As we mentioned in our recent Preemption Teaser post, last month's concurrence in denial of certiorari in Lipschultz v. Charter Advanced Services (MN), LLC, ___ S. Ct. ___, 2019 WL 5300908 (U.S. Oct. 21, 2019), provides an indication that, at least to some extent, Justice Thomas might have found a kindred spirit of sorts in Justice Gorsuch (who joined that concurrence) as to some of his hitherto idiosyncratic preemption views. In particular, the opinion repeated, id. at *2, the "freewheeling judicial inquiry" catchphrase from Justice Thomas' concurrence in Wyeth v. Levine, 555 U.S. 555, 558 (2009), in which he, alone among the Justices, rejected the concept of "obstacle to purposes and objectives" implied preemption (which hereafter we'll just call "obstacle") altogether for precisely that reason.
As an alternative to "obstacle" preemption, the Lipschultz concurrence posits a theory whereby implied conflict preemption occurs when state law "logically contradicted the 'Constitution,' the 'Laws of the United States,' or 'Treaties." Id. at *1 (quoting Supremacy Clause). Under such a theory, "final agency action" would have "preemptive effect" as to "federal standards and policies that are set forth in, or necessarily follow from, the statutory text." Id. (quoting Thomas concurrence in Wyeth v. Levine, 555 U.S. 555 (2009)). Since the petitioner in Lipschultz didn't make this argument, Justices Thomas and Gorsuch concurred in the denial of certiorari. Id. at *2. That amounts to an engraved invitation to make the argument in the future.
On to Buckman. In concluding that fraud on the FDA claims were preempted in Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), the 7-justice majority followed what was essentially an obstacle preemption rationale.
The conflict stems from the fact that the federal statutory scheme amply empowers the FDA to punish and deter fraud against the Administration, and that this authority is used by the Administration to achieve a somewhat delicate balance of statutory objectives. The balance sought by the Administration can be skewed by allowing fraud-on-the-FDA claims under state tort law.
Id. at 348. Thus Buckman's analysis looked to: (1) the FDA's extensive disclosure requirements; (2) the FDA's ability to detect, deter, and punish fraud; (3) the FDA's nuanced position on off-label use; and (4) that tort claims attacking the adequacy of submissions to the FDA could gum up the regulatory works with additional, unnecessary paper. Id. at 348-51.
The two main holdings in Buckman are, first, that claims attacking agency decisions as fraudulently obtained are preempted, and second, that private persons (such as tort plaintiffs) lack the ability to enforce the FDCA and thus cannot assert claims in which purported violations are a "critical element." Id. at 353.
Applying Justice Thomas' preemption views, how can we reach the same result?
First of all, the scope of preemption cannot "wander far from the statutory text." Levine, 555 U.S. at 583 (Thomas, J., concurring). Philosophically, for Justice Thomas, preemption rests upon supreme federal powers that are "few and defined." Id. at 585. The Supremacy Clause grants supremacy only to "[t]his Constitution, and the Laws of the United States which shall be made in Pursuance thereof; and all Treaties," id. at 586, so that is where preemption starts and stops – not "broad federal policy objectives, legislative history, or generalized notions of congressional purposes that are not contained within the text of federal law." Id. at 587.
This rationale alone should be plenty to support Buckman's second prong, concerning private FDCA enforcement. The pertinent statutory language, as Buckman aptly put it, "leaves no doubt that it is the Federal Government rather than private litigants who are authorized to file suit for noncompliance." 531 U.S. at 349 n.4.
(a) Except as provided in subsection (b), all such proceedings for the enforcement, or to restrain violations, of this chapter shall be by and in the name of the United States. . . .
(b)(1) A State may bring in its own name and within its jurisdiction proceedings for the civil enforcement, or to restrain violations, of [enumerated FDCA provisions concerning] food . . . located in the State.
21 U.S.C. §337(a-b).
"Pre-emption must turn on whether state law conflicts with the text of the relevant federal statute or with the federal regulations authorized by that text." Levine, 555 U.S. at 588 (Thomas, J., concurring). See also Virginia Uranium, Inc. v. Warren, 139 S. Ct. 1894, 1901 (2019) ("a litigant must point specifically to 'a constitutional text or a federal statute' that does the displacing or conflicts with state law") (Gorsuch, J., joined by Thomas & Kavanaugh, JJ.). With respect to private FDCA enforcement masquerading as a state-law tort, nobody claims – at least in this century − that the federal government lacks the constitutional authority to enact the FDCA and invest enforcement solely (for everything other than some food-related provisions) in the hands of the FDA. Thus a "comparison between federal and state law," that reveals a state-law action seeking to impose liability for failure to comply with purported "duties" created by the FDA/FDCA has found something directly contrary to the express terms of the federal act. Preclusion of private FDCA enforcement flows directly from the express terms "set forth in" the FDCA. Lipschultz, 2019 WL 5300908, at *2.
