Riegel v. Medtronic, Inc : Federal Preemption of State Tort Law Regarding Medical Devices with FDA Premarket Approval.
Explains FDA premarket notification and premarket approval (PMA) of medical devices. Outlines Federal preemption of State laws, presenting pro/con arguments for Federal preemption of State law tort claims such as strict liability; breach of implied warranty; and negligence in design, testing, manufa...
| Corporate Authors: | , |
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| Format: | eBook |
| Language: | English |
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[Place of publication not identified] :
[publisher not identified],
2009.
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| Series: | U.S. Congressional Research.
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| Subjects: | |
| Online Access: | Connect to the full text of this electronic book |
| Summary: | Explains FDA premarket notification and premarket approval (PMA) of medical devices. Outlines Federal preemption of State laws, presenting pro/con arguments for Federal preemption of State law tort claims such as strict liability; breach of implied warranty; and negligence in design, testing, manufacturing, labeling, distribution, sale, inspection, or marketing of medical devices. Reviews Riegel v. Medtronic, Inc., in which Supreme Court ruled that if FDA grants PMA to a medical device, the device manufacturer is immune from certain suits under State tort law, due to an express preemption provision in the Medical Device Amendments of 1976. |
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| Item Description: | Record is based on bibliographic data in ProQuest U.S. Congressional Research Digital Collection (last viewed Dec. 2010). Reuse except for individual research requires license from ProQuest, LLC. CRS Report. Electronic resource. |
| Physical Description: | 1 online resource. |