United States v. Rutherford

Background

Terminally ill cancer patients and some spouses sued to stop the Government from blocking interstate shipment and sale of Laetrile, a drug not approved as “safe and effective.” A District Court at one point allowed limited purchases for a plaintiff, and the Tenth Circuit later approved use by certified terminal patients under strict conditions. The FDA Commissioner held public hearings and concluded Laetrile was a “new drug,” not generally recognized as safe and effective and not covered by the statute’s grandfather exceptions.

Reasoning

The central question was whether the federal drug law implicitly allows terminal patients to use an unapproved drug. The Court said the statute’s plain words make no special exception for terminally ill people. It deferred to the FDA’s long practice of applying safety and effectiveness standards to life‑threatening illnesses. The Justices explained that “effective” need not mean a cure but can mean relief, longer life, or reduced pain, and that “safe” requires weighing risks against possible benefits. The Court concluded the law applies to terminal patients and reversed the Court of Appeals, restoring the FDA’s authority to require approval.

Real world impact

The ruling prevents courts from creating a general right for terminal patients to obtain unapproved drugs like Laetrile across state lines. Patients can still seek access through regulated investigational programs, and Congress could change the law if it wishes. The case was sent back for further proceedings on other claims the lower courts did not decide.