550 U.S. 544 (2007) Cited 269,419 times 367 Legal Analyses
Holding that a complaint's allegations should "contain sufficient factual matter, accepted as true, to 'state a claim to relief that is plausible on its face' "
518 U.S. 470 (1996) Cited 2,422 times 35 Legal Analyses
Holding that the presence of a state-law damages remedy for violations of FDA requirements does not impose an additional requirement upon medical device manufacturers but "merely provides another reason for manufacturers to comply with . . . federal law"
470 U.S. 821 (1985) Cited 2,051 times 21 Legal Analyses
Holding that a statute did not provide meaningful standards because it did not "speak to the criteria which shall be used by the agency for investigating possible violations of the [statute]"
544 U.S. 431 (2005) Cited 552 times 11 Legal Analyses
Holding that a preemption clause barring state laws "in addition to or different" from a federal Act does not interfere with an "equivalent" state provision
Holding court lacked jurisdiction to consider district court's denial of plaintiff's postjudgment motions because he did not file an amended, or separate, notice of appeal
21 U.S.C. § 360c Cited 789 times 22 Legal Analyses
Instructing FDA to determine the safety and effectiveness of a "device" in part by weighing " any probable benefit to health . . . against any probable risk of injury or illness . . ."
21 C.F.R. § 814.39 Cited 152 times 4 Legal Analyses
Authorizing medical device manufacturers to change labels to "add or strengthen a contraindication, warning, precaution, or information about an adverse reaction"