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Hybrid Medical Device Not Exempt From State Liability

By William Vogeler, Esq. on March 07, 2018 | Last updated on March 21, 2019

Walter Shuker had a complicated hip replacement surgery.

It wasn't just the total replacement of his hip that was complicated. It was the device -- an apparatus comprised of a metal head, metal sleeve, a stem connecting the metal head to the thigh bone, a metal liner, etc. Together, the pieces created a "metal-on-metal articulation."

That's where his post-operative pain began and a subsequent lawsuit emerged in Shuker v. Smith and Nephew. The case -- with a question of first impression -- was as complicated as the corrective surgery.

First Impression

Shuker and his wife Vivian Shuker sued under Pennsylvania law for negligence, strict liability, and other claims, but a federal judge dismissed under federal preemption provisions of the Medical Device Amendments in 21 U.S.C. Section 360k(a).

The statute preempts any state requirement that has "the effect of establishing a substantive requirement for [the] specific device" in question that relates to safety, effectiveness, or "any other matter" that forms a federal requirement, so long as the state requirement is "different from, or in addition to," the federal mandate.

On appeal, the U.S. Third Circuit Court of Appeals said Congress gave medical device manufacturers "broad" preemption from state laws in exchange for compliance with strict federal requirements. However, the appeals court said, it was the first time a court had to apply the preemption to "a medical device comprised of multiple components" that were not subject to those requirements.

Reuters reported it was the first decision of its kind on so-called hybrid devices.

Sum of the Parts

The plaintiffs argued that the hip replacement system, manufactured by British company Smith & Nephew, should be considered for liability as a whole. They said preemption did not apply because a critical component had been used for a non-approved purpose.

The Third Circuit gave them a partial victory. It affirmed dismissal of their claims for negligence, strict liability and breach of implied warranty on one hand.

But on the other hand, the appeals court said the Shukers could pursue three tort claims for alleged off-label promotion. That included negligence, loss of consortium and fraud.

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