TORTS TODAY - course materials
& news for Torts, Business Torts, Product Liability, and Remedies students of George Conk at Fordham Law School
gconk@law.fordham.edu
Pages
▼
Friday, December 17, 2010
Faulty DePuy Artificial Hip Points to Broken Implant System - NYTimes.com
As I am wont to say about drugs - post-approval is Phase IV: the mass, poorly controlled, human experiment stage, so with devices like hip implants which, if they are "substantially equivalent" to devices already on the market, or make only minor changes, are subject to minimal FDA review. Followed, of course, by maximum marketing. “You are basically testing these devices in an uncontrolled way on a large number of people,” said Dr.Sidney M. Wolfe, the director of the Public Citizen’s Health Research Group and a longtime F.D.A. critic. Faulty DePuy Artificial Hip Points to Broken Implant System - NYTimes.com
No comments:
Post a Comment