Judge rejects Guidant's plea agreement in unsafe defibrillator case as too lenient

The Justice Department might have to get tougher on Guidant Corp., for its handling of a potentially fatal flaw in some of its heart defibrillators. A U.S. District judge on Tuesday ruled that a proposed plea agreement did not go far enough in holding Guidant accountable for its conduct and rejected the deal.

U.S. District Judge Donovan Frank in Minnesota said the government should have sought probation for Guidant and its parent Boston Scientific and should have required Guidant to carry out charitable activities to improve device safety and care for minority patients. Frank also urged that part of a fine against Guidant be used to reimburse Medicare for its expenses related to the devices, but the judge didn't agree that patients were owed restitution, the Wall Street Journal reported.

Boston Scientific said in a statement that it will work with the Justice Department to modify the plea agreement so it is acceptable to the court.

The Justice Department launched an investigation after allegations in 2005 that Guidant failed to alert doctors and patients to a potentially fatal flaw in some of its defibrillators. At least six patients who got the devices died.

Boston Scientific acquired Guidant in 2006 shortly after the investigation began.

Under the proposed plea agreement, Guidant would have pleaded guilty to two misdemeanors and paid a $296 million fine, described as the largest against a medical devicemaker.

Frank said the deal did not "adequately address Guidant's history and the criminal conduct at issue." In a New York Times article on the ruling, medical products lawyer Daniel Margolis said probation is effectively a way for a court to maintain some control over a company's activities.

Several doctors and patients had urged Frank to reject the proposed deal and argued for criminal charges against former Guidant executives. But in his ruling, Frank said prosecutors, not the court, decide who should be prosecuted, the Times reported.

To learn more:
- read the Wall Street Journal article
- read this New York Times article
- read Boston Scientic's statement