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Allocation of Artificial Hearts in the Year 2002: Minerva v. National Health Agency

Published online by Cambridge University Press:  29 April 2021

George J. Annas
George J. Annas*
Affiliation:
Harvard College; 1970, Harvard Law School; 1972, Harvard School of Public Health; Center for Law and Health Sciences, Boston University; Boston University School of Medicine
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Abstract

The rapid growth of medical technology gives rise to difficult dilemmas concerning the appropriateness of, and access to, new equipment and devices capable of maintaining life or improving its quality. Such a dilemma already exists, for example, with regard to kidney dialysis machines. In 1972, Congress amended the Social Security Act to make such machines available under Medicare to all who needed them. But almost immediately the overwhelming cost of such equipment—in the billions of dollars—made the original appropriations totally inadequate, and prompted serious questions of whether access to kidney dialysis should be made available at public expense—and, if so, to whom.

This Comment takes the reader 25 years into the future through the medium of a hypothetical U.S. Supreme Court decision** regarding a federal health agency's regulations that establish a system for allocating artificial hearts to those whose lives can be lengthened by implantation. The author assumes that a national health insurance system has been enacted and implemented, that all physicians are employees of the federal government, and that the enabling legislation has placed broad powers in the hands of the federal government to regulate the development and allocation of scarce and expensive medical resources. The opinions of the various Supreme Court Justices reflect a broad range of legal and ethical viewpoints, and—in keeping with the difficult, indeed frightening, life-or-death issues involved—are often intensely personal in nature.

Type
Comments
Information
American Journal of Law & Medicine , Volume 3 , Issue 1 , Spring 1977 , pp. 59 - 76
Copyright
Copyright © American Society of Law, Medicine and Ethics and Boston University 1977

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Footnotes

A version of this Comment was originally prepared for the Boston University Program on Public Policy for Quality Health Care's November 1976 Conference on Health Care Technology and Quality of Care under the title Rationing Health Technology: Legal and Ethical Issues, copyright 1976 by George J. Annas. This Comment copyright© 1977 by George J. Annas and the American Journal of Law & Medicine.

**

Footnotes in this Comment are to be read as footnotes to the various hypothetical written opinions of the Supreme Court Justices. To comply with JOURNAL style, the footnotes below are numbered consecutively. In an actual Supreme Court case, of course, each Justice's written opinion would have its own set of consecutively numbered footnotes.

References

1 21 C.F.R. 324.885 (1)-(2) (1998). The government has had similar schemes under study for more than three decades. See, e.g., Dep't of Health, Education, and Welfare, Pub. No. (NIH) 74-191, The Totally Implantable Artificial Heart: A Report of the Artificial Heart Assessment Panel of the National Heart and Lung Institute (June 1973); Katz, J. & Capron, A. M., Catastrophic Diseases: Who Decides What? 184–196 (1975)Google Scholar; and Moore, F., Transplant: The Give and Take of Tissue Transplantation 107, 287 (1972)Google Scholar.

2 Van Alstyne, , The Demise of the Right-Privilege Distinction in Constitutional Law, 81 Harv. L. Rev. 1439, 1454-55 (1968)CrossRefGoogle Scholar, citing Weiman v. Updegraff, 344 U.S. 183, 192 (1952). In Weiman this Court struck down a state loyalty oath which the Court read as not containing a scienter requirement, saying, “we need not pause to consider whether an abstract right to public employment exists. It is sufficient to say that constitutional protection does extend to the public servant whose exclusion pursuant to a statute is patently arbitrary or discriminatory.“

3 See generally Note, Developments in the Law—Equal Protection, 82 Harv. L. Rev. 1065 (1969)CrossRefGoogle Scholar.

4 Cf. Ross v. Moffitt, 417 U.S. 600 (1974) (equal protection does not require absolute equality, only freedom from unreasonable distinctions).

