Benten v. Kessler

Decision Date14 July 1992
Docket NumberNo. CV-92-3161 (CPS).,CV-92-3161 (CPS).
Citation799 F. Supp. 281
PartiesLeona BENTEN, on behalf of herself and all others similarly situated, Dr. Louise B. Tyrer, and Lawrence Lader, Plaintiffs, v. David KESSLER, in his official capacity as Commissioner of the Food and Drug Administration, Carol Hallett, in her official capacity as Commissioner of the Bureau of Customs, Anthony Liberta, in his official capacity as Regional Commissioner of Customs for New York, and Robert K. Hering, FDA Compliance Officer, Defendants.
CourtU.S. District Court — Eastern District of New York

The Center for Reproductive Law & Policy by Simon Heller, Rachael Pine, Lynn Paltrow, and Catherine Albisa and Lefrak Newman & Myerson by Marshal Beil, New York City, for plaintiffs.

Stuart M. Gerson, Asst. Atty. Gen., Civ. Div., Office of Consumer Litigation U.S. Dept. of Justice by Drake Cutini and Deborah S. Smolover, Washington, D.C. and Andrew J. Maloney, U.S. Atty., E.D.N.Y. by Paul Weinstein, Asst. U.S. Atty., Brooklyn, N.Y., for defendants.

MEMORANDUM DECISION AND ORDER

SIFTON, District Judge.

This was a lawsuit waiting to happen. The record before this Court reveals a history of political and bureaucratic timidity mixed with well-intentioned blundering in dealing with two of the most charged and significant issues of our time: AIDS and abortion. A well-intentioned effort to except personal use of untested AIDS drugs from the new drug testing requirements imposed by Congress was adopted by the Food and Drug Administration ("FDA") without the notice of rule making and opportunity for comments that such decisions require. The absence of notice and public comment itself resulted in the ill-considered promulgation of an exception to the new drug testing requirements for drugs imported for personal use of such breadth as to include on its face the importation of an abortion drug never before approved for distribution in this country. In the face of political outcry, a retreat was ordered by the FDA, again without the investigation, notice or comment required by law. Now, a plaintiff has taken advantage of this sink of illegality to relieve her own understandable anxieties over employing surgical procedures to end her unwanted pregnancy. She has imported the abortion drug under the personal use exception, alleging that the ban on importation of that drug was illegally promulgated by the FDA.

She is right that the FDA has proceeded illegally, and she is entitled to the narrower relief she seeks, namely, the release of the drug to her. The broader remedy she asks for has not, at this juncture, been demonstrated to be necessary. The still larger question, whether RU486 should be available to women in this country, generally, is not before this Court for decision but should promptly be addressed by the agency assigned the task of resolving it according to the legal procedures mandated by Congress for resolving such issues.

* * *

This action—brought by plaintiffs Leona Benten, Dr. Louise B. Tyrer, and Lawrence Lader, pursuant to the Administrative Procedure Act, 5 U.S.C. §§ 706(2)(A) and 553, 21 C.F.R. § 10.70, and the United States Constitution—seeks to secure the return of a small quantity of the abortifacient drug Mifepristone, known colloquially as RU486, seized by the defendants from two of the plaintiffs on July 1, 1992, at John F. Kennedy International Airport. In addition, the complaint seeks to enjoin the enforcement of a ban on the importation of the drug.

The matter is currently before the Court on an application by plaintiffs seeking preliminary relief in the form of an order directing the immediate return of the drug to Ms. Benten so that she can, under the supervision of her personal physician, Dr. Tyrer, use it to terminate her pregnancy prior to July 18, 1992, after which date the drug can no longer be employed for that purpose. In addition, plaintiffs seek an order restraining defendants from implementing a ban on the importation of RU486 pending the trial of this action.

This matter is being determined on the basis of the papers, including affidavits from the plaintiffs and others, submitted by both sides without an evidentiary hearing, with the parties' consent.1

Having considered the affidavits and exhibits as well as the factual arguments presented both in the papers in support of and in opposition to the motion and at a hearing held on July 10, 1992, I find that plaintiffs are entitled to part of the emergency relief they seek, that is, the return of the medication for the purposes and according to the protocol set forth in plaintiff Tyrer's affidavit of July 6, 1992. The broader preliminary relief sought by the plaintiffs is, at this juncture, denied. What follows sets forth the findings of fact and conclusions of law on which these determinations are based as required by Rule 65(a) of the Federal Rules of Civil Procedure.

