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PMA and Negligence Per Se Post Preemption - Then What?

By James M. Beck and Mark Herrmann

Not too long ago, the Sixth Circuit - in an unpublished opinion in a below-the-radar case - held that a PMA medical device plaintiff had successfully threaded the preemption needle in Howard v. Sulzer Orthopedics, Inc., ___ Fed. Appx. ___, 2010 U.S. App. Lexis 12290, slip op. (6th Cir. June 16, 2010) (it's also in our device preemption scorecard).  The one claim that the court held survived summary judgment was a negligence per se claim in the nature of a manufacturing defect claim based upon an FDA Good Manufacturing Practices regulation that the court admitted could be read two different ways.  Slip op. at 8 ("The provision, as we say and as the dissent illustrates, can reasonably be read either way").  Based on some language it found in FDA "comments" and guidance documents, the court concluded that the plaintiff was interpreting the regulation in a way consistent with the FDA's reading, and thus held that the regulatory-based claim survived preemption.  Id. at 7-8.

We don't know enough about either the device or the regulatory history of the particular section that the plaintiff in Howard hung his hat on to say anything particularly useful.

What we're interested in is where a defendant goes from here.  We were all set to pummel the defendant for ignoring the state-law based defenses to negligence per se that we've pontificated about at length when we noticed this in the Sixth Circuit's opinion:

We also leave it to the district court to consider [the defendant's] alternative ground for summary judgment: namely, whether Oklahoma law recognizes a negligence per se action based on violations of FDA regulations. All that we decide today, rather, is that [plaintiff's] negligence per se claim for GMP violations is not preempted.

Slip op. at 9.  So it wasn't the defendant's fault.  If it was anyone's, blame the court for reaching a constitutional issue when there were non-constitutional grounds available.

Let's see ... Oklahoma law.  Don't know much about it with respect to negligence per se.  So let's go through the issues that we laid out in our earlier pontification:

(1) Negligence per se is improper where it is inconsistent with the legislative intent of the enactment that was allegedly violated.

(2) Negligence per se is improper where it would impose novel duties that are not analogous to any existing common-law duty.

(3) Negligence per se is improper in some jurisdictions where only a regulation, and not a statute, was violated. It is improper everywhere where the alleged transgression involved something that lacks full force of law.

(4) Negligence per se is improper where the allegedly violated statute is vague or imprecise.

(5) Negligence per se is improper where the allegedly violated statute only required that the defendant obtain a license of some sort.

Well, it looks like we can disregard #5 in Howard because it isn't a dispute over the FDA's approval of the product, but rather how the device was put together.
 
The key point is that congress explicitly barred private enforcement of the FDCA.  21 U.S.C. §337(a).   Lots of courts, such as Buckman, have held this.  So have courts applying Oklahoma law.  See  Alexander v Smith & Nephew PLC, 98 F. Supp. 1299, 1308 (N.D. Okla. 2000); Alexander v Smith & Nephew PLC, 98 F. Supp. 1310, 1319-20 (N.D. Okla. 2000); Alexander v Smith & Nephew PLC, 98 F. Supp. 1225, 1234 (N.D. Okla. 2000); several other Alexander-named cases in 98 F. Supp.; Johnson v. Smith & Nephew Richards, Inc., 1999 WL 1117105, at *2 (N.D. Okla. Sept. 30, 1999).
 
A lot of states link that kind of legislative intent to the applicability of negligence per se.  Anything in Oklahoma?  Lo and behold, yes.  "Discernment of legislative intent is required" in Oklahoma negligence per se cases.  Lockhart v. Loosen, 943 P.2d 1074, 1078 (Okl. 1997).

It is the ascertainment of this intent which is the cardinal rule of statutory construction.  A statute's language, when given its plain and ordinary meaning, is the yardstick for divining the drafters' objective.

Id. (footnotes omitted).  Negligence per se does not lie where it would  "would affront the Legislature's declared intent."  Gorton v. Mashburn, 995 P.2d 1114, 1117 (Okla. 1999).  Thus, Oklahoma law looks inclined to read §337(a) according to its plain terms.  So what implications does express denial of a private right of action have upon negligence per se in Oklahoma? 
 
In Rosson v. Coburn, 876 P.2d 731 (Okla. Civ. App. 1994), the plaintiff tried to bring a negligence per se action for the violation of another federal statute (Title XIX of the federal Social Security Act) that didn't allow private enforcement.  Rosson said "no way":

Among other things, to establish negligence per se by violation of a statute or regulation, the injured party must be one of a class intended to be protected by the statute or regulation.  We find the purpose of the statutes and regulations relied on by [plaintiff] was not to afford protection to any individuals, therefore her proposition must fail.

The Medicaid Act is an administrative scheme providing medical assistance benefits to qualified recipients through states, implying no private right of action. . . .  Whether [defendant] violated Medicaid statutes or regulations by receiving Medicaid funded compensation for the sterilization procedure on [plaintiff] appears to be in controversy, but even presuming he did receive such compensation, it would not establish negligence per se.

876 P.2d at 736 (lots of citations omitted).  A recent Oklahoma trial court decision reached the same result, reasoning that, because the Toxic Substances Control Act did not allow a private cause of action for damages, Oklahoma law would bar a plaintiff from seeking damages for a TSCA violation in the guise of negligence per se:

[A] negligence per se claim alleging a violation of the TSCA is little different than an implied right of action under the TSCA for money damages.  Since the latter is not available because of Congress' desire to provide aggrieved parties with only equitable remedies, this Court finds that the former is preempted as well.

