Motus v. Pfizer, Inc.’s Empirical Analysis
2000
Citation profile
1 district · 6 state decisions
How this case has been cited
Cited by 16 later decisions (1 by the Supreme Court) — most recently March 2023
1 district · 6 state decisions
Later decisions citing this case, by decade. The current decade is in progress, and our corpus holds fewer opinions from the most recent years, so the latest bars are undercounted — not a real decline.
Relationships
Applies 21 U.S.C. § 355 (Federal Food, Drug, and Cosmetic Act)
Relies on Anderson v. Liberty Lobby, Inc. · Celotex Corporation v. Catrett H · Matsushita Electric Industrial Co., Ltd. v. Zenith Radio Corporation · Hillsborough County v. Automated Medical Laboratories, Inc. · English v. General Electric Co.
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 16 citing decisions cite the case generally; a passage count includes only decisions quoting that exact language verbatim.
“Adverse Reactions” section listed "suicide ideation and attempt” as events that had occurred in clinical trials and the frequency with which they had occurred. Pfizer’s Exh. 26. Second, the "Adverse Reactions” section stated "It is important to emphasize that although the events reported occurred during treatment with Zoloft, they were not necessarily caused by it.” Id. Third, the "Precautions” section stated, “The possibility of a suicide attempt is inherent in depression and may persist until significant remission occurs. Close supervision of high-risk patients should accompany initial drug therapy. Prescriptions for Zoloft should be written for the smallest quantity of tablets consistent with good patient management in order to reduce the risk of overdose.”
3 later decisions quote this exact passage · from the majority“The Commissioner . . . advises that these labeling regulations do not prohibit a manufacturer, packer, rela-beler, or distributor from warning health care professionals whenever possibly harmful adverse effects associated with the use of the drug are discovered. The addition to labeling and advertising of additional warnings, as well as contraindications, adverse reactions, and precautions regarding the drug, or the issuance of letters directed to health care professionals (e.g., Dear Doctor letters containing such information) is not prohibited by these regulations. In considering these regulations in a product liability case, at least one court has held that an NDA [New Drug Application] holder may have a duty to add a warning before FDA approval of a supplemental application.”
1 later decision quote this exact passage · from the majority“Moreover, and perhaps most importantly, although FDA did not require Pfizer to include suicide-related warnings in Zoloft’s label, FDA has not prohibited Pfizer from doing so. • On the occasions cited by Pfizer that FDA considered links between suicide and SSRIs, FDA did find that the evidence did not support requiring manufacturers to include additional suicide-related warnings. But FDA never stated that it would be impermissible to include additional warnings. This is consistent with the regulatory provision governing warning labels, 21 C.F.R. § 201.57 (e), which indicates only those warnings that must be included in drug labeling, but does not prohibit any warnings.”
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.