Walter Shuker v. Smith & Nephew PLC
885 F.3d 760 (2018)
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Rule of Law:
When a medical device system is comprised of components with different FDA risk classifications, federal preemption under the Medical Device Amendments is analyzed at the component level. State common law tort claims challenging the safety and effectiveness of a Class III component that received premarket approval are expressly preempted, even if that component is used off-label in a hybrid system with non-preempted Class II components.
Facts:
- In 2009, Walter Shuker underwent a total hip replacement surgery.
- The implanted device, manufactured by Smith & Nephew, was a hybrid system comprised of multiple components.
- Most components, such as the metal head and hip socket component, were Class II devices approved through the less rigorous § 510(k) process.
- One component, the 'R3 metal liner,' was a Class III device that had received rigorous premarket approval (PMA) from the FDA.
- The FDA's PMA for the R3 metal liner was for its use only as part of a different device, the Birmingham Hip Resurfacing System, not for use in a total hip replacement system.
- Smith & Nephew marketed the R3 metal liner as an 'option' for the total hip replacement system Mr. Shuker received.
- Approximately 21 months after his surgery, Mr. Shuker developed severe pain caused by metallic debris generated from the 'metal-on-metal articulation' involving the R3 liner.
- Mr. Shuker required multiple revision surgeries to replace the liner and eventually the entire hip replacement system.
Procedural Posture:
- Walter and Vivian Shuker filed suit against Smith & Nephew, Inc. and its parent company, PLC, in a Pennsylvania state court.
- The defendants removed the action to the U.S. District Court for the Eastern District of Pennsylvania.
- The Shukers filed a Second Amended Complaint alleging common law tort claims such as negligence, strict liability, and breach of implied warranty.
- The District Court granted PLC's motion to dismiss for lack of personal jurisdiction.
- The District Court granted Smith & Nephew's motion for summary judgment on the Second Amended Complaint, holding that the state law claims were expressly preempted by the Medical Device Amendments.
- The Shukers were granted leave to file a Third Amended Complaint alleging non-preempted 'parallel claims' based on off-label promotion.
- The District Court subsequently dismissed the Third Amended Complaint for failure to state a claim.
- The Shukers appealed these rulings to the U.S. Court of Appeals for the Third Circuit.
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Issue:
Does the express preemption provision of the Medical Device Amendments preempt state law tort claims challenging a hybrid medical device system when the core of the claims challenge the safety and effectiveness of a Class III component, even though that component was used off-label in combination with Class II components?
Opinions:
Majority - Krause, Circuit Judge.
Yes. The state law claims are expressly preempted because the analysis must be conducted at the component level, and the claims impose requirements on a Class III component that are different from or in addition to those imposed by the federal government. The court first addressed the threshold question of whether preemption analysis for a hybrid system should occur at the system or component level. Citing the statutory text defining a 'device' to include its 'component, part, or accessory,' the statutory scheme's contemplation of off-label use, and the FDA's persuasive amicus brief, the court concluded that a component-level analysis is required. Applying the two-step test from Riegel v. Medtronic, the court found: 1) The federal government had established specific requirements for the R3 metal liner (the Class III component) through the rigorous premarket approval (PMA) process. 2) The Shukers' state law negligence, strict liability, and breach of implied warranty claims would impose requirements 'different from, or in addition to,' these federal requirements because the 'heart' of their claims challenged the liner's safety and effectiveness, which the FDA had already approved. Therefore, these common law claims were expressly preempted under 21 U.S.C. § 360k(a).
Analysis:
This case establishes an important precedent for products liability litigation involving multi-component, or 'hybrid,' medical devices. By mandating a component-level preemption analysis, the court clarifies that the robust preemption protection afforded to manufacturers for their high-risk Class III devices is not lost when those components are used in systems with lower-risk parts. This decision narrows the path for plaintiffs, forcing them to either target non-preempted components specifically or frame their lawsuits as 'parallel claims' alleging violations of federal law, such as off-label promotion. The ruling reinforces the quid pro quo of the Medical Device Amendments: manufacturers who submit to the FDA's most rigorous approval process receive protection from the vagaries of state tort law for those specific, approved products.
