44 Cited authorities

Ashcroft v. Iqbal
556 U.S. 662 (2009) Cited 261,602 times 281 Legal Analyses
Holding court need not credit "mere conclusory statements" in complaint
Bell Atl. Corp. v. Twombly
550 U.S. 544 (2007) Cited 274,949 times 368 Legal Analyses
Holding that allegations of conduct that are merely consistent with wrongdoing do not state a claim unless "placed in a context that raises a suggestion of" such wrongdoing
Medtronic, Inc. v. Lohr
518 U.S. 470 (1996) Cited 2,446 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 1,048 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 1,203 times 82 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
Geier v. Am. Honda Motor Co.
529 U.S. 861 (2000) Cited 798 times 16 Legal Analyses
Holding the absence of an express pre-emption clause “does not bar the ordinary working of conflict pre-emption principles”
Edwards v. Marin Park, Inc.
356 F.3d 1058 (9th Cir. 2004) Cited 1,341 times
Holding that the plaintiff's admittedly "opaque" allegations of discriminatory retaliation were sufficient to withstand a motion to dismiss
In re Medtronic, Inc., Sprint Fidelis Leads
623 F.3d 1200 (8th Cir. 2010) Cited 315 times 5 Legal Analyses
Holding "[w]here a federal requirement permits a course of conduct and the state makes it obligatory, the state's requirement is in addition to the federal requirement and thus is pre-empted."
Stengel v. Medtronic Inc.
704 F.3d 1224 (9th Cir. 2013) Cited 230 times 12 Legal Analyses
Holding that "the MDA does not preempt a state-law claim for violating a state-law duty that parallels a federal-law duty under the MDA"
Perez v. Nidek Co.
711 F.3d 1109 (9th Cir. 2013) Cited 185 times 9 Legal Analyses
Holding that because a plaintiff did not intend to have further eye surgery, he did not have standing to pursue injunctive relief under the California CLRA
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 355,868 times 945 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 39,699 times 329 Legal Analyses
Requiring that fraud be pleaded with particularity
Rule 201 - Judicial Notice of Adjudicative Facts
Fed. R. Evid. 201 Cited 29,213 times 26 Legal Analyses
Holding "[n]ormally, in deciding a motion to dismiss for failure to state a claim, courts must limit their inquiry to the facts stated in the complaint and the documents either attached to or incorporated in the complaint. However, courts may also consider matters of which they may take judicial notice."
Section 360k - State and local requirements respecting devices
21 U.S.C. § 360k Cited 1,037 times 21 Legal Analyses
Authorizing the FDA to determine the scope of the Medical Devices Amendments' pre-emption clause
Section 337 - Proceedings in name of United States; provision as to subpoenas
21 U.S.C. § 337 Cited 681 times 21 Legal Analyses
Restricting FDCA enforcement to suits by the United States
Section 803.50 - If I am a manufacturer, what reporting requirements apply to me?
21 C.F.R. § 803.50 Cited 150 times 8 Legal Analyses
Requiring device manufacturers to report adverse medical device events to the FDA

Perez v. Medtronic Incorporated et al

44 Cited authorities

Holding court need not credit "mere conclusory statements" in complaint

Holding that allegations of conduct that are merely consistent with wrongdoing do not state a claim unless "placed in a context that raises a suggestion of" such wrongdoing

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 the absence of an express pre-emption clause “does not bar the ordinary working of conflict pre-emption principles”

Holding that the plaintiff's admittedly "opaque" allegations of discriminatory retaliation were sufficient to withstand a motion to dismiss

Holding "[w]here a federal requirement permits a course of conduct and the state makes it obligatory, the state's requirement is in addition to the federal requirement and thus is pre-empted."

Holding that "the MDA does not preempt a state-law claim for violating a state-law duty that parallels a federal-law duty under the MDA"

Holding that because a plaintiff did not intend to have further eye surgery, he did not have standing to pursue injunctive relief under the California CLRA

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

Restricting FDCA enforcement to suits by the United States

Requiring device manufacturers to report adverse medical device events to the FDA