In 1976, Congress amended the FDCA to require any post-1976 devices to be approved via the rigorous Pre-Market Approval (PMA) process, unless the manufacturer could show that the device was “substantially equivalent” to a pre-1976 device or that the FDA had acted to classify the device as Class I or Class II device.
Under the banner, “what is old is new again, ” some device manufacturers are rummaging through their pre-1976 devices and devising new, off-label uses for these devices. Of course, this medical innovation is acceptable and laudable; however, device-makers are required to obtain the FDA’s stamp of approval for such uses of pre-1976 devices that go beyond their original, intended uses. False Claims Act liability will likely be triggered when a manufacturer sidesteps this important approval step.
Similar allegations were raised in a successful False Claims Act qui tam action against Medtronic, Inc. In that case, the United States recovered $2.8 million to resolve allegations that it caused physicians to submit claims to Medicare and TRICARE for medical procedures known as SubQ stimulation that were not reimbursable. According to the lawsuit, Medtronic promoted this procedure by, among other strategies, arranging to have physician-customers attend Medtronic-sponsored “on-site training programs.”