Pearson v. Shalala’s Empirical Analysis
2001
Citation profile
5 district ·
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. § 343 (Federal Food, Drug, and Cosmetic Act) · 5 U.S.C. § 706
Relies on Citizens to Preserve Overton Park, Inc. v. Volpe · Elrod v. Burns · Central Hudson Gas Electric Corporation v. Public Service Commission of New York · Bates v. State Bar of Arizona · City of Lakewood v. Plain Dealer Publishing 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 6 citing decisions cite the case generally; a passage count includes only decisions quoting that exact language verbatim.
“However, as the Pearson [i] opinion strongly suggests, the FDA may not ban the Folic Acid Claim simply because the scientific literature is inconclusive about whether synthetic folic acid is superior to naturally occurring food folate. See Pearson, 164 F.3d at 658 . The question which must be answered under Pearson is whether there is any “credible evidence” that synthetic folic acid is superi- or to naturally occurring food folate. See id. (observing that “it appears that credible evidence did support” the Folic Acid Claim). There clearly is such evidence, as the FDA itself acknowledged. J.R. at 14 (“IOWNAS (1998) did note that the available evidence for a protective effect from folic acid is much stronger than that for food folate.”). Consequently, the agency erred in concluding otherwise. In short, even if the FDA’s criticism of the sub-claim is valid, this criticism does not make the Claim inherently misleading; rather, it suggests the need for a well-drafted disclaimer, which the FDA has steadfastly thus far refused to even consider.”
1 later decision quote this exact passage · from the majority“[T]he FDA’s determination that the Folic Acid Claim is “inherently misleading” and cannot be cured by disclaimers is arbitrary and capricious, ivhether the two sub-claims are examined in isolation or together. Consequently, the Court concludes that the FDA did not undertake the necessary analysis required by Pearson, especially as evidenced by its failure to consider clarifying disclaimers that could cure the alleged misleading nature of the Folic Acid Claim. For all the forgoing reasons, the Court concludes that there is a substantial likelihood that Plaintiffs will prevail on the merits of their claim.”
1 later decision quote this exact passage · from the majority“[bjecause the FDA has not yet exhausted the 540-day period within which they must make a final decision on Plaintiffs’ health claims, ... Plaintiffs have not suffered any First Amendment injury which this Court can address.” Pearson v. Shalala, Civ. A. No. 95-1865, 2000 WL 767584 , at (D.D.C. May 24, 2000) (Kessler, J.). 9 . Plaintiffs request issuance of”
1 later decision quote this exact passage · from the majoritye.g. Whitaker v. Thompson
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.