Ellinor v. Morrisett, 2004 WL 5453027 (Okla. Dist. Tulsa Co. Dec. 15, 2004).

The Alexander line of cases also supports this result, specifically in the FDCA context, but are less direct in tying the dismissal of the claim to the lack of any private right of action.  That's just one of many reasons for dismissal.  E.g., Alexander, 98 F. Supp. at 1321 ("the parties acknowledge that the FDCA does not provide a private right of action. Nevertheless, Plaintiff seeks to enforce the FDCA by arguing that the FDA's labeling requirements constitute a minimum standard of care").  Based upon a quickie review of Oklahoma law, we don't think that, as a matter of that state's legislative intent element for negligence per se, it would recognize the cause of action being alleged in Howard.

As for issue #2, there are also states that reject negligence per se where its effect is to impose a "novel" duty beyond ordinary tort principles.  But we haven't found anything suggesting that Oklahoma is one of those states.  Moreover, we don't know the facts well enough to say, one way or the other, how novel the plaintiff's manufacturing violation claim really is.

Looking at issue #3, the negligence per se claim in Howard (as in most FDCA-based negligence per se actions) is based on an administrative regulation, rather than a legislative enacted statute.  Is that a problem in Oklahoma?  Well, there's not a lot to go on, but Oklahoma Supreme Court precedent only speaks to "statutes" and "ordinances" - stuff enacted by legislative bodies.  E.g., Mansfield v. Circle K. Corp., 877 P.2d 1130, 1132 (Okla. 1994); Hamilton v. Allen, 852 P.2d 697, 699 (Okla. 1993).  As for administrative regulations, Claborn v. Plains Cotton Co-operative Ass'n, 211 P.3d 915 (Okla. Civ. App. 2009), suggests that they might not be kosher as grounds for negligence per se.  Quoting with approval from a Nebraska case, Claborn held:

Our holding is consistent with this court's prior law providing that the violation of a safety regulation, established by statute or ordinance, is not negligence as a matter of law, but is evidence of negligence.

Id. at 919 (rejecting negligence per se based upon violation of an OSHA regulation).  Cf. Smith v. American Flyers, Inc., 540 P.2d 1212, 1215 (Okla. App. 1975) (assuming regulations could impose a duty; finding no duty existed under the facts).  We don't think the Oklahoma Supreme Court has gone further than allowing regulatory violations as evidence of negligence, see Jack Cooper Transport Co. v. Griffin, 356 P.2d 748, 754 (Okla. 1960), as opposed to negligence per se - but we're not claiming exhaustive research.

Given that no Oklahoma court has ever imposed negligence per se liability based on an administrative regulation, we think that fundamental considerations of federalism, discussed at length here, should preclude a federal court exercising diversity jurisdiction from expanding liability under Oklahoma law in what would be an unprecedented fashion.  E.g. Kurczi v. Eli Lilly & Co., 113 F.3d 1426, 1429 (6th Cir. 1997) ("A federal court in a diversity case is not free to engraft onto state rules exceptions or modifications which may commend themselves to the federal court, but which have not commended themselves to the State in which the federal court sits") (refusing to adopt market share liability); Taylor v. Phelan, 9 F.3d 882, 887 (10th Cir. 1993)("[a]s a federal court, we are generally reticent to expand state law without clear guidance from its highest court").

Looking at the other part of #3, force of law, we note that what the Howard court did to interpret the scope of the relevant FDA regulation for purposes of preemption, isn't kosher in state-law negligence per se cases.  The court had to resort to items not having force of law, Federal Register "comments" and FDA guidance documents to support its theory of what the regulation meant.  In negligence per se litigation, nothing lacking force of law can be the basis of such a claim, something we discussed in great detail here, although we confess we didn't cite anything specifically from Oklahoma.  Cf. Metropolitan Paving Co. v. Puckett, 389 F.2d 1, 4 (10th Cir. 1968) (negative implication that measures without force of law cannot be negligence per se under Oklahoma law)
Looking at issue #4 - the allegedly violated standard sets forth a clear standard of conduct - it's pretty obvious in Howard that plaintiff's claim flunks this test.  The Court of Appeals frankly admitted that the regulation could be interpreted in two diametrically opposed ways.  Howard, slip op. at 8 (quoted above).  Assuming that Oklahoma law wouldn't give negligence per se effect to something without force of law, what does Oklahoma law say about the admittedly vague regulation itself?  Hmmm....  In Athey v. Bingham, 823 P.2d 347 (Okla. 1991), the court held that traffic statutes imposing vague standards ("not follow another vehicle more closely than is reasonable and prudent"; "shall drive the [vehicle] at a careful and prudent speed"; "drive at an appropriate reduced speed" in the presence of listed hazards) couldn't be relied upon as negligence per se:

[A] statute requiring a driver to drive so as to be able to stop within a clear distance ahead do[es] not impose any positive objective standards nor do they proscribe any greater or lesser degree of care than that required of a driver under the prevailing rules at common law.  In order to find a violation of the statute the trier of fact must first determine if the actions amounted to common law negligence.   Whether the defendant was driving too fast to bring the car to a clear stop is a determination for the jury to make in this case and not the subject of a legal presumption.

Id. at 349 (emphasis added).

Thus, the preemption finding in Howard does no more than get that plaintiff through the gate.  It merely disposes of a federal defense.  In Oklahoma, as elsewhere, where a plaintiff asserts a negligence per se claim based upon a purported FDCA violation, there are numerous state-law hurdles that should preclude recognition of such a novel theory.

Full post as published by Drug and Device Law on July 02, 2010 (boomark / email).