the decision in Tigert v. Ranbaxy Pharms.,
No. 12-00154 (RBK/JS), 2012 U.S. Dist. LEXIS 178475 (D.N.J. Dec. 18, 2012),
with interest. It involved a recurring
question that the Supreme Court failed to address in Warner-Lambert Co. v. Kent, 552 U.S. 440 (2007)—whether state
statutory provisions that require a plaintiff to prove some version of
fraud-on-the-FDA as a predicate to recovery on certain claims are preempted by Buckman Co. v. Plaintiff’s Legal Comm.,
531 U.S. 341 (2001), in situations where FDA has not concluded that such a
fraud occurred. Well, that is how we
frame the question, having dealt with dealt for a while with Buckman, state tort reform statutes, and
plaintiffs who think the jury should be allowed to award big bucks based on its
conclusion that the FDA was defrauded by what the sponsor-defendant did or did
not submit as long as the verdict form lacks a section entitled “CAUSE OF
ACTION #3 – FRAUD ON THE FDA (pssst, answer Yes for free donuts).” This subject, of course, has been addressed
in several prior posts, and it is no secret that we think Garcia
v. Wyeth-Ayerst Labs., 385 F.3d 961 (6th Cir. 2004), was right on the
Michigan statute where Desiano v.
Warner-Lambert, 467 F.3d 85 (2d Cir. 2006), was wrong and Lofton v. McNeil Consumer & Specialty
Pharms., 672 F.3d 372 (5th Cir. 2012), was right on the Texas statute. So, we hoped that the analysis in Tigert
of the same Texas statute as in Lofton
would follow Lofton. We were disappointed. (Despite the time of year, we are trying to
refrain from references to holidays, resolutions, or our memories of the past
year. We leave such to others.)
drug claim—plaintiff took Solodyn, a prescription acne medication made by
defendant Medicis Pharmaceutical Corporation, experienced liver failure while
on the medication, and sued. Since the
prescriptions and use were apparently in Texas—the decision never says that—and
the Second Amended Complaint—yes, like we pointed out in prior posts, we seem
to see serial amendments of complaints for weak cases—alleged that the Solodyn
label had warnings approved by FDA, the defendant teed up a 12(c) motion for
judgment on the pleadings that the presumption against liability where an
allegedly inadequate warning was approved by FDA would hold because the
exception for fraud on the FDA was preempted by Buckman. Much like shoddy
wrapping or a package in the shape of socks, there were some signs we were not
going like where this decision ended up.
(We waited two whole sentences, one a complete run-on, before failing to
hint was that the plaintiff was identified as “a 21 year old college student,”
which does not seem relevant to the 12(c) standard of whether “plaintiff can
prove no set of facts in support of [her] claim which would entitle [her] to
relief.” 2012 U.S. Dist. LEXIS 178475,
** 2 & 4. The second was in the lack
of detail about what was plead—remember this is a motion for judgment on the
pleadings, addressing the adequacy of the third version of the complaint. The opinion characterized the complaint as
claiming the label “grossly understated the risks” of the drug, even though it
was approved by FDA. Id. at *2.
The risk of liver failure? The
risk of something else? Were the
warnings allegedly inadequate based upon information that existed before
approval or only after approval? What
was wrong with the warnings according to the complaint? Tigert
also never stated that the complaint alleged any specific fraud on FDA, related
to liver failure or otherwise, pre-approval or post-approval. That struck us as strange. The decision ultimately did decline to
consider whether the plaintiff failed to allege fraud with particularity as
required by Fed. R. Civ. P. 9(b) because the argument was not raised until the
reply. While we find it hard to believe
that defendant’s motion did not identify the shortcomings of plaintiff’s fraud
allegations, all we can say from this decision on the adequacy of the pleadings
is that we still do not know what plaintiff pled on fraud.
details matter because the exemption at issue requires the plaintiff to
establish that “the defendant, before or after pre-market approval . . .
withheld from or misrepresented to the United States Food and Drug
information that was material
and relevant to the performance of
the product and was causally
related to the claimant’s injury” (emphasis added). That means not just any allegations of fraud
on the FDA should suffice for this case.
At a minimum, the alleged non-disclosure or misrepresentation would need
to have related to the risk of liver failure.
