Court Opinion

ID: 9488605
Source: CourtListenerOpinion
Date Created: 2023-08-05 12:50:16.913989+00
Date Added: 2024-06-11T17:52:59.262892
License: Public Domain

REINHARDT, Circuit Judge,
concurring:
I join fully in Judge Ferguson’s opinion for the court. I write separately to clarify further the meaning of the word “requirement” as it is used in 21 U.S.C. § 360k(a). The Medical Device Amendments of 1976 (the “MDA”) preemption provision states:
[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—
(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.
21 U.S.C. § 360k(a).
The first reference to “requirement” is to requirements imposed by states or local entities, while the second and third references are to federal requirements imposed under the MDA. It is the meaning of the first “requirement” — state or local requirements applicable to medical devices — that is at issue here.1
Some courts have concluded that the term “requirement” as it relates to state or local regulation includes state common law of general applicability. These courts have either accepted that view without explanation, relied on a plurality holding endorsing the proposition in a different context in Cipollone v. Liggett Group, Inc., 505 U.S. 504, 112 S.Ct. 2608, 120 L.Ed.2d 407 (1992), or read 21 C.F.R. § 808.1(b) in isolation from the rest of § 808.1.2 As discussed in Judge Ferguson’s opinion for the court, the dicta and occasional holdings of the courts that have concluded that the MDA preempts state common law ignore the controlling interpretation of § 360k(a) adopted by the FDA, the federal agency charged with implementing the Medical Device Amendments.
The term “requirement” is not self-defining, and Congress did not provide any definition of the term as it is used in relation to the actions of a state (the first reference) or in *1461relation to federal actions (the second and third references). Rather, Congress left to the FDA the task of adopting implementing regulations defining “requirement,” and explaining the operation of other provisions of the MDA. The controlling interpretations of the term “requirement” are found in 21 C.F.R. § 808.1. Read in its entirety, section 808.1 clearly provides that § 306k(a) preempts only state and local requirements the terms of which are specifically “applicable to medical devices,” and that it does not preempt state and local requirements “of general applicability;” i.e., state and local requirements the purpose of which relates “to other products in addition to [medical] devices.” 21 C.F.R. § 808.1(a); 21 C.F.R. § 808.1(d)(1). In other words, the FDA’s implementing regulations define and limit the term (state) “requirement.” Under those regulations, what is preempted by the MDA are state and local medical device requirements, not state and local general laws, whether tort or contract, common or statutory. 21 C.F.R. § 808.1(d)(1). In short, § 808.1 makes it clear that general state tort law is not preempted by the MDA.
A few courts have pointed to the inclusion of the term “court decisions” in 21 C.F.R. § 808.1(b) as evidence that state tort law claims are generally preempted. See, e.g., Gile v. Optical Radiation Corp., 22 F.3d 540, 544 n. 3 (3rd Cir.), cert. denied, — U.S. -, 115 S.Ct. 429, 130 L.Ed.2d 342 (1994). They argue that the inclusion of “court decisions” demonstrates that all state common law is preempted. The argument is a non sequitur. The court decisions that are preempted are only those that involve state requirements of specific rather than general applicability. The fact that a court decision involves a medical device is not determinative of whether that court decision constitutes a preempted state requirement; what is determinative is whether the court decision implements a principle of general tort law or is based on a rule or regulation aimed specifically at medical devices. A contrary interpretation would bring § 808.1(b) into direct conflict with § 808.1(d)(1). There is no reason for such a conflict, since the two provisions, read in context, can easily be reconciled.3
Section 808.1(b) sets forth the “general rule” that states may not establish or maintain “requirements” with respect to medical devices that differ from the federal rules governing these devices. As noted supra, the term “requirement” is defined as including “court decisions.” We can assume for purposes of this decision that were we to read § 808.1(b) in isolation, there might be some ambiguity with respect to the latter term, and that it could be read to refer either to all court decisions or only to those court decisions that adopt special rules applicable to medical devices. However, when read together with § 808.1(d)(1), any ambiguity disappears.
In § 808.1(d)(1), which, of course, appears after § 808.1(b), the scope of the earlier section is expressly clarified and limited. Section 808.1(d)(1) specifically provides that “requirements” involving laws of general applicability, are not preempted. Since, under § 808.1(b), “requirements” includes “court decisions,” “court decisions” must be read as *1462not including decisions involving rules of general applicability. Any other reading would make the scope of the term “court decisions” far broader than, and entirely inconsistent with, the other terms (i.e. statute, ordinance, and regulation) which are included within the definition of “requirement.” In short, the inclusion of the term “court decision” in § 808.1(b) cannot serve to modify the provision in § 808.1(d) that limits the term “requirements” to those provisions applicable expressly to medical devices. If for no other reason than the order in which they appear, it is § 808.1(d) that specifically limits and explains the scope of the term “court decision,” as used in § 808.1(b), not vice-versa.
To summarize, if a state common law requirement is not specifically directed at medical devices, but affects such devices in the same manner as it affects all other products, a claim based upon that state law requirement is not preempted. Accordingly, generally applicable state common law, including tort law, is not preempted by § 360k(a).

