We were planning to write about the Bartlettoral argument today (we still might) when we learned about Howard v. Zimmer, Inc., ___ P.3d ___, 2013 WL 1130759 (Okla. March 19, 2013), in which the Supreme Court of one of the reddest states in the country, overruling prior precedent, held that, in general, violations of federal regulations suffice as a basis for negligence per se under Oklahoma law. Contrary to a stiff dissent, the court reached this result notwithstanding 21 U.S.C. §337(a) in which Congress expressed its intent that claimed violations of the FDCA only be enforced by the federal government. Id. at *6-7.  

Prior Oklahoma precedent (rather like the law of Kentucky that we discussed earlier) had declined to permit state-law negligence per se to be brought on the basis of claimed violations of purely federal regulations. E.g., Claborn v. Plains Cotton Co-op. Ass’n, 211 P.3d 915 (Okla. App. 2009) (no negligence per se for claimed OSHA violations); Christian v. First Capital Bank, 147 P.3d 908 (Okla. App. 2006) (same; federal usury regulations on agricultural loans); Rosson v. Coburn, 876 P.2d 731 (Okla. App. 1994) (same; Medicaid abortion regulations).

Howard was, of course, a case where federal preemption had wiped out the usual product liability claims plaintiffs would normally bring against the defendant. A couple of years ago, in the same peripatetic case, the Sixth Circuit, in a non-precedential decision, allowed a “parallel claim” to escape preemption. Howard v. Sulzer Orthopedics, Inc., 382 Fed. Appx. 436 (6th Cir. 2010) (“Howard I”). Howard I, of course, did not purport to decide that such a parallel claim existed under state law. Id. at 442 (not reaching “whether Oklahoma law recognizes a negligence per se action based on violations of FDA regulations”).

That was the Oklahoma Supreme Court’s job. Procedurally, at least, we think that the Tenth Circuit chose a better path in certifying the issue to that court. Under Erie, certification was a proper avenue, although we have to wonder why the plaintiff didn't do this during the prior appeal in the Sixth Circuit. Unlike Fulgenzi v. PLIVA, Inc., ___ F.3d ___, 2013 WL 949096 (6th Cir. March 13, 2013), at least, the Tenth Circuit respected the limited authority of federal courts in diversity actions and certified the negligence per se question rather than making up novel state law claims out of whole cloth. And "whole cloth" is the right description − there was nothing in prior Oklahoma law that remotely suggested what the happened next.

Make something up is exactly what Oklahoma Supreme Court did. Not only did it overrule all prior precedent barring federally based negligence per se as a general matter, it decided not to follow its own prior precedents precluding private allegations of alleged violations where a particular piece of legislation“indicate[es that] . . . the law-making body concerned itself specifically with the problem of who should be able to bring an action . . . and it then resolved not to confer a remedy on private individuals.” Holbert v. Echeverria, 744 P.2d 960, 965 (Okla. 1987); see also State ex rel. Oklahoma Bar Ass’n v. Mothershed, 264 P.3d 1197, 1227 (Okla. 2011) (wherea statute “clearly places enforcement in the hands of governmental authorities the right of action is exclusively vested in such governmental authority”); Walls v. American Tobacco Co., 11 P.3d 626, 631 (Okla. 2000) (failure to make private cause of action retroactive was legislative intent not to permit earlier claims amounting to private enforcement).

Governmental authority exclusivity is exactly what Congress mandated with the FDCA when it enacted §337(a). Howarddiscounted that intent, but the weirdest thing is that Howard didn’t do so because of anything really having to do with state law. Rather, the court considered FDCA-based negligence per se as somehow having been “blessed” by Supreme Court decisions that did no more than hold that such claims, if they existed, were not preempted (and in Riegel did a lot less, since the claim had been waived):

There is little question that, under this Court's jurisprudence, [plaintiff] would have no authority [under §337(a)] to bring an enforcement action based on the violation of a federal regulation promulgated under the FDCA. Nevertheless, while [plaintiff] seeks to show violation of [an FDA regulation], he does not claim that he should be entitled to bring a private action under the FDCA. . . . However, [in Riegel] 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. The situation described in [Riegel] as a“parallel claim” which should be allowed to proceed is precisely the situation presented here.

* * * *

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. . . . We align ourselves with those jurisdictions which would allow a negligence per se claim to proceed. 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 and Lohr.

Howard, 2013 WL 1130759, at *6-7 (footnotes and citations omitted) (emphasis added).

“Blessed by”? Riegel didn’t even consider such claims because they had been waived. 552 U.S. at 330 (“Although [plaintiffs] now argue that their lawsuit raises parallel claims. . . . We decline to address that argument in the first instance”). Lohr –addressing a Florida cause of action − held simply:

Nothing in § 360k denies Florida the right to provide a traditional damages remedy for violations of common-law duties when those duties parallel federal requirements. Even if it may be necessary as a matter of Florida law to prove . . . additional elements of the state-law cause of action would make the state requirements narrower, not broader, than the federal requirement.

