title: A pivotal medical-device case.
authors.forename: Stephen M
authors.initials: SM
authors.lastname: Picca
mesh_terms: D018795:Device Approval / Q000331:legislation & jurisprudence*; D006801:Humans; D007221:Industry / Q000331:legislation & jurisprudence; D016365:Liability, Legal; D013219:State Government; D035521:Supreme Court Decisions; D014481:United States; D014486:United States Food and Drug Administration