United States v. Rutherford
Unites States - Defendant vs. Glen L Rutherford on behalf of Terminally Ill Cancer Patients: Plaintiffs
No. 78-605
Supreme Court of the United States
442 U.S. 544
Argued: April 25th, 1979; Decided: June 18th, 1979

Facts of the Case:
In 1975, terminally ill cancer patients filed suit urging the government to stop interfering with the marketing and distribution of the cancer drug, Laetrile. Laetrile at the time was available outside the US and was believed to be an effective cancer treatment. It was derived from an extract of apricot pits and almonds. These terminally ill patients felt this drug was their last option. The FDA blocked approval under the Federal Food Drug and Cosmetic Act because it was waiting on further clinical research for efficacy and safety of this drug. The district court ordered the government to permit purchases of the drug by a plaintiff when it was found that Laetrile was nontoxic at normal doses. The Court of Appeals had the District Court ask the FDA to determine if Laetrile was considered a “new drug” in addition to determining if it was exempt from the Food Drug and Cosmetic Act’s two grandfather clauses on premarketing approvals. The Commissioner of the FDA determined Laetrile was a new drug by definition and was not exempt under either of the grandfather clauses. The District Court concluded that Laetrile was considered a new drug but was allowed exemption from the 1962 grandfather clause. The district court also felt the FDA “infringed constitutionally protected privacy interests by denying cancer patients’ access to Laetrile.”

Key Issue and Court Decision:
The question of this case was can the Food Drug and Cosmetic Act prohibit terminally ill cancer patients from obtaining Laetrile due to no FDA approval for safety and efficacy? The Court of Appeals upheld the District Court decision because