Buckman Co. v. Plaintiffs' Legal Comm

In Buckman Co. v. Plaintiffs' Legal Comm. (2001) 531 U.S. 341, the plaintiffs suffered injuries after orthopedic bone screws were implanted in their spines. (Buckman, supra, 531 U.S. at p. 343.) The plaintiffs then brought state tort law claims in which they alleged that the defendant made fraudulent representations to the FDA in obtaining approval to market these class III devices, and they would not have been injured if these representations had not been made. (Ibid.) The Buckman court began its discussion by observing that "policing fraud against federal agencies is hardly 'a field which the States have traditionally occupied,' " and thus the nature of the plaintiffs' claims was insufficient to warrant a presumption against preemption. (Buckman, at p. 347.) The court based this conclusion on the principle that "the relationship between a federal agency and the entity it regulates is inherently federal in character because the relationship originates from, is governed by, and terminates according to federal law." (Ibid.) Based on this "analytical framework," the court held that the state law fraud-on-the-FDA claims conflicted with, and thus, were impliedly preempted by federal law. (Buckman, supra, 531 U.S. at p. 348.) As the court explained, "the conflict stems from the fact that the federal statutory scheme amply empowers the FDA to punish and deter fraud against the Administration, and that this authority is used by the Administration to achieve a somewhat delicate balance of statutory objectives. The balance sought by the Administration can be skewed by allowing fraud-on-the-FDA claims under state tort law." (Ibid.) After reviewing the extensive disclosure requirements of the MDA and the provisions governing the detection, deterrence and punishment of false statements made during the approval process, the court concluded that state tort law fraud-on-the-FDA claims would "inevitably conflict with the FDA's responsibility to police fraud consistently with the Administration's judgment and objectives." (Buckman, at pp. 349-350.) Since the court held that the claims were impliedly preempted, it did not consider whether the claims were expressly preempted under 21 United States Code section 360k. (Buckman, at p. 348, fn. 2.)