The plaintiff filed suit under New York law against the manufacturer of Class III device (balloon catheter) which received pre-market approval from the FDA in 1994. As contrasted with the “substantially equivalent” device at issue in Lohr, pre-market approval imposes “requirements” under the MDA. “Unlike general labeling duties, premarket approval is specific to individual devices. And it is in no sense an exemption from federal safety review – it is federal safety review. Thus, the attributes that Lohr found lacking in §510(k) review are present here. While §510(k) is ‘focused on equivalence, not safety,’ premarket approval is focused on safety, not equivalence.” The Court noted that: “State requirements are pre-empted under the MDA only to the extent that they are ‘different from, or in addition to’ the requirements imposed by federal law. Thus, §360k does not prevent a State from providing a damages remedy for claims premised on a violation of FDA regulations; the state duties in such a case ‘parallel,’ rather than add to, federal requirements.” However, in this particular case, the district court interpreted the claims to assert that the device violated state tort law notwithstanding compliance with the relevant federal requirements. See Riegl v. Medtronic, 128 S.Ct. 999 (2008).
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