We just read one of the more remarkable decisions we’ve ever seen, insofar as it disregards controlling precedent. That opinion is In re Medtronic, Inc., Implantable Defibrillators Litigation, 2006 WL 3420285 (D. Minn. Nov. 28, 2006). To understand how this decision puts the preemption rabbit in the hat and then makes it disappear first requires some discussion of the controlling precedent involved – Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001), in which a unanimous court held that tort claims alleging fraud on the FDA were preempted. Indeed, in Buckman seven justices held that such claims were preempted even where the FDA itself determined it was defrauded.
In Buckman the plaintiffs claimed that, in a state-law action, they could undertake to prove that the defendants had obtained FDA approval fraudulently. The Supreme Court found the claim impliedly preempted due to the inherent conflict presented by state law presuming to determine when a federal agency decision was fraudulently obtained, and therefore could be treated as illegitimate. Buckman made the following points in finding preemption:
- Policing submissions by regulated entities to federal agencies “is hardly “a field which the States have traditionally occupied.” 531 U.S. at 347.
- The submissions at issue “were prompted by the [federal statute], and the very subject matter of [the submissions] were dictated by that statute’s provisions.” Id. at 347-48.
- The preemptive “conflict stems from the fact that the federal statutory scheme amply empowers the FDA to punish and deter fraud” and the FDA uses “this authority. . .to achieve a somewhat delicate balance of statutory objectives” – a “balance [that] can be skewed by allowing fraud-on-the-FDA claims under state tort law.” Id. at 348.
- Administrative “flexibility is a critical component of the statutory and regulatory framework under which the FDA pursues difficult (and often competing) objectives.” Id. at 349.
- Thus, fraud on the FDA allegations “inevitably conflict with the FDA’s responsibility to police fraud consistently with [its] judgment and objectives.” Id. at 350.
- The conflict also has “practical” aspects – such claims would “dramatically increase the burdens facing potential applicants” in ways “not contemplated by Congress” – specifically, “applicants may be discouraged from seeking [product] approval,” or else might compensate for “fear that their disclosures to the FDA. . .[might] later be judged insufficient in state court” by “submit[ting] a deluge of information that the Administration neither wants nor needs.” Id. at 350-51.
- Fraud on the FDA claims do not present “parallel” state-law requirements because such claims “exist solely by virtue of the FDCA disclosure requirements.” FDA fraud claims “would not be relying on traditional state tort law [that] predated the federal enactments” but rather “the existence of these federal enactments is a critical element in their case.” Id. at 353.
There is controlling Eighth Circuit precedent that FDA pre-market approval (which these defibrillators had) mandates extensive preemption of state-law product liability claims. See Brooks v. Howmedica Inc., 273 F.3d 785, 798 (8th Cir. 2001) (en banc), cert. denied, 535 U.S. 1056 (2002). To avoid preemption under Brooks, the Implantable Defibrillators decision relies entirely upon allegations that the defendant either failed to disclose information to the FDA or affirmatively withheld such disclosure. It then concludes that, notwithstanding multiple claims challenging the design, manufacture, and warnings passed upon by the FDA during several pre-market approvals, there was no “conflict” with federal requirements. Implantable Defibrillators, 2006 WL 3420285, at *7.
The specific allegations mentioned in the opinion are that the defendant supposedly: (1) “withheld critical information from the FDA while seeking the PMA Supplement approval,” id.; (2) “failed to notify the FDA. . .that the battery was defective,” id.; (3) “sought PMA approval for three new devices, but continued to use the known-to-be defective battery in them,” id.; and (4) “did not advise the FDA that it knew-for longer than a year-that the [battery] had exhibited a ‘previously undetected failure mode.’” Id. “Lacking such knowledge,” the allegations continue, “the FDA approved [defendant’s] PMA Supplement applications.” Id. Only later, after the defendant received field reports concerning failures previously seen only in laboratory tests, did the defendant issue a “Dear Doctor” letter which prompted the FDA “to order a recall.” Id.
