2d 415 (holding that the question of negligence per se under 63 0.$.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 0.8. 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 0.S.1981 § 11-310(a) and 47 0.8. 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).

. 49 C.F.R. §§ 383.1; 383.113; 391.11; 391.31; 392.7.

. 47 0.8. §§ 11-311; 11-801(B)(2); 47 0.$.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, 126, 272 P.3d 705, 716.

. 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.

. Howard v. Sulzer Orthopedics, Inc., 382 Fed. Appx. 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.

. Brief in Chief of Appellants Brian C. Howard, M.D., and Suzanne Howard, at 11.

. 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-ss0000 1 .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.

. 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.