International Law

Medical Device Manufacturer?s Ads Not Proven False

This posting was written by William Zale, Editor of CCH Advertising Law Guide.

A home health care provider had standing to sue under the Lanham Act as a competitor of a manufacturer of infrared lamps, but the care provider?s claims that the manufacturer falsely advertised its lamps were rejected by the federal district court in Indianapolis.

The care provider asserted that two statements made by the manufacturer were false: (1) that its infrared lamp was a treatment for peripheral neuropathy and (2) that the Food and Drug Administration had approved or cleared the device as a treatment for peripheral neuropathy.

Care Provider?s Standing to Sue

The manufacturer contended that the care provider lacked standing because it was an end-consumer of the manufacturer?s devices and thus could not suffer the competitive injury required for asserting a Lanham Act claim.

The care provider asserted a commercial injury on the theory that both parties competed for the same patient dollars for the treatment of peripheral neuropathy. Every sale of the manufacturer?s self-use lamp model to an individual based on the allegedly false advertising was said by the care provider to be a sale lost for its more-comprehensive range of in-home services for the relief of peripheral neuropathy symptoms.

The care provider was a competitor and therefore had Lanham Act standing, the court held.

FDA Clearance

The care provider cited no evidence that the alleged misrepresentation as to FDA clearance of the lamps for the treatment of peripheral neuropathy was made in commercial advertisements, the court found. The only evidence relating to this representation was that it was made personally from the manufacturer? sales representative to the care provider?s personnel, which was not grounds for a Lanham Act claim.

The fact that the lamps? FDA marketing clearance was limited to pain and circulation did not mean that the lamps were not a safe and effective treatment for peripheral neuropathy, according to the court.

?Treatment? Ad Claims

There was no dispute that the manufacturer promoted its lamp generally as a treatment for peripheral neuropathy.

The manufacturer contended that the ?treatment? claim meant that the lamp provided relief from the symptoms of pain and numbness associated with peripheral neuropathy. The care provider contended that ?treatment,? without further qualification, meant only that the lamp was a cure or treatment for the disease or disorder of peripheral neuropathy itself, not that it provided only symptomatic relief. The care provider maintained that because there is no cure or treatment for peripheral neuropathy, the manufacturer?s advertisements were false.

The care provider?s interpretation was too narrow. In light of the common definition and medical definition of the word ?treatment? as including the providing of relief from symptoms and the evidence on the nature of peripheral neurology, the court found no genuine dispute on the question of whether the manufacturer?s ?treatment? advertisements were false or misleading. Summary judgment rejecting the false advertising claims was granted.

The opinion in Nightingale Home Healthcare, Inc. v. Anodyne Therapy, LLC will be reported at CCH Advertising Law Guide ¶63,145.

Full post as published by Trade Regulation Talk on October 20, 2008 (boomark / email).