Source: http://de.findacase.com/research/wfrmDocViewer.aspx/xq/fac.20180301_0000163.C03.htm/qx
Timestamp: 2019-04-21 05:06:44+00:00

Document:
SMITH & NEPHEW, PLC; SMITH & NEPHEW, INC.
On Appeal from the United States District Court for the Eastern District of Pennsylvania (E.D. Pa. No. 5-13-cv-06158) Honorable Juan R. Sánchez.
Robert Astrachan [Argued] Eric G. Zajac Zajac & Arias, Counsel for Appellants.
Sara J. Gourley [Argued] Eugene A. Schoon Jana D. Wozniak Sidley Austin One South Dearborn Street Chicago, Counsel Appellee Smith & Nephew PLC.
Edward W. Gerecke Joseph H. Lang, Jr. [Argued] David J. Walz Carlton Fields Jorden Burt.
David W. O'Quinn Irwin Fritchie Urquhart & Moore, Counsel for Appellee Smith & Nephew, Inc.
Before: JORDAN, GREENAWAY, JR., and KRAUSE, Circuit Judges.
With the Medical Device Amendments of 1976, Congress 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). This case presents an issue of first impression among the Courts of Appeals: how courts should apply that 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, Riegel v. Medtronic, Inc., 552 U.S. 312, 322-23 (2008), and some of which are from medical devices that carry a different class designation and are not subject to those requirements, see Medtronic, Inc. v. Lohr, 518 U.S. 470, 475-78, 494-95 (1996).
Because the plaintiffs' negligence, strict liability, and breach of implied warranty claims in their Second Amended Complaint are expressly preempted, we will affirm the District Court's ruling in that respect. But 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, we will reverse the District Court's dismissal of some of the plaintiffs' claims in their Third Amended Complaint, vacate the District Court's personal jurisdiction ruling, and remand for proceedings consistent with this opinion.
After Walter Shuker underwent a hip replacement surgery that resulted in unexpected complications, he and his wife, Vivian Shuker, 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. Before turning to the details of Mr. and Mrs. Shuker's dispute with Smith & Nephew and with PLC, we review the relevant statutory and regulatory scheme for context.
For purposes of federal statutes governing medical devices, the term "device" is a broad one, encompassing 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. Riegel, 552 U.S. at 316-17.
The Federal Food, Drug, and Cosmetic Act did not originally authorize federal regulation in connection with the introduction of new medical devices, but, over time, consumers and the U.S. Food and Drug Administration ("FDA") began voicing "mounting . . . concern" about the unexamined health risks of devices being introduced to the public. Lohr, 518 U.S. at 475-76. Several states responded to those concerns by adopting regulatory measures, but Congress "stepped in" by enacting the Medical Device Amendments of 1976, "which swept back some state obligations and imposed a regime of detailed federal oversight." Riegel, 552 U.S. at 315-16. As explained in more detail below, Congress's approach here, as in other regulatory contexts,  was twofold: first, it established a system of federal regulation over the introduction of new devices, instituting tiered federal requirements calibrated to each device's risk level, and, second, it enacted a provision stating that federal medical device requirements supersede any different or additional state safety or effectiveness requirements. See Medical Device Amendments of 1976, Pub. L. No. 94-295, sec. 2, §§ 513-516, 521, 90 Stat. 539, 540-60, 562 (codified as amended at 21 U.S.C. §§ 360c-360f, 360k).
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. Lohr, 518 U.S. at 476-77; see 21 U.S.C. §§ 360c(a)(1), 360d, 360e. Because Class I devices pose the least risks, Class II devices are "more harmful, " and Class III devices pose the greatest risks, Lohr, 518 U.S. at 477; see 21 U.S.C. § 360c(a)(1), Class III devices receive "the most federal oversight, " and Class I and II devices receive much less, Riegel, 552 U.S. at 316-17. We describe the FDA's comprehensive approval procedures for Class III devices before summarizing the more lenient approval procedures for Class I and Class II devices.
Before becoming available to the public, a Class III device must receive "premarket approval" through a process by which the device's manufacturer "provide[s] reasonable assurance of [the device's] safety and effectiveness." 21 U.S.C. § 360c(a)(1)(C). The premarket approval process "is a rigorous one, " requiring manufacturers to "submit detailed information regarding the safety and efficacy of their devices, which the FDA then reviews, spending an average of 1, 200 hours on each submission." Lohr, 518 U.S. at 477.
