Opinion ID: 771658
Heading Depth: 3
Heading Rank: 3

Heading: Comparing Federal and State Requirements

Text: 43 Having established the existence of pertinent state and federal requirements, we must now compare those requirements. Following the Supreme Court's lead, we search for (1) outright incompatibility between the state and federal requirements, or for (2) state laws that defeat the purpose of federal law or Congressional intent. Justice Stevens's comparison between the Lohr plaintiff's common law claims and applicable federal requirements focused on both these paths to preemption. See Lohr, 518 U.S. at 501. 44 Justice Stevens suggested that state regulations that complement federal regulations, i.e., those that peacefully coexist without imposing conflicting duties upon manufacturers, would not yield to 360k's preemptive reach. Justice Stevens analogized complementary state requirements to local fire prevention regulations and to zoning codes, neither of which requires manufacturers to avoid compliance with federal health requirements enunciated in the MDA. See id. at 501-502. 45 In addition, state requirements that duplicate federal requirements pose no threat to federal law, and thus will not be preempted. Only state requirements that differ from federal law, see 21 U.S.C. 360k(a)(1), and those that are divergent from federal law, see 21 C.F.R. 808.1(d), require preemption. See Lohr, 518 U.S. at 496-97 (Stevens, J., joined by Breyer, J.) (The regulations promulgated by the FDA expressly support the conclusion that 360k 'does not preempt State or local requirements that are equal to, or substantially identical to, requirements imposed by or under the act.') (quoting 21 C.F.R. 808.1(d)(2)); id. at 513 (O'Connor, J.) (Section 360k does not preclude States from imposing different or additional remedies, but only different or additional requirements.) (italics in original). Thus a state law that provides a remedy for violation of FDA regulations, for example, doesn't impose a burden on manufacturers that is different from federal law. See Lohr, 518 U.S. at 495. 46 Howmedica argues that the FDA's labeling requirements for Simplex are inconsistent with a hypothetical adverse judgment on Brooks's state-law failure-to-warn claim. Howmedica professes that it is powerless to alter Simplex's packaging or warning insert, and hence it couldn't comply with both a state-law judgment and the federal labeling regulations. In effect, while the state-law judgment would require Howmedica to add to its labeling and package insert, it asserts, federal regulations would require Howmedica not to add to its labeling and package insert. Howmedica submits that this Catch-22 epitomizes the need for, and importance of, 360k preemption. 47 Howmedica's argument suffers from a fatal defect: the argument misstates a critical premise. FDA regulations do not in fact mandate that Simplex's labeling and package inserts remain frozen in their 1971-approved state. The regulations require only that Howmedica provide no less information and warning than the 1971-approved labeling. Howmedica is free to provide more information, and more detailed warnings, to consumers. See 21 C.F.R. 814.39(d)(2)(i) (authorizing medical device manufacturers to change labels to add or strengthen a contraindication, warning, precaution, or information about an adverse reaction), (d)(2)(ii) (permitting [l]abeling changes that add or strengthen an instruction that is intended to enhance the safe use of the device). 48 Howmedica's assertion that the 1971 labeling on Simplex is set in stone by virtue of FDA regulations is wrong. See Lohr, 518 U.S. at 497 n.16; Connelly v. Iolab Corp., 927 S.W.2d 848, 854 (Mo. 1996) (Nothing in [the FDA] regulations prohibits Iolab from adding a warning to the label regarding unreasonably high complication rates.). An adverse judgment on Brooks's failure-to-warn claim would not, as Howmedica posits, force Howmedica to choose between complying with FDA regulations and the state law judgment. Nothing prohibits Howmedica from increasing the warnings and information it provides to consumers and health practitioners on Simplex's package and package insert. 49 Likewise, a judgment adverse to Howmedica on Brooks's failure-to-warn claim wouldn't interfere with Congressional intent or FDA policy. The FDA's raison d'etre is to review new medical devices to ensure that the devices are moderately safe before they are released into the marketplace. We struggle to imagine how a common law judgment requiring greater warnings would interfere with that purpose. Brooks's counsel captured the essence of this point when he remarked at oral argument that FDA regulations create floors, not ceilings. A common law judgment against a manufacturer such as Howmedica would raise the floor, not puncture the ceiling. 50 Because Howmedica could have added language warning consumers of asthma risks associated with exposure to Simplex without running afoul of federal requirements, Howmedica doesn't face a Catch-22. Howmedica could comply with both an adverse state-law judgment and FDA regulations. Accordingly, preemption is inappropriate in this instance. The district court erred in granting Howmedica's motion for summary judgment on Brooks's failure-to-warn claim. 51 At first blush, there appears to be tension between our holding and the language of 360k. We hold that 360k does not preempt a failure-to-warn action that might, if successful, require Howmedica to add to Simplex's warnings. Section 360k forbids state requirements that are different from, or in addition to federal law. 21 U.S.C. 360k(a)(1) (emphasis added). The apparent tension is illusory, however, because (as the Supreme Court explained in Lohr) 360k doesn't really mean what it says. 52 Justice Breyer demonstrated the folly of reading 360k's different from, or in addition to language literally: every state requirement would then be preempted because, in some small or obscure way, every such state requirement could be deemed different or additive. See Lohr, 518 U.S. at 505 (Breyer, J.) (Congress must have intended that courts look elsewhere for help [i.e., beyond the words in 360k] as to just which federal requirements pre-empt just which state requirements, as well as just how they might do so.). Justice Breyer sought refuge in basic pre-emption principles, id. at 508, the twin notions of conflict and field preemption, see id. at 508-509. Justice Stevens likewise acknowledged the importance of conflict preemption analysis as a reprieve from 360k's ambiguity. See id. at 503 (Stevens. J.). 53 The best illustration of Justices Stevens and Breyer's reliance upon conflict preemption to the exclusion of 360k's very language comes from Justice O'Connor's separate opinion. Justice O'Connor dissented precisely on this point; she would have interpreted 360k literally, as preempting each and every state law different from, or in addition to federal law. 54 If 360k's language is given its ordinary meaning, it clearly pre-empts any state common-law action that would impose a requirement different from, or in addition to, that applicable under the FDCA -- just as it would pre-empt a state statute or regulation that had that effect. . . . 55 The plurality's reasons for departing from this reading are neither clear nor persuasive. . . . The Court holds that an FDCA requirement triggers pre-emption only when a conflict exists between a specific state requirement and a specific FDCA requirement applicable to the particular device. 56 Lohr, 518 U.S. at 511. 57 Under Justice O'Connor's view, Brooks's failure-to-warn claim would certainly be preempted as an additional state requirement. But Justice O'Connor failed to garner four additional votes for her position. Thus her opinion demonstrates, by negative implication, that five other Justices interpreted 360k's ambiguous language to require conflict preemption analysis. The conflict preemption analysis we undertook with respect to Brooks's case reveals no tension between her failure-to-warn claim and FDA labeling requirements. 58