FDA Presses “Heckler Defense” in Appeal of Unapproved Thiopental Sodium Death Row Inmate Case

By Kurt R. Karst –      

FDA’s opening brief in the Agency’s appeal of a March 27, 2012 Memorandum Opinion and accompanying Order issued by Judge Richard J. Leon of the U.S. District Court for the District of Columbia (as modified by a June 22, 2012 Order) in Beaty v. FDA, 853 F. Supp. 2d 30 (D.D.C. 2012) (now Cook v. FDA) concerning FDA’s exercise of enforcement discretion with regard to the importation of unapproved sodium thiopental for use by state Departments of Corrections to carry out death sentences by lethal injection is all about the U.S. Supreme Court’s decision in Heckler v. Chaney, 470 U.S. 821 (1985).  In Heckler, the Court rejected a challenge to FDA’s determination that the Agency would not take enforcement action in the lethal injection context, and held that FDA’s determinations about the circumstances in which the Agency would take enforcement action were not subject to judicial review, because “agency refusals to institute investigative or enforcement proceedings are committed to agency discretion.”  In Beaty, the outcome was different.  

As we previously reported (here and here), Judge Leon’s decision to grant summary judgment to Plaintiffs stems from a February 2011 lawsuit (amended in July 2011) brought against FDA by death row inmates alleging violations of the Administrative Procedure Act (“APA”) and the FDC Act.  Specifically, the Plaintiffs alleged that FDA violated the APA (5 U.S.C. § 706(2)(A)) by improperly allowing shipments of a misbranded and unapproved new drug to enter the U.S. contrary to the FDC Act, and violated the APA (5 U.S.C. § 706(2)(A)) by departing from longstanding Agency policies and undermining the purpose of the FDC Act. 

At issue in the case is FDC Act § 801(a), which concerns imports.  The statute states, in relevant part, that “[i]f it appears from the examination of such [imported] samples or otherwise” that the product violates the FDC Act’s misbranding or new drug approval requirements, “then such article shall be refused admission” (emphasis added).   Although FDA contended that FDC Act § 801(a)does not impose a mandatory duty on the Agency to refuse admission of an import, Judge Leon, in a rather colorful decision, ruled that the statute is clear: “Congress’ intent was for ‘shall’ to impose a mandatory obligation on [FDA] to refuse to admit the misbranded and unapproved drug, thiopental, into the United States.”  Judge Leon also ruled that FDA’s determination not to pursue enforcement action was arbitrary and capricious.  As a result, Judge Leon permanently enjoined FDA “from permitting the entry of, or releaseing any future shipments of, foreign manufacted thiopental that appears to be misbranded or in violation of (FDC Act § 505].” 

FDA had argued that U.S. Supreme Court’s Heckler decision should apply to the case at bar.  In issuing his decisions, however, Judge Leon distinguished Heckler, and wrote that “[u]nlike in Heckler, here, the FDA’s decision did not involve a decision whether to initiate enforcement proceedings against a violator of the Act; rather, it involved a decision to ignore an administrative directive.”  The bottom line, wrote Judge Leon, is that “FDA appears to be simply wrapping itself in the flag of law enforcement discretion to justify its authority and masquerade an otherwise seemingly callous indifference to the health consequences of those imminently facing the executioner’s needle.  How utterly disappointing!”

FDA, in the Agency’s opening brief, attempts to hammer home for the DC Circuit why Heckler applies and is in controlling in this case: 

The district court’s contrary conclusion was premised almost entirely on the use of the word “shall” in a sentence providing that “[i]f it appears” that an FDA-regulated article fails to comply with certain requirements, “then such article shall be refused admission.”  21 U.S.C. § 381(a).  The presumption in favor of enforcement discretion is not overcome by the bare use of words like “shall,” which are routinely interpreted to preserve rather than eliminate administrative discretion in the enforcement context.  Here, the sentence upon which the district court relied merely describes the consequences of a determination by FDA, after any appropriate administrative procedures, that enforcement action is warranted and a given article is subject to removal.  It in no way constrains the agency’s discretion over whether to make such a determination in the first place.

As the Supreme Court recognized in Heckler, overriding an agency’s discretion to decide whether to engage in enforcement proceedings interferes with the agency’s determinations about whether particular enforcement actions are counterproductive or unduly tax agency resources in relation to other responsibilities that the agency may regard as more pressing.  FDA exercises enforcement discretion to not impede controlled imports of medically necessary drugs in response to drug shortages in the United States, and to avoid diverting agency resources on individual attempts to import small amounts of foreign prescription drugs for personal use.  The district court’s reasoning provides no basis for curtailing these exercises of the agency’s discretion in favor of an inflexible mandate to undertake enforcement proceedings in response to every apparent violation of the statute that occurs in the import context, and its judgment should be reversed. 

Interestingly, in another recent case also concerning FDA’s exercise of enforcement discretion, but in the context of compounded versions of hydroxyprogesterone caproate injection that compete with the approved drug MAKENA marketed by K-V Pharmaceutical Company, Judge Amy Berman Jackson of the DC District Court ruled for FDA.  In that case, which is not cited in FDA’s opening brief, Judge Jackson found the Plaintiff’s claims unreviewable, because the APA “precludes judicial review of final agency action, including refusals to act, when review is precluded by statute or ‘committed to agency discretion by law,’” and because Heckler is controlling (see our previous post here).  Last week, K-V appealed that decision to the DC Circuit (Docket No. 12-5349). 

REMINDER:  You can follow us on Twitter @fdalawblog.