Intellectual Property Law

Ninth Circuit Finds Lanham Act No Workaround to FDCA's Bar to Suit

By Michael Atkins

On April 14, the Ninth Circuit considered whether a medical device manufacturer that is not permitted to bring a private right of action to enforce the Food, Drug, and Cosmetic Act (FDCA) may nevertheless maintain a suit under the Lanham Act based on a claim that a competitor violated the FDCA by misrepresenting that its product had received FDA clearance when it had not.

In PhotoMedex, Inc. v. Dean Irwin, the Southern District of California answered in the negative and granted defendant Irwin and RA Medical Systems, Inc., summary judgment on PhotoMedex’s Lanham Act claim.

The Ninth Circuit affirmed, finding that for the most part, PhotoMedex could not do under the Lanham Act what it can’t do under the FDCA.

“Our court has not previously spoken to the question of whether the FDCA limits claims under the Lanham Act,” the court found. “We conclude, in the circumstances of this case, that it does. Because 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.

“To be clear, we do not suggest that the Lanham Act can never support private party claims involving FDA approval or clearance of drugs or medical devices. That is not the case. If, for example, it was clear that an affirmative statement of approval by the FDA was required before a given product could be marketed and that no such FDA approval had been granted, a Lanham Act claim could be pursued for injuries suffered by a competitor as a result of a false assertion that approval had been granted. But this case does not fit that pattern.

“Permitting PhotoMedex’s Lanham Act claim to proceed in the circumstances of this case would intrude on the exclusive government enforcement authority established under the FDCA.”

The case cite is Photomedex, Inc. v. Irwin, __ F.3d __, 2010 WL 1462377, No. 07-56672 (9th Cir. 2010).

Full post as published by Seattle Trademark Lawyer on April 20, 2010 (boomark / email).