Wyeth v. Levine

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

Riegel v. Medtronic, Inc.

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

Cabral v. Ralphs Grocery Co.

Rejecting claimed exception to duty of care for stopping alongside a freeway

Germain v. Teva Pharmaceuticals

Holding that brand-name manufacturers cannot be held liable for damages caused by ingestion of generic drugs under negligent misrepresentation law of 22 states

Brown v. Superior Court

Holding manufacturers immune from strict liability for pharmaceutical design defects

Carlin v. Superior Court

Holding that breach of warranty claim predicated on an allegation of failure to warn could not be dismissed for failure to state a claim, but that the claims were subject to the learned intermediary doctrine

Robinson v. McNeil Consumer Healthcare

Finding a plaintiff's claim for an injury that occurred before the FDA's rejection of a proposed label change, which was clear evidence that it would not have accepted the plaintiff's proposed warning, to be preempted

Foster v. American Home Prod. Corp.

Holding that "a plaintiff seeking to recover for an injury by a product [must] demonstrate that the defendant manufactured the product at issue" under Maryland law

Colacicco v. Apotex, Inc.

In Colacicco, the plaintiff brought an action against both a brand manufacturer, GlaxoSmithKline, and generic manufacturer, Apotex Corp., alleging that his wife committed suicide after ingesting the generic equivalent of Paxil.

Warner Constr. Corp. v. City of Los Angeles

Holding that the "nondisclosure of the cave-ins and special drilling techniques used in drilling the test holes transformed" the logs contained in the plans and specifications of the contract for construction into "misleading half-truths"

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 352 - Misbranded drugs and devices

Setting labeling requirements for drug products

Section 156 - Extension of patent term

Granting five-year extension of patent term based upon regulatory review of the product Abilify® (aripiprazole) by the FDA

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 201.57 - Specific requirements on content and format of labeling for human prescription drug and biological products described in Section 201.56(b)(1)

Listing requirements for different subsections for indications, dosage, and clinical studies

Section 314.80 - Postmarketing reporting of adverse drug experiences

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

Section 312.21 - Phases of an investigation

Describing the three phases of clinical investigation

Section 314.81 - Other postmarketing reports

Requiring transmittal of the advertisement with Form FDA-2253

Section 312.23 - IND content and format

Requiring drug sponsors to submit "[a]dequate information" about studies "involving laboratory animals" which allow the sponsor to conclude "that it is reasonably safe to conduct" human trials

Section 314.92 - Drug products for which abbreviated applications may be submitted

Noting that, with limited exceptions not relevant here, ANDAs are suitable only for "[d]rug products that are the same as a listed drug," and that "the same as" includes drugs with label modifications made for patent carve-outs

Section 312.20 - Requirement for an IND