Heckler v. Chaney

LOCATION: New Mexico State Police Headquarters

DOCKET NO.: 83-1878
DECIDED BY: Burger Court (1981-1986)
LOWER COURT: United States Court of Appeals for the District of Columbia Circuit

CITATION: 470 US 821 (1985)
ARGUED: Dec 03, 1984
DECIDED: Mar 20, 1985

Kenneth Steven Geller - Argued the cause for the petitioner
Stephen M. Kristovich - Argued the cause for the respondents

Facts of the case

Several prison inmates convicted of capital offenses and sentenced to death by lethal injection petitioned the Food and Drug Administration (FDA) alleging that the drugs to be used for their executions were not approved for use in human executions and therefore violated the Federal Food, Drug and Cosmetic Act (FDCA). When the FDA denied enforcement, the inmates brought suit claiming violations of the FDCA and requesting that the FDA be required to take enforcement actions. The district court granted summary judgment to the FDA holding that decisions declining to initiate enforcement proceedings were not judicially reviewable. The Court of Appeals for the District of Columbia Circuit reversed, finding that the decision not to begin an enforcement action was judicially reviewable under 5 U.S.C. Section 701(a)(2) and an abuse of discretion.


Are decisions made by the FDA not to exercise enforcement authority over the use of drugs precluded from judicial review by Section 701(a)(2) of the Administrative Procedure Act, 5 U.S.C. Section 501 et seq. (APA)?

Media for Heckler v. Chaney

Audio Transcription for Oral Argument - December 03, 1984 in Heckler v. Chaney

Warren E. Burger:

Mr. Geller, I think you may proceed whenever you're ready.

Kenneth Steven Geller:

Thank you.

Mr. Chief Justice, may it please the Court:

This case presents an important issue of administrative law that we had thought was well settled prior to the District of Columbia Circuit's decision in this case.

That issue is whether the courts have authority to review and set aside an administrative agency's discretionary determination not to bring law enforcement proceedings against someone who is alleged to have violated a provision of the agency's statute.

Sandra Day O'Connor:

Mr. Geller, let me stop you right off the bat, if you don't mind, to just see whether that's the question we would necessarily have to answer.

The FDA apparently believed that its statutory mandate just didn't reach the question of state-sanctioned use of lethal injections for executions, and if that is correct would our inquiry just end there?

Kenneth Steven Geller:

Justice O'Connor, that was one of many reasons that the FDA gave for not bringing an enforcement action in this case.

It also--

Sandra Day O'Connor:

Well, if we thought that was right?

Kenneth Steven Geller:

--Well, before the Court could reach the question of whether that was right or not, it would seem that the Court would first have to answer the question whether this decision of the FDA is reviewable.

If it's reviewable, then the Court can decide whether the FDA made an error.

Sandra Day O'Connor:


Well, do you think that the question of whether something is within the statutory jurisdiction of FDA at all is something that is reviewable?

Kenneth Steven Geller:

Not when the question arises in the context of a challenge to the failure or the refusal to bring enforcement proceedings.

But here the FDA didn't just say that it didn't have statutory authority.

The letter, which is reprinted in the appendix to the petition beginning on page 81A, went on to say as a second and separate basis of denial, it gave a number of reasons why it would not bring this proceeding even if in fact the language of its statute could be stretched to cover this situation.

Now, in the last several years a number of states have passed statutes prescribing lethal injection with drugs as the method of carrying out the death penalty.

Respondents are a group of prison inmates who have been sentenced to capital punishment in two of these states, Texas and Oklahoma.

In 1980 they filed a citizen petition with the FDA contending that the states of Texas and Oklahoma were intending to violate the federal Food, Drug and Cosmetic Act, apparently because the FDA had never approved the drugs in question as safe and effective for the purposes of human execution.

The Respondents asked the FDA to require warning labels on these drugs stating that they couldn't be used as a means of execution, and also asked that the FDA adopt a policy of seizing the drugs, bringing injunctive proceedings, and even criminal prosecutions of the responsible state prison officials.

The FDA declined to take any of these enforcement measures.

As I just mentioned in my colloquy with Justice O'Connor, the FDA first concluded that it didn't have jurisdiction to intervene in the states' practice of administering capital punishment, but went on to say that, even if it had jurisdiction, it would decline to exercise it under its inherent discretion not to pursue certain enforcement matters.

Respondents then brought suit to challenge the FDA's decision.

The district court dismissed the complaint on the grounds that the enforcement decisions of an executive agency are simply not amenable to judicial review.

But a divided panel of the District of Columbia Circuit reversed.

The D.C. Circuit held that the FDA in fact did have jurisdiction to intervene in this area under the misbranding provisions of the food and drug laws.

These provisions prohibit the misbranding of drugs while they are "held for sale", and the Court of Appeals' reasoning seems to have been that these drugs are misbranded because they're warning labels don't state that they can be used for purposes of capital punishment and that they are held for sale when they are forceably administered to these prisoners pursuant to a court order.

The court then went on to hold that the FDA's decision not to exercise its enforcement discretion is subject to judicial review and that the FDA had acted arbitrarily, capriciously, and without legal authority here.

Now, what the District of Columbia Circuit's ruling amounts to is this.