Health Law Daily To overcome preemption, complaint must allege federal violation
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Monday, June 24, 2019

To overcome preemption, complaint must allege federal violation

By Jeffrey H. Brochin, J.D.

A patient may proceed on a negligence and strict product liability claim as long as he claims the breach of a well-recognized duty owed under state law, and, that he was harmed by a violation of specific federal law.

A federal court in Florida has dismissed the amended complaint filed by a patient who was implanted with a spinal cord stimulator indicated for the management of chronic and intractable pain, which, he alleged caused him injuries due to heating up during charging. His claims were preempted by FDA approval, which could only be overcome by properly pleading violation of a specific federal regulation and not mere conclusions (Womack v. Nevro Corp.June 21, 2019, Moody, J.).

Extremely hot implant. In September, 2017, the patient was implanted with Nevro Corp.’s Senza™ SCS System, a surgically implanted spinal cord stimulator that was cleared for commercial distribution as a Class III Medical Device by the FDA. Shortly thereafter, he complained to a Nevro representative that the implant felt extremely hot, and she responded that the heat he sensed would stop after the device had finished charging. However, the patient alleged that that never happened. He subsequently suffered personal injuries related to the implant, and on March 12, 2019, filed his original complaint alleging that design, manufacturing, and labeling defects. Nevro moved to dismiss those claims on the grounds that Section 360k(a) of the Medical Device Amendments (MDA), 21 U.S.C. §§ 360 et seq., to the federal Food, Drug, and Cosmetic Act (FDC Act) preempted them.

He subsequently filed an amended complaint, alleging negligence, strict products liability, failure to warn, and misleading advertising pursuant to Florida law. Nevro moved to dismiss all claims for failure to state a claim under Rule 12(b)(6) of the Federal Rules of Civil Procedure, which, for the reasons stated below, the court granted.

A narrow pleading gap. The MDA provides for two types of preemption of certain state law claims relating to medical devices: express and implied. The express preemption provision bars any claim based on a state law requirement that is different from, or in addition to, any requirement under the MDA that relates to the safety or effectiveness of the device or any other MDA requirement. The implied preemption provision of the MDA requires that all proceedings for the enforcement, or to restrain violations of the MDA shall be by and in the name of the United States. The Supreme Court has interpreted the implied preemption provision to bar claims that merely attempt to enforce duties owed to the FDA, so-called "fraud-on-the-FDA claims."

Taken together, the two types of preemption leave a "narrow gap" through which a patient bringing a medical device claim must proceed, and to make it through that gap, the patient must sue for conduct that violates a federal requirement (avoiding express preemption), but cannot sue only because the conduct violated that federal requirement (avoiding implied preemption). Accordingly, the patient could proceed on his claim so long as he claimed the breach of a well-recognized duty owed to him under state law and so long as he can show that he was harmed by a violation of applicable federal law.

No pleading of federal law violation. In the instant case, the amended complaint was silent as to any applicable federal regulation that was violated; rather, the complaint merely alleged that Florida law imposed a duty on Nevro to exercise all reasonable care when producing, manufacturing, distributing, and selling the Senza, and that Nevro breached that duty of care when it produced the Senza in a manner that did not comply with the design specifications approved by the FDA. Similarly, the strict liability claim broadly alleged that the Senza was unreasonably dangerous because it was produced and manufactured in a manner that violated federal law.

Because the complaint contained no allegations of a particular regulation or design specification that was violated, the court could find no facts describing how any alleged manufacturing violations rendered the device unreasonably dangerous. For the foregoing reasons, the court granted Nevro’s motion to dismiss, but with leave to amend.

The case is No.: 8:19-cv-00698-JSM-SPF.

Attorneys: Andrew M. Wellman (The Florida Law Group) for Donald Womack. Damon J. Brinson (Bowman and Brooke LLP) for Nevro Corp.

Companies: Nevro Corp.

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