Bexis vividly remembers how he first learned of 21 U.S.C. §337(a).  It was early 1995, and he had just joined the Danek Medical legal team in the early going of the Orthopedic Bone Screw MDL.  The plaintiffs’ complaints went on and on about “negligence per se” and purported violations of the FDCA.  Bexis figured that he better learn all he could about negligence per se as fast as he could.  He had already (since 1987) been churning out internal monthly memos to the firm product liability group about new developments in Pennsylvania personal injury law, and some of those cases involved negligence per se.  So he searched for the term.  That produced a couple of intriguing (and then relatively recent) OSHA cases, Ries v. National Railroad. Passenger Corp., 960 F.2d 1156 (3d Cir. 1992), and Rolick v. Collins Pine Co., 975 F.2d 1009 (3d Cir. 1992) – and Third Circuit law governed where the just-being-established Orthopedic Bone Screw MDL was situated.

OSHA has a provision, 29 U.S.C. §653(b)(4), that provided, in relevant part “Nothing in this chapter shall be construed . . . to enlarge or diminish or affect in any other manner the common law. . . .”  Both Rolick and Ries had held that that provision meant that “a violation of an OSHA regulation could not constitute negligence per se.”  Rolick, 975 F.2d 1015 (quoting Ries, 960 F.2d at 1165.  That seemed pretty good, so Bexis pulled out the maroon colored statute book that contained the FDCA and read it from beginning to end, looking for anything analogous that he could argue did the same for tort claims based on the FDCA.  He found §337(a), which provides:  “all such proceedings for the enforcement, or to restrain violations, of this chapter [the FDCA] shall be by and in the name of the United States.”

That seemed pretty good, even better than the OSHA language in some respects.  There wasn’t much law, and nothing in the product liability field, but it was “run whatcha brung.”  With plaintiffs trying to create new causes of action, it was up to our side to create new defenses.  So Bexis ran (some would say amok) with §337(a) throughout the Bone Screw MDL litigation – eventually all the way to the Supreme Court where, in a Bone Screw appeal, the Supreme Court agreed.  “The FDCA leaves no doubt that it is the Federal Government rather than private litigants who are authorized to file suit for noncompliance with the medical device provisions.”  Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341, 349 n.4 (2001) (quoting §337(a)).

That, in a nutshell, is how Buckman came to be.

And Buckman (and §337(a)) is the gift that keeps on giving, most recently in Amarin Pharma, Inc. v. International Trade Comm’n, 923 F.3d 959 (Fed. Cir. 2019).  Yes, that’s the same Amarin.  Amarin v. ITC, involved completely different claims concerning the same drug, Vascepa, that several years ago produced the landmark First Amendment decision in Amarin Pharma, Inc. v. FDA, 119 F. Supp.3d 196 (S.D.N.Y. 2015).  This time Amarin asserted Lanham Act claims that competing products containing the same active ingredient were “deceptively” labeled and advertised as “dietary supplements” when they were really illegal “new drugs” that had never received proper FDA approval.  923 F.3d at 961-62.  It filed a statutory action (under the Tariff Act of 1930) with the International Trade Commission, seeking to bar importation of those “supplements.”  Id. at 961.

The FDA, however, had reached no such conclusion, and let the ITC know about it:

[T]he FDA submitted a letter urging the Commission not to institute an investigation and instead to dismiss Amarin’s complaint.  In the FDA’s view, the FDCA prohibits private enforcement actions, including unfair trade practice claims that seek to enforce the FDCA.

Id. at 962 (record cites omitted).  The ITC agreed with the FDA, “declining to institute an investigation and dismissing the complaint.”  Id.  Amarin appealed.

Amarin’s main argument was that a more recent Supreme Court decision, POM Wonderful LLC v. Coca-Cola Co., 573 U.S. 102 (2014), which we blogged about here and here, meant that §337(a) was a dead letter in the Lanham Act context and that it could therefore challenge the FDA classifications of products – here, dietary supplement versus prescription drug – in a private action.  Once again, the FDA intervened, filing an amicus brief through the Department of Justice in Amarin v. ITC.  The FDA liked Buckman and §337(a) in a big way:

“The FDCA leaves no doubt that it is the Federal Government rather than private litigants who are authorized to file suit for noncompliance with” the FDCA.  Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 349 n.4 (2001).  Private parties are expressly prohibited from bringing “proceedings for the enforcement, or to restrain violations, of ” the FDCA.  21 U.S.C. §337(a).  Yet that is precisely what Amarin seeks to do here. Amarin’s claims, though nominally brought under the Tariff Act, attempt to enforce or restrain violations of the FDCA because they seek − as a necessary component of the stated cause of action − to prove FDCA violations and compel obedience to the FDCA through the remedies provided by that statute. For that reason, the International Trade Commission correctly concluded that Amarin’s claims are precluded by the FDCA.

Amarin v. ITC, FDA amicus brief at 1 (now also available at 2018 WL 8459460).

And again:

The FDCA prohibits private proceedings “for the enforcement, or to restrain violations, of” that statute.  21 U.S.C. §337(a).  The FDCA instead commits enforcement exclusively to the federal government to ensure that complex enforcement decisions are made with the benefit of FDA’s scientific and regulatory expertise.  As a consequence, private parties . . . may not initiate proceedings in a court or administrative agency to remedy alleged violations of the FDCA.  Nor can private parties circumvent that prohibition by wrapping their FDCA enforcement claims inside some other cause of action.  The FDCA prohibits “all” private proceedings to enforce or restrain violations of the FDCA, id., including private claims that are nominally brought under another statute but seek to prove violations of the FDCA.

