Opinion ID: 771658
Heading Depth: 2
Heading Rank: 1

Heading: Brooks's Failure-to-Warn Claim

Text: 12 Brooks alleged that Howmedica failed to warn her of the risk of contracting asthma through repeated exposure to methyl methacrylate vapors. The district court ruled that Howmedica was entitled to summary judgment because Brooks's state-law failure-to-warn claim was preempted by federal law. We reverse. 13 The MDA contains an express preemption provision that governs federal preemption of state law with respect to medical devices: 14 [N]o State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement -- 15 (1) which is different from, or in addition to, any requirement applicable under this chapter to the device, and 16 (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. 17 21 U.S.C. 360k(a). 18 The Supreme Court recently analyzed the meaning and scope of 360k preemption in Lohr. The plaintiff in Lohr suffered a complete heart block that required emergency surgery after her Medtronic pacemaker failed. She filed suit against Medtronic alleging products liability causes of action stemming from the failure of the company's Model 4011 pacemaker lead. After considering the nature and scope of 360k preemption, the Supreme Court held that none of Lohr's Florida law causes of action were preempted. 19 Lohr clarified several aspects of 360k preemption, but the Court's fractured holding has troubled the lower federal courts. See, e.g., Kemp v. Medtronic, Inc., 231 F.3d 216, 224 (6th Cir. Nov. 1, 2000) (The various courts of appeals that have confronted issues of preemption arising under the MDA have struggled mightily with Lohr's language in the effort to discern its holding.). Justice Stevens favored very narrow preemption; he wrote a plurality opinion for four Justices. See Lohr, 518 U.S. at 474-503 (Stevens, J., joined by Kennedy, Souter and Ginsburg, JJ.). Justice O'Connor favored far broader federal preemption, and wrote a partial concurrence and partial dissent for four Justices. See id. at 509-14 (O'Connor, J., joined by the Chief Justice, and Scalia and Thomas, JJ.). Justice Breyer agreed with portions of both opinions, and with Justice Stevens's overall result, but wrote a separate opinion. See id. at 503-508 (Breyer, J.). From this, then, we must divine the Supreme Court's intentions. 20 All nine Justices agreed that 360k's reference to state requirements included common law tort actions. See Lohr, 518 U.S. at 486-91 (Stevens, J.), 504-505 (Breyer, J.), 510 (O'Connor, J.). Justices Stevens and Breyer then parted company from Justice O'Connor's foursome. Justices Stevens and Breyer argued that courts' interpretation of 360k should be informed by the FDA's own regulations explaining 360k. See id. at 495-97 (Stevens, J.), 505-507 (Breyer, J.). Justice O'Connor bitterly dissented from the Court's decision to look to the FDA's preemption regulations for guidance. See id. at 509 (O'Connor, J.) (decrying the decision as bewildering and seemingly without guiding principle). Notwithstanding Justice O'Connor's opinion for four Justices, however, a majority 1 of the Court sought assistance from FDA regulations in interpreting 360k's preemptive force. 21 The FDA preemption regulation provides that state requirements are pre-empted 'only' when the FDA has established 'specific counterpart regulations or . . . other specific requirements applicable to a particular device.' Id. at 498 (quoting 21 C.F.R. 808.1(d)). The FDA regulation also states that 360k is not intended to pre-empt 'State or local requirements of general applicability where the purpose of the requirement relates either to other products in addition to devices . . . or to unfair trade practices in which the requirements are not limited to devices.' Id. at 499 (quoting 21 C.F.R. 808.1(d)). 22 Justice Stevens -- joined by Justice Breyer in this portion of the plurality opinion -- proceeded to interpret 360k in view of that FDA preemption regulation. Justice Stevens's analysis divided the overarching preemption question into three distinct steps. Each step focused on a separate aspect of the preemption analysis: the state requirement, the federal requirement, and a thoroughgoing comparison of the two requirements. See Lohr, 518 U.S. at 500. 23 Preemption analysis begins with an examination of the putative state requirement described in 360k(a). Only state laws specific to the medical device in question, or general state laws that have the effect of establishing a substantive requirement for a specific device, Lohr, 518 U.S. at 500, may be preempted. Whether the state law is specific or general, the state law must relate to the safety or effectiveness of the device. See 21 U.S.C. 360k(a)(2). 