Court Opinion

ID: 9497201
Source: CourtListenerOpinion
Date Created: 2023-08-05 16:45:31.832439+00
Date Added: 2024-06-11T17:58:03.252257
License: Public Domain

FUENTES, Circuit Judge,
dissenting.
Following her husband’s death, Barbara Horn filed a lawsuit in the U.S. District Court, under state common law, alleging that her husband died as a result of TCI’s defectively designed heart pump. In her complaint, she alleges that the suture on Mr. Horn’s HeartMate had worn through and that the screw ring linking the pump to the output side had disconnected. As a result, an air embolus traveled to Mr. Horn’s brain, causing his death. The majority has concluded that Horn’s common-law claims, grounded in negligence and defective design, create “specific requirements” under state law and are therefore preempted by § 360k(a) of the MDA. I cannot agree, however, that Horn’s generalized common-law claims impose any specific state-law “requirements” on the HeartMate. This is because § 360k(a) preemption works only against state requirements that are “different from, or in addition to” federal requirements. In my view, because Horn’s suit is not seeking to impose any specific requirement on the HeartMate, it is not preempted. Additionally, I believe that allowing common-law liability would simply have the effect of encouraging TCI and other device manufacturers to go above and beyond FDA standards, and this effect would clearly not contradict the MDA’s purpose of enhancing medical device safety. I therefore respectfully dissent.
I.
I have no quarrel with the majority’s conclusion that the PMA process is a specific federal regulation governing the HeartMate.27 I believe, however, that the District Court erred by looking only at whether the federal regulation here (the PMA) was specific to a particular device, and not examining whether the state law under which Horn sued was device-specific. Horn argues that a state common-law claim is preempted only if the state claim is device-specific and the purportedly preempting federal regulation is device-specific. TCI responds that the District Court correctly analyzed only the federal side of the equation, because Medtronic, Inc. v. Lohr, 518 U.S. 470, 116 S.Ct. 2240, 135 L.Ed.2d 700 (1996), made that the only relevant inquiry. The Circuits are split on this question, with the Seventh and Ninth Circuits holding that preemption requires only a device-specific federal regulation, Mitchell v. Collagen Corp., 126 F.3d 902, 912 (7th Cir.1997); Papike v. Tambrands Inc., 107 F.3d 737, 742 (9th Cir.1997); and the Tenth Circuit holding that preemption *181additionally requires a device-specific state law. Oja v. Howmedica, Inc., 111 F.3d 782, 789 (10th Cir.1997). Although my colleagues acknowledge some kind of state-law specificity requirement, they effectively agree with the Seventh and Ninth Circuits in holding that even the most generalized tort claims, such as those in the case before us,- are preempted under § 360k(a).
I respectfully dissent from this conclusion. The FDA regulations concerning preemption clarify that preemption only occurs when the FDA “has established specific counterpart regulations or there are other specific requirements applicable to a particular device under the act.” 21 C.F.R. § 808.1(d) (emphasis added). The preemption clause does not “preempt State or local requirements of general applicability where the purpose of the requirement relates either to other products in addition to devices (e.g., [the UCC]) or to unfair trade practices in which the requirements are not limited to devices.” 21 C.F.R. § 808.1(d)(1) (emphasis added).
In 1996, the Supreme Court issued Lohr, a fractured opinion that examined MDA preemption of state law. The majority of the Lohr Court agreed that a strong presumption exists in favor of a narrow scope of preemption because policing health is the traditional province of the states. 518 U.S. at 485, 116 S.Ct. 2240. Another key factor in analyzing the scope of preemption is Congress’s intent in passing the legislation. Id. at 485-86, 116 S.Ct. 2240. The Court split, however, as to whether the MDA preempted state common-law claims premised on the unsuitability of a medical device under state standards more stringent than the FDA standards governing the device. Justice Breyer agreed with a. four-justice bloc (Stevens,- Kennedy, Souter and Ginsburg) that the term “requirement” in § 360k(a) is ambiguous, and does not entail the preemption of all common-law tort suits holding manufacturers to . higher standards than the FDA. Id. at 488-89, 116 S.Ct. 2240 (Stevens, J., plurality (hereinafter “plurality”));28 id. at 505-06, 116 S.Ct. 2240 (Breyer, J., concurring (hereinafter “Breyer”)). The remaining four Justices disagreed, opining that § 360k(a) bars all state-law claims, common-law or otherwise, that hold manufacturers to a higher standard than federal regulations. Id. at 511— 12, 116 S.Ct. 2240 (O’Connor, J., concurring in part and dissenting in part (hereinafter “dissent”)).
