false advertising claim based on alleged misbranding of drug as supplement fails

Amarin Pharma, Inc. v. Int’l Trade Comm’n, Nos. 2018-1247, 2018-114, 2019 WL 1925649, -- F.3d – (Fed. Cir. May 1, 2019)

The court of appeals upheld the ITC’s decision not to institute an investigation into Amarin’s complaint of an unfair method of competition or unfair act under 19 U.S.C. § 1337(a)(1)(A). Amarin sells Vascepa, a prescription drug that consists of the omega-3 acid commonly known as “EPA,” synthetically produced from fish oil. Vascepa is the only purified ethyl ester E-EPA product sold in the United States as an FDA-approved drug (for reducing triglyceride levels in adults with severe hypertriglyceridemia).

Amarin filed a complaint alleging violations under § 337 of the Tariff Act of 1930, as amended. Specifically, certain companies were allegedly falsely labeling and deceptively advertising their imported synthetically produced omega-3 products as (or for use in) “dietary supplements,” where the products are actually unapproved “new drugs” as defined in the FDCA.  This allegedly constituted an unfair act or unfair method of competition under § 337 because it violated § 43(a) of the Lanham Act, and also violated the Tariff Act “based upon the standards set forth in the FDCA.” Amarin sought to exclude synthetically produced omega-3 products from entry into the United States.

The FDA submitted a letter urging the Commission not to institute an investigation, arguing that the FDCA precludes any claim that would “require[ ] the Commission to directly apply, enforce, or interpret the FDCA.” In addition, it argued that the Commission should decline to institute an investigation based on principles of comity (which I didn’t know was federally a thing).  The ITC ultimately held that Amarin’s allegations were precluded by the FDCA.

The Federal Circuit endorsed the Ninth Circuit’s view that, “[b]ecause the FDCA forbids private rights of action under that statute, a private action brought under the Lanham Act may not be pursued when, as here, the claim would require litigation of the alleged underlying FDCA violation in a circumstance where the FDA has not itself concluded that there was such a violation.”

Here, the alleged violations of § 337 were “based entirely on—and could not exist without—the FDCA.” For dietary supplements, affirmative FDA approval isn’t required.  Whether there’s been a violation should in the first instance be resolved by FDA guidance about whether these products are “new drugs.” 

[The way I teach this is that a claim is precluded where it can only exist—there can only be falsity—because the FDA exists and has rules.  If, by contrast, there is alleged falsity that could exist in a counterfactual world without the FDA, then the claim should not be precluded.  That doesn’t rule out using FDA standards to help judge falsity in the world we actually have, though.  For example, FDA requirements may well shape consumer understanding of what the word “generic” means—but even without FDA requirements, the word could have a cognizable and falsifiable meaning.  Here, however, the drug/supplement distinction is allegedly created only because the FDCA distinguishes them.  And reformulating Amarin’s claim to avoid preclusion might be difficult—it’s perhaps plausible that consumers think differently about the accused products because they’re labeled supplements and not prescription drugs, but that difference seems likely to favor the prescription pharmaceutical, though I can imagine situations in which consumers think supplements are "milder" or less likely to have side effects.]

Anyway, “Amarin’s claims are precluded at least until the FDA has provided guidance as to whether the products at issue are dietary supplements.”  That’s the ITC’s position; the US as amicus apparently sought an even broader ruling of preclusion regardless of whether the FDA has provided guidance, but the court of appeals declined to reach the issue.

Pom Wonderful didn’t change the analysis. The case “did not open the door to Lanham Act claims that are based on proving FDCA violations.”

A dissent would have found lack of appellate jurisdiction over a decision not to institute an investigation, and would have instead exercised mandamus jurisdiction and concluded that Amarin didn’t show that the “extraordinary remedy” of issuing a writ of mandamus was appropriate.