The United States Court of Appeals for the Third Circuit (“Federal Appellate Court”) addressed the issue of how courts should apply the federal express preemption provision to state law tort claims challenging the design and manufacture of a medical device comprised of multiple components, some of which are from Class III medical devices subject to federal requirements, and some of which are from medical devices that carry a different class designation and are not subject to those requirements, in its opinion filed on March 1, 2018.
The Medical Device Amendments of 1976 added comprehensive medical device approval processes to the Federal Food, Drug, and Cosmetic Act, prescribing tiers of federal requirements for certain devices corresponding to the device’s inherent risk level. In exchange for compliance with the strictest federal mandates, Congress afforded manufacturers express preemption from state laws imposing different or additional “safety or effectiveness” requirements for those devices. 21 U.S.C. § 360k(a)(2).
The Federal Appellate Court held that because the plaintiffs’ negligence, strict liability, and breach of implied warranty claims in their Second Amended Complaint are expressly preempted, it affirmed the District Court’s ruling in that respect. However, because the plaintiffs adequately pleaded other, non-preempted claims, and because jurisdictional discovery is warranted with respect to personal jurisdiction over one of the defendants, the Federal Appellate Court reversed the District Court’s dismissal of some of the plaintiffs’ claims in their Third Amended Complaint, vacated the District Court’s personal jurisdiction ruling, and remanded for proceedings consistent with its opinion.
In the case the Federal Appellate Court was deciding, the plaintiff had hip replacement surgery that resulted in unexpected complications, after which he and his wife brought tort claims against Smith & Nephew, Inc. (“Smith & Nephew”), the manufacturer of his hip replacement system, and Smith & Nephew, PLC (“PLC”), the manufacturer’s parent company.
Under federal law, “medical devices” encompass instruments, machines, implants, and “other similar or related” articles, and “including any component, part, or accessory” of those articles. 21 U.S.C. § 321(h). “Device” refers not just to “replacement heart valves, implanted cerebella stimulators, and pacemaker pulse generators,” but also to “such devices as elastic bandages and examination gloves,” as well as to the constituent parts of those items.
Approval procedures for new medical devices under the Medical Device Amendments vary depending on a device’s class designation. The statute divides devices into three classes “based on the risk that they pose to the public” and applies more rigorous prerequisites to devices that pose greater risks. Because Class I devices pose the least risks, Class II devices are “more harmful,” and Class III devices pose the greatest risks, Class III devices receive “the most federal oversight,” and Class I and II devices receive much less.
In contrast to the rigorous premarket approval process for Class III devices, Class I and Class II devices are subject to “a limited form of review” set forth at 21 U.S.C. § 360(k) and known as the “§ 510(k) process” (reflecting the number of the relevant section in the Federal Food, Drug, and Cosmetic Act). In many cases, § 510(k) approval rests not on proof of the device’s safety, but merely on a finding that a device is “substantially equivalent” to a preexisting approved medical device. A § 510(k) approval thus provides comparatively “little protection to the public.”
The Medical Device Amendments’ comprehensive and tiered approval procedures for medical devices leave only limited room for additional state regulation, especially considering the statute contains a broad express preemption provision (“no State . . . may establish or continue in effect with respect to a device . . . any requirement” that “is different from, or in addition to,” any federal requirement and that relates either “to the safety or effectiveness of the device” or “to any other matter” included in a federal requirement applicable to the device. 21 U.S.C. § 360k(a)).
Thus, the statute preempts any state requirement that has “the effect of establishing a substantive requirement for [the] specific device” in question that relates to safety, effectiveness, or “any other matter” that forms a federal requirement, so long as the state requirement is “different from, or in addition to,” the federal mandate (the overarching concern behind this provision is “that pre-emption occur only where a particular state requirement threatens to interfere with a specific federal interest”).
Because manufacturers of Class I and Class II devices receive only § 510(k) approval and emerge from the approval process with no safety review specific to those devices, manufacturers do not receive the benefit of express preemption. In contrast, because a manufacturer of a Class III device must receive premarket approval, clear “federal safety review” that “is specific to [the] individual device,” and thereby satisfy federal requirements applicable to the device, the manufacturer of that Class III device receives express preemption protections from state requirements that are “different from, or in addition to,” the federal requirements imposed on the device through the premarket approval process. This protection inures to manufacturers regardless of how a device is used by third parties, including off-label use.
However, even for Class III devices, the Medical Device Amendments’ express preemption provision does not reach “parallel” claims, i.e., claims premised on state requirements that merely incorporate applicable federal requirements and therefore are not “different from, or in addition to,” federal requirements.