The plurality and Justice Breyer turned to the above-quoted FDA regulations to help determine when a common-law claim constitutes a state “requirement” under § 360k(a). Id. at 498-99, 116 S.Ct. 2240; id. at 505-06, 116 S.Ct. 2240 (Breyer). Relying on these regulations, the five Justices concluded that preemption is only triggered by specific FDA regulations applying to a particular device, and not by generally applicable FDA regulations, i.e., those governing the design or labeling of medical devices as a whole. Id. at 500-01, 116 S.Ct. 2240. Part V of the plurality opinion, which Justice Breyer joined, also stated that the MDA does not preempt generalized state-law claims, such as negligence in manufacturing or failure to warn, as opposed to state laws governing particular medical devices. Id. at 501-02, 116 S.Ct. 2240.
Thus, Part V of the Lohr opinion, which represents the views of five Justices, excepted generalized common-law claims like failure to warn and negligent manufacture *182from the ambit of MDA preemption. Id. at 501-02, 116 S.Ct. 2240. The Lohr majority reasoned that “general state common-law requirements” that “were not specifically developed ‘with respect to’ medical devices ... are not the kinds of requirements that Congress and the FDA feared would impede the ability of federal regulators to implement and enforce specific federal requirements.” Id. at 501,116 S.Ct. 2240. Here, Horn’s four claims of negligence, strict liability, breach of warranty and failure to warn are all general common-law tort claims that were not crafted specifically to govern medical devices, and so are excepted from the scope of § 360k(a).
This conclusion is bolstered by the FDA regulations on preemption, relied upon by the Lohr majority. As mentioned above, the FDA has declared that preemption only occurs when the FDA “has established specific counterpart regulations or there are other specific requirements applicable to a particular device under the act.” 21 C.F.R. § 808.1(d) (emphasis added). The regulations go on to say that “there are other State and local requirements that affect devices that are not preempted by [§ 360k(a) ] because they are not ‘requirements applicable to a device’ within the meaning of [§ 360k(a) id., and lists as an example “State or local requirements of general applicability where the purpose of the requirement relates either to other products in addition to devices (e.g., [the UCC]) or to unfair trade practices in which the requirements are not limited to devices.” 21 C.F.R. § 808.1(d)(1). This reference to the speci-fieity of state regulations would be superfluous if all that mattered was the specificity of the federal regulation. Moreover, the exemption of generalized state requirements is never qualified by the further condition that those requirements infringe on a generalized federal requirement. Finally, the regulations belie my colleagues’ conclusion that generalized state requirements can be preempted if they merely affect the manufacture of medical devices. See Maj. Op. at 174-76 (state-law claim is preempted if it has the effect of imposing a greater burden on a device manufacturer than the FDA). In short, the regulations support the view that state-level device-specificity is a requisite for § 360k(a) preemption.
