Steele v. Collagen Corp.

BLEASE, Acting P. J., Concurring and Dissenting.

I concur in the reversal of the summary judgment. However, I disagree with the majority opinion because it misreads or ignores the relevant text of Medtronic, Inc. v. Lohr (1996) 518 U.S. _ [ 116 S.Ct. 2240 , 135 L.Ed.2d 700 ] (Medtronic), with which five justices agree.

The majority opinion reverses the summary judgment granted Collagen on the ground it failed to show that “Zyderm was designed, manufactured, and labeled according to the specifications approved by the FDA.” (Maj. opn. ante, this page.) With this much I agree. However, this implies that the only ground upon which the product may be challenged is for lack of conformity with the FDA specifications. This amounts to a claim that the premarket *1491 approval of a device occupies the field relating to the device, precluding state regulations which differ from the specifications. Curiously, it reaches this conclusion by reading Medtronic from the point of view of the dissent.

The proper test of preemption of state tort actions of general applicability, consistent with Justice Breyer’s concurring views and part V of the plurality opinion, is that the Medical Device Amendments of 1976 (MDA) preempts a state law tort action only where it “actually conflicts” with a federal requirement. (See, e.g., Medtronic, supra, 518 U.S. at p._[ 116 S.Ct. at p. 2261 , 135 L.Ed.2d at pp. 729-730 conc. opn. of Breyer, J.)

This case arises on a summary judgment in favor of defendant Collagen Corporation (Collagen). The sole ground upon which the relief was sought was that “each and every one of plaintiff’s causes of action is . . . expressly preempted under ... 21 U.S.C. § 360k as added by the [MDA], and regulations promulgated thereunder.” The principal, material, undisputed fact adduced by the defendant was that a product manufactured and distributed by Collagen, Zyderm, a class HI device, had been given premarket approval (PMA) by the federal Food and Drug Administration (FDA) and “had been shown to be safe and effective for use as recommended in the submitted labeling.” The only defense tendered is that premarket approval preempts any state cause of action. For this reason the allegations of the plaintiff’s complaint stand unchallenged.

The allegations are exceedingly general. Little more is alleged than that Collagen designed, manufactured, tested, sold and labeled Zyderm, that the plaintiff was injected with the substance and as a result developed an autoimmune disease, and that Collagen is responsible for the injury under theories of unfair trade practices, strict liability, negligence, breach of express or implied warranty, fraud and negligent misrepresentation. Collagen did not seek to determine, by contention interrogatories or other means of discovery, in what way plaintiff contends Zyderm was designed, manufactured or labeled so as to give rise to liability. Accordingly, we are presented with an essentially abstract question of law, whether the MDA preempts the causes of action so pled. In this context it is not possible to tell whether the state claims “actually conflict” with any federal requirement.

Medtronic concerns the construction and application of the MDA and the implementing FDA regulations. In pertinent part the MDA (hereafter section 360k) provides that:

Ҥ 360k. State and local requirements respecting devices

“(a) General rule

*1492 “Except as provided in subsection (b)[ 1 ] of this section, no 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).)

In Medtronic the plaintiffs sought damages for injury caused by the negligent design and manufacture of a pacemaker and for failure to warn of its tendency to fail. A majority of the court, relying on FDA regulations which define the terms of section 360k, found the plaintiffs’ claims were not preempted by the FDA’s general rules regulating manufacturing practices and labeling requirements.

This prompted a dissent which reasoned that section 360k is clear on its face, that no resort need be made to the FDA regulations implementing section 360k, that the term “requirement” encompasses common law causes of action, that such causes are preempted to the extent their recognition would impose a requirement different from or in addition to the FDA requirements applicable to the device and that the general regulations at issue impose “comprehensive” requirements which preempt the plaintiffs’ negligent manufacturing and failure-to-warn claims. ( Medtronic, supra, 518 U.S. at p. _ [116 S.Ct. at pp. 2262-2264, 135 L.Ed.2d at pp. 730-734] (conc. & dis. opn. of O’Connor, J.).)

The majority opinion in this case disagrees with the dissent in Medtronic only regarding the last claim. In particular, the majority opinion assumes that the phrase “different from, or in addition to,” in section 360k, is clear and means that any variation from a federal requirement by a state requirement is preempted. This is the same as saying that the federal requirement, whatever it is, always preempts the field applicable to the device.