The Federal Appellate Court stated that the issue it had to decide was, “How do we apply the Medical Device Amendments’ express preemption provision to a ‘hybrid system,’ i.e., a system that is itself a “device” but that is comprised of Class II components in addition to one or more Class III components?”
The Plaintiff’s Hip Replacement System
The hip replacement system implanted in the plaintiff was regulated as a “device” under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 321(h), but was comprised of multiple components, all manufactured by Smith & Nephew. Some components replaced the top of the plaintiff’s femur with a metal head, metal sleeve, and a stem connecting the metal head to the femur, while another component rested on his hip socket (acetabulum). These components were all Class II devices approved through the relatively lenient § 510(k) process.
A final component, the “R3 metal liner,” mediated the connection between his acetabulum and his femur, and was seated atop the hip socket component. Unlike the other components, the liner underwent the rigorous premarket approval process as a supplemental component for a separate Smith & Nephew Class III device, the Birmingham Hip Resurfacing System. Together with the metal head and metal head sleeve replacing the top of the plaintiff’s femur, the metal liner created a “metal-on-metal articulation” at the plaintiff’s hip socket.
The FDA’s premarket approval requirements for the liner extended to the liner’s accompanying labeling, which was required to state that “the R3 metal liner [was] intended for use as part of the [Birmingham Hip Resurfacing System] only” and that “the R3 metal liner must be replaced with an R3 poly[ethylene] liner” if the Birmingham Hip Resurfacing System were abandoned or later revised in favor of a total hip replacement system. Thus, because the R3 metal liner’s labeling reflected that the FDA had not approved the liner for use outside of the Birmingham Hip Resurfacing System or in a total hip replacement system, Smith & Nephew’s promotional materials marketing the R3 metal liner as an “option for its R3 Acetabular System,” a separate hip system, constituted “off-label promotion,” and the liner’s use in the plaintiff’s total hip replacement system constituted an “off-label” use.
The Plaintiff’s Alleged Injury
About twenty-one months after his hip replacement surgery, the plaintiff began developing increasing pain and discomfort in his buttocks, groin, and thigh, which limited his daily activities. The plaintiff’s surgeon performed an aspiration procedure that revealed metallic debris within the plaintiff’s body, indicating that the plaintiff’s pain was caused by metal sensitivity due to the degeneration of the metal-on-metal articulation, which needed to be replaced to relieve his pain. The plaintiff subsequently underwent revision surgery to replace the R3 metal liner, followed by additional surgeries to remove and replace his entire hip replacement system when the first revision surgery did not relieve his pain.
The plaintiff’s federal lawsuit sought to hold Smith & Nephew and its parent company PLC liable for his hip replacement complications and for his wife’s loss of consortium, alleging various common law claims and later adding claims based on violations of federal law.
PLC moved for dismissal from the case for lack of personal jurisdiction, and Smith & Nephew moved for summary judgment on some of the plaintiffs’ claims, arguing that the Medical Device Amendments expressly preempted those claims. The District Court granted PLC’s motion to dismiss and granted summary judgment in favor of Smith & Nephew, holding that the negligence, strict liability, and breach of implied warranty claims in the plaintiffs’ Second Amended Complaint were preempted because the heart of each of the plaintiffs’ claims challenged the safety and effectiveness of the R3 metal liner, which had received premarket approval, was therefore subject to federal requirements, and, hence, Smith & Nephew had the benefit of express preemption.
The plaintiffs filed an appeal.
Federal Appellate Court Opinion
The U.S. Supreme Court has prescribed a two-step framework for determining whether a state law cause of action is preempted. The first inquiry is whether the Federal Government has established requirements applicable to the specific “device” at issue. If it has, then the second inquiry is whether the plaintiffs’ claims are based upon state requirements with respect to the device that are different from, or in addition to, the federal ones, and that relate to safety and effectiveness. If the answer to both questions in the affirmative, then the plaintiffs’ claims are expressly preempted. However, if the answer to the second question is no, then the state duties in such a case “parallel,” rather than add to, federal requirements, and the claims are not preempted.
The Federal Appellate Court was faced with an initial question before applying the two-step test: what device is the subject of the federal requirements when a hybrid system contains both Class II and Class III components? Furthermore, is the analysis of express preemption at the level of the system or the component?
