718 F.2d 1174 (D.C. Cir. 1983), 82-2321, Chaney v. Heckler

Docket Nº:82-2321.
Citation:718 F.2d 1174
Party Name:Larry Leon CHANEY et al., Appellants, v. Margaret M. HECKLER, as Secretary of Health and Human Services.
Case Date:October 14, 1983
Court:United States Courts of Appeals, Court of Appeals for the District of Columbia Circuit
 
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Page 1174

718 F.2d 1174 (D.C. Cir. 1983)

Larry Leon CHANEY et al., Appellants,

v.

Margaret M. HECKLER, as Secretary of Health and Human Services.

No. 82-2321.

United States Court of Appeals, District of Columbia Circuit

October 14, 1983

Argued May 20, 1983.

Rehearing En Banc denied Jan. 17, 1984.

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Appeal from the United States District Court for the District of Columbia (D.C. Civil Action No. 81-02265).

Stephen M. Kristovich, Washington, D.C., with whom David E. Kendall, Washington, D.C., Joel Berger, and Anthony G. Amsterdam, New York City, were on the brief, for appellants.

Margaret G. Halpern, Atty., Dept. of Justice, Washington, D.C., with whom Robert B. Nicholson, Atty., Dept. of Justice, Washington, D.C., Thomas Scarlett, Chief Counsel, Food and Drug Admin., Washington, D.C., and Arthur N. Levine, Rockville, Md., Deputy Chief Counsel, Food and Drug Admin., were on the brief, for appellee.

Before WRIGHT and SCALIA, Circuit Judges, and WEIGEL, [*] Senior District Judge.

Opinion for the court filed by Circuit Judge J. SKELLY WRIGHT.

Dissenting opinion filed by Circuit Judge SCALIA.

J. SKELLY WRIGHT, Circuit Judge:

In the Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. Sec. 301 et seq. (1976 & Supp. V 1981), Congress has required the Secretary of Health and Human Services or her delegate, the Commissioner of the Food and Drug Administration (FDA), 1 to assure that all "new drugs" are "safe and effective" for use under the conditions prescribed, recommended, or suggested on the official labeling. 2 Id. Sec. 355(a). Before the Commissioner can allow a "new drug" to be distributed in interstate commerce, FDA must assure the safety of the drug and the adequacy of its branding. Id. Secs. 331, 355; see also 21 C.F.R. Sec. 201 et seq. (1983). A drug is "misbranded," and impermissibly available for use by consumers, unless its labeling bears adequate directions for use and such adequate warnings against unapproved uses or methods of administration as are necessary for the protection of its users. 21 U.S.C. Sec. 352(f). The Commissioner has previously interpreted FDCA's labeling requirements to impose upon FDA the "obligat[ion]" to investigate and take appropriate action against unapproved uses of approved drugs where such unapproved use becomes widespread or endangers the public health. See Legal Status of Approved Labeling for Prescription Drugs; Prescribing for Uses Unapproved by the Food and Drug Administration, 37 Fed.Reg. 16503, 16504 (August 15, 1972) (hereinafter Policy Statement ). 3

In this case we review FDA's decision to take no action--either investigatory or regulatory-

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--against the unapproved use of approved drugs in state capital punishment systems. Appellants, eight prison inmates under sentence of death in Texas and Oklahoma, 4 claim that FDA has arbitrarily and capriciously refused to prevent the use of drugs not proven "safe and effective" as a means of human execution. 5 Their petition to FDA asserted that use of barbiturates and paralytics as capital punishment devices, without prior FDA approval, violates the "new drug" and "misbranding" provisions of FDCA, see 21 U.S.C. Secs. 352, 355. 6 FDA, in response, asserted that its jurisdiction did not extend to the regulation of state-sanctioned use of lethal injections and that, even if it did, FDA would, as a matter of its inherent enforcement discretion, undertake no investigatory or regulatory activity. Letter dated July 7, 1981 from the Commissioner to appellants' counsel (hereinafter Letter from the Commissioner), Joint Appendix (JA) 86-89. The District Court granted summary judgment against appellants' challenge to FDA's inaction. See Memorandum Opinion filed August 30, 1982 in D.D.C. Civil Action No. 81-2265 (hereinafter Dist.Ct.Op.), JA 215-231. Because we believe that FDA arbitrarily and capriciously refused to exercise its regulatory jurisdiction, we vacate the District Court's judgment and remand the case to it for further action consistent with this opinion.

