Thursday, January 03, 2013

Presuming Preemption Out

           We read 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.)

            Tigert involved a fairly straightforward 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 refrain.) 

            The first 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.

            The 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 Administration required 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.

            Instead, Tigert jumped to an issue of 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.

            We have previously slammed questioned the reasoning of Desiano that Buckman 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:

Policing fraud against federal agencies is hardly a field 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.

Buckman, 531 U.S. 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.

            So, not 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 preempted.

            Somewhat 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 notwithstanding.

No comments: