Duvall’s Empirical Analysis

Citation profile

2 district · 3 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 16 citing decisions cite the case generally; a passage count includes only decisions quoting that exact language verbatim.

1. “Class I devices, such as tongue depressors, do not present an unreasonable risk of illness or injury and are subject only to general controls. 21 U.S.C.A. § 360c (a)(1)(A); 21 C.F.R. § 880.6230 (1996). Class II devices, such as bone-conduction hearing aids, for which ‘general controls by themselves are insufficient to provide reasonable assurance of the safety and effectiveness of the device,’ are subject to special controls. 21 U.S.C.A. § 360c (a)(1)(B); 21 C.F.R. § 874.3300 (1996). Class III devices are those devices: (1) for which there is insufficient information to determine that the controls applicable to Class I and II devices are alone enough to provide reasonable assurance of the safety and effectiveness of the device; and (2)(a) that are to be used for ‘supporting or sustaining human life’ or that are ‘of substantial importance in preventing impairment of human health’ or (2)(b) that ‘present[ ] a potential unreasonable risk of illness or injury.’ 21 U.S.C.A. § 360c(a)(l)(C).”

   1 later decision quote this exact passage · from the majority
   e.g. 482 F. Supp. 2d 746 - Rattay v. Medtronic, Inc.

2. “§ 360k(a) preempts an express warranty claim to the extent that the claim is based on FDA-mandated labeling, packaging, or advertising. Indeed, the essence of the holding in [Lohr] — that § 360k(a) gives rise to preemption when the FDA has imposed specific requirements on a particular device — lends credence to our previous conclusion that when the FDA requires the manufacturer of a device to employ certain words to convey information about its product, § 360k(a) operates to preempt differing or additional state law requirements.”

   1 later decision quote this exact passage · from the concurrence
   e.g. 482 F. Supp. 2d 746 - Rattay v. Medtronic, Inc.

3. “Except as provided in subsection (b) of this section, no 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.”

   1 later decision quote this exact passage · from the majority
   e.g. 218 F. Supp. 2d 802 - Woods v. Gliatech, Inc.