By contrast, both the plurality opinion in Medtronic and the concurring opinion of Justice Breyer found the phrase “different from or in addition to” ambiguous and deferred to the FDA regulations which define the key terms in the statute. ( Medtronic, supra, 518 U.S. at pp__-_[116 S.Ct. at pp. 2255-2256 and 2260-2261, 135 L.Ed.2d at pp. 722 and 728-729 respectively].) *1493 These are found in 21 Code of Federal Regulations, section 808.1(d) (1996). 2 Of significance, they require a divergence between a specific federal requirement with respect to a device and a specific state regulation of the device. This is another way of saying there must be an actual conflict between the federal and state requirements.

Applying this test, the majority in Medtronic, consisting of part V of the plurality opinion, together with Justice Breyer, who joined in the part, agreed with the plaintiffs that “because only state requirements ‘with respect to a device’ may be pre-empted, and then only if the requirement ‘relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device,’ section 360k(a) mandates pre-emption only where there is a conflict between a specific state requirement and a federal requirement ‘applicable to’ the same device.” (518 U.S. at p_[116 S.Ct. at pp. 2256-2257, 135 L.Ed.2d at p. 723 ], italics added.)

The court said that the MDA did not preempt the plaintiffs’ negligent manufacturing and labeling claims because they did not come within the regulations. The opinion sets forth the multiple criteria, addressing inter alia the meaning of the term “requirement” as applied to both the MDA and state law. “State requirements must be ‘with respect to’ medical devices and *1494 ‘different from, or in addition to’ federal requirements. State requirements must also relate ‘to the safety or effectiveness of the device . . . and the regulations provide that state requirements of ‘general applicability’ are not pre-empted except where they have ‘the effect of establishing a substantive requirement for a specific device.’ Moreover, federal 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.’ 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.” ( Medtronic, supra, 518 U.S. at p._[116 S.Ct. at pp. 2257-2258, 135 L.Ed.2d at pp. 724-725, italics added & fn. omitted.)

As emphasized, “. . . the regulations provide that state requirements of ‘general applicability’ are not pre-empted except where they have ‘the effect of establishing a substantive requirement for a specific device.’ ” ( Medtronic, supra, 518 U.S. at p._[116 S.Ct. at pp. 2257-2258, 135 L.Ed.2d at pp. 724-725].) 3

The exception dovetails with the concurring views of Justice Breyer. He asked two questions. First, does the MDA ever preempt a state law tort action? Second, if so, does the MDA preempt the particular state-law tort claims at issue here?

He answered the first question by stating that “the MDA will sometimes pre-empt a state-law tort suit” on the ground that “[o]ne can reasonably read the word ‘requirement’ [in section 360k] as including the legal requirements that grow out of the application, in particular circumstances, of a State’s tort law.” ( Medtronic, supra, 518 U.S. at p__[ 116 S.Ct. at p. 2259 , 135 L.Ed.2d *1495 at p. 727 ].) He did not elaborate on this point except to pose an example which appears to be a case of direct conflict between the application of a state tort rule and an MDA requirement. “Imagine that, in respect to a particular hearing aid component, a federal MDA regulation requires a 2-inch wire, but a state agency regulation requires a 1-inch wire. If the federal law, embodied in the ‘2-inch’ MDA regulation, pre-empts the state ‘1-inch’ agency regulation, why would it not similarly pre-empt a state law tort action that premises liability upon the defendant manufacturer’s failure to use a 1-inch wire (say, an award by a jury persuaded by expert testimony that use of a more than 1-inch wire is negligent)?” ( Medtronic, supra, 518 U.S. at p._[ 116 S.Ct. at p. 2259 , 135 L.Ed.2d at p. 727 (conc. opn. of Breyer, J.).)

Justice Breyer also said that “ordinarily, 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.” (518 U.S. at p__[ 116 S.Ct. at p. 2260 ].) As Justice Breyer makes clear, what is at issue here is an actual conflict. That is shown in the following section which answers the second question, whether the MDA preempted the plaintiffs’ state law claims.

Of significance, the two-inch wire example was again introduced in connection with a discussion of implied preemption. There Breyer pointed out that “. . . the MDA’s pre-emption provision [i.e., § 360k] is highly ambiguous. That provision makes clear that federal requirements may preempt state requirements, but it says next to nothing about just when, where, or how, they may do so. The words ‘any [state] requirement’ and ‘any [federal] requirement’, for example, do not tell us which requirements are at issue, for every state requirement that is not identical to even one federal requirement is ‘different from, or in addition to’ that single federal requirement; yet, Congress could not have intended that the existence of one single federal rule, say about a 2-inch hearing aid wire, would pre-empt every state law hearing aid rule, even a set of rules related only to the packaging or shipping of hearing aids.” ( Medtronic, supra, 518 U.S. at p_[ 116 S.Ct. at p. 2260 , 135 L.Ed.2d at p. 728 ] (conc. opn. of Breyer; J.); italics in original.)

