The Lanham Act: A Tool to Enforce the FDC Act?

April 15, 2010

The March/April 2010 issue of FDLI Update contains an article by Hyman, Phelps & McNamara, P.C.’s Peter M. Jaensch and John R. Fleder that addresses the increasing number of cases brought under the federal Lanham Act law where plaintiffs have arguably sought to privately enforce the FDC Act.  In particular, the article analyzes Schering-Plough Healthcare Products, Inc., v. Schwarz Pharma, Inc. et al., 586 F.3d 500 (7th Cir. 2009).  The Court of Appeals ruled that the plaintiff was improperly seeking to enforce the FDC Act, and was treading on FDA’s primary jurisdiction over drug labeling issues.

Just after this article was published, the Ninth Circuit issued a similar ruling on April 14, 2010, in PhotoMedex, Inc. v. Irwin. The plaintiff commenced a Lanham Act case based on allegations of misrepresentations made by defendants regarding: (1) clearance by FDA to market their laser device, (2) the anticipated date their laser would be available for purchase, and (3) Irwin’s role as inventor of the device. 

The Court ruled that the first alleged misrepresentation would have required the Court to address whether a medical device manufacturer which is not permitted to bring a private action to enforce the FDC Act may nevertheless maintain a suit under the Lanham Act based on a claim that a competitor misrepresented that its product had received FDA clearance, when the FDA had declined to make such a finding or bring an enforcement action. The Court concluded that because the FDA permits Defendants to determine in the first instance whether their laser device was covered by an FDA clearance previously given to a similar device and to market their device without an affirmative statement of approval by the FDA, the Lanham Act claim could not proceed.  The Court did, however, allow the other two alleged misrepresentations.

The Court of Appeals cautioned that it was not suggesting that the Lanham Act can never support a claim involving FDA approval or clearance of drugs or medical devices.  It stated that if a company makes “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.

Categories: Enforcement