If it did not, then the opinion should not have reached the
constitutional issue of preemption and should have just granted the motion for
judgment on the pleadings. If plaintiff
chose to allege that the label was approved—she did—without alleging the relevant
fraud on FDA to meet the statutory exemption—maybe she did—then the pleading
did not state a claim for relief under Texas law.
constitutional law that perhaps it did not have to reach and then proceeded to
discuss it without any consideration of the alleged facts of the case. For Tigert,
the issue was whether to follow the Fifth Circuit’s decision in Lofton that the Texas exemption was
preempted or the Second Circuit’s decision in Desiano that the Michigan exemption was not preempted. Huh?
Did we miss the D.N.J. moving to the Second Circuit or Michigan annexing
Texas? While the opinion rejected the
arguments that it should follow Lofton
simply because it was the only circuit decision on the Texas statute and that
Texas is within the Fifth Circuit, the promise to “evaluate the question of
federal preemption independently” did not materialize. Rather, the remaining headings in the opinion
were “The Lofton Decision” and
“Reconsidering Lofton,” each of which
critiqued the reasoning in Lofton or
compared it to the reasoning in Desiano. Any “independent” analysis of Buckman, the FDCA, preemption, and the
Texas statute was nowhere to be found.
Also missing was any mention of the non-precedential holding in Kent, the appeal of Desiano.
preemption did not apply to the Michigan exemption because the plaintiff was
not really choosing to assert a fraud on the FDA claim when trying to proceed
under the exemption.
With limited consideration of Buckman
itself—which it characterized without analysis as a “narrow ruling,” the Tigert opinion missed the flaws in Desiano and endorsed its approach. It then figured the Fifth Circuit had not
come to the same conclusion—Lofton
rightly determined that making fraud on the FDA a predicate to recovery was
enough under Buckman—because it had
“[s]kirt[ed] the question of whether the presumption against preemption
applied.” Id. at *12. Based on a
distinction without difference, Tigert
concluded that Lofton had “failed to
recognize the applicability of the presumption against preemption and expanded Buckman preemption to §
82.007(b)(1).” Id. at *14. Thus, “the Court
finds that § 82.007(b)(1) is not preempted by federal law.” Id.
at *15. Perhaps it would have been a
good idea actually to review exactly why Buckman
ousted the presumption against preemption:
which the States have traditionally occupied, such as to warrant a presumption
against finding federal pre-emption of a state-law cause of action. To the contrary, the relationship between a
federal agency and the entity it regulates is inherently federal in character
because the relationship originates from, is governed by, and terminates
according to federal law.
at 347 (citations and quotation marks omitted).
Does the Texas statute involve “the relationship between a federal
agency and the entity it regulates”? On
its face, it does by specifying that the defendant must have “withheld from or
misrepresented to the United States Food and Drug Administration.” § 82.007(b)(1). One simply cannot apply a presumption against
preemption in this situation without ignoring Buckman. But that is
precisely what Tigert (and Desiano) did.
only was Tigert engaged in a misguided
critique of Lofton rather than the promised
independent evaluation of federal preemption, it also answered the wrong
question. Under 12(c), a court is supposed
to decide whether the pleadings, construed favorably to the non-movant, stated
a claim for failure to warn under Texas law given that the live complaint
alleged the warnings were approved by FDA, apparently had some allegations
relating to some sort of fraud of FDA, and apparently did not allege that FDA
had found that such a fraud had been perpetrated. It is not a matter of whether § 82.007(b)(1)
is preempted, but whether the cause of action that plaintiff had pled is
ironically, Tigert made note of what
could have been a rational path to a decision on the issue actually
presented. In setting up how brilliant
it thought Desiano was, the opinion noted
that the Sixth Circuit’s Garcia
decision held “that unless the FDA itself had already found fraud, plaintiff
could not attempt to overcome the presumption of non-liability by invoking the
‘fraud-on-the-FDA’ [Michigan] statutory exception.” Id.
at *8. If the plaintiff had decided to
plead that FDA had concluded that it was defrauded with regard to “information
that was material and relevant to the performance of the product and was
causally related to the claimant’s injury”—in addition to pleading that the
drug came with an FDA-approved label for some reason—then she would have gotten
past preemption at this stage. Perhaps
some concern over the facts or Rule 11 precluded the plaintiff from making the
allegation about what FDA had concluded.
And perhaps, in 2013 or beyond, when it is apparent that the plaintiff
has no evidence of a relevant fraud on FDA or FDA’s finding of such a fraud, Tigert will be kicked on another motion,
the over-inflated, wrongly-applied, and (perhaps after Mensing) non-existent presumption against preemption