Guidant Consultant Urged Disclosure of Device Defects

March 2006

Newly released court records prove a consultant for Guidant advised the company to tell doctors about their heart device defects out of ethical obligation. Company consultant Dr. Richard N. Fogoros also urged Guidant to change their reporting practices.

The two letters were sent to Guidant executives just before controversy erupted. Dr. Fogoros wrote he believed the company was violating the responsibility it had to alert doctors of the potential flaws.

Guidant claims they did not tell physicians about the heart device defects because they thought patients had a greater risk having surgery to replace the defibrillators and pacemakers. Dr. Fogoros stated Guidant had an obvious conflict of interest in not disclosing product failures.

The flaws in Guidant defibrillators and pacemakers came to light only after a patient died from the short-circuit flaw. Since then more than 100,000 Guidant defibrillators and pacemakers have been recalled and seven deaths have been attributed to the fatal flaw.

The Senate Judiciary Committee may create new legislation that would make it a federal crime for a corporation to knowingly distribute defective products. A doctor whose patient died because of a defective Guidant defibrillator is scheduled to testify.

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