TCI argues that the FDA has published regulations contravening the state specificity requirement, but the cited regulations only state that in the context of a particular California law “general requirements not applicable to specific devices ... are not preempted unless they are applied to a specific device in such a way as to establish requirements” for an FDA-regulated device. 45 Fed.Reg. 67321, 67322. Thus, general requirements are still not preempted under this regulation; the only state requirements that are preempted are ones that affect specific devices. Even if TCI’s interpretation of this statement were correct, one isolated statement in the Federal Register would not trump the actual regulations contained in the C.F.R., especially when those regulations have been adopted by the Supreme Court as instructive.29
*183The main argument against the state specificity requirement rests in the language of Justice Breyer’s concurrence in Lohr. After joining Part V of the Stevens opinion, Justice Breyer wrote separately that common-law claims could in fact be preempted where they imposed different standards for devices than the counterpart device-specific FDA regulations. Lohr, 518 U.S. at 504, 116 S.Ct. 2240 (Breyer). Justice Breyer raised the example of a jury finding for a plaintiff in a negligence suit on the grounds that a hearing aid wire was longer than 1 inch, even though FDA regulations had approved wires up to 2 inches. Id. Justice Breyer concluded that this jury award would be preempted even though it was based on the generalized state tort law of negligence because it effectively established a device-specific state requirement of 1-inch wires for hearing aids. Id.
My colleagues have found this language from Justice Breyer difficult to reconcile with his agreement with Part V of the majority opinion, which exempted generalized state causes of action from preemption. Maj. Op. at 180. The Seventh and Ninth Circuits also perceived a contradiction and chose to ignore Justice Breyer’s vote for Part V, instead crediting the apparently contrary reasoning in his concurrence. Mitchell, 126 F.3d at 912; Papike, 107 F.3d at 742. With all due respect to my colleagues and these two Circuit Courts, however, I do not believe that Justice Breyer’s concurrence is in disagreement with Part V of the majority opinion.30 Justice Breyer’s opinion shows concern that in certain situations a state could fashion, through its common law, a specific requirement for a particular device. For example, a plaintiff could sue under a theory of negligence per se, where the negligence is premised on deviation from a specific state requirement for a device (like a 1-inch hearing aid wire). Similarly, a judge could give a jury instruction telling the jury that, as a matter of law, it should find a manufacturer negligent if it violated a certain standard for a device (i.e., “you should find the manufacturer negligent if it used a hearing aid wire longer than 1 inch”). *184Both of these examples involve a specific requirement being imposed upon a device by the state through its common law. A simple negligence action, in contrast, does not impose any specific requirement on the device, but simply alleges that the device was designed/manufactured improperly.
In this case, because Horn’s suit is not seeking to impose any specific requirement on the HeartMate, it is not preempted. It is true that Horn’s cause of action may have the indirect consequence of holding the HeartMate to a higher standard than does the FDA, but this consequence is sanctioned by Part V of the Lohr opinion and not expressly barred by Justice Breyer’s concurrence. Moreover, even if my colleagues were correct that the content of Justice Breyer’s concurrence contradicted Part V, the correct course of action would be to follow Part V as the majority opinion of the Supreme Court, not to elevate a one-justice concurrence above the five-justice majority. Cf. Alexander v. Sandoval, 532 U.S. 275, 285 n. 5, 121 S.Ct. 1511, 149 L.Ed.2d 517 (2001) (concurrence is not given as much precedential weight as majority opinion, even if concurrence is compatible with majority opinion).
Finally, even if Justice Breyer’s concurrence were given equal weight to Part V, this jurisprudential “tie” should be broken by reference to the presumption against a wide scope of preemption. Lohr, 518 U.S. at 485, 116 S.Ct. 2240. TCI argues that this presumption has since been discarded. However, all of the cases TCI cites for that proposition either (1) found the presumption irrelevant because the language was clear, Sprietsma v. Mercury Marine, 537 U.S. 51, 62-63, 123 S.Ct. 518, 154 L.Ed.2d 466 (2002); Crosby v. National Foreign Trade Council, 530 U.S. 363, 374 n. 8, 120 S.Ct. 2288, 147 L.Ed.2d 352 (2000); or (2) found the presumption inapplicable to the particular statute in question because it did not deal with a traditional province of state law, Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 347, 121 S.Ct. 1012, 148 L.Ed.2d 854 (2001); United States v. Locke, 529 U.S. 89, 108, 120 S.Ct. 1135, 146 L.Ed.2d 69 (2000). In conclusion, I would follow Part V of the Lohr opinion, as I feel we are bound to do, and hold that a state common-law claim is preempted only if it establishes a specific requirement for a particular device, rather than alleging breach of a generalized duty of care. Accordingly, the District Court’s finding of express preemption should be reversed.31
II.
