By Kurt R. Karst –
In a decision and accompanying Order handed down on March 27, 2012, Judge Richard J. Leon of the U.S. District Court for the District of Columbia ordered that FDA “immediately notify any and all state correctional departments which it has reason to believe are still in possession of any foreign manufactured thiopental that the use of such drug is prohibited by law” and that such drug product be returned immediately to FDA, and that FDA “be permanently enjoined from permitting the entry of, or releasing any future shipments of, foreign manufactured thiopental into interstate commerce.”
Judge Leon’s decision (which follows his recent ruling against FDA on the Agency’s regulation requiring the display on cigarette packages of graphic warnings – see our previous post here) stems from a February 2011 lawsuit (amended in July 2011) brought against FDA by death row inmates in three states over the importation of unapproved thiopental sodium, one of the drugs used by some states to administer a lethal injection, alleging violations of the Administrative Procedure Act (“APA”) and the FDC Act (see our previous post here). In issuing his decision, Judge Leon granted the Plaintiff inmates’ Motion for Summary Judgment and Declaratory Relief on Counts I and III (concerning alleged APA violations – 5 U.S.C. § 706(2)(A)) and denied FDA’s Motion to Dismiss and/or for Summary Judgment.
Although FDA contended that the Plaintiffs in the case lacked standing to bring their claims for failure to adequately show injury or causation, Judge Leon found otherwise. “For standing purposes, an increased risk of future harm is a category of the injury-in-fact prong. . . . Here, the threatened injury – that unapproved foreign thiopental will fail to anesthetize plaintiffs properly during execution, causing conscious suffocation, pain, and cardiac arrest – is, to say the least, severe,” wrote Judge Leon. “Because unapproved thiopental exposes plaintiffs to the risk that the drug will not function as intended, plaintiffs have shown at least a ‘modest’ increment of risk that the use of foreign thiopental in their executions would result in conscious suffocation, pain, and cardiac arrest.” Having dealt with the injury prong, Judge Leon turned to causation and FDA’s contention that there is no causal connection between Plaintiffs’ threatened injury and FDA’s failure to reject unapproved foreign thiopental. “The threatened injury, however, arises directly from defendants' actions,” wrote Judge Leon. FDA’s “admission of foreign thiopental shipments allows state [departments of correction] to use thiopental in their lethal injection protocols. In so doing, plaintiffs’ risk of conscious suffocation, pain, and cardiac arrest increases. Thus, plaintiffs have standing to pursue their claims.”
Moving on the Plaintiffs’ Count I – 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 – Judge Leon pointed to the word “shall” in FDC Act § 801(a). That statutory provision concerns imports and 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.” Although FDA contended that the FDC Act does not impose a mandatory duty on the Agency to refuse admission of an import, Judge Leon said in his opinion that the statute is crystal clear: In FDC Act § 801(a) “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.”
FDA’s Heckler defense – that is, that under the U.S. Supreme Court’s decision in Heckler v. Chaney, 470 U.S. 821 (1985), (another death row inmate case) FDA’s decision not to take enforcement action with respect to thiopental sodium is not subject to judicial review because “agency refusals to institute investigative or enforcement proceedings are committed to agency discretion” (internal citation and quotation omitted) – fell on deaf ears. “[A] decision to admit or exclude an imported product is not the type of discretion – like prosecutorial discretion – that the Supreme Court considered in its decision in Heckler,” wrote Judge Leon. “Unlike 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.”
Turning to Plaintiffs’ Count III – that FDA violated the APA (5 U.S.C. § 706(2)(A)) by departing from longstanding Agency policies and undermining the purpose of the FDC Act – Judge Leon ticked off some examples of where FDA has been inconsistent with the Agency’s own regulations and policies insofar as importation of unapproved drugs into the U.S. is concerned, and said that FDA failed to proffer a reasoned explanation for such inconsistencies. This all led Judge Leon to conclude his opinion with a rather colorful statement: “In the final analysis, the 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!”