We’ve commented extensively on COVID–19–related vaccination cases, because vaccines are prescription medical products.  We haven’t commented on another aspect of litigation intended to sabotage public health efforts to combat the COVID-19 pandemic – attacks on masking requirements − mostly because masks don’t require prescriptions.  The kind of masks involved in mask mandates are Class I (least heavily regulated) medical devices, and can be bought in any drugstore by anyone who wants them, no prescription necessary.

But the recent decision in Lloyd v. School Board of Palm Beach County, ___ F. Supp.3d ___, 2021 WL 5353879 (S.D. Fla. Oct. 29, 2021), is independently of interest because it addressed something we on the defense side in prescription medical product liability litigation are all too familiar with – an attempt to create a private FDCA-based cause of action.  As thoroughly established in Buckman and its progeny, the FDCA doesn’t allow anybody but the government to enforce the FDCA.  21 U.S.C. §337(a).

One of the theories (indeed, the first that the opinion addressed) that the plaintiffs advanced in Lloyd to attack the defendant school district’s mandatory student masking policy was that it “is invalid because it is preempted by the Federal Food, Drug, and Cosmetic Act (‘FDCA’).”  Plaintiffs contended that masks – which have been around for decades – were somehow “investigational” (plaintiffs also misuse “experimental” in this context) products, which also somehow led to preemption.  Id. at *3.  Early in the course of the COVID-19 pandemic, HHS issued an emergency use authorization (“EUA”) “clarifying that facemasks, including cloth face coverings, are authorized for use by the general public to cover their noses and mouths, in accordance with CDC recommendations.”  Lloyd, 2021 WL 5353879, at *4.  This wasn’t done because protective facemasks were in any way new or unusual, but rather because such masks were in “insufficient supply” early on, given unprecedented demand.  4/24/20 EUA at 1.  Plaintiffs deliberately misconstrued the EUA to assert that facemasks required some form of informed consent.

To turn this alleged preemption into a cause of action, the plaintiffs in Lloyd tacked their allegations onto a claim ostensibly under 42 U.S.C. §1983 – yes, the civil rights statute.  The court’s holding that a private plaintiff cannot bring a §1983 action predicated on the FDCA could be useful to prescription medical product defense counsel generally, since plaintiffs have been known to try this same stunt in product liability actions.

Basically, this stunt worked about as well as an Evel Knievel-style Grand Canyon halfway ticket.

Lloyd rejected plaintiffs’ attempt to assert a §1983-based claim for purported violation of the FDCA.  Even actual preemption (rare for Class I devices) would not create a §1983 action:

Given the variety of situations in which preemption claims may be asserted, in state court and in federal court, it would obviously be incorrect to assume that a federal right of action pursuant to §1983 exists every time a federal rule of law pre-empts state regulatory authority.

Golden State Transit Corp. v. City of Los Angeles, 493 U.S. 103, 108-09 (1989).  The only exception is for a federal statute that is not only preemptive of state law, but that in addition “include[s] a federal right for which §1983 provides a remedy.”  Id. at 109.  Lloyd held that the FDCA is not that kind of statute.

First, “[p]laintiffs may not assert their rights under the FDCA in a §1983 premised upon a violation of the Supremacy Clause because the FDCA clearly states that its requirements may only be enforced by the United States government.”  Lloyd, 2021 WL 5353879, at *5 (footnote citing §337(a), citation and quotation marks omitted).

Thus, because the availability of private relief under the FDCA is foreclosed by express provision of the statute itself, the Court finds that the §1983 remedy is unavailable to Plaintiffs insofar as they seek to assert a claim that the FDCA preempts the Mask Mandate under the Supremacy Clause.

Id. (citations and quotation marks omitted).

Plaintiffs argued that there was an exception to this principle for suits seeking only injunctive relief.  Id.  Nope.  “[T]he Supremacy Clause is not the source of any federal rights, and certainly does not create a cause of action.”  Id. (quoting Armstrong v. Exceptional Child Center, Inc., 575 U.S. 320, 324 (2015)):

It is unlikely that the Constitution gave Congress such broad discretion with regard to the enactment of laws, while simultaneously limiting Congress’s power over the manner of their implementation, making it impossible to leave the enforcement of federal law to federal actors.

Id. (again quoting Armstrong, 575 U.S. at 326).  This is an excellent explication of the Buckman rationale, but comes from an entirely different statutory scheme – so it might be worth adding to our no-private-enforcement arguments.

Somewhat inconsistently, the plaintiffs in Lloyd also attempted to rely on Wyeth v. Levine, 555 U.S. 555 (2009), which as regular Blog readers know, is perhaps the most anti-FDCA-preemption decision the United States Supreme Court has ever issued.  See 2021 WL 5353879, at *6.  Lloyd found such reliance “highly tenuous.”  Id.  First, “the notion that a state tort claim can proceed despite the existence of the FDCA does not remotely stand for the proposition that an individual can assert rights under the FDCA, independent from any state tort claim.”  Id.  In other words, Levine did not “remotely” impair what Buckman held concerning private FDCA enforcement.  Second, Levine contrasted drugs with medical devices, observing that an express preemption clause applied to the latter.  Lloyd, 2021 WL 5353879, at *6.  However, masks are medical devices, not drugs, rendering Levine “inapplicable.”  Id.  Thus, Levine:

if anything, stands for the opposite proposition − that is, that because Congress enacted an express preemption provision for medical devices, Congress did not intend for individuals to bring private state law claims to vindicate their rights under the FDCA.  In other words, because Congress was not silent on preemption with respect to medical devices, that is powerful evidence that Congress did intend for FDA oversight to be the exclusive means of medical device safety and effectiveness.

Id. (emphasis added).  We couldn’t agree more.

The part of Lloyd that interests us (the rest of the opinion involves the same borderline frivolous constitutional arguments that we’ve seen in the vaccine cases) finishes with a similar analysis of the plaintiffs’ attempt to predicate their FDCA-based claims on the Declaratory Judgment Act, which like the FDCA “is not an independent source of federal jurisdiction.”  Id. at *7.  To allow FDCA-based claims under this statute:

would be to create a private right of action where none exists.  Allowing [plaintiffs] to proceed in a declaratory judgment action with [the FDCA] as the source of the underlying substantive law is tantamount to allowing a private cause of action. . . .  Moreover, it would essentially transform the Declaratory Judgment Act into an independent jurisdictional source for any statute, which the Supreme Court has made clear it is not.

Id. (citations and quotation marks omitted).

While we would be overjoyed if, as the plaintiffs in Lloyd argued, FDCA preemption could support an affirmative exercise of federal jurisdiction, unfortunately that ship sailed long ago in Merrell Dow Pharmaceuticals v. Thompson, 478 U.S. 804, 817 (1986) (cited at Lloyd, 2021 WL 5353879, at *5).  Thus, we’ll content ourselves with Lloyd’s forceful reaffirmation of the proposition that private plaintiffs cannot enforce the FDCA – and we’ll keep watching cases adjudicating attempts to induce judges to sabotage anti-pandemic public health measures for holdings that, as in Lloyd, we can use in defense of prescription medical product liability litigation.