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' "

Cooper v. Pickett

Holding that where complaint asserting claims of improper revenue recognition identified some of the defrauded customers, the type of conduct, the general time frame, and why the conduct was fraudulent, it was "not fatal to the complaint that it [did] not describe in detail a single specific transaction . . . by customer, amount, and precise method"

Kelley v. Corrections Corp. of America

Holding that failing to restrict adverse employment actions to those in response to employee opposition "would significantly blur and perhaps obliterate the distinction between an action for failure to accommodate or engage in the interactive process and retaliation"

Utts v. Bristol-Myers Squibb Co.

Holding that a written report that relies on FDA FAERS data does not constitute "newly acquired information"

Motus v. Pfizer Inc.

Finding that plaintiff failed to create a question of fact for the jury because although the treating doctor testified that if he had been aware of a different warning he would have passed that information along to his patient, the court stated that his testimony did not establish that if that warning had been provided, he would not have prescribed Zoloft

Marcus v. Forest Labs., Inc. (In re Celexa & Lexapro Mktg. & Sales Practices Litig.)

Holding that federal law preempted the state law claims because the Federal Food, Drug, and Cosmetic Act ("FDCA") prohibited unilateral changes to FDA-approved labels, and therefore prohibited the drug manufacturer from changing its label in light of state law requirements

Dolin v. GlaxoSmithkline LLC

Concluding that it was not necessary to determine whether "clear evidence" involves a factual or legal question because "given the facts [of the] case, no reasonable jury could find that the FDA would have approved [plaintiffs' proposed warning] under the CBE regulation"

Mitchell v. Boehringer Ingelheim Pharms., Inc.

Granting in part defendants' motion to dismiss Tennessee product liability claims on preemption grounds

Shah v. Forest Labs., Inc.

Rule 9 - Pleading Special Matters

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

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