This bears out the view that Breyer is talking about an actual conflict. If a federal rule about the length of wire in a device does not rule out a state law rule regarding packaging of the device, the federal rule does not preempt the field of regulation of the device. The way is open for state regulation of those matters which do not actually conflict with, i.e., which supplement, the federal requirement.

*1496 The point is made in Justice Breyer’s answer to his second question, “[D]oes the MDA pre-empt the particular state-law tort claims at issue here[?]” He said the answer turns on Congress’s intent. That led him to a discussion of implied preemption. He said that section 360k is “highly ambiguous” and, deferring to the regulation, that the “regulation does not fill all the statutory gaps, for its word ‘divergent’ does not explain, any more than did the statute, just when different device-related federal and state requirements are closely enough related to trigger preemption analysis. But the regulation’s word ‘specific’ does narrow the universe of federal requirements that the agency intends to displace at least some state law.” ( Medtronic, supra, 518 U.S. at p_[116 S.Ct. at pp. 2260-2261, 135 L.Ed.2d at pp. 728-729].)

Applying this reasoning Breyer found that “[i]nsofar as there are any applicable FDA requirements here, [they] are not ‘specific’ in any relevant sense. . . . Hence, ... the FDA’s . . . pre-emption rule . . . does not intend these requirements to pre-empt the state requirements at issue here.” ( 518 U.S. at p. _ [ 116 S.Ct. at p. 2261 , 135 L.Ed.2d at p. 729 ].) That being the case, Breyer resorted to the law of implied preemption. (Id. at p__[ 116 S.Ct. at p. 2261 , 135 L.Ed.2d at pp. 729-730].) He said that the court “would ‘seldom infer, solely from the comprehensiveness of federal regulations, an intent to pre-empt in its entirety a field related to health and safety’ ” and that “ordinary principles of ‘conflict’ and ‘field’ pre-emption point in the same direction. Those principles make clear that a federal requirement pre-empts a state requirement if (1) the state requirement actually conflicts with the federal requirement—either because compliance with both is impossible ... or because the state requirement ‘stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress,’ ... or (2) the scheme of federal regulation is ‘so pervasive as to make reasonable the inference that Congress left no room for the States to supplement it,’ . . .” (Id. at p._[ 116 S.Ct. at p. 2261 , 135 L.Ed.2d at p. 729 ]; citations omitted.)

Applying these principles to the plaintiffs’ case, Justice Breyer said: “I can find no actual conflict between any federal requirement and any of the liability-creating-premises of the plaintiffs’ state law tort suit; nor . . . can I find any indication that either Congress or the FDA intended the relevant FDA regulations to occupy entirely any relevant field.” ( Medtronic, supra, 518 U.S. at p__[ 116 S.Ct. at p. 2261 , 135 L.Ed.2d at p. 730 ] (conc. opn. of Breyer, J.).)

I would apply the test of “actual conflict” to this case. The first question is whether the premarket approval (PMA) process results in specific federal *1497 requirements applicable to the device under section II of Justice Breyer’s Medtronic concurrence. I would answer with a qualified yes. 4

The second question is whether a state law tort action invariably presents an actual conflict with those specific federal requirements. I and the majority both say no. The majority correctly concludes that a state law tort action which premises liability upon the defendant manufacturer’s failure to adhere to the specific federal requirements presents no actual conflict.

I do not agree with the view that this is the only circumstance in which a state law tort suit does not present an actual conflict. An actual conflict means that compliance with both the federal requirement and the state requirement is impossible or the state requirement obstructs the accomplishment of the federal statutory objective. ( Medtronic, supra, 518 U.S. at p._ [ 116 S.Ct. at p. 2261 , 135 L.Ed.2d at p. 729 ] (conc. opn. of Breyer, J.).) The latter occurs when, notwithstanding the possibility of dual compliance, the state law requirement is one that has been rejected in the premarket approval process: “a case in which the Federal Government has weighed the competing interests relevant to the particular requirement in question, reached an unambiguous conclusion about how those competing considerations should be resolved in a particular case or set of cases, and implemented that conclusion via a specific mandate on manufacturers or producers.” ( Medtronic, supra, 518 U.S. at p__[ 116 S.Ct. at p. 2258 , 135 L.Ed.2d at p. 725 ].)