24 Second, a specific federal requirement must govern the medical device at issue. [F]ederal requirements must be 'applicable to the device' in question, and, according to the regulations, pre-empt state law only if they are 'specific counterpart regulations' or 'specific' to a 'particular device.' Lohr, 518 U.S. at 500. 25 Third, if both such state and federal requirements exist, they must be compared using traditional principles of conflict 2 preemption. This comparison is the heart of the analytical framework. If state and federal laws render a medical device manufacturer's compliance with both impossible, then federal law preempts state law. See id. at 501 (Stevens, J.) (explaining that 360k protects specific federal regulations from interference by potentially contradictory state requirements), 507-508 (Breyer, J.). In addition, if state law necessarily impedes the fulfillment of Congressional objectives, federal law preempts state law. See id. at 501 (Stevens, J.) (explaining that most general common law claims would not impede the ability of federal regulators to implement and enforce specific federal requirements), 507-508 (Breyer, J.). 26 The statute and regulations, therefore, require a careful comparison between the allegedly pre-empting federal requirement and the allegedly pre-empted state requirement to determine whether they fall within the intended pre-emptive scope of the statute and regulations. 27 Id. at 500 (Stevens, J.). 28 With this tripartite scheme in mind, we turn our attention to the respective state and federal laws, and their compatibility.
29 Brooks claimed that Howmedica failed to warn her of the dangers of exposure to methyl methacrylate vapors while mixing Simplex. Brooks argues that a common law failure-to-warn claim is generic, and therefore cannot constitute a specific state requirement subject to federal preemption. 30 We agree with Brooks that Minnesota failure-to-warn claims are generic in the sense that such claims apply to a wide range of products. Cf., e.g., Kallio v. Ford Motor Co., 407 N.W.2d 92, 99-100 (Minn. 1987) (motor vehicle); Germann v. F.L. Smithe Machine Co., 395 N.W.2d 922, 924-25 (Minn. 1986) (hydraulic press); Frey v. Montgomery Ward & Co., Inc., 258 N.W.2d 782, 787-88 (Minn. 1977) (space heater); Marcon v. Kmart Corp., 573 N.W.2d 728, 730-32 (Minn. Ct. App. 1998) (plastic snow sled). But this conclusion doesn't resolve the more difficult question framed in Lohr: may an otherwise generic common law claim act as a device-specific requirement by virtue of the claim's application to a particular product? 31 Five Justices in Lohr indicated that generic common law claims could be preempted, though such claims aren't device-specific in the abstract. Those Justices (through the opinions of Breyer and O'Connor, JJ.) concluded that, in application, a common law judgment adverse to a medical device manufacturer would force compliance in much the same fashion as a state's enactment of regulations or other positive law specific to the medical device at issue. Justice Breyer stated that insofar as the MDA pre-empts a state requirement embodied in a state statute, rule, regulation, or other administrative action, it would also pre-empt a similar requirement that takes the form of a standard of care or behavior imposed by a state-law tort action. Lohr, 518 U.S. at 504-505 (Breyer, J.). Justice O'Connor's partial concurrence echoed Justice Breyer's sentiment that common law tort actions frequently act as state requirements, as described in 360k. See id. at 510-11 (O'Connor, J.); see also id. at 500 (Stevens, J.) (allowing for the remote possibility that general state requirements could sometimes be preempted). 32 A judgment favoring Brooks would provide precisely the sort of specific state-law mandate, or requirement, envisioned by Justices Breyer and O'Connor. If a jury found Howmedica liable for failing to warn Brooks and others of Simplex's asthma-inducing propensity, then the resulting judgment against Howmedica would effectively require Simplex to bear more expansive labeling detailing the risk of contracting asthma from exposure to chemical byproducts in the mixing process. Thus we find that Brooks's state law failure-to-warn claim would have the effect of a specific state law requirement, the first step in the preemption triad.
