initial determination

Two minors brought suit against Merrell Dow Pharmaceuticals, claiming they suffered limb reduction birth defects because their mothers had taken Bendectin, a drug prescribed for morning sickness to about 17.5 million pregnant women in the United States between 1957 and 1982. Limb reduction defects occur in fewer than one birth out of every 1000. Scientists do not know the mechanism by which any teratogen causes such defects. The plaintiffs offered testimony from three groups of experts. One group proposed to testify to a statistical link between Bendectin ingestion during pregnancy and limb reduction defects based on reanalyses of published studies that had reported no such association. A second group proposed to testify that Bendectin causes limb reduction defects in humans because it causes such defects in laboratory animals. A third group proposed to testify based on the similarity of Bendectin's chemical structure to other drugs suspected of causing birth defects. The district court granted summary judgment to Merrell Dow after excluding the plaintiffs' expert testimony. The Ninth Circuit affirmed that decision. The Supreme Court granted certiorari, reversed, and remanded for consideration under Federal Rule of Evidence 702. On remand, the Ninth Circuit examined the affidavits and prior trial testimony of the plaintiffs' experts. None of the experts had studied the effect of Bendectin on limb reduction defects before being hired to testify in this or related cases. None had published his work on Bendectin in a scientific journal. The only review their work had received was by judges and juries. Plaintiffs' epidemiological experts made vague assertions of a statistically significant relationship between Bendectin and birth defects but did not state that the relative risk exceeded two. With the exception of Dr. Palmer, the remaining experts were willing to testify only that Bendectin is capable of causing birth defects. Dr. Palmer alone was willing to testify that Bendectin did cause the limb defects in each of the children, based on his review of the plaintiffs' medical records and his conclusion that Bendectin is a teratogen.

George Eldridge was first awarded Social Security disability benefits in June 1968. In March 1972 he received a questionnaire from the state agency charged with monitoring his medical condition. He completed and returned the questionnaire, indicating that his condition had not improved and identifying recent medical sources. The state agency obtained reports from his physician and a psychiatric consultant. After reviewing those reports and other information in his file, the agency sent Eldridge a letter stating that it had made a tentative determination that his disability had ceased in May 1972. The letter included a statement of reasons for the proposed termination and advised Eldridge that he could request time to submit additional information. Eldridge responded in writing, disputing one characterization of his medical condition and asserting that the agency already possessed sufficient evidence of his disability. The state agency then made a final determination that Eldridge had ceased to be disabled in May 1972; the Social Security Administration accepted that determination. In July 1972 Eldridge received written notice that his benefits would terminate after that month and that he could seek reconsideration by the state agency within six months. Instead of requesting reconsideration, Eldridge filed suit in the United States District Court for the Western District of Virginia. He challenged the constitutionality of the Secretary's termination procedures and sought an injunction barring termination of benefits until a pretermination evidentiary hearing was provided, together with immediate reinstatement of benefits. The District Court held that the existing procedures violated the Fifth Amendment's Due Process Clause, ordered the Secretary to provide Eldridge a pretermination hearing, and directed reinstatement of benefits pending that hearing. The Court of Appeals for the Fourth Circuit affirmed. The Supreme Court noted probable jurisdiction and heard the case.

By the late 1970s, spent nuclear fuel had accumulated at reactor sites across the country, totaling some 8,000 metric tons with projections of 72,000 metric tons by the year 2000. Government studies indicated that several reactors could be forced to shut down in the near future due to insufficient storage capacity in on-site pools. California responded to these concerns and the absence of a permanent disposal method by amending its energy laws in 1976. In 1974 California had enacted the Warren-Alquist State Energy Resources Conservation and Development Act. The Act requires any utility seeking to construct an electric power generating plant, including a nuclear facility, to obtain certification from the State Energy Resources Conservation and Development Commission after a multi-stage review process. The Warren-Alquist Act was amended in 1976 to provide additional state regulation of new nuclear powerplant construction. This section directs the Commission to determine on a case-by-case basis that adequate storage capacity for spent fuel rods will exist when needed. Each utility must also maintain continuous on-site full core reserve storage capacity. Section 25524.2 established a moratorium on the certification of new nuclear plants. Certification is barred until the Commission finds that a demonstrated technology or means for the permanent disposal of high-level nuclear waste has been developed and approved by the United States. In 1978 petitioners Pacific Gas & Electric Co. and Southern California Edison Co. filed suit in the United States District Court for the Eastern District of California. They sought a declaratory judgment that the two sections and other provisions of the Warren-Alquist Act were pre-empted by the Atomic Energy Act of 1954. The District Court held that the petitioners had standing, that the challenges were ripe, and that both sections were invalid as pre-empted. The Court of Appeals for the Ninth Circuit affirmed standing and ripeness as to section 25524.2 but held the challenge to section 25524.1(b) unripe. On the merits, the court held that the nuclear moratorium provisions of § 25524.2 were not pre-empted because §§ 271 and 274(k) of the Atomic Energy Act constitute a congressional authorization for States to regulate nuclear powerplants for purposes other than protection against radiation hazards. The Supreme Court granted certiorari limited to the ripeness of the challenges to both sections and the pre-emption of section 25524.2.