Id., FDA amicus brief at 7 (emphasis original).

There’s still more:

Centralizing FDCA enforcement authority within FDA ensures that FDA’s expertise will inform often-difficult factual and legal determinations, such as which requirements apply to particular articles and whether an article is being distributed in violation of the FDCA.  It also ensures that discretionary determinations − like whether enforcement measures should be pursued for a violation, and if so, which remedies are appropriate − will be made by policymakers, not private parties.  And it promotes uniformity. . . .  Congress deliberately chose to centralize within FDA the crucial decision whether to seek to prove and redress alleged violations of the FDCA.  Doing so maximizes the benefits of centralized enforcement.

The FDCA’s prohibition on private “proceedings for the enforcement, or to restrain violations, of” the Act, 21 U.S.C. §337(a), means that private parties may not bring suit under the FDCA itself to remedy what they allege to be violations of the Act.  It also means that private parties may not circumvent this straightforward prohibition by invoking some other cause of action, under another federal statute, in order to bring what is, at bottom, still an action “for the enforcement” or “to restrain violations” of the FDCA. See Buckman, 531 U.S. at 353 (preempting state fraud claims that “exist solely by virtue of the FDCA”).

Id., FDA amicus brief at 9-10 (other citations omitted) (emphasis original).  We particularly like these last two quotes because the twice-emphasized “other” places the government on record squarely on the defense side of the ledger with respect to the “Buckman is nothing more than fraud on the FDA” rationale of a Second Circuit panel back in Desiano v. Warner-Lambert & Co., 467 F.3d 85 (2d Cir. 2006), aff’d by equally divided court, 552 U.S. 440 (2008).

So, almost as much as we liked Amarin winning on the First Amendment, we were rooting against it in Amarin v. ITC.  And that’s what happened.  Private FDCA enforcement – under the Lanham Act or anywhere else – took it on the chin.  As a matter of law, a complaint about the FDA’s failure to act could not be “unfair competition” under either the Tariff Act, the Lanham Act, or seemingly anything else.

First, as the Supreme Court recognized in the aforesaid POM Wonderful decision, “The FDCA provides the United States with ‘nearly exclusive enforcement authority.’”  Amarin v. ITC, 923 F.3d at 966 (quoting POM Wonderful, 573 U.S. at 109).  Under both Buckman and POM Wonderful, “[p]rivate parties may not bring suits to enforce the FDCA.  Id.  Amarin v. ITC discussed various decisions that had examined the relationship between the Lanham Act and the FDCA, particularly PhotoMedex, Inc. v. Irwin, 601 F.3d 919 (9th Cir. 2010); Alpharma, Inc. v. Pennfield Oil Co., 411 F.3d 934 (8th Cir. 2005), and Sandoz Pharmaceuticals Corp. v. Richardson-Vicks, Inc., 902 F.2d 222 (3d Cir. 1990).  Analyzing them, and POM Wonderful, Amarin v. ITC concluded:

[T]he FDA has not provided guidance as to whether the products at issue in this case should be considered “new drugs” that require approval.  Given this lack of guidance . . .  a complainant fails to state a cognizable claim under §337 where that claim is based on proving violations of the FDCA and where the FDA has not taken the position that the articles at issue do, indeed, violate the FDCA. Such claims are precluded by the FDCA.

923 F.3d at 968.  Only if the FDA concluded that the products in question violated the FDCA, could the plaintiff go back to the ITC.  Id. (“Amarin is free to file a new complaint once the FDA issues sufficient guidance with respect to the accused products such that the Commission is not required to interpret the FDCA in the first instance”).  The court thus did not reach the amicus position of the United States (discussed above) that “that all such claims are precluded regardless of whether the FDA has provided guidance.”  Id. (emphasis original).

But having the government on record is a good thing.

In the final holding of significance to blog readers, the court held that POM Wonderful did not expand the traditional role of the Lanham Act with respect to FDCA matters.  Nothing in the Supreme Court’s decision authorized private plaintiffs to usurp the role of the FDA in deciding, in the first instance, whether any given conduct violated the FDCA:

[Plaintiff] views POM Wonderful as rejecting the view that the FDCA precludes Lanham Act claims.  But this reads POM Wonderful too broadly.  Although POM Wonderful held that the FDCA does not categorically preclude a Lanham Act claim . . ., the court did not open the door to Lanham Act claims that are based on proving FDCA violations.  The allegations underlying the Lanham Act claim in POM Wonderful did not require proving a violation of the FDCA itself.  This stands in stark contrast to the allegations in our case, which are based solely on alleged violations of the FDCA’s requirements.

923 F.3d at 969 (POM Wonderful citations omitted).  By the way, there was a dissent in Amarin v. ITC, but only on an issue of appealability, and the dissent did not address the substantive rationale discussed this post.

Thus, Amarin v. ITC is helpful to our side in at least two ways.  First, definitively rejects post-POM Wonderful attempts to pursue new FDCA violations that the FDA has not found, relying on a strong reading of Buckman and §337(a).  Second, the litigation has resulted in a useful explication of the FDA’s current views regarding private FDCA enforcement, which turns out to be at least as strong as anything that the Court held in Buckman itself – and utterly inconsistent with plaintiff-side attempts to hide attacks upon the sufficiency of submissions to the FDA behind the smokescreen of some “other” cause of action.  Particularly given the Supreme Court’s recent comments in Albrecht, 2019 WL 2166393, at *7, about the FDA being “fully informed,” it is a very good thing to have another decision like Amarin v. ITC on the books for the proposition that whether the FDA is fully informed about any particular matter is something for the FDA to decide in the first instance.