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Leslie C. Packer, Ellis & Winters LLP, Raleigh, NC, recently obtained a dismissal with prejudice of a lawsuit alleging various state law causes of action stemming from a medical device manufacturer’s alleged off-label promotion of its device. This important win confirms that private litigants may not circumvent, through state law claims against drug and device manufacturers, the FDA’s exclusive authority to enforce the Food Drug and Cosmetics Act (“FDCA”).

The Plaintiff had undergone back surgery to relieve severe neck pain caused by a car accident. The complaint alleged that on the eve of surgery, Plaintiff’s surgeon bent and modified a surgical rod manufactured by the Defendant. Plaintiff’s surgeon then implanted the modified device into Plaintiff’s back. Plaintiff sued claiming the Defendant’s representative promoted modification of the device in violation of the FDCA.

The Defendant moved to dismiss Plaintiff’s claims as preempted under the United States Supreme Court’s decision in Buckman Company v. Plaintiffs’ Legal Committee, arguing that Plaintiff’s attempt to hold them liable under state law for off-label promotion undermined the FDCA’s comprehensive regulatory scheme and usurped the FDA’s authority to enforce the FDCA.

The federal trial judge agreed that Plaintiff’s heavy reliance on the FDCA to allege her claims implicated a substantial federal issue and further agreed that Plaintiff was “effectively suing for a violation of the FDCA.” Thus, the judge held that Plaintiff’s state law claims contravened the FDA’s exclusive authority to regulate the FDCA. In a significant victory for drug and device manufacturers, the court agreed with the Defendant that the Supreme Court’s Buckman analysis is not limited to fraud-based claims but extends to all state law claims that depend on a violation of the FDCA.

Congratulations, Leslie!

Do you have a triumph to share? Send a brief summary and a recent photograph to Scott Salter at ssalter@starneslaw.com


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