Argued: June 16, 2017
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.
Astrachan [Argued] Eric G. Zajac Zajac & Arias, Counsel
J. Gourley [Argued] Eugene A. Schoon Jana D. Wozniak Sidley
Austin One South Dearborn Street Chicago, Counsel Appellee
Smith & Nephew PLC.
W. Gerecke Joseph H. Lang, Jr. [Argued] David J. Walz Carlton
Fields Jorden Burt.
W. O'Quinn Irwin Fritchie Urquhart & Moore, Counsel
for Appellee Smith & Nephew, Inc.
Before: JORDAN, GREENAWAY, JR., and KRAUSE, Circuit Judges.
KRAUSE, CIRCUIT JUDGE.
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).
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.
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.
Statutory and Regulatory Context
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.
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).
Medical Device Approval Procedures
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.
Class III Devices: Premarket Approval
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.
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).
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.
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.
Class I and Class II Devices: § 510(k) Approval
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
Express Preemption Provision
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.
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).
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.
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.
Factual and Procedural History
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.
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.
twenty-one months after his hip replacement surgery, Mr.
Shuker "began developing increasing pain and discomfort
in his buttocks, groin, and thigh, limiting his daily
activities." Shuker, 2015 WL 1475368, at *3.
His surgeon performed an aspiration procedure that revealed
"metallic debris" within Mr. Shuker's body,
indicating that "Mr. Shuker'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. Id. Mr. Shuker then
underwent revision surgery to replace the R3 metal liner,