Most recalled medical devices were approved without FDA scrutiny
This week the National Research Center for Women and Families published data analyzed and compiled by Diana M. Zuckerman, Paul Brown and Dr. Steven E. Nissen, the Cleveland Clinic cardiologist who blew the whistle on defective cardiac devices several years ago. The researchers noted that the FDA initiated 113 "high-priority" recalls from 2005 to 2009, in response to concerns about patient safety. Fully seventy percent of these "high priority recalls" involved devices that had not been subjected to the normal FDA investigation and scrutiny because they were deemed "equivalent" to a device already on the market. This is called the "510K" process. The 510K process involves little or no testing but still grants the manufacturer immunity from liability under a recent activist U.S. Supreme Court interpretation that surprised most legal specialists. The Court led by Justice Roberts has made many similar decisions that favor large corporations and wealthy individuals at the expense of consumers and citizens.