Yesterday we applauded a preemption decision by the District of Maryland for its well-reasoned analysis which included a focus on the FDA’s exclusive enforcement mechanism created by the Federal Food Drug and Cosmetic Act (“FDCA”). The lack of a private cause of action to enforce the FDCA is a fairly predominant theme on this blog, for the obvious reason of it being the cornerstone for preemption of product liability pharmaceutical and medical device litigation.
Today we decided to draw your attention to a recent case that reaffirms FDA enforcement exclusivity and take the opportunity to remind ourselves of another one of the reasons why that is important -- negligence per se. First, the case. In K-V Pharmaceutical Co. v. FDA, 2012 U.S. Dist. LEXIS 126330 (D.D.C. Sept. 6, 2012), the plaintiff pharmaceutical company brought an action against the FDA seeking to require the FDA to take certain enforcement actions. Plaintiff manufacturers the only FDA-approved drug used to treat pregnant women with a history of preterm birth by reducing the risk of another preterm birth. Id. at *2. The drug is considered an “orphan” drug because it is used to treat a rare condition, and therefore, the manufacturer is given exclusivity in the market for 7 years. Id. at *4-5. However, generic versions of the drug are “compounded” by pharmacies (pharmacists combine ingredients to make a customized drug to meet the needs of a particular patient). Id. at *6. In its complaint, plaintiff took issue with the FDA’s decision not to take enforcement action against the compounders for various violations of the FDCA they alleged were occurring. Now, plaintiff may have had legitimate concerns about the scope and extent of the compounding and other issues and we don’t express any opinion on the actual circumstances. Our interest in the case is solely as it relates to the court’s recognition that there is no private cause of action to enforce the FDCA.
That brings us to how this case is important in the product liability arena. The court summed up plaintiff’s claims as allegations of “ongoing violations of substantive provisions of the FDCA.” K-V Pharmaceutical Co., at *32. Sound familiar? Sound like our plaintiffs’ negligence per se claims? Sure does.
In granting FDA’s motion to dismiss, the court relied heavily on Heckler v. Chaney, 470 U.S. 821 (1985) (FDCA frees the FDA to pursue whatever remedies the FDA thinks best fit the violation) which had previously held that FDA decisions not to take enforcement action are presumed to be immune from judicial review. K-V Pharmaceutical Co., at *28. The Supreme Court’s ruling in Chaney turned in large part on the fact that the FDCA’s “enforcement provisions . . . commit complete discretion to the Secretary to decide how and when they should be exercised.” Chaney, 470 U.S. at 835. We know this from Buckman. The FDCA explicitly precludes private litigants from seeking to prosecute any statutory or regulatory violation:
Except as provided in subsection (b) of this section, all such proceedings for the enforcement, or to restrain violations, of this chapter shall be by and in the name of the United States.
21 U.S.C. §337(a). So, both in the context of reviewability of enforcement decisions (Chaney) and in products liability (Buckman), the Supreme Court has held that §337(a) “leaves no doubt that it is the Federal Government rather than private litigants who are authorized to file suit for noncompliance.” Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341, 349 n.4 (2001).
It is this enforcement exclusivity that led the court to find that plaintiff’s complaint “is fundamentally an effort to get the Court to direct and oversee the FDA's enforcement activities, and that it cannot do.” K-V Pharmaceutical Co., at *32. We believe the same reasoning holds true for negligence per se claims. If the FDA has chosen not to pursue a particular alleged violation of the FDCA, it is not for the product liability plaintiff or the court to step in and do otherwise. By seeking to litigate alleged FDCA violations, plaintiffs ask courts “to get right smack in the middle of agency operations. Directing the FDA to bring a particular sort of enforcement action . . . is directing it how to allocate its finite enforcement resources – a decision that is peculiarly within the agency’s expertise and discretion.” Id. at *38 (citation and quotation marks omitted).
We regularly cite to Buckman in our preemption arguments for support that Congress intended the FDCA to be enforced exclusively by the federal government. But this point is critical in defending against product liability plaintiffs who attempt private enforcement of the FDCA through negligence per se. Only statutes that the legislature (Congress, in the case of the FDCA) intended to be privately enforced can give rise to negligence per se. That’s why we make sure to include cases like K-V Pharmaceutical Co. v. FDA on our blog. While not a products liability case, it’s another decision that illustrates that Congress intended that the FDA be the exclusive enforcer of the FDCA and strengthens the argument that plaintiffs cannot create a private right of action via a back-door negligence per se claim. For a more thorough discussion of the defenses to negligence per se claims, including legislative intent, we direct you to our post here.