Leslie C. Packer
Nora F. Sullivan
Leslie Packer and Nora Sullivan 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. Ellis & Winters represented medical device manufacturer Pioneer Surgical Technology, Inc. and its successor, RTI Surgical, Inc. in the case captioned Williams v. Zimmer U.S. Inc. et el., No. 5:14cv468-F. Williams follows an earlier case of first impression in the Eastern District of North Carolina, Evans v. Rich, No. 5:13-CV-868-BO. Ms. Packer and Ms. Sullivan successfully obtained dismissal of that case, too. Together, Williams and Evans confirm that private litigants may not circumvent the FDA’s exclusive authority to enforce the Food Drug and Cosmetics Act (“FDCA”) through state law claims against drug and device manufacturers.
The Plaintiff in Williams 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 Pioneer/RTI defendants. Plaintiff’s surgeon then implanted the modified device into Plaintiff’s back. Plaintiff sued Pioneer and RTI claiming that their representative promoted modification of the device in violation of the FDCA.
The Pioneer/RTI defendants moved to dismiss Plaintiff’s claims as preempted under the United States Supreme Court’s decision in Buckman Company v. Plaintiffs’ Legal Committee. They argued 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. Plaintiff responded with a motion to remand the case back to state court, arguing that the complaint did not implicate a federal issue. The Pioneer/ RTI defendants opposed that motion.
Judge James C. Fox of the United States District Court for the Eastern District of North Carolina denied Plaintiff’s motion to remand and granted the Pioneer/RTI defendants’ motion to dismiss. Judge Fox agreed that Plaintiff’s heavy reliance on the FDCA to allege her claims implicated a substantial federal issue that could be resolved without raising concerns of federalism.
Judge Fox further agreed that Plaintiff was “effectively suing for a violation of the FDCA.” Judge Fox 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 Pioneer/RTI defendants 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. The Court cited several cases construing Buckman to preempt a variety of state law claims, including breach of warranty, negligence per se, design defect, and failure to warn.
Finding that any amendment to the complaint would have been futile, the Court dismissed Plaintiff’s complaint with prejudice.