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In re Orthopedic Bone Screw Product Liability Litigation

Dismissal of Federal Torts Claims Act (FTCA) claim against the Food and Drug Administration (FDA) for granting clearance to market certain types of pedicle screw fixation devices affirmed because FDA's actions were protected by the discretionary function exception to the FTCA's general waiver of sovereign immunity.

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Argued: June 28, 2001

OPINION OF THE COURT

This Federal Torts Claims Act (FTCA) claim against the Food and Drug Administration (FDA) for granting clearance to market certain types of pedicle screw fixation devices (referred to generally as bone screws) was dismissed by the District Court pursuant to the discretionary function exception to the FTCA.*fn2 Appellants contend here that this jurisdictional exception should not apply because FDA officials were guilty of misconduct in the process of granting the clearance, and because Appellants should have been given more opportunity to discover proof of that misconduct. Moreover, Appellants argue that, even if the discretionary function exception does apply to the aspect of the bone screw clearance process challenged in their suit–i.e., the clearance of bone screws based on their substantial equivalence to devices already on the market–the exception does not bar Appellants’ claims because the FDA’s substantial equivalence determination does not involve the requisite element of judgment and choice, and is not the type of policy-based decision that the exception is designed to protect. Because the record establishes the Court’s lack of jurisdiction, we will affirm.

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