We’ve always been of the opinion that the rationale for preemption in Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), concerning:  (1) the FDA’s exclusive enforcement power, and (2) the adverse effects that common-law second-guessing of the sufficiency of submissions to the FDA would have on the Agency’s ability to do its job, should have impact well beyond cases labeled “fraud on the FDA.”  In particular, we’ve pointed out “embedded” fraud on the FDA claims of various sorts, including where plaintiffs seek to introduce fraud on the FDA evidence to support some other sort of claim and were stopped cold by preemption.  

Here’s another one, In re Incretin Mimetics Products Liability Litigation, 2014 WL 4987877 (S.D. Cal. Oct. 6, 2014).  Incretininvolved an MDL discovery dispute – plaintiffs sought “to compel production of adverse event source documents and databases” relating to the product in question.  Id. at *1.  Their excuse for being entitled to rummage through all of the defendant’s adverse event reporting was “all of the source documents underlying the adverse event reports are necessary to determine whether Defendants misreported or under-reported information to the FDA.”  Id.

The court refused to compel this information, because Buckmanprecluded plaintiffs from second-guessing the adequacy of the defendant’s reporting to the FDA.  Although fraud on the FDA wasn’t, of course, pleaded (plaintiffs are not stupid), it was inherent in the claims they were alleging:

Plaintiffs frequently invoke allegations of misreporting and underreporting as a justification for additional discovery, and as pertinent to a preemption defense. . . .  Whether Plaintiffs’ state law failure-to-warn claims are preempted is not the issue before the Court.  Instead, the Court considers whether the policy underlying the Supreme Court’s holding in Buckman precludes Plaintiffs from asserting fraud-on-the-FDA type claims as a defense to federal preemption or as other-wise relevant to a preemption analysis, and thereby precludes discovery thereon.

Id. at *2.  As we’ve argued, Buckman’s rationale is not as limited as plaintiffs try to make it.  Such claims “inevitably conflict” with whatever portion of the “FDA regulatory scheme” the plaintiffs claim isn’t being reported correctly.  Id.  They “dramatically increase the burdens facing potential [drug] applicants by causing [them] to fear that their disclosures to the FDA, although deemed appropriate by the Administration, will later be judged insufficient in state court.”  Id. (both quoting Buckman in part).

Thus, the court held that the “underreporting” claims that plaintiffs advanced as the basis for their discovery were preempted byBuckman’s rationale.  “Plaintiffs’ assertions that there are ‘reasons to believe [adverse events] were not correctly reported and were under-reported’ and that information was ‘withheld by Defendants from the FDA’ are fraud-on-the-FDA claims expressly preempted byBuckman.”  Id. (we assume “express” refers to the terms of Buckman itself, rather than to the type of preemption, which is implied conflict preemption).  That plaintiffs didn’t call their claims “fraud on the FDA” didn’t matter.  “While Buckman may not speak directly to whether fraud-on-the-FDA claims are relevant to a preemption determination, Buckman definitively establishes that such claims are preempted for fear of “exert[ing] an extraneous pull on the scheme established by Congress,” and “[t]he same rationale suggests fraud-on-the-FDA claims should not be allowed to rebut the defense of federal preemption.”  Id. at *4.

Because of Buckman’s “policy,” generalized discovery related to under-reporting and mis-reporting was “irrelevant” due to preemption any basis for it:

The policy underlying Buckman also supports deferring consideration of those claims when raised not as an individual basis for relief, but as relevant to a preemption analysis.  To allow otherwise and permit fraud-on-the-FDA type claims to alter a federal preemption analysis would put at issue allegations expressly removed from judicial consideration.  Accordingly, the Court finds the fraud-on-the-FDA type allegations asserted by Plaintiffs in support of their motion irrelevant to the determination of whether Plaintiffs state law failure-to-warn claims are preempted.

Id. at *2-3.  “[E]ven if Plaintiffs could establish Defendants committed fraud-on-the-FDA . . ., the analysis of whether Plaintiffs' state law claims are preempted would not change.”  Id. at *3.

Nor could a court adjudicating exclusively state common-law actions do anything about the generalized allegations of misreporting that the plaintiffs sought discovery to prove:

[T]he absence of or mis-characterization of data due to alleged FDA reporting violations is not within the purview of the Court.  It is not the role of courts to evaluate or enforce the degree to which manufacturers comply with FDA regulations.  The judiciary and its litigants are neither the appropriate people nor the appropriate forum for evaluations of compliance with FDA reporting requirements.

Id. (citations omitted).  The federal “regulatory scheme” must prevail over obstructions from state-law tort claims:

The power of the FDA to regulate reporting requirements compliments, rather than conflicts with, the affirmative defense of federal preemption. The conflict arises not within the context of federal preemption versus the FDA’s power to regulate, but within the fraud-on-the-FDA type arguments and Plaintiffs’ multi state law failure-to-warn claims.  To allow discovery, and by extension judicial consideration, of compliance with federal reporting requirements would erode the FDA’s role in pharmaceutical regulation and neglect the policy underlying Buckman.  Thus, the tension is not, as Plaintiffs suggest, the result of two regulatory provisions, but with the plaintiffs’ state law claims and the regulatory scheme promulgated by Congress.

Id. at *4.  “Granting the discovery sought on the basis such claims are relevant to preemption would require courts to overstep the bounds placed in effect by the FDA's federal regulatory scheme and Supreme Court precedent.”  Id.

The court did recognize that, on an individualized basis, some plaintiffs might resort to violation-based warning claims of the sort allowed by the Ninth Circuit in Stengel v. Medtronic, Inc., 704 F.3d 1224 (9th Cir. 2013).  But Stengel involved “parallel” claims, and did not turn on what the FDA received, but rather on what particular plaintiffs’ treating physicians could have learned. Incretin, 2014 WL 4987877, at *3-4.  “[W]hether providing information to the FDA would have changed the FDA’s conclusion” was an entirely different matter, and was “a fraud-on-the-FDA theory which was rejected by the Supreme Court in Buckman.”  Id.at *4 n.5.  While some individualized discovery during relevant periods could perhaps be relevant to Stengel-type claims, the plaintiffs proposed generalized fishing expedition with respect to “preemption” was not.  “Granting the discovery sought on the basis such claims are relevant to preemption would require courts to overstep the bounds placed in effect by the FDA’s federal regulatory scheme and Supreme Court precedent.”  Id. at *4.  Any individual Stengel claims were “not before the Court.”  Id.

Plaintiffs’ non-preemption attempts to justify blanket discovery into adverse event preparation and reporting also failed.  The discovery wasn’t relevant to causation because adverse event reports don’t prove causation (see our cheatsheet):

[T]he Court is not persuaded the source documents and databases Plaintiffs seek are relevant to general causation as defined by the Court.   As Defendants submit, Courts have recognized that adverse event reports are collected without any medical controls or scientific assessment,” and as a result are “one of the least reliable sources to justify opinions about both general and individual causation.

Id. at *4-5 (citation and quotation marks omitted).

Nor was this discovery as costless as plaintiffs made it out to be. Under proportionality principles (which will be even more salient under the new rules) “the additional time as well as expense of identifying, redacting, and producing the source files outweighs the likely benefit that will result from evaluating source files for instances of mis-classification.”  Id. at *5.