Posted On: October 27, 2007
FDA approval does not insure a the safety of a medical device
As a Chicago medical malpractice lawyer I have known for a long time that drugs and medical devices are not necessarily safe just because the FDA says so. The fact is that the FDA is full of people that either used to or want to work for the drug and medical device companies. There are time when the regulatory system is so incestuous that safety is compromised. Consider this story from Barry Meier of the New York Times:
“A Congressional committee notified the Food and Drug Administration yesterday that, as a result of a recall by Medtronic of a product linked to patient deaths, it was reviewing how rigorously the agency required heart device components to be tested. In a letter to the agency, Representative Henry A. Waxman, Democrat of California and chairman of the Committee on Oversight and Government Reform, asked agency officials a series of questions about its oversight of leads, the wires that carry electrical information between an implanted defibrillator and the heart. Among other issues, Mr. Waxman asked the agency to provide information about how it determines how much to test leads before marketing and why the agency does not give leads the same scrutiny that it has given in recent years to defibrillators.”Barry Meier, New York Times, 10-23-07
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