For example, suppose the FDA promulgated a requirement in the PMA process or a regulation concerning the specific warning required for tampons about toxic shock syndrome. A plaintiff who sought to recover in a state law tort action premised on a different warning would likely be barred by preemption. 5 (See Papike v. Tambrands Inc. (9th Cir. 1997) 107 F.3d 737 .) However, I would not predict the outcome without a fully developed factual record if the plaintiff tendered a claim that a warning was required as to some other different disease caused by the device. (Cf. Medtronic, supra, 518 U.S. at p__[ 116 S.Ct. at p. 2260 , 135 L.Ed.2d at p. 728 ] (conc. opn. of *1498 Breyer, J.) “Congress could not have intended that the existence of one single federal rule, say, about a 2-inch hearing aid wire, would pre-empt every state law hearing aid rule, even a set of rules related only to the packaging or shipping of hearing aids.”)

In this case there is a dearth of evidence and developed claims of actual conflict between the plaintiff’s state common law tort causes of action and particularized federal requirements engendered by the PMA process. I would not rule out the prospect that some claims may be viable even if plaintiff cannot show that the defendant disobeyed standards prescribed in the federal PMA process.

Subsection (b) provides inter alia that a state, upon application to the FDA, may establish regulations which are “more stringent” than the federal law.

The regulation provides in pertinent part:

“(d) State or local requirements are preempted only when the Food and Drug Administration has established specific counterpart regulations or there are other specific requirements applicable to a particular device under the act, thereby making any existing divergent State or local requirements applicable to the device different from, or in addition to, the specific Food and Drug Administration requirements. There are other State or local requirements that affect devices that are not preempted by section 521(a) of the act [21 U.S.C. § 360k] because they are not ‘requirements applicable to a device’ within the meaning of section 521(a) of the act. The following are examples of State or local requirements that are not regarded as preempted by section 521 of the act:

“(1) Section 521(a) 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., requirements such as general electrical codes, and the Uniform Commercial Code (warranty of fitness)), or to unfair trade practices in which the requirements are not limited to devices.

“(2) Section 521(a) does not preempt State or local requirements that are equal to, or substantially identical to, requirements imposed by or under the act.

t.

“(6)(i) Section 521(a) does not preempt State or local requirements respecting general enforcement, e.g., requirements that State inspection be permitted of factory records concerning all devices ....

“(ii) Generally, section 521(a) does not preempt a State or local requirement prohibiting the manufacture of adulterated or misbranded devices. Where, however, such a prohibition has the effect of establishing a substantive requirement for a specific device, e.g., a specific labeling requirement, then the prohibition [may] be preempted.” ( 21 C.F.R. § 808.1 (d) (1996); Medtronic, supra, 518 U.S. at p. _ , fn. 18 [ 116 S.Ct. at p. 2257 , 135 L.Ed.2d at pp. 723-724].)

The majority found no reason to apply the exception to the plaintiffs’ claims. Thus, the plurality opinion, in part V ( Medtronic, supra, 518 U.S. at p__[116 S.Ct. at pp. 2253-2258, 135 L.Ed.2d at pp. 719-726]), with which Justice Breyer concurred (Id. at p__[ 116 S.Ct. at p. 2259 , 135 L.Ed.2d at p. 726 ]), states:

“[T]he general state common-law requirements in this case were not specifically developed ‘with respect to’ medical devices. Accordingly, they 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. The legal duty that is the predicate for the Lohrs’ negligent manufacturing claim is the general duty of every manufacturer to use due care to avoid foreseeable dangers in its products. Similarly, the predicate for the failure to warn claim is the general duty to inform users and purchasers of potentially dangerous items of the risks involved in their use. These general obligations are no more a threat to federal requirements than would be a state-law duty to comply with local fire prevention regulations and zoning codes, or to use due care in the training and supervision of a workforce. (518 U.S. at p_ [ 116 S.Ct. at p. 2258 , 135 L.Ed.2d at p. 725 ], italics added.)

The qualification is that the PMA process, although device specific, may include requirements that are too general to warrant preemption. For example, the PMA process might require that the specific device be manufactured in accord with the same kind of good manufacturing practices standards found too general to be specific requirements in Medtronic.

I qualify this answer, because it is possible that a detailed showing of the nature of the regulation or the PMA process might lead to a judgment that the state requirement does not stand as an obstacle to attaining the federal statutory purpose. For example, a claim that the different warning was warranted by material research that was conducted after the regulation was promulgated or the PMA process completed might be tenable. (See Medtronic, supra, 518 U.S. at p___ fn. 16 [ 116 S.Ct. at p. 2256 , 135 L.Ed.2d at p. 722 ], noting that, notwithstanding PMA, the agency permits changes to enhance safety without prior FDA approval.)