Hostname: page-component-586b7cd67f-tf8b9 Total loading time: 0 Render date: 2024-12-04T19:32:19.488Z Has data issue: false hasContentIssue false
  • English
  • Français

Benten v. Kessler: The RU 486 Import Case

Published online by Cambridge University Press:  29 April 2021

Rachael N. Pine
Get access Rights & Permissions [Opens in a new window]

Extract

On July I, 1992, I received a phone call from a reporter asking for my response to Leona Benten's choice to defy the U.S. Food and Drug Administration's ban on RU 486 by bringing a single personal dose of the abortifacient drug into the U.S. on a flight from Europe. By the end of the day, my colleagues and I at the New York-based Center for Reproductive Law and Policy had been asked and had agreed to represent Leona and her companions, Dr. Louise Tyrer and Lawrence Lader, in their legal challenge to the import ban and, more urgently, in their effort to retrieve the RU 486 pills that were confiscated from Leona by U.S. Customs officials at the airport. Leona, who was 6 weeks pregnant and who desperately wanted to terminate her pregnancy by a non-surgical abortion method, had only two more weeks in which to use the drug according to prevailing medical protocol.

Type
Ethical and Legal Issues
Information
Law, Medicine and Healthcare , Volume 20 , Issue 3 , Fall 1992 , pp. 238 - 242
Copyright
© 1992 American Society of Law, Medicine & Ethics

