BMJ  2008;336:470 (1 March), doi:10.1136/bmj.39503.345694.DB

News

US confirms federal authority for safety of medical devices

Fred Charatan

1 Florida

The first 150 words of the full text of this article appear below.

In a landmark decision, the US Supreme Court voted by eight to one last month to bar a lawsuit in a state court brought by the widow of a man injured by a cardiac catheter that had been approved for sale by the Food and Drug Administration.

When Congress enacted the Medical Device Amendments of 1976 to the Federal Food, Drug, and Cosmetic Act, it gave the responsibility for overseeing the safety of medical devices to the FDA and over-ruled state oversight laws.

The dispute the Supreme Court had to settle was whether an injured patient could challenge the FDA’s decision by suing in a state court for products that have received federal approval.

Charles Riegel survived open heart surgery but died in 2004 after a catheter ruptured in his coronary artery. His widow, Donna Riegel, brought a suit against device manufacturer Medtronic. The catheter had received premarket approval from . . . [Full text of this article]


Add to CiteULike CiteULike   Add to Complore Complore   Add to Connotea Connotea   Add to Del.icio.us Del.icio.us   Add to Digg Digg   Add to Reddit Reddit   Add to StumbleUpon StumbleUpon   Add to Technorati Technorati    What's this?

Relevant Article

94% of patients suing Merck over rofecoxib agree to company’s offer
Fred Charatan
BMJ 2008 336: 580-581. [Extract] [Full Text] [PDF]

Access jobs at BMJ Careers
Whats new online at Student BMJ