Preemption in Product Liability Continued from page 31


and imposed a regime of detailed federal oversight.”9 In


addition to establishing various levels of federal oversight for medical devices, depending on the risks presented,10 the Congress had approved an express preemption clause providing, in part,11


that:


Except as provided in subsection (b) of this section, no State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement--


(1) which is different from, or in addition to, any requirement applicable under this chapter to the device, and


(2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter.12


Te Supreme Court discussed at length the “rigorous”


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nature of the pre-market approval process for Class III devices, such as the balloon catheter at issue.13


After submission by the


manufacturer of its studies and investigations in support of the device’s safety and effectiveness and extensive FDA review (approx. 1,200 hrs.), the FDA may grant pre-market approval only where it finds that “there is a ‘reasonable assurance’ of the device's ‘safety and effectiveness,’ § 360e(d). Te agency must ‘weig[h] any probable benefit to health from the use of the device against any probable risk of injury or illness from such use.’ § 360c(a)(2)(C).”14


Of particular import to the Supreme Court’s later analysis was the fact that:


[o]nce a [Class III] device has received pre-market approval, the MDA forbids


the manufacturer manufacturing processes,


make, without FDA permission, changes in design specifications,


to labeling, or any other attribute, that would affect safety or


9 552 U.S. at 312, 128 S.Ct. at 1003 (citing 21 U.S. C. 360k (a)). 10 Class I devices are subject to the lowest level of oversight: “general controls,” such as labeling requirements. 21 U.S.C. § 360c(a)(1)(A) (devices as examination gloves). Class II devices are additionally subject to “special controls” such as performance standards and post-market surveillance measures, 21 U.S.C. § 360c(a)(1)(B)(devices such as powered wheelchairs). Class III devices are subject to the greatest federal oversight (devices such as heart valves, pacemaker pulse generators). A device is designated Class III if a lesser classification would not provide reasonable assurance of safety and effectiveness and the particular device is “purported or represented to be for a use in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health,” or “presents a potential unreasonable risk of illness or injury.” 21 U.S.C. § 360c(a)(1)(C)(ii).


11 21 U.S.C. 360k (b) allows the FDA to exempt some state and local requirements from preemption if:


(1) the requirement is more stringent than a requirement under this chapter which would be applicable to the device if an exemption were not in effect under this subsection; or


(2) the requirement-- (A) is required by compelling local conditions, and (B) compliance with the requirement would not cause the device to be in violation of any applicable requirement under this chapter.


12 21 U.S.C. 360k (emphasis added). 13 552 U.S. 312, 128 S.Ct. at 1004 (citing Medtronic, Inc., v. Lohr, 518 U.S. 470, 477, 116 S.Ct. 2240).


14 Pre-market approval includes FDA review of the device’s proposed labeling and the safety and effectiveness under the use conditions on the device’s label. 21 U.S.C. § 360c(a)(2)(B).


34 Trial Reporter / Winter 2010


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