. The Eleventh Circuit erroneously suggests that this court understands the first reference to “requirement” to include general state tort law. Lohr v. Medtronic, Inc., 56 F.3d 1335, 1342 (11th Cir.1995). The Lohr court's suggestion is based on dicta in Anguiano v. E.I. Du Pont De Nemours & Co., 44 F.3d 806, 809 (9th Cir.1995). In Anguiano, we actually considered the second and third references to "requirement” (the federal references) in § 360k(a), and held that the plaintiffs’ state claims were not preempted. We concluded that the federal controls applicable to the Class II device in question were too insubstantial to constitute a "requirement" under the MDA. Id. at 810. Class III devices were not at issue in that case and our speculation as to how Class III devices might be treated under the statute was just that — speculation. So, too, were any observations regarding the scope or preemptive effect of the first reference to "requirement,” the requirement at issue here.

. See, e.g., Gile v. Optical Radiation Corp., 22 F.3d 540, 542 (3rd Cir.), cert. denied, — U.S. -, 115 S.Ct. 429, 130 L.Ed.2d 342 (1994) (declaring that the Supreme Court has clearly stated that the’word “requirement,” in the context of an express preemption provision, includes state law claims); Slater v. Optical Radiation Corp., 961 F.2d 1330, 1333 (7th Cir.), cert. denied, - U.S. -, 113 S.Ct. 327, 121 L.Ed.2d 246 (1992) (suggesting in dicta that § 360k(a) preempts state common law decisions); Martello v. Ciba Vision Corp., 42 F.3d 1167, 1168 (8th Cir.1994), cert. denied, - U.S. -, 115 S.Ct. 2614, 132 L.Ed.2d 857 (1995) (relying on phrase "whether established by statute, ordinance, regulation, or court decision” in 21 C.F.R. § 808.1(b) to conclude preemption extends to state tort actions); Lohr, 56 F.3d at 1342 (adopting the Seventh Circuit's reasoning and relying on the conclusions of other circuits that common law actions are state requirements within the meaning of § 360k(a)).

. Appellate courts have generally ignored 21 C.F.R. § 808.1(d)(1). Only a few circuit courts even bother to mention the subsection. See Michael v. Shiley, Inc., 46 F.3d 1316, 1323 n. 4 (3rd Cir.1995) (noting plaintiff's argument based on the "general applicability” language in § 808.1(d)(1) but expressing no view on the effect of § 808.1(d)(1) "because Shiley disclaimed all implied warranties as it was entitled to do under the Code”); Gile, 22 F.3d at 543 n. 2 (ignoring the "general applicability” language and seemingly relying on the fact that neither the phrases "state tort claim” nor "common law claim" are listed in 21 C.F.R. § 808.1(d)); King v. Collagen Corp., 983 F.2d 1130, 1139 (1st Cir.), cert. denied, - U.S. -, 114 S.Ct. 84, 126 L.Ed.2d 52 (1993) (Aldrich, J., concurring) (offering the proposition that "When a statute is clear the agency interpretation must give way" as explanation for why § 808.1(d)(1) does not conflict with the court’s decision). District courts have addressed § 808.1(d)(1) more often than appellate courts with varied conclusions. Compare Mitchell v. Collagen Corp., 870 F.Supp. 885 (N.D.Ind.1994) (rejecting plaintiffs contention, based upon § 808.1(d), "that state tort laws of general applicability (i.e., not applicable only to medical devices) are not preempted”) with Ministry of Health v. Shiley, 858 F.Supp. 1426, 1435 (C.D.Cal.1994) (relying on the “general applicability" language of § 808.1(d)(1) and Advisory Opinions issued by the Office of the Chief Counsel for the FDA to conclude state tort claims are not subject to blanket preemption).