Photo of Bexis

It’s only a small piece of what product liability claims are all about, but the Sixth Circuit in Fulgenzi v. PLIVA, Inc., No. 12-3504, slip op. (6th Cir. March 13, 2013), has ruled (creating something of a circuit split with the 5th Circuit’s nonprecedential Morris decision from last month), that “failure to update” claims are not preempted in a case involving a generic drug.  Everything else is gone, and Fulgenzi goes to great pains to state that even evidence of any other possible warning isn’t admissible, but this one claim remains.

As is typical with any court that rejects a preemption argument, Fulgenzi references a “presumption against preemption,” slip op. at 8, even though the Supreme Court majority in Mensing did not rely  on any such thing (and four justices would have eliminated it altogether).  Mensing impossibility preemption did not apply because there was nothing impossible – the updating in question had already been ordered by the FDA:

In our case, not only could PLIVA have independently updated its labeling to match that of the branded manufacturer through the CBE process . . . but it had a federal duty to do so.  As a result, compliance with federal and state duties was not just possible; it was required. Impossibility preemption is inappropriate in such a case.

Slip op. at 9 (citations omitted).

The more problematic aspect Fulgenzi is how it dealt with what we’ve always thought of as the strongest argument against failure to update, which is that under Buckman a duty to update claim is an improper disguised attempt to enforce an FDCA updating duty that doesn’t exist under federal law.  We’ve read Fulgenzi twice on this point, and we still don’t see the rationale, so we’ll let our readers noodle over it:

[T]he result of this violation does raise concerns that [plaintiff] is simply attempting to enforce a federal-law violation through state litigation.  Where, as here, the statute specifically excludes a private cause of action, 21 U.S.C. §337(a), state tort suits premised on violations of federal law may be impliedly preempted . . . if the claims “exist solely by virtue of” the regulatory scheme . . . .  Here, [plaintiff’s] suit is not even premised on violation of federal law, but rather on an independent state duty.   The alleged breach arises from the same act, but the legal basis is different. This is simply not grounds for preemption.  The federal duty of sameness is not a “critical element” in [plaintiff’s] case.  Failure to update from one adequate warning to another would violate the FDCA, but not Ohio law.  Her suit instead relies upon the adequacy of the warnings and the causation of her injuries.

Fulgenzi, slip op. at 12-13 (emphasis original).  But state law does not have anything to do with “sameness,” one way or the other.  That’s an entirely federal concept.  That “duty” exists only by virtue of the FDCA.  For plaintiffs to substitute that duty (the only one that survives Mensing express preemption), is to put state law in the position of enforcing federal law, which the FDCA explicitly prohibits.  As even Fulgenzi is forced to admit, “violation of the federal duty of sameness is essential to [plaintiff’s] case.  Id. at 13.  Whether or not there’s a “violation” is irrelevant to §337(a), the duty is unquestionably federal.  Only the federal government may enforce it.  Whether the “same” warning is, or is not, also “adequate” under state law amounts to nothing more than coincidence.  At least that’s how we see it.

The court also rejected “purposes and objectives” preemption, holding that no generalized congressional intent to encourage generic drugs prevented any and all product liability claims against their manufacturers.  “A vague policy of encouraging use of generic drugs, untethered from the structure of the Act, is not enough to support purposes-and-objectives preemption.”  Fulgenzi, slip op. at 11.

So what’s left?  A small piece of a claim.  Apparently, after preemption is overcome, the “duty of sameness” drops from the case altogether:

On the merits, whether [defendant] has violated its federal duties is irrelevant to the adequacy of its warnings.  A jury need not know about the duty of sameness at all.

Fulgenzi, slip op. at 13.  The FDA goes unmentioned at trial (even though it is simultaneously “essential”), but the plaintiff is forbidden from challenging the “adequacy” of the generic warning under state law with anything other than the FDA-approved “update.”  Id.

So there’s not that much left, and even the duty to update claim is factually specific to this one generic drug.  We don’t know of any other generic drug litigation where there’s any factual basis for a failure to update claim.  That’s why what bothers us the most about Fulgenzi is the mess the court made when as it tries to fit something into Ohio law that has no basis in Ohio precedent.  The opinion states: “[T]here is nothing in the Ohio product-liability law inconsistent with a claim that a defendant failed to warn, even inadequately.”  Slip op. at 13.  That litodes is just the double negative way of stating that there’s not a scrap of Ohio product liability law affirmatively recognizing a viable claim for failure to give an inadequate warning.

We go on until we’re blue in the face that federal courts sitting in diversity are not supposed to predict expansions of state law that have no support in that law.  It’s not enough that no court might have had occasion to reject a novel and bizarre theory like failure to give an inadequate warning nonetheless being a basis for liability.  There must be state-law precedent somewhere affirmatively supporting a claim for a federal court to predict its adoption.  Ohio imposes a “reasonable care” statutory standard for warning claims.  Nothing supports the proposition that a concededly “inadequate” warning nonetheless constitutes “reasonable care,” and Fulgenzi cites nothing.  This double negative approach is inconsistent with Erie.

[F]ederal courts must proceed with caution when making  pronouncements about state law. Sitting in diversity, we are not commissioned to take a position regarding the advisability or fairness of the state rule to be applied, but must determine the issue as would the highest court of the state.   This Court’s proper reluctance to speculate on any trends of state law applies with special force to a plaintiff in a diversity case. . . .  When given a choice between an interpretation of state law which reasonably restricts liability, and one which greatly expands liability, we should choose the narrower and more reasonable path.

Combs v. International Insurance Co., 354 F.3d 568, 577 (6th Cir. 2004) (citations and quotation marks omitted); see Ventas, Inc. v. HCP, Inc., 647 F.3d 291, 328 n.15 (6th Cir. 2011 (quoting and following Combs); 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”) (quoting Day & Zimmermann, Inc. v. Challoner, 423 U.S. 3, 4 (1975)).

So completely apart from preemption, we think that Fulgenzi‘s plucking of a failure-to-give-an-inadequate-warning theory of liability from thin air is more than simply wrong – it’s a usurpation of the rights of the Ohio state courts to determine, in the first instance, what Ohio law is supposed to be.  It’s not merely a matter of causation (not being able to say “that a severely inadequate warning would never cause an injury that a moderately inadequate warning would have prevented,” slip op. at 14), it’s a matter of whether such a duty – that not giving a legally inadequate warning is required as a matter of “reasonable care” – exists in the first place.  No federal court should make that prediction in the first instance.

We’ve said it before, tort preemption makes courts do strange things; but that doesn’t make it right.

Still, what’s left, even after violence has been done to both §337(a) and Ohio law, isn’t very much.  Another “narrow gap” – this time between Mensing and Buckman must be navigated.  Slip op. at 14.

The arguments [plaintiff] makes, the proofs she offers, and the evidence she submits are all subject to limitation by preemption principles. . . .  [Plaintiff] must use the language of the 2004 FDA-approved label in her proximate-cause argument, not (or not merely) the fact of the failure to update.

Fulgenzi, slip op. at 14-15.  That’s all that’s left, and in a generic preemption case involving a different drug where there hasn’t been any failure to update, not even that.

Thus, while to some extent Fulgenzi is a hash, it’s also a tempest in a teapot – unless and until some other court in some other case involving some other product picks up that dead cat of a failure-to-give-an-inadequate-warning claim and tries to run with it.