Mason v. SmithKline Beecham Corp.’s Empirical Analysis

Citation profile

7 federal appellate · 3 district · 2 state decisions

Most-quoted passages

The sentences later courts lift from this opinion, ranked by how many decisions quote each — the parts of the opinion doing the work. These counts are smaller than the citation total above because most of the 28 citing decisions cite the case generally; a passage count includes only decisions quoting that exact language verbatim.

1. “The ability to make CBE labeling changes underscores a central premise of federal drug regulation: A ‘manufacturer bears responsibility for the content of its label at all times.’ Levine, 129 S.Ct. at 1197-98 . While it is important for a manufacturer to warn of potential side effects, it is equally important that it not overwarn because overwaming can deter potentially beneficial uses of the drug by making it seem riskier than warranted and can dilute the effectiveness of valid warnings. Therefore, warnings may only be added when there is ‘reasonable evidence of an association of a serious hazard with the drug.’ 21 C.F.R. § 201.57 (2003). It is technically a violation of federal law to propose a CBE that is not based on reasonable evidence. 18 U.S.C. § 1001 .”

   2 later decisions quote this exact passage · from the majority
   e.g. 119 F. Supp. 3d 749 - Rheinfrank v. Abbott Laboratories, Inc. · 87 F. Supp. 3d 916 - D.W.K. v. Abbott Laboratories, Inc.

2. “an actual conflict between state and federal law such that it is impossible for a person to obey both.”

   2 later decisions quote this exact passage · from the majority
   e.g. Guilbeau v. Pfizer Inc. · Dolin v. GlaxoSmithKline LLC

3. “(A) [t]o add or strengthen a contraindication, warning, precaution, or adverse reaction for which the evidence of a causal association satisfies the standard for inclusion in the labeling under § 201.57(c) of this chapter; (B) [t]o add or strengthen a statement about drug abuse, dependence, psychological effect, or overdose; (C) [t]o add or strengthen an instruction about dosage and administration that is intended to increase the safe use of the drug product; (D) [t]o delete false, misleading, or unsupported indications for use or claims of effectiveness; or (E) [when a]ny labeling change normally requiring a supplemental submission and approval prior to distribution of the drug product that FDA specifically requests be submitted under this provision.”

   1 later decision quote this exact passage · from the majority
   e.g. 17 F. Supp. 3d 1109 - Koho v. Forest Laboratories, Inc.