Because I would find no express preemption here, I would reach TCI’s implied preemption argument, and conclude that Horn’s claims are not impliedly preempted. Implied preemption can exist in either of two situations: (1) when Congress intended federal law to occupy an entire *185field of law exclusively (“field preemption”), or (2) when state law actually conflicts with federal law (“conflict preemption”). E.g., Freightliner Corp. v. Myrick, 514 U.S. 280, 287, 115 S.Ct. 1483, 131 L.Ed.2d 385 (1995). Conflict preemption can in turn be shown in two ways: (1) it is impossible for a party to comply with both federal and state requirements, or (2) the state law frustrates Congressional intent. Id. Here, the only implied preemption claim at issue is the frustration prong of conflict preemption: TCI and Amicus Curiae U.S. Chamber of Commerce (“USCC”) do not argue that field preemption or impossibility conflict preemption apply.
Since there is no express language to rely on in a frustration conflict preemption analysis, the key factor to consider is, unsurprisingly, Congressional purpose. E.g., Barnett Bank of Marion County, N.A. v. Nelson, 517 U.S. 25, 31, 116 S.Ct. 1103, 134 L.Ed.2d 237 (1996). As the Lohr court observed, the purpose of the MDA was to protect consumers by ensuring the safety and effectiveness of medical devices. Lohr, 518 U.S. at 476, 116 S.Ct. 2240. Contrary to USCC’s and PLAC’s assertions, protection of the medical device industry from excessive regulation was a minimal concern. Id. at 490-91, 116 S.Ct. 2240 (plurality); see also id. at 476, 116 S.Ct. 2240 (MDA was motivated by concern on the part of consumers and regulators, not industry). The plurality specifically disclaimed the idea of a Congressional “fear that product liability actions would hamper the development of medical devices.” Id. at 490, 116 S.Ct. 2240 (plurality).32 This clearly pro-regulatory, pro-consumer safety purpose of the MDA compels the conclusion that state common-law suits are not impliedly preempted by the MDA. This conclusion is supported by the presumption in favor of a narrow scope of preemption, mentioned above. Moreover, although the presence of an express preemption clause (§ 360k(a)) does not conclusively rule out implied preemption, it does imply that “Congress did not intend to pre-empt other matters.” Myrick, 514 U.S. at 288, 115 S.Ct. 1483.
None of TCI’s or USCC’s arguments are persuasive toward finding implied preemption here. TCI relies on Buckman, 531 U.S. at 350, 121 S.Ct. 1012, for the proposition that the MDA allows for implied preemption. Buckman, however, found implied preemption of a state-law claim that the defendant had defrauded the FDA by sending it false § 501(k) equivalency information. Id, at 343, 121 S.Ct. 1012. The conflict in Buckman existed because the MDA had given the FDA full power and discretion to remedy acts of fraud perpetrated on it; a state-law suit seeking to prosecute fraud against the FDA would necessarily conflict with the FDA’s discretionary decision to forego a fraud prosecution against itself. Id. at 349, 121 S.Ct. 1012. Indeed, the Buckman court distinguished fraud-on-the-agency claims from suits based on “traditional state tort law principles of the duty of care,” which are the principles involved in this case. Id. at 352, 121 S.Ct. 1012.
TCI’s other argument, echoed by USCC, is that allowing state-law tort suits conflicts with federal law because it allows juries to second-guess the FDA’s determination that the PMA-approved device is safe. There is not necessarily any conflict, however, between the FDA’s allowing TCI to market the HeartMate and a state finding that the HeartMate is unsafe: the *186natural way to reconcile these two positions is to see the PMA process as a “floor” of minimum standards for Class III devices, but not a “ceiling.” Under this view, a state could still raise the standards of safety within its own jurisdiction. Cf. Barnett Bank, 517 U.S. at 31, 116 S.Ct. 1103 (federal law permitting banks to sell insurance in small towns does not necessarily conflict with state law banning such sales, since federal law could be read as permitting sales to the extent that they are permitted by state law).
