58 Cited authorities

Ashcroft v. Iqbal
556 U.S. 662 (2009) Cited 251,785 times 279 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 265,756 times 364 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 2,412 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 1,030 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 1,181 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
Swartz v. KPMG LLP
476 F.3d 756 (9th Cir. 2007) Cited 2,853 times 3 Legal Analyses
Holding that “[t]o the extent Swartz seeks a declaration of defendants' liability for damages sought for his other causes of action,” claim must be dismissed as “merely duplicative”
Kearns v. Ford Motor Co.
567 F.3d 1120 (9th Cir. 2009) Cited 2,247 times 5 Legal Analyses
Holding that circumstances constituting fraud must be stated with particularity
Fox v. Ethicon Endo-Surgery, Inc.
35 Cal.4th 797 (Cal. 2005) Cited 1,241 times 2 Legal Analyses
Holding that "[r]esolution of the statute of limitations issue is normally a question of fact."
Lazar v. Superior Court
12 Cal.4th 631 (Cal. 1996) Cited 1,657 times 3 Legal Analyses
Holding that justifiable reliance is a required element of a fraud claim
Norgart v. Upjohn Co.
21 Cal.4th 383 (Cal. 1999) Cited 1,294 times 1 Legal Analyses
Holding that the discovery rule "postpones accrual of a cause of action until the plaintiff discovers, or has reason to discover, the cause of action, until, that is, he at least suspects, or has reason to suspect, a factual basis for its elements"
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 344,855 times 920 Legal Analyses
Granting the court discretion to exclude matters outside the pleadings presented to the court in defense of a motion to dismiss
Rule 8 - General Rules of Pleading
Fed. R. Civ. P. 8 Cited 155,692 times 193 Legal Analyses
Holding that "[e]very defense to a claim for relief in any pleading must be asserted in the responsive pleading. . . ."
Rule 9 - Pleading Special Matters
Fed. R. Civ. P. 9 Cited 38,849 times 316 Legal Analyses
Permitting "[m]alice, intent, knowledge, and other conditions of a person's mind [to] be alleged generally"
Section 335.1 - Assault, battery or injury or death caused by wrongful act or negligence
Cal. Code Civ. Proc. § 335.1 Cited 2,284 times 4 Legal Analyses
Imposing two-year statute of limitations for personal injury claims
Section 360k - State and local requirements respecting devices
21 U.S.C. § 360k Cited 1,025 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 787 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 666 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 351 - Adulterated drugs and devices
21 U.S.C. § 351 Cited 340 times 32 Legal Analyses
Referencing the U.S. Pharmacopeia's strength, quality, and purity standards
Section 808.1 - Scope
21 C.F.R. § 808.1 Cited 259 times 1 Legal Analyses
Explaining that federal law preempts requirements "having the force and effect of law (whether established by statute, ordinance, regulation or court decision)."
Section 803.50 - If I am a manufacturer, what reporting requirements apply to me?
21 C.F.R. § 803.50 Cited 149 times 7 Legal Analyses
Requiring device manufacturers to report adverse medical device events to the FDA
Section 814.80 - General
21 C.F.R. § 814.80 Cited 102 times 1 Legal Analyses
Prohibiting the production or labeling of any device in a manner inconsistent with any conditions of approval specified in the approval order
Section 820.70 - [Effective until 2/2/2026] Production and process controls
21 C.F.R. § 820.70 Cited 49 times 4 Legal Analyses
Requiring manufacturers to "establish and maintain procedures for the use and removal of such manufacturing material to ensure that it is removed or limited to an amount that does not affect the device's quality"
Section 806.10 - Reports of corrections and removals
21 C.F.R. § 806.10 Cited 18 times 6 Legal Analyses
Requiring that "[e]ach device manufacturer or importer shall submit a written report to FDA of any correction or removal of a device" including " description of the event giving rise to the information reported . . ."

De La Paz v. Bayer AG et al

58 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 “[t]o the extent Swartz seeks a declaration of defendants' liability for damages sought for his other causes of action,” claim must be dismissed as “merely duplicative”

Holding that circumstances constituting fraud must be stated with particularity

Holding that "[r]esolution of the statute of limitations issue is normally a question of fact."

Holding that justifiable reliance is a required element of a fraud claim

Holding that the discovery rule "postpones accrual of a cause of action until the plaintiff discovers, or has reason to discover, the cause of action, until, that is, he at least suspects, or has reason to suspect, a factual basis for its elements"

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

Holding that "[e]very defense to a claim for relief in any pleading must be asserted in the responsive pleading. . . ."

Permitting "[m]alice, intent, knowledge, and other conditions of a person's mind [to] be alleged generally"

Imposing two-year statute of limitations for personal injury claims

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

Referencing the U.S. Pharmacopeia's strength, quality, and purity standards

Explaining that federal law preempts requirements "having the force and effect of law (whether established by statute, ordinance, regulation or court decision)."

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

Prohibiting the production or labeling of any device in a manner inconsistent with any conditions of approval specified in the approval order

Requiring manufacturers to "establish and maintain procedures for the use and removal of such manufacturing material to ensure that it is removed or limited to an amount that does not affect the device's quality"

Requiring that "[e]ach device manufacturer or importer shall submit a written report to FDA of any correction or removal of a device" including " description of the event giving rise to the information reported . . ."