These allegations are in substance, if not name, a fraud on the FDA claim. They make the same claim that was before the Supreme Court in Buckman: that the defendant withheld and/or manipulated the information it submitted to the FDA, and as a result the duped Agency took action approving (here through supplemental approvals) the product in question. Had the FDA had that information, these allegations continue, it would not have issued these approvals. Under Buckman there is no doubt that this type of claim is preempted. The only practical difference here is that, instead of captioning the allegations “fraud on the FDA,” these plaintiffs couched them in terms of traditional state-law causes of action. The discussion of these causes of action in the opinion, however, confirms that they are merely disguised fraud on the FDA claims.
The opinion starts with “parallel requirements.” 2006 WL 3420285, at *8. What, however, is the “parallel” pre-existing state-law requirement that takes the case out of Supreme Court’s analysis in Buckman? The opinion lists violations of 21 C.F.R. §803.50 (“Individual Adverse Event Reports”), §803.53 (“Five-Day Reports”), §814.3 (the “definitions” section of the Part concerning “Pre-Market Approval”), §814.39 (“PMA Supplements”), and §814.84 (“Reports”). Every one of these provisions deals with FDA reporting and/or approval. None of them directly concerns design, warnings, or manufacture – the sort of pre-existing state-law claims that Buckman holds are necessary to distinguish unpreempted “parallel” claims from preempted claims relating to a manufacturer’s interactions with the FDA.
Other than a claim of defective manufacture (which is not addressed by any of the regulations the opinion cites), most of the litany of allegations relate solely to the defendant’s interactions with the FDA:
[Defendant] failed to comply with PMA approval requirements; failed to comply with FDA reporting obligations; misrepresented and concealed information during the FDA approval process.
Implantable Defibrillators, 2006 WL 3420285, at *8 (record citations omitted). In substance, it is unmistakable that the “parallel requirements” claim the opinion allows to escape preemption is the same claim that the unanimous Supreme Court held to be preempted in Buckman as not involving a “parallel” requirement.
There is, of course, the mandatory allegation of failure to warn, 2006 WL 3420285, at *8, but the opinion goes on to reveal that these “warning” claims are just another repackaging of the same FDA-related allegations – that the defendant failed to warn about the same information it supposedly withheld from the FDA. Id. at *9 (defendant “discovered the battery defect. . .but made no report to the FDA”; “it thereafter submitted PMA Supplement applications. . . without disclosing the possibility of this defect to the FDA”). Indeed, the analysis relies upon these same FDA non-disclosure claims in an attempt to distinguish Brooks. 2006 WL 3420285, at *9. Because the warning claims depend upon the identical allegations that information was withheld from the FDA, they are merely fraud on the FDA claims in disguise.
The implied warranty discussion contains reference to allegations of departures from FDA-mandated “manufacturing standards.” Id. A manufacturing-based claim – if supported by evidence – might well escape preemption as a “parallel requirements” claim. The trouble here is the nature of the purported manufacturing claims is never described in the opinion, and neither is any separate count alleging a manufacturing defect mentioned. To the extent that the implied warranty claims are yet another restatement of the FDA-related allegations already discussed, they would be preempted under Buckman regardless of what FDA regulations concerning the scope of express preemption state about implied warranty (Buckman holds that implied preemption operates independently of express preemption, 531 U.S. at 352).
Express warranty is another type of claim that may escape preemption under some circumstances. Once again, the opinion does not contain a sufficient discussion of the claims to determine whether they are yet another iteration of the plaintiffs’ fraud on the FDA allegations. 2006 WL 3420285, at *10. The absence of any other articulated factual basis strongly suggests that they are.
The same is true of the consumer fraud allegations – except that, since this type of claim is entirely informational, it is highly likely that this is yet another guise under which the plaintiffs’ fraud on the FDA claims are masquerading. The failure of the opinion, id. at *11, to include any description of any aspect of the defendant’s supposed “promotion” that does not involve the information allegedly withheld from the FDA further reinforces this impression.
The fraud on the FDA rabbit that the Implantable Defibrillators opinion put into the hat in its analysis of express preemption vanishes entirely in the subsequent discussion of implied preemption – which is what the Buckman decision is all about. All of the essential facts are the same as in Buckman: there was no dispute that, (1) the product “received [FDA] approval”, and (2) “the FDA has never found or cited [defendant] for a regulatory violation.” 2006 WL 3420285, at *11. Here, as in Buckman the plaintiffs deprecate in-force FDA product approvals.
