Talbott v. C.R. Bard, Inc.’s Empirical Analysis

Citation profile

4 federal appellate · 7 district · 4 state decisions

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 20 citing decisions cite the case generally; a passage count includes only decisions quoting that exact language verbatim.

1. ““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).”

   2 later decisions quote this exact passage · from the majority
   e.g. 447 Pa. Super. 403 - Rosci v. AcroMed, Inc. · 448 Pa. Super. 26 - Burgstahler v. AcroMed Corp.

2. “[t]he FDA retains rigid control over the labeling and packaging of Class III products, largely displacing the ability of manufacturers to make additional claims. This high level of control contrasts with the low level of control in Cipollone , and ensures that manufacturers will not be held liable for packaging and labeling imposed by the FDA.”

   1 later decision quote this exact passage · from the majority
   e.g. 913 F. Supp. 56 - Goldsmith v. Mentor Corp.

3. “[P]reemption is not restricted to State requirements that directly conflict with Federal law, but rather extends to requirements that are different from, or in addition to, any requirement applicable to the device under the act.”

   1 later decision quote this exact passage · from the majority
   e.g. English III v. Mentor Corporation