PLIVA, Inc. v. Mensing’s Empirical Analysis
564 U.S. 604 · 2011
Citation profile
13 federal appellate · 13 district · 22 state decisions
Appellate journey
reviewedthe decision below (from Eighth Circuit Court of Appeals)
Relationships
Applies 21 U.S.C. § 301 (Animal Drug Amendments of 1968) · 21 U.S.C. § 321 (Federal Food, Drug, and Cosmetic Act) · 21 U.S.C. § 352 (Federal Food, Drug, and Cosmetic Act) · 21 U.S.C. § 355 (Federal Food, Drug, and Cosmetic Act) · 21 U.S.C. § 360K (Federal Food, Drug, and Cosmetic Act) · 49 U.S.C. § 30103
Relies on Hines v. Davidowitz · Rice v. Santa Fe Elevator Corp. · Auer v. Robbins · Cipollone v. Liggett Group, Inc. · Florida Lime & Avocado Growers, Inc. v. Paul
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 169 citing decisions cite the case generally; a passage count includes only decisions quoting that exact language verbatim.
“question for 'impossibility' is whether the private party could independently do under federal law what state law requires of it.”
3 later decisions quote this exact passage · from the concurrence“applicable to Wyeth allowed the company, of its own volition, to strengthen its label in compliance with its state tort duty.”
2 later decisions quote this exact passage · from the concurrence“First, the proposed generic drug must be chemically equivalent to the approved brand-name drug: It must have the same "active ingredient" or "active ingredients," "route of administration," "dosage form," and "strength" as its brand-name counterpart. 21 U.S.C. §§ 355 (j)(2)(A)(ii) and (iii). Second, a proposed generic must be "bioequivalent" to an approved brand-name drug. § 355(j)(2)(A)(iv). That is, it must have the same "rate and extent of absorption" as the brand-name drug. § 355(j)(8)(B). Third, the generic drug manufacturer must show that "the labeling proposed for the new drug is the same as the labeling approved for the [approved brand-name] drug." § 355(j)(2)(A)(v).”
1 later decision quote this exact passage · from the majority
How this case has been treated — in progress
Whether each later court followed, distinguished, criticized, or overruled this decision. The treatment classification (task #35) runs highest-cited cases first and lights up here as it reaches this one.