· 3/19/1993
Jennifer Stamps v. Collagen Corporation
Citations
- 984 F.2d 1416
- 1993 WL 43588
How courts have described this case
Verbatim parenthetical descriptions written by other courts when citing this decision. Ranked by citation-network relevance.
- holding that MDA regulatory structure for a Class III device preempts inadequate labeling, defective design and manufacture claims
- holding that plaintiffs claims against the manufacturer of antiwrinkle treatment product for defective design, inadequate warnings and negligent failure to warn were preempted by the MDA
- concluding that regulation 808.1(d) poses the same test as the statute
- preempting claims for inadequate labeling, failure to warn, defective design and manufacture against manufacturer of Zyplast, a Class III device with PMA
- preempting tort claims against manufacturer of penile prosthesis, which bypassed premarket approval through 510(k
- discussing the FDA’s classification of medical devices and different requirements for each
Source: CourtListener parenthetical corpus (CC0).
Judges: Goldberg, Smith, Garza
Read full opinion on CourtListenerSourced from CourtListener / Free Law Project (CC0).
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.