Riegel v. Medtronic, Inc : Federal Preemption of State Tort Law Regarding Medical Devices with FDA Premarket Approval.

Format:

Book

Government document

Author/Creator:

Library of Congress. Congressional Research Service.

Language:

English

Subjects (All):

Judge-made law.

Federal government.

Labels.

Physical Description:

1 online resource (27 pages, digital, PDF file)

Place of Publication:

[Place of publication not identified] : [publisher not identified], 2009.

System Details:

text file

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.

Notes:

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.

Other Format:

Microfiche version: Library of Congress. Congressional Research Service. Riegel v. Medtronic, Inc.

Access Restriction:

Restricted for use by site license.