To avoid Buckman, the decision relies on the labels plaintiffs give to their allegations rather than the substance of those claims. 2006 WL 3420285, at *11 (“the claim at issue in Buckman was actual ‘fraud-on-the-FDA,’ and not state tort claims involving the plaintiffs’ personal injuries”). The opinion thus takes the view that preemption is governed solely by whatever caption the plaintiffs choose to name their allegations of FDA-related misconduct. Because no plaintiff will be so foolish as to call anything “fraud on the FDA” after Buckman, this reasoning is tantamount to ignoring controlling Supreme Court authority. No precedent is cited for this singular holding – only an article from a CLE program sponsored by the American Trial Lawyers Association. 2006 WL 3420285, at *12.
Next, the opinion asserts “[p]laintiffs do not complain of fraud on the FDA. Rather, they claim they, themselves, were deceived.” Id. Some courts have drawn this distinction, but only where there are facts showing both: (1) statements other than those concerning FDA-related information, and (2) individual reliance upon those statements. Neither prerequisite for non-FDA-related fraud is mentioned here. The continued marketing of allegedly fraudulently approved devices and the same battery defect involved in the FDA-related allegations are all that is opinion cited. Id. Reliance is ignored entirely. Id. Instead, the opinion resorts to the “historic primacy of the states” argument, id., that was decisively rejected in Buckman. 531 U.S. at 347.
The opinion then seeks to distinguish Buckman as involving off-label use. 2006 WL 3420285, at *12. Off-label use, however, was cited by the Supreme Court in Buckman only as an “example” of the “difficult task of regulating” that the FDA has to carry out. 531 U.S. at 349-50. There is no suggestion either in Buckman or in any of the many cases applying it that fraud on the FDA claims not involving off-label use somehow escape preemption. Preemption of FDA-related misconduct claims having nothing to do with off-label use is frequently affirmed. E.g., Cupek v. Medtronic, Inc., 405 F.3d 421, 424 (6th Cir.) (“disguised fraud on the FDA claim” preempted), cert. denied, 126 S. Ct. 420 (2005); Kemp v. Medtronic Corp., 231 F.3d 216, 235 (6th Cir. 2000), cert. denied, 534 U.S. 818 (2001); Mitchell v. Collagen Corp., 126 F.3d 902, 914 (7th Cir. 1997), cert. denied, 523 U.S. 1020 (1997). “[P]laintiffs cannot bootstrap their arguments regarding defendant’s alleged failure to report and to investigate adverse incidents to the FDA into a defective warning case.” Webster v. Pacesetter, Inc., 259 F. Supp. 2d 27, 36 (D.D.C. 2003).
The “final” reason for denying implied preemption is that an “expansive” reading of Buckman “would place [the decision] outside the legion of cases upholding parallel requirements to federal violations as actionable.” 2006 WL 3420285, at *12. As already discussed, however, each and every one of the claimed “parallel” violations of FDA regulations listed in the opinion, id. at *8, involves a claimed FDA reporting or approval violation. Thus, these claims are not like the other cases the opinion cites, but rather fit snugly within Buckman’s discussion of why allegations involving FDA-related misconduct are simply not “parallel” violation claims. See 531 U.S. at 353.
The decision closes with dictum that even it concedes is not the law, suggesting that there should be “no preemption at all” if the defendant violated “a Congressionally-imposed affirmative duty to disclose this information to the FDA.” 2006 WL 3420285, at *13. Here the true thrust of the opinion’s analysis is revealed. This final discussion is nothing more and nothing less than a call for resurrection of the very fraud on the FDA claims the Supreme Court unanimously declared to be preempted in Buckman. Fraud on the FDA may well have been “a condition Justice Breyer never contemplated in Lohr.” 2006 WL 3420285, at *13. However, it was a condition that all nine of the justices directly confronted in Buckman – and all nine of them found preemption because this sort of claim “inevitably conflict with the FDA’s responsibility.” 531 U.S. at 350.