Rutherford v. United States
438 F. Supp. 1287, 1977 U.S. Dist. LEXIS 12577 (1977)
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Rule of Law:
A substance is exempt from "new drug" status under the 1962 grandfather clause of the Federal Food, Drug, and Cosmetic Act if, prior to October 10, 1962, it was commercially used, marketed for the same uses, and generally recognized by qualified experts as safe for those uses. Furthermore, individuals possess a constitutional right to privacy that encompasses making personal healthcare decisions, including the choice to use a non-toxic, unproven remedy, especially for a terminal illness where conventional treatments have been exhausted or rejected.
Facts:
- Amygdalin (later called Laetrile) was first isolated by French chemists in 1830.
- Reports of Amygdalin's employment in the treatment of cancer were first published in 1845 and 1846.
- In 1949, doctors utilizing Amygdalin as a cancer treatment in the United States coined the term "Laetrile."
- Prior to October 10, 1962, Laetrile (Amygdalin) was commercially used and sold in the United States for the treatment of cancer.
- Before October 10, 1962, Laetrile was generally recognized by qualified experts as safe for use in the treatment of cancer.
- Many individuals suffering from terminal cancer have exhausted conventional treatment options and seek Laetrile for comfort or hope, sometimes by traveling to other countries for treatment.
- On July 29, 1977, the FDA Commissioner announced that Laetrile is not generally recognized by qualified experts as a safe and effective cancer drug and is not exempt from pre-market approval requirements, concluding its distribution in interstate commerce is illegal.
Procedural Posture:
- Plaintiffs, including Glen Rutherford, brought a lawsuit against the Food and Drug Administration (FDA) to challenge its restrictions on Laetrile.
- The U.S. District Court for the Western District of Oklahoma (trial court) initially ordered the FDA to develop an administrative record regarding Laetrile in Rutherford v. United States, 424 F.Supp. 105 (W.D.Okl.1977).
- The U.S. Court of Appeals for the Tenth Circuit (intermediate appellate court) affirmed in part, reversed in part, and remanded the case, holding that the FDA must support its 'new drug' determination with substantial evidence and noting the existence of 'grandfather' exemptions in Rutherford v. United States, 542 F.2d 1137 (10th Cir. 1976).
- On remand, the FDA Commissioner, on July 29, 1977, issued a decision reaffirming that Laetrile is not generally recognized as safe and effective and is not exempt from the pre-market approval requirements for new drugs.
- Plaintiffs then challenged this administrative decision of the Commissioner in the U.S. District Court for the Western District of Oklahoma.
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Issue:
Is the Food and Drug Administration's (FDA) determination that Laetrile is a "new drug" lawful and constitutional, or does Laetrile qualify for exemption under the Act's "grandfather clause," and is the FDA's prohibition on its use a violation of patients' fundamental right to privacy in healthcare decisions?
Opinions:
Majority - Bohanon, District Judge
No, the FDA's determination that Laetrile is a "new drug" is unlawful and unconstitutional. The Commissioner’s decision of July 29, 1977, is arbitrary, capricious, an abuse of discretion, and not in accordance with law, and its enforcement procedures violate plaintiffs' constitutional rights. The court first affirmed that Laetrile is a "drug" because its well-recognized intended use is for the treatment of cancer, fitting the statutory definition of 21 U.S.C. § 321(g)(1)(B). While acknowledging a fierce debate and controversy among medical professionals regarding Laetrile's efficacy and finding that the Commissioner’s conclusion that Laetrile is not "generally recognized as safe and effective" was not arbitrary and capricious, this point was not dispositive for determining "new drug" status. Crucially, the court found that Laetrile is exempt from "new drug" requirements under the 1962 "grandfather clause" (Pub.L. 87-781, § 107(c)(4), reprinted at 21 U.S.C. § 321, n.). The administrative record established that Laetrile (Amygdalin) had been commercially used and sold in the U.S. for cancer treatment for over 25 years prior to October 10, 1962, and was generally recognized by qualified experts as safe for such use. The court rejected the FDA's interpretation that a drug for a life-threatening disease must be recognized as both safe and effective to qualify for the 1962 exemption, noting that the 1962 amendments were the first to give FDA power to scrutinize effectiveness. The court found the record insufficient to qualify Laetrile under the 1938 grandfather clause. Furthermore, the court held that the FDA's proscription of Laetrile violated patients' constitutional right to privacy. Citing Roe v. Wade and Doe v. Bolton, the court recognized a fundamental right of personal privacy, including the freedom to care for one's health and person and to select a healthcare approach. This right, particularly for terminally ill patients for whom no orthodox cure is available, extends to enlisting non-toxic, unconventional treatments recommended by a physician. The court reasoned that regulation of such fundamental rights requires a "compelling state interest" and must be "narrowly drawn." By denying access to a non-toxic substance for personal health-care, the FDA offended this constitutional right. The court clarified that this ruling does not prevent FDA from combating false or fraudulent advertising.
Analysis:
This case marked a significant, albeit temporary, challenge to the FDA's authority by carving out a constitutional right to personal healthcare decisions, particularly for unproven, non-toxic treatments for terminal illnesses. It clarified the application of the 1962 "grandfather clause," emphasizing that pre-1962 drugs only needed to be generally recognized as safe, not necessarily effective, for exemption from new drug status. This ruling initially empowered patients to access alternative treatments and constrained FDA's ability to prohibit substances based solely on a lack of proven efficacy, influencing debates on patient autonomy and experimental remedies. However, this aspect of the ruling would later be overturned by the Supreme Court in United States v. Rutherford (1979), which held that the FDCA did not create an exception for terminally ill patients and did not violate a right to privacy, limiting the broader constitutional implications of this District Court decision.
