Judge Rejects Infusion Pump Plea Agreement
We have recently written about the defective heart defibrillators sold by the Guidant Corporation and the dangers they present. Last week a federal judge in Minnesota rejected a plea agreement between the federal government and the Guidant Corporation, saying that the deal did not hold the company sufficiently accountable.
The plea agreement worked out between federal prosecutors and Guidant requires Guidant to plead guilty to two misdemeanors and pay a $296 million fine.
But, the judge held that the agreement was not in the best interest of justice and failed to adequately serve the public’s interest. He found that it did not adequately address the seriousness of the offenses.
The judge found that prosecutors should have sought probation for Guidant and its parent, Boston Scientific. Probation would have allowed the court to maintain control over Guidant to ensure that agreed upon remedial steps were implemented.
The judge also suggested other provisions that might be suitable in a new plea deal, including charitable activities by Guidant to improve heart device safety and improve medical care among minority patients.
After a hearing last month, several doctors and patients wrote to the judge urging him to reject the deal and arguing that former Guidant executives should be criminally charged in the case.
The case results from disclosures in 2005 that Guidant did not alert doctors and patients that some of its defibrillators had a defect that might cause them to fail. At least six patients died.
Recently, prosecutors charged in court papers that Guidant had knowingly sold potentially flawed defibrillators. But that issue was not addressed in the plea agreement. Instead, the company agreed to plead guilty to two misdemeanor charges that related to the completeness and accuracy of its filings with the FDA.