I. BACKGROUND

During the last six years at least five states, including Texas and Oklahoma, have enacted statutes adopting lethal injection as a means of human execution. 7 Prisons in these five states house over 200 of the approximately 1,100 persons sentenced to death in the United States, and at least six other states (with 300 persons on death row) apparently are considering adopting lethal injection as a means of capital punishment. 8 On December 7, 1982 Texas became the first state to actually administer a lethal injection to a condemned inmate. 9

Because the lethal injection statutes authorize state prison officials to make unapproved use of drugs distributed in interstate commerce, appellants petitioned FDA to enforce the Act against the states. 10 Their December 19, 1980 petition recited the known evidence concerning lethal injection, which strongly indicates that such drugs pose a substantial threat of torturous pain to persons being executed. ROYAL COMMISSION ON CAPITAL PUNISHMENT, 1949-1953 REPORT (1953), Exhibit 1 to Letter dated December 19, 1980 from counsel for appellants to the Secretary of Health and Human Services (hereinafter Letter to the Secretary), JA 34-40. Appellants appended to their petition affidavits of leading medical and scientific experts which aver that there is no "expert consensus" founded upon "substantial evidence" that these drugs will produce death quickly and without pain and

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discomfort. Exhibit 2 to Letter to the Secretary, JA 43-83. Indeed, these affiants were not aware of any published data or investigations that would establish the effectiveness of such drugs for lethal injection. Id. With this evidence as grounds, appellants requested that FDA take the following actions:

1. Affix a boxed warning to the labels of the drugs specified for use in a lethal injection by statutes or prison policies in Texas, Oklahoma, Idaho and New Mexico that these drugs are not approved for use as a means of execution, are not considered safe and effective as a means of execution, and should not be used as a means of execution[;]

2. Prepare and send to the manufacturers of the drugs and to prisons and departments of corrections in Texas, Oklahoma, Idaho and New Mexico * * * notices advising that the drugs specified in those states' execution statutes or prison policies for use in an execution as well as any other drug or drugs are not approved for use as a means of execution, are not considered safe and effective as a means of execution, and should not be used as a means of execution;

3. Place in the Drug Bulletin an article advising that the drugs specified for use in a lethal injection by statutes or prison policies in Texas, Oklahoma, Idaho and New Mexico are not approved for use as a means of execution, are not considered safe and effective as a means of execution, and should not be used as a means of execution;

4. Adopt a policy and procedure for the seizure and condemnation from prisons or state departments of corrections of drugs which are destined or held for use as a means of execution; [and]

5. Recommend the prosecution of manufacturers, wholesalers, retailers and pharmacists who knowingly sell drugs for the unapproved use of lethal injection and prison officials who knowingly buy, possess or use drugs for the unapproved use of lethal injections.

Letter to the Secretary at 18-19, JA 31-32. In addition, appellants requested an evidentiary hearing on any issue of controlling fact. Id. at 19, JA 32. 11

On July 7, 1981 the Commissioner of FDA, by letter, refused to take any of the actions requested in appellants' petition. Letter from the Commissioner at 2, JA 87. Rather than investigate appellants' claims, the Commissioner asserted that FDA's jurisdiction did not extend to the regulation of state-sanctioned use of lethal injections. Id. Indeed, because these were "duly authorized statutory enactments [that furthered] * * * proper State functions," the Commissioner indicated that, even if it had jurisdiction, FDA would not gather any evidence or pursue any enforcement. Id. at 3, JA 88. He noted two reasons for refusing to investigate or to enforce: (1) the case law on the unapproved use of drugs otherwise approved by FDA was not uniform, and (2) FDA had a policy of not initiating enforcement action against unapproved uses of approved drugs absent "serious danger to the public health." Id. The Commissioner could find no such "danger" where a state had properly enacted a capital punishment law. Id.

On September 16, 1981 appellants filed suit in the District Court seeking to compel FDA to fulfill its statutory obligation to investigate and to regulate the unapproved use of approved drugs in human execution systems. After limited discovery, both appellants and FDA filed cross-motions for summary judgment.

On August 30, 1982 the District Court granted summary judgment to FDA. The court declined to decide the jurisdictional issue, but went on to hold that "decisions of executive departments and agencies to refrain from instituting investigations and enforcement proceedings are essentially unreviewable by the courts." Dist.Ct.Op. at 10, JA 224 (emphasis in original). Thus FDA's "decision to refrain from interfering with the implementation of state capital punishment statutes constitutes a defensible

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exercise of [its] considerable investigative and enforcement discretion * * *." Id. at 2, JA 216. The District Court noted that the Commissioner had explained FDA's reasons for not acting, id. at 13, JA 227, and, though the court could not review these reasons for their rationality, 12 it therefore found that FDA had not completely abdicated its statutory responsibilities, id. at 15, JA 229.

Larry Leon Chaney and the other seven prisoners then filed this appeal.

II. FDA'S JURISDICTION OVER LETHAL INJECTIONS

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