Ashcroft v. Iqbal

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

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' "

Wyeth v. Levine

Holding that the FDA's drug labeling judgments pursuant to the FDCA did not obstacle preempt state law products liability claims

Robbins v. Oklahoma

Holding that collective allegations do not satisfy a plaintiff's "burden . . . to provide fair notice of the grounds for the claims made against each of the defendants"

Pliva, Inc. v. Mensing

Holding that state tort law that required generic drug manufacturers to provide adequate warning labels was preempted where federal law required manufacturers to use the same labels as their brand-name counterparts

Vess v. Ciba-Geigy Corp. USA

Holding that the Rule 9(b) pleading standards apply to California CLRA, FAL, and UCL claims because, though fraud is not an essential element of those statutes, a plaintiff alleges a fraudulent course of conduct as the basis of those claims

Swartz v. KPMG LLP

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”

Mut. Pharm. Co. v. Bartlett

Holding "state-law design-defect claims that turn on the adequacy of a drug's warnings are pre-empted by federal law under PLIVA"

Lazar v. Superior Court

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

Neilson v. Union Bank of California, N.A.

Holding that plaintiffs could prevail if they could prove at trial that certain transfers made pursuant to a Ponzi scheme were made within the limitations period of California's UFTA

Rule 12 - Defenses and Objections: When and How Presented; Motion for Judgment on the Pleadings; Consolidating Motions; Waiving Defenses; Pretrial Hearing

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

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

Requiring that fraud be pleaded with particularity

Rule 201 - Judicial Notice of Adjudicative Facts

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 355 - New drugs

Granting the court discretion to change the date on which an ANDA may be approved if "either party to the action failed to reasonably cooperate in expediting the action"

Section 321 - Definitions; generally

Defining “new drug”

Section 352 - Misbranded drugs and devices

Setting labeling requirements for drug products

Section 377.60 - Persons who may assert action

Creating a "cause of action for the death of a person caused by the wrongful act or neglect of another"

Section 333 - Penalties

Defining civil and criminal penalties for violations of Section 331

Section 314.70 - Supplements and other changes to an approved NDA

Defining "major changes" as those "requiring supplement submission and approval prior to distribution of the product"

Section 314.50 - Content and format of an NDA

Recognizing the proprietary nature of DSD and SP specifications by requiring that each ANDA applicant provide its own distinct specifications

Section 314.80 - Postmarketing reporting of adverse drug experiences

Requiring report of “serious and unexpected” adverse event within 15 days

Section 314.71 - Procedures for submission of a supplement to an approved application