USCC argues that while Barnett Bank recognized that there was not necessarily a contradiction between federal permission and state prohibition of a practice, Barnett Bank produced a bright-line rule that federal permission to engage in a practice preempts state law liability incurred by engaging in that practice. Accordingly, USCC concludes, the FDA’s permission to market HeartMate triggers frustration conflict preemption against Horn’s suit declaring that the HeartMate is designed defectively. USCC mischaracterizes Barnett Bank, however: the Supreme Court did not lay down any blanket rule on frustration conflict preemption, but merely followed the normal procedure of looking to the legislature’s intent to determine if frustration conflict preemption existed. Id. at 32-37, 116 S.Ct. 1103. The Barnett Bank court concluded that a federal statute permitting banks to sell insurance in small towns preempted a state statute banning such sales because the purpose behind the federal statute was to empower banks. Id. Here, in contrast, the MDA was not created to empower industry, but to protect consumers by ensuring safe devices. Thus, the conflict that existed in Barnett Bank does not exist here.
The instant case is also distinguishable from Barnett Bank in that Barnett Bank dealt with a state’s outright statutory ban of a permitted practice, while there is no corresponding ban here (i.e., the state of Pennsylvania outlawing heart pumps). In this case, TCI is not prohibited from marketing the HeartMate, but must simply live with the possibility of liability if the HeartMate does not live up to Pennsylvania’s applicable standards of care. Although the risk of liability may admittedly be a deterrent to TCI’s marketing efforts, the Supreme Court has held that the incidental regulation incurred by liability under generally applicable state law is less intrusive, and therefore less prone to preemption, than “direct regulation on the operation of federal projects.” Goodyear Atomic Corp. v. Miller, 486 U.S. 174, 185-86, 108 S.Ct. 1704, 100 L.Ed.2d 158 (1988).
USCC also cites to Pokorny v. Ford Motor Co., 902 F.2d 1116, 1123-25 (3d Cir.1990), to support its proffered bright-line rule that federal permission to engage in a practice preempts state law liability incurred by engaging in that practice. Po-komy, however, is distinguishable for the same reason as Barnett Bank: the purpose behind the federal regulation in Po-komy was specifically to give automobile manufacturers flexibility to choose to equip their automobiles with manual safety belts instead of automatic belts and/or airbags. Id. As Horn points out, the Pokomy court rejected the manufacturer’s claim that the regulation also preempted a claim based on a lack of protective netting, because there was no evidence that Congress or the Department of Transportation contemplated protective netting when the regulation was promulgated. Id. at 1126. Indeed, the Pokomy court allowed common-law liability as a permissible way for the state to “ ‘encourage’ automobile manufacturers to provide safety features in addition to those listed in” the federal regulation. Id. Similarly, in the instant case, allowing common-law liability would simply have the effect of encouraging TCI and *187other device manufacturers to go above and beyond FDA standards, and this effect would clearly not contradict the MDA’s purpose of enhancing medical device safety.33
IV.
Five Justices of the Supreme Court have joined an opinion that requires specificity of state claims in addition to specific federal requirements for the triggering of preemption under the MDA. Specificity of state claims is also mandated by the applicable FDA regulations, to which we must show deference. My colleagues, however, have rejected both the binding instructions of the Supreme Court in Lohr and the FDA regulations based on their perception of a single Justice’s opinion in Lohr and the FDA’s current litigation position, to which we owe no deference. Accordingly, I must respectfully dissent:

. For this reason, the majority’s discussion of the difference between the PMA process and the § 510k “substantial equivalence” process is not relevant. Maj. Op. at 167. That difference only speaks to why the PMA process is a specific federal requirement; my disagreement with the majority is not over the federal side of the equation at all, but rather over whether Horn’s suit implicates the state-law specificity requirement in Lohr.

