Guidant failed to inform FDA changes in device

Fred McCoy, head of Guidant’s cardiac rhythm management division, stated during a January 2006 deposition that Guidant altered the design of one of the company’s defibrillators in 2002 and later misinformed federal regulators stating that the change had no effect on the product’s performance

McCoy went on to state,”This particular failure mechanism does not have the capacity to kill a patient. It may be unable, as a device, to save the patient.” A distinction that seems to lack a difference. The defibrillator in question is the Ventak Prizm 2 Model 1861.

The changes McCoy was referring to were never approved by the FDA. Furthermore, only one of them was ever made public, and that was under the guise that it did not affect the performance of the defibrillator. The company then claimed two years later that the FDA did aprove the alterations. It was not until three years later that Guidant came out publicly with the flaws in the device, and January to state that they were not approved by the FDA.

McCoy claimed that he was not informed about any issues with the defibrillators until May of 2005. He further stated that if he had an issue with his heart and needed a defibrillator from Guidant, that he would not want to be informed if there was a defect in the product that could prove deadly. “As an individual, I would not want to know,” he said. “But I can concede many would.”

Guidant, which Boston Scientific Corp. officials hope to acquire by the end of next month, faces state and federal regulatory investigations as well as 60 class action lawsuits and another 145 individual suits related to its recalls, according to documents filed Wednesday afternoon with the Securities and Exchange Commission.

Joe Duffey, the Florida-based producer of an online support site for defibrillator patients and their families, said he was surprised by McCoy’s statements.

“If someone wants to keep their head in the sand, that’s their business,” he said. “But personally, I would want all the information available so I could make a reasoned decision with my doctor. Guidant has a responsibility to the end user to tell us what the heck is going on so we can make an informed judgment. That’s what they deprived people of.”

Guidant and Natick, Mass.-based Boston Scientific are still awaiting regulatory and shareholder approval for their $27.2 billion cash-and-stock acquisition. The companies hope to complete the deal by March 31.

This device was one of the some 88,000 recalled by the company for defects, and there are also more than 200,000 Guidant heart devices that have safety warning relating to them. The defective devices have been linked to shocking, premature battery drain, misfiring, and at least seven deaths. The first product liability suit arising from the recalls is pending in Texas.