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

Excerpt from a presentation by the author, Pine, Rachael N., at American Society of Law & Medicine meeting, Toronto, Canada (July 1992).Google Scholar
Complaint, Benten et al. v. Kessler et al., No. 92-3161 (E.D.N.Y. filed July 7, 1991).Google Scholar
The ban is largely symbolic in effect because the French company that manufactures RU 486, Roussel-Uclaf, has never applied to the FDA for the regulatory authority to test and distribute the drug in the U.S. Such FDA regulatory approval, following an appropriate application by the manufacturer, see note 7 infra, would be unaffected by the import ban, which applies only to drugs not approved through this process. The company's decision not to seek approval for full scale marketing of the drug is a consequence of its perception that doing so in the present political climate could present long-term economic liabilities for Roussel and its German parent company. See Reproductive Health Technologies Project, The Case for Antiprogestins at 13–14 (1992).Google Scholar
Benten, Plaintiffs Leona, Dr.Tyrer, Leona and Lade, Lawrence were represented by Heller, Simon, Esq. and the author from The Center for Reproductive Law and Policy and by Marshall Beil, Esq. of the firm of LeFrak, Newman and Myerson.Google Scholar
See Benten v. Kessler, 112 S. Ct. 1919 (1992) (denial of application to vacate stay of district court's order releasing the drugs to plaintiff Leona Benten).Google Scholar
See Memorandum Decision and Order, Benten v. Kessler, No. 92-3161 (E.D.N.Y. July 14, 1992); see discussion infra.Google Scholar
See 21 U.S.C. § 301 et seq. This regulatory approval process ordinarily follows the filing of an Investigational New Drug Application (IND), id. at § 355(a)(1), and/or a New Drug Application (NDA), id. at § 355(c), by the drug sponsor.Google Scholar
21 U.S.C. § 381(a)(3).Google Scholar
Id.; Heckler v. Chaney, 470 U.S. 821 (1985); Community National Inst. v. Young, 818 F.2d 943, 950 (D.C. Cir. 1987).Google Scholar
FDA Pilot Guidance (July 20, 1988) (revising Regulation Procedures Manual Chapter 9–71 on a pilot basis).Google Scholar
The final version of what has become known as the “personal use” rule reads in pertinent part as follows: In deciding whether to exercise discretion to allow personal shipments of drugs or devices, FDA personnel should consider a more permissive policy in the following situations: when the intended use is appropriately identified, such use is not for treatment of a serious condition, and the product is not known to represent a significant health risk; or when (1) the intended use is unapproved and for a serious condition for which effective treatment may not be available domestically either through commercial or clinical means; (2) there is no known commercialization or promotion to persons residing in the United States by those involved in the distribution of the product at issue; (3) the product is considered not to represent an unreasonable risk; and (4) the individual seeking to import the product affirms in writing that it is for the patient's own personal use (generally not more than three months supply) and provides the name and address of the doctor licensed in the U.S. responsible for his or her treatment with the product or provides evidence that the product is for the continuation of a treatment begun in a foreign country. RPM Chapter 9-71-30(C) (adopted February 1, 1989).Google Scholar
FDA Import Alert 66–813 (issued September 26, 1988).Google Scholar
FDA Import Alert 66–47 (issued June 6, 1989).Google Scholar
See generally Benten v. Kessler, No. 92–3161, slip op. at 8–12 (discussing the history of the current import ban and the political pressure that led to its issuance).Google Scholar
See FDA Import Alert 66–47 (issued June 6, 1989).Google Scholar
Id.Google Scholar
Benten v. Kessler, No. 92–3161, slip op. at 12.Google Scholar
Benten v. Kessler, 112 S. Ct. at 2931 (Stevens, J, dissenting) (Opinion of the Court did not discuss the safety record of RU 486 at all). For a complete review of the medical literature demonstrating the safety and effectiveness of RU 486 as an abortifacient when coupled with an appropriate prostaglandin, see Irving Spitz and C. Wayne Bardin, RU 486 (1992) (available from the Institute of Biomedical Research of the Population Council, New York, NY); Michael Klitsch, Antiprogestins and the Abortion Controversy: A Progress Report, 23 Fam. Plan. Persp. at 275 nn. 5–6 (1991).Google Scholar
See 5 U.S.C. § 553(b). See generally Bellarno International Limited v. Food and Drug Administration, 678 F. Supp. 410 (E.D.N.Y. 1988) (FDA import alert providing for detention and re-exportation of over-the-counter drugs found to be invalid due to lack of public notice and comment).Google Scholar
See 5 U.S.C. § 706(2)(A).Google Scholar
Citizens to Preserve Overton Park v. Volpe, 401 U.S. 402, 416 (1971).Google Scholar
Planned Parenthood of Southeastern Pennsylvania v. Casey, 112 S. Ct. 2791, 2820 (1992) (O'Connor, Kennedy, Souter, JJ.). In an opinion by Justices O'Connor, Kennedy, and Souter, the Court articulated and explained a new “undue burden” standard as follows: To protect the central right recognized by Roe v. Wade while at the same time accommodating the State's profound interest in potential life. We will employ the undue burden analysis as explained in this opinion. An undue burden exists, and therefore a provision of law is invalid, if its purpose or effect is to place a substantial obstacle in the path of a woman seeking an abortion before the fetus attains viability. Id. at 2821.Google Scholar
Tight control of access to RU 486 by its manufacturer, Roussel-Uclaf, and by the regulatory authorities of countries like Britain and France, which have approved the drug's use, insure that few women will be able to obtain even a personal dose of the drug for importation purposes.Google Scholar
Benten v. Kessler, 112 S. Ct. at 2930 (Stevens, J. dissenting).Google Scholar
While prevailing surgical methods of abortion are exceedingly safe and effective in the U.S., physical and psychological factors can render a non-surgical method, in the form of RU 486, preferable. Such drug-induced abortion is less invasive, more private and more natural, in the sense that it resembles a miscarriage. See Marge Berer, Inducing a Miscarriage: Woman-Centered Perspectives on RU 486/Prostaglandin as an Early Abortion Method (this issue).Google Scholar
See Complaint, Benten v. Kessler, No. 91–3161.Google Scholar
Benten v. Kessler, No. 92–3161, slip op. at 2.Google Scholar
Id., slip op. at 12.Google Scholar
Congressman Dornan urged, inter alia, that “[t]he U.S. government should not be involved in abetting abortion. This includes regulations that would allow the use of abortifacients such as RU 486.” Letter of Congressmen Dornan, Hyde and LaFalce to then- Commissioner of the FDA, dated May 5, 1989, cited in Benten v. Kessler, No 92–3161, slip op. at 10–11.Google Scholar
Id.Google Scholar
Id., slip op. at 24.Google Scholar
Id., slip op at 14. Responding to the goverment's suggestion that Leona and her physician simply turn around, get back on a plane, and perform the abortion procedure in a “hotel room in Paris or London,” the court noted the regulatory restrictions in these countries, the interest of Ms. Benten in obtaining her medical care at home and concluded that the suggestion “mistakes the role of equity.” Id. slip op at 15–16.Google Scholar
Id., slip op. at 16–20.Google Scholar
Id., slip op. at 20–21, citing Vargas v. INS, 938 F.2d 360, 363 (2d Cir. 1991); Detsel by Detsel v. Sullivan, 895 F.2d 58, 63–64 (2d Cir. 1990).Google Scholar
Id., slip op. at 25.Google Scholar
Id., slip op at 23. As stated above, the court was not asked to reach the constitutional issues in the context of the motion for urgent relief for Leona Benten.Google Scholar
Benten v. Kessler, 112 S.Ct. 2929.Google Scholar
112 S.Ct. at 2930.Google Scholar
Id.Google Scholar
While the Benten case as a whole is not, technically speaking, moot, for all practical purposes it may well have run its course in the courts.Google Scholar
Benten v. Kessler, 112 S.Ct. at 2930 (Stevens, J., dissenting).Google Scholar
Id. at 2931.Google Scholar
See Id. at 2930 (weighing “the relative significance of the burden [on the exercise of the constitutional right] …and the governmental interest at stake” under the Court's new “undue burden” analysis).Google Scholar
See generally Pine, Rachael N. and Law, Sylvia, Envisioning a future for Reproductive Liberty; Strategies for Making the Rights Real, 27 Harv. C.R.-C.L. 407, 441–42 (Summer 1992)Google Scholar