Tigert involved a fairly straightforwarddrug claim—plaintiff took Solodyn, a prescription acne medication made bydefendant Medicis Pharmaceutical Corporation, experienced liver failure whileon the medication, and sued. Since theprescriptions and use were apparently in Texas—the decision never says that—andthe Second Amended Complaint—yes, like we pointed out in prior posts, we seemto see serial amendments of complaints for weak cases—alleged that the Solodynlabel had warnings approved by FDA, the defendant teed up a 12(c) motion forjudgment on the pleadings that the presumption against liability where anallegedly inadequate warning was approved by FDA would hold because theexception for fraud on the FDA was preempted by Buckman. Much like shoddywrapping or a package in the shape of socks, there were some signs we were notgoing like where this decision ended up. (We waited two whole sentences, one a complete run-on, before failing torefrain.)
The firsthint 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 canprove no set of facts in support of [her] claim which would entitle [her] torelief.” 2012 U.S. Dist. LEXIS 178475,** 2 & 4. The second was in the lackof detail about what was plead—remember this is a motion for judgment on thepleadings, addressing the adequacy of the third version of the complaint. The opinion characterized the complaint asclaiming the label “grossly understated the risks” of the drug, even though itwas approved by FDA. Id. at *2. The risk of liver failure? Therisk of something else? Were thewarnings allegedly inadequate based upon information that existed beforeapproval or only after approval? Whatwas wrong with the warnings according to the complaint? Tigertalso never stated that the complaint alleged any specific fraud on FDA, relatedto liver failure or otherwise, pre-approval or post-approval. That struck us as strange. The decision ultimately did decline toconsider whether the plaintiff failed to allege fraud with particularity asrequired by Fed. R. Civ. P. 9(b) because the argument was not raised until thereply. While we find it hard to believethat defendant’s motion did not identify the shortcomings of plaintiff’s fraudallegations, all we can say from this decision on the adequacy of the pleadingsis that we still do not know what plaintiff pled on fraud.
Thedetails matter because the exemption at issue requires the plaintiff toestablish that “the defendant, before or after pre-market approval . . .withheld from or misrepresented to the United States Food and DrugAdministration requiredinformation that was materialand relevant to the performance ofthe product and was causallyrelated to the claimant’s injury” (emphasis added). That means not just any allegations of fraudon the FDA should suffice for this case. At a minimum, the alleged non-disclosure or misrepresentation would needto have related to the risk of liver failure. If it did not, then the opinion should not have reached theconstitutional issue of preemption and should have just granted the motion forjudgment on the pleadings. If plaintiffchose to allege that the label was approved—she did—without alleging the relevantfraud on FDA to meet the statutory exemption—maybe she did—then the pleadingdid not state a claim for relief under Texas law.
Instead, Tigert jumped to an issue ofconstitutional law that perhaps it did not have to reach and then proceeded todiscuss 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 waspreempted 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 annexingTexas? While the opinion rejected thearguments that it should follow Loftonsimply because it was the only circuit decision on the Texas statute and thatTexas is within the Fifth Circuit, the promise to “evaluate the question offederal preemption independently” did not materialize. Rather, the remaining headings in the opinionwere “The Lofton Decision” and“Reconsidering Lofton,” each of whichcritiqued the reasoning in Lofton orcompared it to the reasoning in Desiano. Any “independent” analysis of Buckman, the FDCA, preemption, and theTexas statute was nowhere to be found. Also missing was any mention of the non-precedential holding in Kent, the appeal of Desiano.
We havepreviously
Policing fraud against federal agencies is hardly a fieldwhich the States have traditionally occupied, such as to warrant a presumptionagainst finding federal pre-emption of a state-law cause of action. To the contrary, the relationship between afederal agency and the entity it regulates is inherently federal in characterbecause the relationship originates from, is governed by, and terminatesaccording to federal law.
Buckman, 531 U.S.at 347 (citations and quotation marks omitted). Does the Texas statute involve “the relationship between a federalagency and the entity it regulates”? Onits face, it does by specifying that the defendant must have “withheld from ormisrepresented to the United States Food and Drug Administration.” § 82.007(b)(1). One simply cannot apply a presumption againstpreemption in this situation without ignoring Buckman. But that isprecisely what Tigert (and Desiano) did.
So, notonly was Tigert engaged in a misguidedcritique of Lofton rather than the promisedindependent evaluation of federal preemption, it also answered the wrongquestion. Under 12(c), a court is supposedto decide whether the pleadings, construed favorably to the non-movant, stateda claim for failure to warn under Texas law given that the live complaintalleged the warnings were approved by FDA, apparently had some allegationsrelating to some sort of fraud of FDA, and apparently did not allege that FDAhad 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 ispreempted.
Somewhatironically, Tigert made note of whatcould have been a rational path to a decision on the issue actuallypresented. In setting up how brilliantit thought Desiano was, the opinion notedthat the Sixth Circuit’s Garciadecision held “that unless the FDA itself had already found fraud, plaintiffcould 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 toplead that FDA had concluded that it was defrauded with regard to “informationthat was material and relevant to the performance of the product and wascausally related to the claimant’s injury”—in addition to pleading that thedrug came with an FDA-approved label for some reason—then she would have gottenpast preemption at this stage. Perhapssome concern over the facts or Rule 11 precluded the plaintiff from making theallegation about what FDA had concluded. And perhaps, in 2013 or beyond, when it is apparent that the plaintiffhas 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 preemptionnotwithstanding.
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