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Suit Based on Fraud Against FDA in Medical Device Application May Proceed
Description Class action suit against company based on fraudulent misrepresentation for intended market of medical devices, bone screws, that allegedly caused problems when used in spinal surgery, may proceed. Congress did not preempt common law actions for fraud against FDA.
Topic Torts
Key Words Misrepresentation; FDA; MDA
C A S E   S U M M A R Y
Facts Over 2,000 actions were consolidated for pleadings against Buckman, claiming that it "made misrepresentations to the FDA serious enough to play a substantial role in the events which resulted in their injuries." The bone screw devices are regulated by the FDA under the Medical Device Amendment. Buckman had put the screws through the FDA review process and received marketing approval in 1986. Plaintiffs claim that Buckman failed to reveal to the FDA that it would use the screws in spinal surgery, where the problems arose, rather than in leg and arm bone-repair surgery. District court dismissed the claims, holding that "the alleged fraud [in information provided to the FDA] cannot be said to have been a proximate cause of plaintiffs' alleged injuries." Plaintiffs appealed.
Decision Reversed. The MDA does not preempt any viable state law claim of fraudulent misrepresentation based on statements by firms to the FDA in the course of application for approval of medical devices. The MDA does not expressly preempt private causes of action for violations of the MDA or FDA Act, so suit may proceed.
Citation In re Orthopedic Bone Screw Products Liability Litigation, 159 F.3d 817 (3rd Cir., 1998)

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