The Federal Appellate Court stated that the statutory definition of “device,” the treatment of off-label uses, and the guidance of the FDA, when taken together, all counsel in favor of scrutinizing hybrid systems at the component-level. In that circumstance, § 360k(a) preempts any state law “with respect to” a Class III component that is “different from, or in addition to” a federal requirement and that relates either “to the safety or effectiveness of the device” or “to any other matter included in a requirement applicable to the device under [the Act].”
The Federal Appellate Court held that given the two-step process (Step One: whether the Federal Government has established requirements applicable to a component of the hybrid system, and Step Two: whether the plaintiffs’ claims are based upon state requirements with respect to that component that are different from, or in addition to, the federal ones, and that relate to safety and effectiveness), the test for hybrid systems comports with the most basic interpretive rule that a statute is to be construed so that effect is given to all its provisions.
Applying the two-prong test to the plaintiffs’ claims, the Federal Appellate Court held that the plaintiffs’ claims satisfied both prongs: as to Step One, the R3 metal liner is a Class III component that received premarket approval as part of the Birmingham Hip Resurfacing System, and that premarket approval imposed requirements on the liner with respect to its composition, dimensions, and labeling, among other specifications. As to Step Two, that is also satisfied given the different requirements that would follow from imposing liability for the tort claims at issue: that is, the negligence, strict liability, and breach of implied warranty claims of the Second Amended Complaint.
The express preemption provision forecloses claims based on “violations of common-law duties” to the extent that they impose more than parallel federal requirements: the plaintiffs’ claims would impose requirements with respect to the R3 metal liner that are different from, or in addition to federal ones because the heart of each of the plaintiffs’ claims challenged the safety and effectiveness of the R3 metal liner. The plaintiffs’ negligence, strict liability and breach of implied warranty claims rest on the premise that the R3 System was defective only because it was used with the R3 metal liner.
The Federal Appellate Court stated that the failure-to-warn allegations embedded in the the plaintiffs’ negligence claim would impose different requirements on the R3 metal liner, as the plaintiffs seek to impose liability because defendants did not accompany their product with proper warnings regarding the risks associated with a premarket-approved device, the R3 metal liner. But the FDA already imposed device-specific labeling requirements on the liner, and thus, as the FDA itself pointed out in its amicus submission, a state warning requirement that applies specifically to the use of the R3 system’s components with the R3 metal liner in particular is preempted.
The Federal Appellate Court stated, “we think the better reading of the statute is to separate a device into its component parts. See 21 U.S.C. § 321(h). Express preemption therefore applies to a so-called ‘combination’ claim, like any other, so long as the claims are based on state requirements ‘with respect to’ a device that are ‘different from, or in addition to’ federal requirements. 21 U.S.C. § 360k(a).”
The Federal Appellate Court held, “the negligence, strict liability, and breach of implied warranty claims asserted in the Second Amended Complaint, would impose non-parallel state law requirements and are therefore expressly preempted. We will affirm the District Court’s order in that respect.”
However, the plaintiffs’ Third Amended Complaint included three state law tort claims based on Smith & Nephew’s alleged off-label promotion in violation of federal law: negligence, loss of consortium, and fraud. The Federal Appellate Court held that the plaintiffs “have met their pleading burden with respect to their negligence and loss of consortium claims. Although they did not adequately plead their fraud claim, which they were required to plead with particularity, see Fed. R. Civ. P. 9(b), we will nonetheless vacate the District Court’s dismissal of that claim to the extent that it was with prejudice [“given that we will reverse the District Court’s dismissal of the negligence and loss of consortium claims and allow those claims to proceed to discovery, we will vacate the dismissal of the fraud claim to the extent that it was with prejudice and without leave to amend”].”
The Federal Appellate Court stated that in order for the plaintiffs to state a parallel negligence claim, the plaintiffs were required to plead (1) a duty arising from federal requirements applicable to a medical device, (2) a breach of that duty, and (3) a causal connection between the breach and the plaintiffs’ injuries.
The Federal Appellate Court held that the plaintiffs’ Third Amended Complaint plausibly alleges each of these three required elements (“we can reasonably infer . . . Smith & Nephew’s misleading marketing in violation of federal law, the R3 metal liner’s subsequent use in [the plaintiff’s] hip replacement surgery, and [the plaintiff’s] ensuing ‘physical injuries’). The Federal Appellate Court further held that because the plaintiffs adequately pleaded a negligence claim premised on the husband’s injuries, they have also adequately pleaded the derivative claim of loss of consortium.
Source Shuker v. Smith & Nephew, PLC, No. 16-3785.
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