Submissions are typically "multivolume application[s], " and thus the time devoted by the FDA to reviewing manufacturers' premarket approval submissions is, unsurprisingly, substantial. Riegel, 552 U.S. at 317-18. Pursuant to the Medical Device Amendments, premarket approval applications must include, among other things, "a full statement of the device's components, ingredients, and properties, " id. at 318 (internal quotation marks omitted); see 21 U.S.C. § 360e(c)(1)(B), which the FDA may choose to subject to "performance standards, " 21 U.S.C. § 360d(a)(1), (a)(2)(B)(i). And they likewise must provide "a specimen of the proposed labeling, " which shall specify "conditions of use" under which the FDA will evaluate the device's safety and effectiveness. Riegel, 552 U.S. at 318; see 21 U.S.C. § 360e(c)(1)(F). The FDA must also determine that the labeling is not false or misleading before granting premarket approval to the device. Riegel, 552 U.S. at 318; see 21 U.S.C. § 360e(d)(1)(A).
After reviewing an application, the FDA grants premarket approval only if, based on a weighing of "any probable benefit to health from the use of the device against any probable risk of injury or illness from such use, " it finds "there is a 'reasonable assurance' of the device's 'safety and effectiveness.'" Riegel, 552 U.S. at 318 (quoting 21 U.S.C. §§ 360c(a)(2)(C), 360e(d)). Once approved, the device may be manufactured, advertised, and distributed to the public, but those marketing activities may not be done in a manner "inconsistent with . . . the [premarket] approval order for the device." 21 C.F.R. § 814.80. To that end, a manufacturer wishing to make "incremental change[s]" that affect the device's safety and effectiveness must submit a supplemental premarket approval application. 21 U.S.C. § 360e(d)(5); accord Riegel, 552 U.S. at 319.
Notwithstanding the strictures imposed on manufacturers, the Act allows more leeway to health care providers. Even after the FDA grants premarket approval to a medical device or to any supplements, it does not "limit or interfere with the authority of a health care practitioner to prescribe or administer any legally marketed device to a patient . . . ." 21 U.S.C. § 396. And physicians' ability to prescribe legally marketed devices as they see fit means that "'off-label' usage, " or use "for some other purpose than that for which [a device] has been approved by the FDA, " is "an accepted and necessary corollary of the FDA's mission to regulate . . . without directly interfering with the practice of medicine." Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341, 350 (2001). Although the statute thus expressly contemplates the possibility that physicians may use a Class III device for unapproved purposes, a manufacturer may not vary the design or manufacture of the pre-approved device, even in anticipation of such uses. See 21 U.S.C. § 396.
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). Lohr, 518 U.S. at 478. Compared to a premarket approval application, compliance with the § 510(k) process requires a far less exhaustive submission. See 21 U.S.C. § 360(k); 21 C.F.R. § 807.87. 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. Lohr, 518 U.S. at 478. A § 510(k) approval thus provides comparatively "little protection to the public." Id. at 493.
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. This provision proclaims that "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). The statute thus 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. Lohr, 518 U.S. at 499-500 (quoting 21 U.S.C. § 360k(a); 21 C.F.R. § 808.1(d)(6)(ii)). 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." Id. at 500.
Application of the express preemption provision tracks the Medical Device Amendments' tiered statutory scheme for medical device approvals. 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, see Lohr, 518 U.S. at 492-94. 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. Riegel, 552 U.S. at 322-23 (quoting 21 U.S.C. § 360k(a)(1)). This protection inures to manufacturers regardless of how a device is used by third parties. See 21 U.S.C. § 396 (contemplating off-label uses of devices by physicians); see also Caplinger v. Medtronic, Inc., 784 F.3d 1335, 1343-45 (10th Cir. 2015) (holding that the fact that a claim alleges off-label use does not "insulate" it from express preemption).
But state laws are not shut out entirely. 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. Lohr, 518 U.S. at 494-95 (citing 21 U.S.C. § 360k(a)(1)); accord Riegel, 552 U.S. at 330.
The question of first impression we confront todayarises at the intersection of these different classes of devices with their different approval schemes: 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? We recount the facts of the parties' dispute before turning to our answer.
Mr. Shuker underwent total hip replacement surgery in 2009. The hip replacement system "implant[ed]" 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 Mr. Shuker's thighbone (or femur) with a metal head, metal sleeve, and a stem connecting the metal head to the thighbone, while another component rested on his hip socket (or 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 hip socket and his thighbone and was seated atop the hip socket component, App. 42; 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. Shuker v. Smith & Nephew PLC, No. 13-6158, 2015 WL 1475368, at *2-3 (E.D. Pa. Mar. 31, 2015). Together with the metal head and metal head sleeve replacing the top of Mr. Shuker's thighbone, the metal liner created a "metal-on-metal articulation" at Mr. Shuker's hip socket. Id. at *3.
As is customary, 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. Id. at *2. Thus, as the parties agree, see Appellant's Br. 6-7; Appellee Smith & Nephew's Br. 6, 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, App. 14, constituted "off-label promotion, " Shuker, 2015 WL 1475368, at *13, and the liner's use in Mr. Shuker's total hip replacement system constituted an "off-label" use, Buckman Co., 531 U.S. at 350.

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