Medtronic, Inc. v. Lohr

In Medtronic, Inc. v. Lohr (1996) 518 U.S. 470, the United States Supreme Court considered a preemption provision of the Medical Device Amendments of 1976 (MDA) ( 360 et seq.). That act classifies and regulates medical devices based on the risk posed to the public, with the most strictly regulated designated class III. Before a new class III device may be marketed, the manufacturer ordinarily must provide the FDA with " 'reasonable assurance' " that the device is safe and effective by complying with a thorough, rigorous, and costly premarket approval process. ( Medtronic, supra, at pp. 476-477.) Under an exception to that process, the MDA also permits devices to be marketed on a showing that they are "substantially equivalent" to devices already on the market before its effective date. ( 360e(b)(1)(B).) The question in Medtronic was whether the MDA preempted a plaintiff's tort claims against the manufacturer of an allegedly defective pacemaker, which had been approved by the FDA under the less stringent "substantially equivalent" procedure. ( Medtronic, at pp. 480-481 116 S. Ct. at p. 2248.) The Court declined to find that the FDA's substantial-equivalence review conducted pursuant to title 21 United States Code section 510(k) imposed device-specific requirements (Lohr, supra, at pp. 493-494.) The court explained that substantial-equivalence review is an exemption to PMA review that allows a device manufacturer to market a device found to be substantially equivalent to one marketed before 1976 without going through the rigors of the PMA process. (Ibid.) "As a result, 'substantial equivalence determinations provide little protection to the public. These determinations simply compare a post-1976 device to a pre-1976 device to ascertain whether the later device is no more dangerous and no less effective than the earlier device. If the earlier device poses a severe risk or is ineffective, then the later device may also be risky or ineffective.' " (Id. at p. 493.)