title: A pivotal medical-device case.
authors.forename: Henry
authors.initials: H
authors.lastname: Greenspan
mesh_terms: D018795:Device Approval / Q000331:legislation & jurisprudence*; D004869:Equipment Safety; D006801:Humans; D007221:Industry / Q000331:legislation & jurisprudence*; D007880:Legislation, Drug; D016365:Liability, Legal; D013219:State Government; D035521:Supreme Court Decisions; D014481:United States; D014486:United States Food and Drug Administration