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non-precedential decision, allowed a “parallel claim” to escape preemption.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). Howard
discounted 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. See
Murthy 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.
Posts
No comments:
Post a Comment