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Boston Scientific Won Guident - What A Prize

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Evelyn Pringle
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Mr Hilliard told the Associated Press that Mr McCoy's testimony could prove that Guidant sold an unapproved defibrillator in a violation of federal law. "They've hung out every single doctor in the country if the device was unapproved," he said.

In the deposition, Mr McCoy also said he was not told about problems with the devices until May 2005.

In addition to all the lawsuits, and the stricter regulatory rules that are bound to be implemented as a result of the Guidant debacle, a Senate committee is considering passing legislation that would make it a crime for company executives to ship products with known defects.

On March 10, 2006, the Senate Judiciary Committee held a hearing on a proposed for criminal sanctions against executives, and witnesses who testified specifically pointed to the Guidant as an example of what happens when corporate executives put profits before human life.

Witness told the panel that the recall only happened because of the March 2005, death of Joshua Oukrop, a 21-year-old college student from Minnesota who received a flawed device.

After the student died, his doctors tried to get Guidant to alert physicians about the problem and when the company refused, they contacted the New York Times which in turn conducted an investigation. The first Guidant recall, was issued just as the results of the Times investigation were about to be made public.

Since the death of their patient, Guidant's most outspoken critics have been these doctors. They say that if the company had informed them of the problem, they could have quickly replaced defibrillator and saved their patient.

Dr Barry Maron, a Minneapolis cardiologist, testified at the Senate Judiciary hearing and explained how he and his colleague, Dr Robert Hauser, came to diagnose and treat the 21-year-old student in 1999.

He then told the panel how on March 14, 2005, three and a half years after receiving his defibrillator, Joshua died suddenly and unexpectedly while on vacation in Utah.

A post-mortem analysis of the defibrillator, Dr Maron said, found a short-circuiting defect that had caused the device to become electrically inoperative and fail.

"In other words," he testified, "when the defibrillator tried to issue a life-saving shock, the electrical energy short-circuited and was dissipated and did not enter Joshua's heart as it should have."

"Due to this defect," the doctor told the committee, "he was unprotected and died."

Shortly after that, Dr Maron said, in a meeting with 4 Guidant executives, he learned that the company had known about this specific defect and problem for over 3 years.

"It then fell upon me," he told the panel, "to inform Joshua's father, who also has a defibrillator for hypertrophic cardiomyopathy, of the developments."

"I cannot forget Mr Oukrop's reaction," Dr Maron said, "when told that Guidant had for several years known that his son's defibrillator was potentially defective and could not save him."

"Although he was controlled," Dr Maron recalled, "it was as if his last breath had left his body."

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Evelyn Pringle is a columnist for OpEd News and investigative journalist focused on exposing corruption in government and corporate America.
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