Unapproved Medical Devices and Uses

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Since 1976, the FDA has had the responsibility to be the medical device gatekeeper, approving or clearing devices for interstate commerce. Unfortunately, the bureaucratic agency has not been able to keep up with the rapidly changing medical device landscape. Too, the FDA regulatory gates have been pried open by Congress, leading to a flood of medically-questionable devices in the market.

According to one expert, “Many high-risk medical devices today are approved on the basis of just one clinical trial (as opposed to new medications which usually require two trials).  And only a small minority of clinical studies of medical devices are randomized, controlled and blinded—the gold standard for reliable evidence (and the benchmark to which studies of drugs are held).”

Even in this lenient environment, many medical device manufacturers are finding it necessary to cheat the FDA, either by fabricating pivotal trial results or by otherwise misrepresenting factual data in the FDA approval or clearance processes. These actions may subject the manufacturer to liability under the False Claims Act and the federal Food, Drug and Cosmetic Act (FDCA).

Under the FDCA, every manufacturer of a medical device is required to obtain authorization from the FDA prior to marketing its device, unless the devices are subject to certain rare exemptions. If the manufacturer intends to market a previously cleared device for a new or different indication for use other than the intended use cleared by the FDA, a new marketing authorization is required. While physicians may prescribe medical devices for unapproved uses, a manufacturer may not distribute medical devices in interstate commerce with the intent that those devices be used for unapproved purposes.

By filing successful qui tam actions against manufacturers that engage in FDA fraud, Nolan Auerbach & White has been at the forefront in helping the government recoup hundreds of millions of healthcare dollars wasted on unapproved drugs. The Firm has also scrutinized the same devious business practices in medical device industry, in which manufacturers market their devices without FDA approval or for uses not approved or cleared by the FDA. Given that many of these devices are used in medically invasive procedures, the Firm and the federal government have a special interest in exposing these manufacturers.