Shuker v. Smith & Nephew, PLC

• Decision Date: 01 March 2018
• Docket Number: No. 16-3785,16-3785
• Citation: 885 F.3d 760
• Parties: Walter SHUKER; Vivian Shuker, Appellants v. SMITH & NEPHEW, PLC; Smith & Nephew, Inc.
• Court: U.S. Court of Appeals — Third Circuit

885 F.3d 760

Walter SHUKER; Vivian Shuker, Appellants

v.SMITH & NEPHEW, PLC; Smith & Nephew, Inc.

No. 16-3785

United States Court of Appeals, Third Circuit.

Argued: June 16, 2017

Opinion Filed: March 1, 2018

Robert Astrachan [Argued], Eric G. Zajac, Zajac & Arias, 1835 Market Street, Suite 2626, Philadelphia, PA 19103, Counsel for Appellants

Sara J. Gourley [Argued], Eugene A. Schoon, Jana D. Wozniak, Sidley Austin, One South Dearborn Street, Chicago, IL 60603, Counsel Appellee Smith & Nephew PLC

Edward W. Gerecke, Joseph H. Lang, Jr. [Argued], David J. Walz, Carlton Fields Jorden Burt, 4221 West Boy Scout Boulevard, Suite 1000, Tampa, FL 33607, David W. O'Quinn, Irwin Fritchie Urquhart & Moore, 400 Poydras Street, Texaco Center, Suite 2700, New Orleans, LA 70130, Counsel for Appellee Smith & Nephew, Inc.

Lindsay Powell, United States Department of Justice, Appellate Section, 950 Pennsylvania Avenue, N.W., Room 7259, Washington, DC 20530, Counsel for Amicus Curiae United States Food and Drug Administration

Before: JORDAN, GREENAWAY, JR., and KRAUSE, Circuit Judges

OPINION OF THE COURT

KRAUSE, Circuit Judge.

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, 128 S.Ct. 999, 169 L.Ed.2d 892 (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, 116 S.Ct. 2240, 135 L.Ed.2d 700 (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.

I. Background

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.

A. Statutory and Regulatory 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, 128 S.Ct. 999.

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, 116 S.Ct. 2240. 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, 128 S.Ct. 999. As explained in more detail below, Congress's approach here, as in other regulatory contexts,¹ 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 ).

1. Medical Device Approval Procedures

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, 116 S.Ct. 2240 ; 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, 116 S.Ct. 2240 ; 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, 128 S.Ct. 999. 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.

a. Class III Devices: Premarket Approval

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, 116 S.Ct. 2240.

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, 128 S.Ct. 999. 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, 128 S.Ct. 999 (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, 128 S.Ct. 999 ; 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, 128 S.Ct. 999 ; 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, 128 S.Ct. 999 (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, 128 S.Ct. 999.

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, 121 S.Ct. 1012, 148 L.Ed.2d 854 (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.

b. Class I and Class II Devices: § 510(k) Approval

In contrast to the rigorous premarket approval process for Class III devices, Class I and Class II devices are subject to "a...