33 We turn now to the second stage of the analysis, the specific federal requirement. We have previously held that the premarket approval (PMA) process to which new medical devices are subjected is a specific [federal] requirement for a device within the meaning of 21 U.S.C. 360k(a) and 21 C.F.R. 808.1(d). Martello v. Ciba Vision Corp., 42 F.3d 1167, 1169 (8th Cir. 1994) (citations omitted). Although Martello was decided before Lohr, we are confident that Martello's holding survives Lohr, at least in this respect. Lohr did not address the preemptive power of the PMA process; instead, Lohr focused on a different (and far less stringent) approval process, the substantial equivalence, or 510(k) process. See Lohr, 518 U.S. at 480. Lohr's conclusion that less rigorous federal review doesn't preempt state common law claims fails to resolve whether more rigorous federal review would preempt a state common law claim -- the question we face. 34 The Supreme Court of Rhode Island, facing the same situation, answered the question in terms that apply equally well in this case. 35 We think rather than expressing entirely generic concerns of safety, the FDA has expressed explicit concerns toward [Simplex]. We conclude that the premarket approval process constitutes a specific federal interest as contemplated in Medtronic [v. Lohr] and that, therefore, the FDA approval served to impose strict FDA [warning and labeling] requirements upon the defendant. 36 Fry v. Allergan Medical Optics, 695 A.2d 511, 516 (R.I. 1997). 37 Our conclusion is buttressed by the considered views of the Sixth and Seventh Circuits, both of whom have recently explained that the PMA process may be considered specific federal regulation. See Kemp, 231 F.3d at 225-28 (dictum); Mitchell v. Collagen Corp., 126 F.3d 902, 911 (7th Cir. 1997) ([T]he PMA process . . . can constitute the sort of specific federal regulation of a product that can have preemptive effect.); but see Goodlin v. Medtronic, Inc., 167 F.3d 1367, 1374-77 (11th Cir. 1999) (concluding that the PMA process is conceptually distinct from specific federal regulation of medical devices). 38 Of course, Simplex was not actually reviewed under the PMA process. When Howmedica developed Simplex in the late 1960s, and submitted Simplex to the FDA in 1971, PMA review had not yet been fashioned by the FDA. But the FDA did test and review Simplex under the older New Drug Application (NDA) process, the precursor to the FDA's post-1976 PMA process. 39 As part of the NDA process, the FDA scrutinized Howmedica's proposed labeling and packaging for Simplex. The FDA reviewed and recrafted language that appeared on Simplex's package and package insert. FDA doctors also met with Howmedica representatives to discuss the content of Simplex's labels and warning inserts. Prior to Simplex's release into the market, the FDA reviewed each label, and every word, included in Simplex's package label and package insert. This federal review process constitutes specific regulation; the full might of the FDA's regulatory power was brought to bear upon a single product, Howmedica's Simplex. 40 Although the PMA process is arguably more rigorous than the older NDA process, the purpose of both processes is identical: to ensure that medical devices are reviewed for safety in advance of their release into the marketplace. As Howmedica points out, PMA is the functional equivalent of the old NDA approval process. Consequently, a medical device subject to NDA review ought to receive the same protection afforded a PMA-reviewed device. 41 Brooks disputes the fact that the PMA and NDA processes are functional equivalents. But even if we assumed the truth of Brooks's contention -- something we are disinclined to do -- Simplex is deemed to have been PMA-approved by operation of law. See 21 U.S.C. 360e(b)(1)(A), 360j(l)(3)(A); 21 C.F.R. 888.3027 (establishing, in combination, that drugs reclassified as devices in 1976 -- such as Simplex -- are considered PMA-compliant). As a result, we are not persuaded by Brooks's argument. 42 As we explained above, Martello holds that a PMA-compliant medical device has been subjected to specific federal regulation. Because Simplex was subjected to a PMA-equivalent approval process (NDA), and because Simplex is deemed PMA-compliant by virtue of federal regulations, Martello applies. Simplex was subject to specific federal regulation.
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