In the Sunday edition of the New York Times, there is a disturbing article in the Business section involving a medical device, the OtisKnee, which was released without proper FDA approval. The OtisKnee was used during knee surgery as a cutting guide to align the surgeon's bone saw. Patients such as Carla Muss-Jacobs have experienced complications including excruciating pain in their knees.
The device was sold to the general public without proper testing because the manufacturer, OtisMed Corporation, was allowed to classify the OtisKnee as a Class I medical device rather than a Class III device as it should have been. (The difference is that a Class I device merely needs to be registered with the agency, while a Class III device needs to undergo extensive medical testing.) Even after the FDA ordered the device to be pulled from the market, over two hundred devices were shipped out, a matter that only came to light thanks to a whistle blower.
My Gut Reaction: When the libertarians talk about getting rid of the FDA all together, this is what they want.
What disturbs me is how little the consequences are for such a breach of the public's trust. The head of OtisMed, Charlie Chi, has pleaded guilty to selling adulterated medical devices, along with the corporation itself, but faces at most three years in prison. That is far too little punishment for the crime.
This isn't simply a case of corporate malfeasance, people's health and lives were ruined. Carla Muss-Jacobs had to get another operation on her knee, driving her into bankruptcy. Her physician, Dr. Ronald Teed, who was apparently a promoter of the OtisKnee, disclaims all responsibility despite having used the device. The court system has sided with Dr. Teed, leaving Muss-Jacobs with little recourse.