Turning to agency fraud claims, we are informed by Justice Thomas' discussion in Mensing, 564 U.S. at 621-23, that the Supremacy Clause is a "non obstante" provision understood by the Framers to preempt state law where it "logically contradicted. . . the 'Laws of the United States.'" Lipschultz, 2019 WL 5300908, at *1 (discussing Mensing). As mentioned in Lipschultz, Justice Thomas is by no means wedded to "physical impossibility" as the defining characteristic of impossibility preemption.
The Court . . . has not explained why a narrow "physical impossibility" standard is the best proxy for determining when state and federal laws "directly conflict" for purposes of the Supremacy Clause. There could be instances where it is not "physically impossible" to comply with both state and federal law, even when the state and federal laws give directly conflicting commands. . . . Therefore, "physical impossibility" may not be the most appropriate standard for determining whether the text of state and federal laws directly conflict.
Levine, 555 U.S. at 590 (Thomas, J., concurring) (citation omitted).
Indeed, the Supremacy Clause "suggests that courts should not strain to find ways to reconcile federal law with seemingly conflicting state law," since non obstante provisions "specif[ied] that they did not want courts distorting the new law to accommodate the old." Mensing, 564 U.S. at 622 (citations omitted). In such situations, preemption is appropriate, under Justice Thomas' view of the law, to prevent FDA-regulated manufacturers from "be[ing] required continually to prove the counterfactual conduct of the FDA and [regulated] manufacturer in order to establish the supremacy of federal law." Id. at 623.
Preemption of agency fraud claims fits neatly within this framework. A fraud on the FDA claim is nothing more – and nothing less – than the assertion that a state-law jury can ignore whatever in-force FDA (or other federal) regulatory determination is under attack because that decision was allegedly induced by the defendant's lies or omissions to the agency. Purported "counterfactual conduct of the FDA" is inherently at issue in such claims, as causation turns on the plaintiff's contention that a fully-informed agency would not have made the decision that it did. Further, fraud on the FDA claims are in logical contradiction with federal law. They necessarily conflict with whatever in-force agency decision the plaintiff is attacking. Forget impossibility. If federal supremacy is to mean what Justice Thomas says it means, then the lawful decisionmaking processes of federal agencies, within the scope of their properly delegated authority, cannot be open to collateral attack by state law. That is the sort of "direct conflict" that would be preemptive in Justice Thomas' view of the preemption world.
Indeed, in Buckman itself, Justice Thomas agreed with preemption, given evidence "that the Food and Drug Administration (FDA) has done nothing to remove the devices from the market, even though it is aware of the basis for the fraud allegations." 531 U.S. at 354 (Thomas, J. joining Stevens, J. concurring opinion). Only if "the FDA had determined that [defendant] had committed fraud," would the inherent logical conflict between the agency fraud claim and the agency's actual decision be resolved, and thus remove the basis for preemption. Id. at 354.
Under those circumstances, respondent's state-law fraud claim would not depend upon speculation as to the FDA's behavior in a counterfactual situation but would be grounded in the agency's explicit actions. In such a case, a plaintiff would be able to establish causation without second-guessing the FDA's decisionmaking
Buckman, 531 U.S. at 354.
We here at the DDLaw Blog are perfectly content with the Buckman majority's resort to "obstacle" preemption to preclude agency fraud allegations and private FDCA enforcement. However, given the doctrinal disdain that Justice Thomas (and perhaps Justice Gorsuch) have for this form of implied preemption, we offer the above as an example of the sort of argument that a defendant can make to ensure that the preemptive force of Buckman survives such doctrinal disputes. Given the current makeup of the Court, a successful implied preemption argument in the prescription medical product liability context is unlikely without the votes of both of these justices. Early in the Blog's existence, we lost Justice Thomas in Warner-Lambert Co., LLC v. Kent, 552 U.S. 440 (2008), and the result was a 4-4 non-precedential tie on a Buckman issue.
Thus, we think that defendants would be well advised to accept the invitation extended in Lipschultz to frame their Buckman preemption arguments not only in the traditional way that the Buckman Court did, but also in a way that would allow Justices Thomas and (perhaps) Gorsuch also to rule in favor of preemption.
This article is presented for informational purposes only and is not intended to constitute legal advice.