Devices

Federal Court Relies on Preemption in Device Liability Case

Lanx, Inc., a spinal fixation device maker, won a product liability case in Mississippi last month by relying upon, among other defense arguments, the Buckman U.S. Supreme Court decision on federal preemption. In Estes v. Lanx, Inc., plaintiff Rocky Estes underwent spinal fusion surgery in 2011 that used the Lanx Telluride Spinal Fixation System to fuse his L5-S1 vertebrae. Within five months, two pedicle screws fractured, and a revision surgery was performed to remove the broken screws and replace the spinal fixation system with new orthopedic hardware.

Estes complaint claimed that Lanx failed to obtain FDA clearance for the Telluride System. In granting in part summary judgment to Lanx, the court relied on the Buckman decision that found federal law preempts state-law causes of action claiming that a medical device manufacturer made fraudulent representations to the FDA. The Mississippi federal court said it agreed that the state law claim would conflict with the FDA’s authority to punish fraud on the agency. Regarding Buckman, it further said: “Not only does federal law provide administrative tools to punish and deter fraud, but the agency’s decision to employ those tools implicates its discretion and special competence. Among the factors that make FDA enforcement ‘a somewhat delicate balance of statutory objectives,’ id., 121 S. Ct. 1012, are the need for administrative efficiency and the possibility that tort liability based on inadequate disclosures would create "an incentive to submit a deluge of information," 531 U.S. at 351, 121 S. Ct. 1012. The court concluded that authorizing tort liability for failure to comply with FDA disclosure requirements ‘would exert an extraneous pull on the scheme established by Congress, and it is therefore pre-empted by that scheme.’ 531 U.S. at 353, 121 S. Ct. 1012; Lofton v. McNeil Consumer & Specialty Pharms., 672 F.3d 372, 375-76 (5th Cir. 2012).”

The court noted that the parties had failed to brief whether federal regulatory law impliedly preempts plaintiff’s causes of action based on Lanx’s submissions to FDA. It ordered them to respond by 1/9 as to whether these claims and others are or are not preempted.

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