Legal analysis from Dean's Law Dictionary will be displayed here.

This section contains the nature of the case and procedural background.

P, a provider of home healthcare services, bought several infrared lamps from D that were designed to relieve pain and improve circulation, paying $6,000 for each lamp. P sued D under the Lanham Act claim claiming that D had falsely represented that the lamp had been approved by the Food and Drug Administration for treatment of peripheral neuropathy. The device was FDA-approved and was intended for the treatment of peripheral neuropathy, and though the FDA had not approved it for that purpose. This did not preclude a physician or other healthcare provider, from prescribing the device to patients as a treatment for that condition. The decision to prescribe such 'off-label usage,' is deemed a professional judgment for the healthcare provider to make. When P replaced D's lamps with the virtually identical lamps of another company (apparently for reasons of price, unrelated to the scope of the FDA's approval), it advertised them just as it had advertised D's lamps-as devices for the treatment of peripheral neuropathy. The judge found that P's Lanham Act claim had no possible merit (which would not by itself demonstrate an abuse of process), and found that P had made the claim in an attempt to coerce a price reduction from D. The fact that the FDA had not approved D's lamps for treatment of peripheral neuropathy was thus of no consequence, for neither had it approved for that purpose the lamps that P bought to replace D's. The court granted D summary judgment and awarded attorney fees in the amount of $72,747. D appealed.

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