Steele v. Collagen Corp.’s Empirical Analysis
1997
Citation profile
4 federal appellate · 3 district · 19 state decisions
Relationships
Applies 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. § 360I (Federal Food, Drug, and Cosmetic Act) · 21 U.S.C. § 360K (Federal Food, Drug, and Cosmetic Act)
Relies on Cipollone v. Liggett Group, Inc. · Medtronic, Inc. v. Lohr · United States v. Carver · Missouri v. Jenkins · Brown v. Hotel and Restaurant Employees and Bartenders International Union Local 54 Danziger
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 34 citing decisions cite the case generally; a passage count includes only decisions quoting that exact language verbatim.
“process at issue in Medtronic. It emphasized that the PMA process imposed requirements that directly affected the safety and effectiveness of the product. Indeed, although the design and labeling of the product might be changed without prior FDA approval to improve its safety or effectiveness, the product is subject to withdrawal from the market if the FDA determines that the changes have rendered the product unsafe or inadequate. 37 We agree that the PMA process, as opposed to the”
2 later decisions quote this exact passage“state requirements in the form of standards of care or behavior are preempted and cannot form the basis of a state common law claim for damages if they are different from or in addition to the specific federal requirements arising from the PMA process.”
2 later decisions quote this exact passage“Before a new Class III device may be introduced to the market, the manufacturer must provide the [Food and Drug Administration (FDA) ] with a `reasonable assurance' that the device is both safe and effective. See 21 U.S.C. § 360e(d)(2). Despite its relatively innocuous phrasing, the process of establishing this `reasonable assurance,' which is known as the `premarket approval,' or `PMA' process, is a rigorous one. Manufacturers must submit detailed information regarding the safety and efficacy of their devices, which the FDA then reviews, spending an average of 1,200 hours on each submission.”
1 later decision quote this exact passage
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.