Posted by Deborah on 2/21/08

More | Report Post

http://www.nytimes.com/2008/02/21/washington/21device.html?_r=1&th&emc=th&oref=slogin

February 21, 2008
Justices Shield Medical Devices From Lawsuits
By LINDA GREENHOUSE
WASHINGTON — Makers of medical devices like implantable
defibrillators or breast implants are immune from liability
for personal injuries as long as the Food and Drug
Administration approved the device before it was marketed
and it meets the agency’s specifications, the Supreme Court
ruled on Wednesday.

The 8-to-1 decision was a victory for the Bush
administration, which for years has sought broad authority
to pre-empt tougher state regulation.

In 2004, the administration reversed longstanding federal
policy and began arguing that “premarket approval” of a new
medical device by the F.D.A. overrides most claims for
damages under state law. Because federal law makes no
provision for damage suits against device makers, injured
patients have turned to state law and have won substantial
awards.

ToxBoard (Gen) Chatboard

LATEST POSTS | BY TOPICS | SUBMIT A POST