Health Law Daily ‘Hybrid’ medical devices containing §510(k) components subject to intense preemption analysis
Tuesday, August 6, 2019

‘Hybrid’ medical devices containing §510(k) components subject to intense preemption analysis

By Jeffrey H. Brochin, J.D.

Hybrid medical device systems are not governed by §360k(a) preemption provisions, and the FDA has not established federal requirements for those systems nor their §510(k)-approved components.

A federal district court in Maryland has denied in part and granted in part the motions of medical device manufacturer Smith & Nephew (Smith) to dismiss claims arising under the Birmingham Hip Resurfacing (BHR) litigation, based on federal preemption of state claims. Although it was indisputable that federal preemption applied to pre-market approval (PMA) devices due to the Medical Device Amendments (MDA), devices approved through the less rigorous §510(k) approval process do not automatically trigger explicit preemption (In Re: Smith & Nephew Birmingham Hip Resurfacing (BHR) Hip Implant Products Liability Litigation, August 5, 2019, Blake, C.).

Two approval tracks. The MDA established federal requirements for introducing new medical devices, and it included an express preemption provision preempting conflicting state law claims. The most stringent requirements pertained to Class III medical devices, which were deemed to pose the greatest potential risk to human health. Under the PMA process, the FDA will only approve a device if there is a reasonable assurance of safety and effectiveness, and that process is a demanding one, under which the FDA spends on average 1200 hours reviewing manufacturer’s submissions.

However, not all devices need to be approved via the PMA process: one exception is for devices that were already on the market prior to 1976, and a second exception applies to devices which are improvements to existing, approved devices. This process of approval is known as §510(k) approval. The §510(k) process focuses on equivalence to existing devices, rather than the safety of the device itself.

Applying preemption to hybrid components. The court addressed applying federal preemption to a device which was a hybrid of PMA-approved components (and therefore had explicit federal preemption) and §510(k)-approved components. The court ruled that as to the non-parallel state-law claims that targeted PMA components of hybrid devices, federal preemption applied. However, it acknowledged that the ruling required further examination as to the hybrid system as a whole, and the system’s §510(k) components.

Although the FDA considers each component of a PMA-approved device to be a distinct PMA device, the FDA has not articulated that claims arising out of a combination of components that includes a PMA-approved component, but that was not itself subject to PMA approval, triggers explicit preemption. The FDA left that question open, stating that the question would depend on fact-specific considerations.

Claims not governed by §360(a). The court found that to the extent that failure to warn claims were directed to hybrid systems as a whole or the §510(k) approved components, the claims were not governed by §360(a) and therefore claims targeting the hybrid system as a whole could proceed to the extent that they alleged that Smith & Nephew breached a duty to warn about the dangers of metal-on-metal devices, because those claims would not directly impugn the safety and efficacy of the BHR components.

However, to the extent that the claims were directed to the BHR metal cup and R3 liner, they could only survive to the extent that parallel state-law causes of action were identified that predated the MDA. And, to the extent that the claims were premised on Smith & Nephew’s alleged false or misleading statements about the hybrid system’s PMA components, those claims would not be preempted.

Accordingly, based on the foregoing, the court granted in part the motion to dismiss, but allowed many of the claims to survive the motion.

The case is No.: 1:17-cv-00949-CCB.

Attorneys: Alex C. Davis (Jones Ward PLC) for Mary Helen Gowin. Sara J. Gourley (Sidley Austin LLP ) and Terri Steinhaus Reiskin (Dykema Gossett PLLC) for Smith & Nephew Inc.

Companies: Smith & Nephew Inc.

MainStory: TopStory FDCActNews PreemptionNews PLDeviceNews SafetyNews MarylandNews

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