Health Law Daily Hybrid device analyzed at component level for preemption purposes
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Friday, March 2, 2018

Hybrid device analyzed at component level for preemption purposes

By Sheila Lynch-Afryl, J.D., M.A.

In a case of first impression, the Third Circuit applied the Medical Device Amendments’ express preemption provision to the component level of a hybrid hip-replacement system that included both Class II and Class III components. The heart of the patient’s claim challenged the safety of a metal liner that, as a component of a different Class III device, had undergone rigorous premarket approval by the FDA. Accordingly, the state-law claims were preempted (Shuker v. Smith & Nephew, PLC, March 1, 2018, Krause, C.).

Hip replacement surgery. In 2009, a patient had a total hip replacement. The hip replacement system had multiple components manufactured by Smith & Nephew, Inc., including a metal head, a metal sleeve, a stem connecting the metal head to the thighbone, and a component resting on his hip socket, all Class II devices. Another component, the "R3 metal liner," which mediated the connection between his hip socket and his thigh bone, underwent the FDA’s rigorous premarket approval process as a supplemental component for a separate Smith & Nephew Class III device. After developing complications, the man had surgeries to replace the R3 metal liner and, later, the entire hip replacement system. He and his wife filed a complaint against Smith & Nephew and its parent company.

District court proceedings. Due to the differing levels of FDA premarket approval, federal law contains an express preemption provision for Class III medical devices but not for Class I or II (see 21 U.S.C. §360k(a)). Because the "heart" of the claims challenged the safety and effectiveness of the R3 liner, which had received premarket approval, the district court granted Smith & Nephew’s motion for summary judgment with respect to the negligence, strict liability, and breach of implied warranty counts on the basis of express preemption (see Preemption, poor pleading prevent hip implant claims from sticking, April 7, 2015). The court also later dismissed the amended complaint as to their non-preempted claims alleging off-label promotion in violation of federal law (see Artificial hip manufacturer finally kicks third off-label promotion complaint, September 30, 2016).

Express preemption. Courts follow a two-step framework pursuant to Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), for determining whether a state law cause of action is preempted: (1) determine whether the federal government has established requirements applicable to the specific device at issue, and, if yes, (2) determine whether the claims are based on state requirements with respect to the device that are "different from, or in addition to" the federal ones, and that relate to safety and effectiveness. On appeal, the Third Circuit noted that before it could apply this test, it must first address a threshold question: What device is the subject of the "federal requirements"?

The court concluded that hybrid systems should be scrutinized at the component level. First, the Food, Drug, and Cosmetic Act’s (FDC Act) definition of "device" includes "any component, part, or accessory" of an article (see 21 U.S.C. §321(h)). In addition, the FDC Act’s scheme for off-label use contemplates that doctors will prescribe or administer components outside of a system with which the FDA approved their use, and premarket approval requirements apply equally to the components. Finally, the FDA’s position is that the device for preemption purposes must be evaluated at the component level.

Furthermore, both prongs of the Riegel preemption analysis were satisfied. The R3 metal liner is a Class III component that received premarket approval as part of a different system, and that approval imposed requirements on the liner with respect to its composition, dimensions, and labeling. The state-law claims would impose requirements with respect to the liner that are different from, or in addition to, federal ones because each of those claims challenged the safety and effectiveness of the liner.

Off-label use. While the district court’s grant of summary judgment on the issue of preemption was affirmed, it erred in holding that certain off-label promotion claims in the third amended complaint failed to state a claim.

The case is No. 16-3785.

Attorneys: Robert Astrachan (Zajac & Arias LLC) for Walter Shuker. Sara J. Gourley (Sidley Austin LLP) for Smith & Nephew, PLC. Edward W. Gerecke (Carlton Fields Jorden Burt, PA) and David W. O’Quinn (Irwin Fritchie Urquhart & Moore LLC) for Smith & Nephew, Inc.

Companies: Smith & Nephew, Inc.; Smith & Nephew, PLC

MainStory: TopStory CaseDecisions FDCActNews AdvertisingNews MDeviceNews PreemptionNews PLDeviceNews SafetyNews DelawareNews NewJerseyNews PennsylvaniaNews

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