. To be precise, I will only use the term "plurality” in reference to portions of Justice Stevens’s opinion in Lohr that were joined by only four Justices. The portions of the Lohr opinion joined by five Justices will not be accompanied by any parenthetical reference.

. My colleagues seem to put great emphasis on the FDA's amicus brief, which sides with TCI. Horn and Amicus Product Liability Advisory Council have also both advanced arguments from previous United States briefs on the scope of 360k(a) preemption as evidence in favor of their views on preemption. As TCI has itself pointed out, however, arguments advanced by the United States in a litigation brief are entitled to “near indifference,” and are only as persuasive as their own merits dictate. United States v. Mead Corp., 533 U.S. 218, 228, 121 S.Ct. 2164, 150 L.Ed.2d 292 (2001) (cited in TCI Br. at 52). Notably, the *183Lohr court gave deference to the FDA’s regulations in particular, not to an amicus brief. 518 U.S. at 495-96, 116 S.Ct. 2240. Consequently, I believe that Lohr mandates that we obey the regulations issued by the FDA, rather than the amicus brief relied upon by the majority.

. My colleagues find it incongruous that Justice Breyer would “write separately to emphasize that duties arising under state law can regularly lead to preemption, but simultaneously agree with the plurality that tort duties are almost always too general to warrant preemption.” Maj. Op. at 174. Not only is this an overstatement of Justice Breyer's language ("I am not convinced that future incidents of MDA pre-emption of common-law claims will be 'few' or 'rare' ”), it also depicts a false conflict: the plurality expressed its views on the frequency of preemption in Part VI of its opinion, which Justice Breyer explicitly refused to join. Lohr, 518 U.S. at 508, 116 S.Ct. 2240 (Breyer). Indeed, the fact that Justice Breyer explicitly declined to join Part VI of the majority opinion highlights his clear intent to join Part V in full. Similarly, the majority somehow turns Justice Breyer’s agreement with the Lohr dissent that "the MDA will sometimes pre-empt a state-law tort suit,” id. at 503, 116 S.Ct. 2240 (Breyer) (emphasis added)-a statement that I entirely agree with-into an agreement with the Lohr dissent’s statement that there is no state-law specificity requirement whatsoever. Id. at 512, 116 S.Ct. 2240 (dissent) (quoted in Maj. Op. at 175). To the contrary, Justice Breyer endorsed a state-law specificity requirement by joining Part V of Justice Stevens’s opinion, and this requirement therefore "enjoys the assent of five Justices.” Marks v. United States, 430 U.S. 188, 192-93, 97 S.Ct. 990, 51 L.Ed.2d 260 (1977). Accordingly, the "narrowest ground” approach evoked by the majority is simply inapplicable to evade the holding of Part V of the Lohr opinion.

. TCI suggests in passing that Part V does not actually require state-level device-specificity, relying on the sentence: “Although we do not believe that this statutory and regulatory language necessarily precludes ‘general’ federal requirements from ever pre-empting state requirements, or 'general' state requirements from ever being preempted, ... it is impossible to ignore its overarching concern that preemption occur only where a particular state requirement threatens to interfere with a specific federal interest.” Lohr, 518 U.S. at 500, 116 S.Ct. 2240. This quoted language, however, only states that the relevant statutory and regulatory texts do not compel the state-level specificity requirement, but that the Lohr majority inferred the state-specificity requirement from that language. Part V later makes it clear that state-level specificity is in fact a requirement for preemption. Id. at 502, 116 S.Ct. 2240 (“These state requirements therefore escape preemption, ... because their generality leaves them outside the category of requirements that § 360k envisioned to be 'with respect to’ specific devices”).

. Justice Breyer did not join the plurality's detailed discussion of statutory purpose because he found it unnecessary for analysis of the case; he made no statement agreeing or disagreeing with it. Id. at 508, 116 S.Ct. 2240 (Breyer).

. Of course, this only shows that common-law liability is in no way impliedly preempted by the MDA; obviously, the express preemption clause does preempt some common-law liability for state standards above and beyond FDA standards.