Lanham Act claim cannot circumvent FDA's exclusive jurisdiction

United States of America
In PhotoMedex Inc v Irwin (Case 07-56672, April 14 2010), the US Court of Appeals for the Ninth Circuit has affirmed a California district court holding that a party may not sue under the Lanham Act to assert a Food, Drug and Cosmetic Act (FDCA) violation if doing so impedes upon the US Food and Drug Administration’s (FDA) exclusive enforcement authority. 

PhotoMedex Inc produces and sells lasers used in dermatological treatments. Defendants Dean Stewart Irwin, a former PhotoMedex employee, and Ra Medical (co-founded by Irwin), manufacture and market a laser that competes directly with a PhotoMedex laser. PhotoMedex sued under the Lanham Act and California false advertising and unfair competition laws, asserting that the defendants:
  • falsely marketed their laser as “FDA approved”;
  • misrepresented the laser’s release date; and
  • misrepresented Irwin’s credentials. 
The district court granted summary judgment in favour of the defendants on all claims. PhotoMedex appealed.

The Ninth Circuit affirmed the district court’s holding that the FDCA limits claims under the Lanham Act when such claims would circumvent or impede upon the FDA’s exclusive enforcement authority. The FDA was aware of the defendants’ laser product and accompanying marketing campaign, but did not take action to prohibit or limit the defendants’ practices. The Ninth Circuit noted that litigating PhotoMedex’s allegation that the defendants improperly marketed its laser as “FDA approved” would require examination of whether there was an FDCA violation, an issue that is solely to be determined by the FDA. The court reasoned that PhotoMedex was precluded from seeking to prove that the defendants violated the FDCA when the FDA itself did not reach that conclusion.

However, the Ninth Circuit vacated the district court’s summary judgment grant regarding PhotoMedex's allegations that the defendants misrepresented their product’s release date and Irwin’s credentials as an inventor. While the district court characterized marketing relating to the laser’s release date as a “non-actionable opinion regarding future events”, the Ninth Circuit held that, because the laser was not released until more than a year after its advertised date, a genuine issue of material fact existed as to whether the defendants’ marketing constituted actionable misrepresentation as “a statement known at the time by the speaker to be false, or a statement by a speaker who lacks a good-faith belief in the truth of the statement”. In addition, the court vacated the summary judgment on the plaintiff’s allegation that the defendants misrepresented Irwin’s credentials because consumers may have been misled as to Irwin’s actual share of inventive contributions when he was employed with PhotoMedex. Both claims were remanded for further proceedings.

The Ninth Circuit explained that its decision was not meant to suggest that the Lanham Act can never support private party allegations involving FDA approval or clearance. Rather, the court highlighted that neither private parties nor the court may encroach upon the FDA’s enforcement powers to determine a violation of the FDCA when the FDA itself declines to make such a finding.

Elisabeth Malis, McDermott Will & Emery LLP, Los Angeles

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