518 U.S. at 495. Actually, as a matter of state law, Florida doesn’t recognize negligence per se in FDCA cases. SeeMurthy v. N. Sinha Corp., 644 So.2d 983, 985 (Fla. 1994) (“look[ing] to the legislative intent of a statute” to determine “negligence per se”); as applied to FDCA-based negligence per se by McClelland v. Medtronic, Inc., 2012 WL 5077401, at *4-5 (M.D. Fla. Sept. 27, 2012); Rounds v. Genzyme Corp., 2010 WL 5297180, at *3 (M.D. Fla. Dec. 20, 2010), aff’d, 440 Fed.Appx. 753 (11th Cir. 2011); Blinn v. Smith & Nephew Richards, Inc., 55 F. Supp.2d 1353, 1361 (M.D. Fla. July 6, 1999), and at least a half dozen other cases. As a matter of Florida law, the Supreme Court in Lohr drew no conclusion at all about the existence of the purported cause of action, it only found it wasn’t preempted.

As Florida law/Lohr demonstrates, United States Supreme Court decisions suggesting that particular state-law claims might not be preempted don’t “bless” the existence of such causes of action under state law − any more than Riegel’s conclusion that design, warning, and a number of other claims were preempted in any way implied that such causes of action don’t exist. Preemption and duty are simply just two different concepts altogether. Thus, the rationale in Howard is makes little sense, except as a way of justifying a result by any means possible.

Moreover, Lohr pointed out that the“traditional” causes of action it was considering imposed “additional elements”beyond mere non-compliance (such as “negligence” or “unreasonable hazard”). 518 U.S. at 495. The Court explained that aspect of parallel claims in more depth in Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), holding that:

[I]t is clear that the [Lohr] claims arose from the manufacturer's alleged failure to use reasonable care in the production of the product, not solely from the violation of FDCA requirements. In the present case, however, the fraud claims exist solely by virtue of the FDCA disclosure requirements. Thus, although [Lohr] can be read to allow certain state-law causes of actions that parallel federal safety requirements, it does not and cannot stand for the proposition that any violation of the FDCA will support a state-law claim.

Id. at 352-53 (Lohr citations omitted).

With that in mind, we look back to Howard to determine what, in addition to the claimed FDCA regulatory violation, is required to establish liability. We find nothing. The Oklahoma court simply“presumes” negligence from a violation and moves on to causation and damages:

[B]ecause 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. 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.

Howard, 2013 WL 1130759, at *8. Under Buckman it is hard to see this “per se” theory as anything other than state-law liability existing “solely by virtue” of the claimed FDCA violation. Certainly “the existence of these federal enactments is a critical element” in Howard, without which that plaintiff cannot establish liability. Buckman, 531 U.S. at 353. Ultimately, we’re not persuaded that this particular “parallel” claim can do what the Oklahoma court intended, which is to escape preemption. It may avoid Riegel, but it seems squarely within the category of FDCA-centric claims that Buckman held would be preempted.

It will, of course, require still more litigation to arrive at that result.

Howard certainly isn’t the first time we’ve encountered questionable, result-oriented reasoning in cases involving the FDCA and preemption of product liability litigation. In Bartlett v. Mutual Pharmaceutical Co., 678 F.3d 30 (1st Cir.),cert granted, 133 S.Ct. 694 (2012) , the court justified its recognition of a most peculiar sort of “design defect” claim – that a state jury can conclude that an FDA-approved product should not be sold at all – in large part because of preemption:

[N]ot only has the Supreme Court not yet said it would extend [Mensing’s] exception to design defect claims, but − while the generic maker has no choice as to label − the decision to make the drug and market it in [the state] is wholly its own. Thus, [plaintiff] having lost her warning claim by [preemption], the Supreme Court might be less ready to deprive [plaintiff] of her remaining avenue of relief.

Id. at 38.

Likewise in Wyeth, Inc. v. Weeks, ___ So.3d___, 2013 WL 135753 (Ala. Jan. 11, 2013), the Alabama Supreme Court decided to expand the liability of branded manufacturers under Alabama law to include injuries from generic products that they did not make in large part due to preemption:

FDA regulations provide that a generic-drug manufacturer's labeling for a prescription drug must be exactly the same as the brand-name-drug manufacturer's labeling. The Supreme Court in [Mensing] held that it would have been impossible for the generic-drug manufacturers to change their warning labels without violating the federal requirement that the warning on a generic drug must match the warning on the brand-name version, preempting failure-to-warn claims against generic manufacturers. In the context of inadequate warnings by the brand-name manufacturer placed on a prescription drug manufactured by a generic-drug manufacturer, it is not fundamentally unfair to hold the brand-name manufacturer liable for warnings on a product it did not produce.

Id. at *19.

At least Bartlett is before the Supreme Court as we speak, so we should get an indication in a few months whether a novel state law cause of action, invented as a way around preemption, can be effective at achieving that goal. As goes New Hampshire, so goes Oklahoma? One can only hope, but until then, Howard is one aspect of Oklahoma that definately isn't OK.