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Brooks v. Mentor Worldwide, LLC.

No. 19-3240.  D.Kan. Judge Carson. Federal Preemption—Medical Device Amendments to Federal Food, Drugs, and Cosmetics Act—Plausibility Standard—Fed. R. Civ. P. 15 Amendment of Pleadings.

January 25, 2021


Plaintiffs received MemoryGel breast implants. Soon thereafter they felt negative effects and suffered health problems. The implants were eventually removed, and this process revealed that the implants had leaked. While some symptoms went away or diminished, other symptoms remained.

Plaintiffs brought claims for failure to warn and manufacturing defects, sounding in ordinary negligence, negligence per se, and strict liability. Plaintiffs alleged that defendant failed to properly conduct a range of post-market approval studies as required by the US Food and Drug Administration (FDA). The district court granted defendant’s motion to dismiss based on federal preemption and determined that, in any event, plaintiffs failed to sufficiently plead their claims. The court also determined that Missouri law rather than Kansas law applied to the claims and denied plaintiffs’ request for leave to amend their complaint.

On appeal, plaintiffs argued that the district court erred in granting the motion to dismiss for failure to state a claim. The parties did not dispute that the Medical Device Amendments (MDA) to the Federal Food, Drug, and Cosmetics Act (FDCA) applies to the breast implants. Under the MDA, to be approved, the FDA must find reasonable assurance of the device’s safety and effectiveness, weighing any probable benefit to health against any probable risk of injury or illness. The FDCA preempts any state tort claim that exists solely by virtue of an FDCA violation, and Congress intended the MDA to be enforced exclusively by the federal government. Thus, a state tort claim may be predicated on conduct that violates the FDCA but may not be brought solely because that conduct violates the FDCA; the conduct must also violate a parallel state law requirement.

Here, the negligence per se and failure to warn claims based on ordinary negligence and strict liability did not meet this narrow standard. Therefore, federal law preempted these claims. Further, negligence per se premised on an MDA violation lacks viability under either Kansas or Missouri law. As to the ordinary negligence and strict liability claims for manufacturing defect, plaintiffs failed to allege facts reflecting negligence in the manufacturing of the implants or that the implants were defective and thus did not state a plausible claim. Accordingly, the district court properly granted the motion to dismiss.

Plaintiffs also argued that the district court erred in denying their request to amend the complaint. Plaintiffs’ request consisted of one sentence at the end of their response to the motion to dismiss and was not a cognizable motion. Therefore, the district court did not abuse its discretion in denying the request.

The dismissal was affirmed.

Official US Court of Appeals for the Tenth Circuit proceedings can be found at the US Court of Appeals for the Tenth Circuit website.

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