So you, or someone you know, has a great idea for how to market a medical device. You start telling folks about your idea and make it part of your marketing efforts. Do you stop to think “how would I survive on Shark Tank” or “how would I survive in prison”? Well, you, or someone you know, should think a little harder.
A federal grand jury in Texas indicted the CEO of medical device maker Vascular Solutions Inc., on charges he conspired to sell a varicose-vein treatment device for unapproved uses in violation of the Food, Drug & Cosmetic Act and FDA regulations. The company was also indicted. The Department of Justice alleges the company marketed a device to use laser heat to seal off veins deep in the leg, even though the Vari-Lase device kit only was approved for superficial blood vessels near the surface of the skin. It is alleged that the company marketed the device for use on deeper veins even after a clinical trial recorded adverse events in patients.
Before implementing a clever marketing campaign or giving advice about unapproved uses, consult FDA regulations and a food and drug law attorney.