BACKGROUND

Plaintiff, Leona Benten, is a twenty-nine-year-old resident of California who is currently in her seventh week of an unwanted pregnancy. She has been pregnant before and in mid-1983 underwent a surgical abortion in a hospital ward in Oakland, California, under general anaesthesia.

Shortly after Ms. Benten became aware of her pregnancy, she consulted with her gynecologist, plaintiff Louise Tyrer, a physician licensed in New York and California and Board Certified in Obstetrics and Gynecology, to determine if she could terminate her pregnancy by medical means not involving surgery. After appropriate testing and examination, Dr. Tyrer, who, I find, is fully familiar with the uses, protocols for use, contraindications, and side effects of the drug, determined that Ms. Benten was an appropriate candidate for the administration of Mifepristone, known as RU486.

RU486 is a medical abortifacient approved and in general use in Great Britain and France, where, it is reported to have extraordinary success in achieving complete abortion and to pose acceptable health risks. L. Silvestre et al., "Voluntary Interruption of Pregnancy with Mifepristone (RU 486) and a Prostaglandin Analogue: A Large-Scale French Experience," 322 New England J. Med. 645 (1990); Michael Klitsch, Antiprogestins and the Abortion Controversy: A Progress Report, 23 Fam. Plan.Persp. 275 (1991).

RU486 is only recommended for use under medical supervision. It can be used to induce an abortion without surgical intervention or hospitalization. Therefore, RU486 abortions can be done in the privacy of one's home. However, RU486 is only recommended for use during the first eight weeks of pregnancy. The procedure involves the ingestion of 600 milligrams of Mifepristone on an empty stomach, followed forty-eight hours later by the ingestion of Cytotec (or another prostaglandin), a prescription drug generally available in the United States. The amniotic sac is generally passed as part of a flow of blood and clots several hours after the second medication is taken.

Surgical abortion (the alternative method of ending pregnancy commonly used in the United States) is not generally recommended until the eighth week of pregnancy. Surgical abortion is generally performed at a clinic or hospital.2

Having explained the procedure, the risks of failure, and side effects of RU486 and having obtained plaintiff Benten's consent, Dr. Tyrer prescribed the requisite dosage. Plaintiff Benten, in the company of plaintiff Lader, traveled to London, where they filled the prescription. On July 1, having alerted defendants that she would be arriving with the drug and would be seeking to import it under an exception to the ban on the importation of untested drugs described more at length hereinafter, she was met at Customs by representatives of the FDA and of Customs who seized the drug and furnished plaintiff Benten with a notice of detention describing as the "Reason for Detention: Automatic Detention, Alert 66-47, RPM."

Regulatory Scheme

In order to understand the legal morass in which the FDA has fallen in this area, it is necessary to have some understanding of how new drugs such as RU486 are regulated in this country. As a general matter, such drugs must be approved by the FDA before they may be distributed in the United States under the Federal Food, Drug and Cosmetic Act. ("FDCA"), 21 U.S.C. §§ 301 et seq. However, since Congress has not given the FDA the resources or the authority to conduct the large-scale laboratory, animal, and human studies necessary to determine the safety and effectiveness of new drugs, the burden has been placed on drug companies to come forward, sponsor the drug, and test it, submitting either a new drug application, 21 U.S.C. § 355(a)(d), or an investigational new drug application, 21 U.S.C. § 355(i), to obtain FDA approval.

The FDA possesses the authority to prohibit the importation of drugs not approved pursuant to this process, 21 U.S.C. § 381(a)(3), although it also possesses the authority in its discretion to allow the importation of new drugs which have not gone through this approval process. Id.; Heckler v. Chaney, 470 U.S. 821, 105 S.Ct. 1649, 84 L.Ed.2d 714 (1985); Community Nutrition Inst. v. Young, 818 F.2d 943, 950 (D.C.Cir.1987).

In July 1988, the FDA exercised this discretion compassionately to promulgate a revision of its Regulatory Procedures Manual ("RPM") addressing the situation of persons suffering from the AIDS epidemic and persons suffering from cancer who sought to import by mail small doses of untested drugs from abroad for personal use for their conditions under the supervision of their physician, in situations in which there was no reason to suspect that the persons were the victims of quacks or that the drugs posed an unacceptable risk to health. This program was announced as a temporary change in the regulations generally prohibiting the importation of unapproved drugs, and the announcement stated that, if the project "proves successful, with no significant problems, Chapter 9-71 of the Regulatory...

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