58 Cited authorities

Ashcroft v. Iqbal
556 U.S. 662 (2009) Cited 252,784 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 266,697 times 365 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' "
Daubert v. Merrell Dow Pharmaceuticals, Inc.
509 U.S. 579 (1993) Cited 26,294 times 225 Legal Analyses
Holding that a trial judge must ensure that all admitted expert testimony "is not only relevant, but reliable"
Matrixx Initiatives, Inc. v. Siracusano
563 U.S. 2011 (2011) Cited 1,338 times 57 Legal Analyses
Holding that plaintiffs had adequately pled a Rule 10b–5 claim—where defendant had disputed the sufficiency of the allegations with respect to the elements of scienter and materiality—by alleging that defendant had forestalled a stock price drop by making affirmative statements confirming the market's impression that defendant's leading product was safe, despite defendant's awareness of evidence suggesting a significant risk that the nasal spray led to loss of sense of smell; when the risk was finally (belatedly) disclosed, the stock price plummeted
Wyeth v. Levine
555 U.S. 555 (2009) Cited 1,432 times 101 Legal Analyses
Holding that the FDA's drug labeling judgments pursuant to the FDCA did not obstacle preempt state law products liability claims
Pliva, Inc. v. Mensing
564 U.S. 604 (2011) Cited 746 times 143 Legal Analyses
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
Sprietsma v. Mercury Marine
537 U.S. 51 (2002) Cited 332 times 7 Legal Analyses
Holding that the Coast Guard's decision not to regulate propeller guards did not impliedly pre-empt petitioner's tort claims
Garside v. Osco Drug, Inc.
895 F.2d 46 (1st Cir. 1990) Cited 1,571 times
Holding that the party who bears the burden of proof on a particular issue may not rely on the absence of competent evidence on that issue to defeat summary judgment
Westberry v. Gislaved Gummi AB
178 F.3d 257 (4th Cir. 1999) Cited 948 times 2 Legal Analyses
Holding an expert must provide some explanation of why other potential causes were not the sole cause
Thom v. Bristol-Myers Squibb Co.
353 F.3d 848 (10th Cir. 2003) Cited 768 times
Holding that the warning in the package insert for the drug Serzone indicating “only that ‘rare reports' of priapism were ‘temporally associated’ with Serzone ... that a ‘causal relationship [of priapism] to nefazodone has not been established’ ” fell “well short” of an adequate warning
Rule 702 - Testimony by Expert Witnesses
Fed. R. Evid. 702 Cited 26,670 times 255 Legal Analyses
Adopting the Daubert standard
Section 314.70 - Supplements and other changes to an approved NDA
21 C.F.R. § 314.70 Cited 353 times 37 Legal Analyses
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)
21 C.F.R. § 201.57 Cited 252 times 27 Legal Analyses
Listing requirements for different subsections for indications, dosage, and clinical studies
Section 314.105 - Approval of an NDA and an ANDA
21 C.F.R. § 314.105 Cited 94 times 5 Legal Analyses
Explaining that a "tentative" approval is the same as a final approval with a delayed effective date
Section 201.80 - Specific requirements on content and format of labeling for human prescription drug and biological products; older drugs not described in Section 201.56(b)(1)
21 C.F.R. § 201.80 Cited 85 times 5 Legal Analyses
Requiring a manufacturer to revise its label “to include a warning as soon as there is reasonable evidence of an association of a serious hazard with a drug”

Calisi v. Abbott Laboratories

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 a trial judge must ensure that all admitted expert testimony "is not only relevant, but reliable"

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

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

Holding that the Coast Guard's decision not to regulate propeller guards did not impliedly pre-empt petitioner's tort claims

Holding that the party who bears the burden of proof on a particular issue may not rely on the absence of competent evidence on that issue to defeat summary judgment

Holding an expert must provide some explanation of why other potential causes were not the sole cause

Adopting the Daubert standard

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

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

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

Requiring a manufacturer to revise its label “to include a warning as soon as there is reasonable evidence of an association of a serious hazard with a drug”