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. American Law Division.

Language:

English

Subjects (All):

United States. Congress.

United States.

Consumers.

Manufactures.

Judge-made law.

Physical Description:

1 online resource (1 online resource (29 p), digital, PDF file)

monochrome

Place of Publication:

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

System Details:

text file

Summary:

This report is one in a series of updates. For the most recent coverage of this report series, please see 09-R4-0534 in the 2009 issue.

Explains FDA premarket notification and premarket approval (PMA) of medical devices. Provides overview of 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. Analyzes legal, procedural, policy, and legislative implications for Congress, consumers, and medical device manufacturers.

Notes:

Record is based on bibliographic data in ProQuest U.S. Congressional Research Digital Collection (last viewed Apr. 2014). Reuse except for individual research requires license from ProQuest, LLC.

CRS Report.

Other Format:

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

Access Restriction:

Restricted for use by site license.