43 Cited authorities

Ashcroft v. Iqbal
556 U.S. 662 (2009) Cited 255,314 times 280 Legal Analyses
Holding that a claim is plausible where a plaintiff's allegations enable the court to draw a "reasonable inference" the defendant is liable
Bell Atl. Corp. v. Twombly
550 U.S. 544 (2007) Cited 269,063 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' "
Medtronic, Inc. v. Lohr
518 U.S. 470 (1996) Cited 2,420 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"
Riegel v. Medtronic, Inc.
552 U.S. 312 (2008) Cited 1,034 times 62 Legal Analyses
Holding that a State’s “‘requirements’” “includ[e] [the state’s] common-law duties”
Buckman Co. v. Plaintiffs' Legal Committee
531 U.S. 341 (2001) Cited 1,188 times 80 Legal Analyses
Holding that federal drug and medical device laws pre-empted a state tort-law claim based on failure to properly communicate with the FDA
Heckler v. Chaney
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]"
Cafasso v. General Dynamics C4 Systems
637 F.3d 1047 (9th Cir. 2011) Cited 2,526 times 15 Legal Analyses
Holding a complaint failed to satisfy Rule 9(b) where the allegations were lacking in detail
Bates v. Dow Agrosciences LLC
544 U.S. 431 (2005) Cited 550 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
Funk v. Stryker Corp.
631 F.3d 777 (5th Cir. 2011) Cited 850 times 1 Legal Analyses
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
Telesaurus VPC, LLC v. Power
623 F.3d 998 (9th Cir. 2010) Cited 405 times
Holding that a plaintiff should have leave to amend where such an amendment would not be futile
Rule 12 - Defenses and Objections: When and How Presented; Motion for Judgment on the Pleadings; Consolidating Motions; Waiving Defenses; Pretrial Hearing
Fed. R. Civ. P. 12 Cited 348,617 times 930 Legal Analyses
Granting the court discretion to exclude matters outside the pleadings presented to the court in defense of a motion to dismiss
Rule 9 - Pleading Special Matters
Fed. R. Civ. P. 9 Cited 39,122 times 321 Legal Analyses
Requiring that fraud be pleaded with particularity
Section 360k - State and local requirements respecting devices
21 U.S.C. § 360k Cited 1,027 times 21 Legal Analyses
Authorizing the FDA to determine the scope of the Medical Devices Amendments' pre-emption clause
Section 360c - Classification of devices intended for human use
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 . . ."
Section 337 - Proceedings in name of United States; provision as to subpoenas
21 U.S.C. § 337 Cited 671 times 19 Legal Analyses
Restricting FDCA enforcement to suits by the United States
Section 360e - Premarket approval
21 U.S.C. § 360e Cited 494 times 17 Legal Analyses
Granting FDA authority to conduct hearings regarding PMA withdrawal
Section 396 - Practice of medicine
21 U.S.C. § 396 Cited 83 times 12 Legal Analyses
Contemplating off-label uses of devices by physicians
Section 814.39 - PMA supplements
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"

Eidson v. Medtronic, Inc. et al

43 Cited authorities

Holding that a claim is plausible where a plaintiff's allegations enable the court to draw a "reasonable inference" the defendant is liable

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' "

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"

Holding that a State’s “‘requirements’” “includ[e] [the state’s] common-law duties”

Holding that federal drug and medical device laws pre-empted a state tort-law claim based on failure to properly communicate with the FDA

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]"

Holding a complaint failed to satisfy Rule 9(b) where the allegations were lacking in detail

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

Holding that a plaintiff should have leave to amend where such an amendment would not be futile

Granting the court discretion to exclude matters outside the pleadings presented to the court in defense of a motion to dismiss

Requiring that fraud be pleaded with particularity

Authorizing the FDA to determine the scope of the Medical Devices Amendments' pre-emption clause

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 . . ."

Restricting FDCA enforcement to suits by the United States

Granting FDA authority to conduct hearings regarding PMA withdrawal

Contemplating off-label uses of devices by physicians

Authorizing medical device manufacturers to change labels to "add or strengthen a contraindication, warning, precaution, or information about an adverse reaction"