Wyeth v. Levine

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

Buckman Co. v. Plaintiffs' Legal Committee

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

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

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"

Reiter v. Cooper

Holding district court has discretion “either to retain jurisdiction or ... to dismiss the case”

Cel-Tech Communications, Inc. v. Los Angeles Cellular Telephone Co.

Holding that for an act to be "unfair," it must "threaten" a violation of law or "violate the policy or spirit of one of those laws because its effects are comparable to or the same as a violation of the law"

Freightliner Corp. v. Myrick

Holding that a suspended Safety Act standard regarding tractor-trailer air brakes did not preempt common law tort actions

Davis v. HSBC Bank Nevada, N.A.

Holding that a "district court's decision to incorporate by reference documents into complaint shall be reviewed for an abuse of discretion"

Hines v. Davidowitz

Holding that the Alien Registration Act of 1940 preempted Pennsylvania's alien registration requirements

Clorox Co. Puerto Rico v. Proctor Gamble

Holding that the court may consider a document "integral to or explicitly relied upon in the complaint, even though not attached to the complaint" (quoting Shaw v. Digit. Equip. Corp., 82 F.3d 1194, 1220 (1st Cir. 1996) )

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

Section 17200 - Unfair competition defined

Prohibiting unlawful business practices

Section 17500 - Untrue or misleading advertising

Requiring action that originated in California to effect consumers in another state

Section 301 - Short title

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 331 - Prohibited acts

Prohibiting the sale of adulterated foods

Section 352 - Misbranded drugs and devices

Setting labeling requirements for drug products

Section 333 - Penalties

Defining civil and criminal penalties for violations of Section 331

Section 393 - Food and Drug Administration

Defining the FDA's mission

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 314.3 - Definitions

Defining "reference listed drug"

Section 10.30 - Citizen petition

Describing the requirements for filing a citizens' petition

Section 314.105 - Approval of an NDA and an ANDA

Explaining that a "tentative" approval is the same as a final approval with a delayed effective date

Section 314.125 - Refusal to approve an NDA

Requiring FDA to reject application when proposed labeling is "false or misleading in any particular"

Section 314.126 - Adequate and well-controlled studies

Stating that among the characteristics of "[a]n adequate and well-controlled study" is that "[a]dequate measures are taken to minimize bias on the part of the subjects, observers, and analysts of the data. The protocol and report of the study should describe the procedures used to accomplish this, such as blinding"