5 The plaintiffs suggest that there may also be an unconstitutional delegation of Congressional authority to the National Health Agency in permitting them to establish an allocation scheme based on arguably arbitrary criteria devised without Congressional guidance or standards. While this is an interesting argument, it is one we have consistently rejected since 1935, the date of the last cases holding a Congressional delegation of authority improper. Panama Refining Co. v. Ryan, 293 U.S. 388, and A.L.A. Schechter Poultry Corp. v. United States, 295 U.S. 495. As we stated in 1940, and consistently thereafter, “Delegation by Congress has long been recognized as necessary in order that the exertion of legislative powers does not become a futility.” Sunshine Anthracite Coal Co. v. Adkins, 310 U.S. 381. While “an unnecessarily broad delegation could combine with encroachment on other protected constitutional interests to create an unconstitutional result” we will not hold any responsible delegation of authority unconstitutional. Davis, Administrative Law § 2.01.

6 As our predecessor Oliver Wendell Holmes so aptly stated, “The law does all that is needed when it does all it can.…“ Buck v. Bell, 274 U.S. 200, 208 (1927).

7 For a brilliant discussion of this concept, see Fuller, , The Case of the Speluncean Explorers, 62 Harv. L. Rev. 616 (1949)CrossRefGoogle Scholar.

8 United States v. Holmes, 26 F. Cases 360, 367 (Cir. Ct. Pa. 1842). See also Holmes v. N.Y. City Housing Authority, 398 F.2d 262 (2d Cir. 1968) (the court indicated it would approve an allocation scheme in public housing based on a first-come, first-serve basis with certain specified exceptions).

9 See Dukeminier, and Sanders, , Legal Problems in Allocation of Scarce Medical Resources: The Artificial Kidney, 127 Arch. Intern. Med. 1133, 1134 (1971)CrossRefGoogle Scholar.

10 Barnard, C. & Pepper, C. B., One Life 311 (1969)Google Scholar.

11 Quoted in Thorwald, J., The Patients 402 (1972)Google Scholar.

12 In this regard it is my view that while a deductible of one year's income would help to measure “desire,” it would not significantly reduce the number of applicants since money becomes less meaningful as the time available to spend it decreases.

13 The plaintiff Minerva is one of the few exceptions to this rule.

14 Glantz, , Patient Selection for Artificial Hearts: The First Year, 28 Am. J. Law & Med. 232 (2001)Google Scholar.

15 Also quoted in Fox, R. and Swazey, J., The Courage to Fail 246 (1974)Google Scholar.

16 Sanders, and Dukeminier, , Medical Advance and Legal Lag: Hemodialysis and Kidney Transplantation, 15 U.C.L.A. L. Rev. 357 (1968)Google Scholar.

17 Note, Patient Selection for Artificial and Transplanted Organs, 82 Harv. L. Rev. 1322, 1339 (1969)CrossRefGoogle Scholar.

18 See, e.g., Childress, Who Shall Live When Not All Can Live?, 53 Soundings 339, 347-53 (1970)Google Scholar. See generally Shaw, G. B., The Doctor's Dilemma (1913)Google Scholar.

19 Communication from Zeno II Tracker Station, NASA Classified Document 2119652 (level of classification is classified) (quoted with permission of the Director).

20 Cf. McGautha v. California, 402 U.S. 183, 196 (1971), in which U.S. Supreme Court rejected the argument that “to leave a jury completely at large to impose or withhold the death penalty as it sees fit is fundamentally lawless and therefore violates the basic command of the fourteenth amendment that no state shall deprive a person of his life without due process of law.” The Court found that there was no offense against the Constitution, especially in light of “the present limitations on human knowledge” in drafting standards.

21 It is worth noting that the scheme does not demand that patients be compared with one another, but only that they themselves meet certain criteria. Thus, there is no real need or incentive for patients to challenge the selection of other patients (although increases in the number of patients in the pool will decrease their individual odds of being chosen for an artificial heart). This, and the fact that it could delay individual choices for years, mandate that patient-applicants not be permitted to challenge other patients, to cross-examine their physicians and other witnesses, or to obtain injunctions against their selection. In denying applicants these rights, the Agency acted properly and wisely.

22 Swift, Gulliver's Travels.

23 While no real market system now exists in health care, of course, since the government owns all the means of production and most health care professionals are government employees, this does not preclude the existence of a market for some medical devices, just as there remains the existence of a market for some drugs, such as marijuana and heroin.