Walter Shuker v. Smith & Nephew PLC
885 F.3d 760
| 3rd Cir. | 2018Background
- Plaintiff Walter Shuker received a total hip replacement comprising multiple components: several Class II components (acetabular cup, metal head, sleeve, stem) and one Class III component (R3 metal liner) that had received FDA premarket approval as part of a different system (Birmingham Hip Resurfacing System).
- Smith & Nephew manufactured all components; the R3 metal liner’s labeling limited approved use to the resurfacing system, but Smith & Nephew allegedly marketed the liner off‑label as an option for a separate R3 Acetabular System.
- After implantation, Shuker developed metal debris-related complications and underwent multiple revision surgeries; he and his wife sued Smith & Nephew, Inc. and parent Smith & Nephew PLC asserting negligence, strict liability, breach of implied warranty, and later claims alleging unlawful off‑label promotion.
- District Court held the negligence, strict liability, and implied warranty claims in the Second Amended Complaint were expressly preempted by 21 U.S.C. § 360k(a) because they challenged the safety/effectiveness of a premarket‑approved Class III component; it dismissed PLC for lack of personal jurisdiction and later dismissed the Third Amended Complaint for failure to state certain claims.
- Third Circuit considered (1) whether express preemption applies to hybrid devices composed of mixed‑class components, (2) whether the Third Amended Complaint adequately pleaded off‑label promotion claims, and (3) whether jurisdictional discovery was warranted concerning PLC.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| 1. Level for §360k preemption analysis (system vs component) | The relevant "device" is the entire hybrid hip system; preemption should not follow from a component’s prior approval when used off‑label in a different system. | Preemption should be analyzed at the component level because the Act defines "device" to include components and FDA treats components as regulated units. | Component‑level analysis governs: preemption applies to state requirements "with respect to" a premarket‑approved Class III component. |
| 2. Whether negligence, strict liability, and breach of implied warranty claims are preempted | Claims challenge the hybrid system’s safety; thus not barred because many components were Class II. | Claims target the R3 metal liner (a premarket‑approved Class III component) and would impose requirements different from federal ones. | Claims in the Second Amended Complaint are expressly preempted under §360k(a) because they seek to impose state duties different from federal requirements with respect to the Class III liner. |
| 3. Sufficiency of Third Amended Complaint’s off‑label promotion claims (negligence & loss of consortium) | Plaintiffs pleaded that Smith & Nephew promoted the liner off‑label and that this caused surgeon reliance and injury. | Defendants argued allegations were insufficient to state plausible causation or a federal‑law duty and that some claims remain preempted. | Negligence and derivative loss of consortium claims survive pleading standards as parallel claims grounded in alleged violations of federal advertising/labeling duties. |
| 4. Fraud claim pleading and personal jurisdiction over PLC | Fraud pleaded; PLC is subject to jurisdiction via alter‑ego/stream‑of‑commerce theories and discovery should be allowed. | Fraud allegations fail Rule 9(b) particularity; stream‑of‑commerce insufficient for specific jurisdiction; PLC denies control necessitating discovery. | Fraud dismissed for lack of particularity but dismissal vacated as to prejudice (leave to amend). Specific jurisdiction via stream‑of‑commerce rejected; alter‑ego theory warrants limited jurisdictional discovery — dismissal of PLC vacated and remanded. |
Key Cases Cited
- Riegel v. Medtronic, 552 U.S. 312 (2008) (establishes two‑step test for §360k express preemption where federal requirements apply to the device)
- Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996) (interprets §360k and explains distinction between §510(k) devices and PMA devices vis‑à‑vis preemption)
- Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (2001) (discusses federal regulation of device usage and off‑label practice of medicine)
- Wyeth v. Levine, 555 U.S. 555 (2009) (explains presumption against preemption of state health and safety laws)
- Bristol‑Myers Squibb Co. v. Superior Court, 137 S. Ct. 1773 (2017) (limits use of national marketing/distributor contacts to establish specific jurisdiction)