King
King v. U.S. Federal Drug Administration
Opinion
Lead Opinion
MEMORANDUM ***
Suzanne King appeals the dismissal for lack of subject matter jurisdiction of her action against the Food and Drug Administration (“FDA”) for negligence in approving the medical device “Seprafilm.” On appeal, King argues (1) dismissal was improper because the FDA’s actions fell outside the discretionary function exception to the Federal Tort Claims Act (“FTCA”); (2) her Seventh Amendment right to a jury trial was violated; (3) the district court improperly considered affidavits in granting defendants’ motion to dismiss; and (4) she should be allowed further leave to amend her complaint. We have jurisdiction pursuant to 28 U.S.C. § 1291 and we affirm. Because the parties are familiar with the factual and procedural details of the case, we will not detail them here except as necessary.
King first argues that the district court erred in concluding that the FDA’s premarket approval of Seprafilm fell within the discretionary function exception to the FTCA. “A district court’s determination that it lacks subject matter jurisdiction under the FTCA and a district court’s application of the discretionary function exception are ... reviewed de novo.” Marlys Bear Medicine v.…