This post was written by Christopher C. Foster.
The Ninth Circuit recently confronted an issue of first impression: whether a plaintiff could maintain an action under the false advertising prong of the Lanham Act, where a determination of the alleged falsity would require the court to impinge on the exclusive purview of the Food and Drug Administration (FDA) in deciding whether there has been a violation of the Food, Drug, and Cosmetic Act (FDCA). Although limited to the particular circumstances presented, the opinion reaffirmed the exclusive authority of the FDA to enforce the provisions of the FDCA, and indicates that a plaintiff may not maintain a lawsuit premised on the allegation of a violation of the FDCA, where the FDA itself has not acted.
PhotoMedex v. Irwin
In PhotoMedex v. Irwin, No. 07-56672, 2010 U.S. App. LEXIS 7640 (9th Cir. Apr. 14, 2010), the Ninth Circuit held that the FDCA, which prohibits private enforcement of its provisions, bars a medical device manufacturer’s claim under the Lanham Act. PhotoMedex involved a Lanham Act claim based upon the allegation that plaintiff PhotoMedex, Inc’s (“PhotoMedex”) competitor made false and misleading statements regarding FDA approval of a medical device marketed by the competitor. The Ninth Circuit concluded that PhotoMedex could not maintain its Lanham Act claim, because resolution of the question of whether the defendant made false statements required litigation of an underlying FDCA violation, a determination reserved to the FDA.
PhotoMedex – a direct competitor of defendants Ra Medical Systems, Inc. and Dean Stewart Irwin (collectively, “Ra Medical”) – alleged that Ra Medical engaged in misleading advertising in violation of the Lanham Act by representing that its dermatological laser product had been approved by the FDA. The device at issue – the Pharos EX-308 Excimer Laser System (“Pharos”) – is considered to be a Class II medical device under the Medical Device Amendments of 1976 (MDA) to the FDCA. The regulatory scheme provided by the FDCA and MDA, which governs FDA approval of the laser, was therefore central to the court’s decision.
A manufacturer of a Class II medical device must obtain “clearance” from the FDA under what is known as the “510(k)” process under the MDA, before it markets the product. Alternatively, a Class II device deemed “substantially equivalent” to a pre-existing FDA-approved device, may be marketed without further regulatory analysis. A device manufacturer, however, must submit a new 510(k) application if a Class II device is about to be “significantly changed or modified in design, components, method of manufacture, or intended use.” It is the responsibility of the manufacturer of a Class II device to pursue a new 510(k) application.
Ra Medical – which had previously obtained a licensing agreement to sell a third company’s “EX-308” laser (“SurgiLight”) – did not submit a new 510(k) application for the Pharos device. Rather, Ra Medical took the position that the Pharos was “substantially equivalent” to the SurgiLight, which had previously received FDA clearance under 510(k). Ra Medical argued that, because the Pharos was “substantially equivalent” to the SurgiLight, its representation that the Pharos had FDA approval was not false or misleading.
The Ninth Circuit, focusing on the regulatory scheme governing the “clearance” process for the medical device at issue, held that PhotoMedex could not maintain its cause of action for a violation of the Lanham Act. Specifically, the court explained that litigation of PhotoMedex’s Lanham Act cause of action would require the trial court to determine whether the Pharos was in fact “substantially equivalent” to the SurgiLight. Such a determination was prohibited because it would conflict with the statute prohibiting private enforcement of the FDCA, which provides that “all such proceedings for the enforcement, or to restrain violations, of [the FDCA] shall be by and in the name of the United States.”
The court’s reasoning suggests that the opinion may not be as broad as it would appear at first blush, and is properly read as limited to the facts presented. The court stated that its opinion did “not suggest that the Lanham Act can never support private party claims involving FDA approval or clearance of drugs or medical devices.” Rather, a plaintiff may not pursue such a claim where the FDA “ha[d] not itself concluded there was such a violation.”
In the case of the Pharos, the court explained that although PhotoMedex had complained on different occasions to the FDA that the Pharos had been promoted without 510(k) clearance, the FDA never reached such a conclusion. At one point in 2005, the FDA inspected the Pharos manufacturing plant , specifically discussing the clearance issue with Ra Medical. The FDA, however, never took further action. Additionally, in 2007, the FDA responded to a 510(k) notification from Ra Medical regarding additional indications for use of the laser by finding the laser “could proceed to market” for the new indications. In sum, although the FDA had the opportunity to take enforcement action against Ra Medical for the alleged violations, it never opted to do so.
Of additional significance to the court was the fact that FDA approval itself never depended upon an affirmative statement from the FDA to the effect that the product had clearance under 501(k). Rather, the approval itself depended in the first instance on the manufacturer’s decision that the product was “substantially equivalent” to an already approved device. The mere fact that the FDA had not affirmatively approved the Pharos, therefore, did not mean the device did not have clearance under the approval of the SurgiLight.
Accordingly, PhotoMedex was not permitted to “circumvent the FDA’s exclusive enforcement authority” by attempting to prove that Ra Medical violated the FDCA, where the FDA had not reached that conclusion, and where the regulatory scheme permitted marketing the device without an affirmative statement of approval from the FDA. To rule otherwise would “permit PhotoMedex to assume enforcement power which the statute does not allow and require the finder of fact to make a decision that the FDA itself did not make.”