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...
