Guidant Defibrillator Problems. Drs. Robert Hauser and Barry Maron, both prominent cardiologists, have asked a federal judge to reject the plea agreement the government struck with Boston Scientific’s Guidant unit for withholding information about faulty defibrillators from federal regulators.
According to New York Times, both doctors were instrumental in bringing the Guidant defibrillator problems to light in 2005. They had cared for a 21-year-old college student who died when his implantable defibrillator made by Guidant failed to deliver a life-saving shock.
In an interview with The Times, Dr. Hauser said the plea agreement should not be allowed because it does not hold anyone accountable. In their letter to Judge Donovan Frank of the U.S. District Court of Minnesota,, both he and Dr. Maron wrote that a financial penalty alone would not be deterrent enough to prevent other company officials from making bad decisions.
On behalf of the patients who died or suffered pain and mental anguish
“On behalf of the patients who died or suffered pain and mental anguish as the direct result of Guidant’s illegal and unethical behavior, we urge you not to accept the plea agreement,” the doctors wrote.
Boston Scientific agreed in November to plead to the charges and pay $296 million – – the largest criminal penalty against a medical device company – to resolve the Guidant charges with the U.S. Department of Justice.
The Department of Justice investigation that resulted in the proposed settlement centered on three Guidant devices that had the potential to short-circuit — the Ventak Prizm 2 DR (Model 1861) and the Contak Renewal (Models H135 and H155) models of implantable defibrillators.
According to the charges filed in federal court, Guidant violated the Food, Drug and Cosmetic Act by concealing information from the U.S. Food & Drug Administration (FDA) about catastrophic short-circuiting failures in the three models. The company discovered problems with one of the products in 2002 and became aware of problems with two others in 2004, the department said.
Three safety alerts were issued about these defibrillators in June 2005. The FDA later determined these were Class I recalls, which are the most serious type of device recall because there is a reasonable change the devices could cause serious health problems or death. Malfunctions in the products were linked to multiple deaths.
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