This is from the DEFENDANTS’ MOTION TO DISMISS in K-V PHARMACEUTICAL COMPANY v. UNITED STATES FOOD AND DRUG ADMINISTRATION (1:12-cv-01105-ABJ):
"Defendants hereby move to dismiss this action pursuant to Fed. R. Civ. P. 12(b)(1) for lack of subject matter jurisdiction because plaintiffs have failed to establish that they have standing inasmuch as the relief they seek either is unavailable as a matter of law or is not likely to redress their injury. Defendants further move to dismiss this action pursuant to Fed. R. Civ. P. 12(b)(6) for failure to state a claim upon which relief can be granted inasmuch as the plaintiffs challenge an exercise of enforcement discretion that is not subject to review by the Court."