Michael v. Shiley, Inc.’s Empirical Analysis
46 F.3d 1316 · 1995
Citation profile
39 federal appellate · 8 district · 17 state decisions
How this case has been cited
Cited by 108 later decisions (1 by the Supreme Court) — most recently February 2019 · most notably Medtronic, Inc. v. Lohr (1996), Gonzales v. Surgidev Corp. (1995)
39 federal appellate · 8 district · 17 state decisions — followed in 11 states
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. § 360 (Federal Food, Drug, and Cosmetic Act) · 21 U.S.C. § 360C (Federal Food, Drug, and Cosmetic Act) · 21 U.S.C. § 360E (Federal Food, Drug, and Cosmetic Act) · 21 U.S.C. § 360H (Federal Food, Drug, and Cosmetic Act) · 21 U.S.C. § 360K (Federal Food, Drug, and Cosmetic Act) · 41 U.S.C. § 351 (Service Contract) · 49 U.S.C. § 1305 · 7 U.S.C. § 136V
Relies on Dandridge v. Williams · Rice v. Santa Fe Elevator Corp. · Cipollone v. Liggett Group, Inc. · Salve Regina College v. Russell · Morales v. Trans World Airlines, Inc.
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 108 citing decisions cite the case generally; a passage count includes only decisions quoting that exact language verbatim.
“[N]o State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement— (1) which is different from, or in addition to, any requirement applicable under this chapter to the device, and (2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter.”
7 later decisions quote this exact passage · from the majority““To assure the reasonable safety and effectiveness of medical devices intended for human use.” H.Conf.Rep. No. 1090, 94th Cong. 2d Sess. reprinted in 1976 U.S.Code Cong. & Admin.News 1070,1103. The MDA gives the FDA broad powers to classify and regulate medical devices. Under the MDA, the FDA must assign a medical device to one of three statutorily delineated categories. Class I devices are those devices which pose little or no threat to public health. They are subject to only general requirements concerned with their manufacture. Tongue depressors are one example of a Class I medical device. See: 21 U.S.C. § 360c(a)(l)(A); 21 C.F.R. § 860.3 (c)(1). Class II devices include items such as tampons and oxygen masks. Use of Class II devices involves some risk of injury and, as a result, the FDA establishes performance standards, postmarket surveillance programs and guidelines for their use. See: 21 U.S.C. § 360c(a)(l)(B); 21 CFR § 860.3 (c)(2). Class III devices are those devices which are implanted in the body or which pose a potentially unreasonable risk of injury. See: 23 U.S.C. § 360c(a)(l)(C); 21 CFR § 860.3 (c)(3). They include Zyderm, as well as pacemakers, heart valves and replacement joints. Because of their inherent dangerousness, Class III devices are subject to the most stringent FDA regulation. All Class III devices are required to obtain premarket approval prior to being released for sale and use. 21 U.S.C. § 360e; 21 CFR § 814.1 (c).”
3 later decisions quote this exact passage · from the majority“applying state law, [and] to perform the same functions initially entrusted to the FDA.”
3 later decisions 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.