Judge Rejects Guidant Settlement After Doctors Call For Harsher Punishment

A federal judge has rejected a $296 million plea deal between Guidant and the U.S. government, saying that the settlement fails to properly punish the company for concealing problems with defective defibrillator implants that have been connected to at least six deaths.

Judge Donovan Frank of the U.S. District Court for Minnesota said that letting the company walk with a $296 million fine did not serve “the interests of justice” and called for both parties to arrange a more stringent settlement. Judge Frank’s rejection comes after two prominent doctors wrote to the Court asking for a harsher punishment for the company and individual executives who are responsible for the misconduct.

Dr. Robert G. Hauser and Dr. Barry J. Maron, two cardiologists who brought attention to the problem after one of their patients died, wrote a letter to Judge Frank asking him to reject the agreement between Guidant, LLC and the Department of Justice (DOJ) over charges that the company tried to hide problems with defective defibrillator implants . The doctors said that the DOJ should hold someone criminally responsible, with the possibility of jail time, for the deaths and negligence, instead of allowing the company to pay its way out of trouble. However, in his ruling, Judge Franks pointed out that it would be the responsibility of prosecutors to determine whether someone should be criminally charged.

DOJ investigators filed charges against Guidant on February 25 in federal court in St. Paul, Minnesota, after a four-year investigation into several models of the company’s implantable cardioverter defibrillators (ICDs). The charges allege that Guidant hid information from the FDA regarding catastrophic failures of its Ventak Prizm 2 DR and Contak Renewal ICDs. Last month Guidant, a subsidiary of Boston Scientific, plead guilty to the charges and agreed to fines of $296 million.

Boston Scientific announced that it was willing to rework the deal, but did not give details. The doctors have said they are pleased with Frank’s decision.

Drs. Hauser and Maron, point out that some people, including a 21-year-old patient of the two doctors, Joshua Okrup, died as a result of the defective defibrillators, and asked Judge Frank not to allow the case to be resolved without any individuals being held responsible.

“[Okrup’s] unnecessary death was caused by a product defect that Guidant Inc. had known about for years and failed to inform patients, physicians, and the U.S. Food and Drug Administration,” the doctors wrote. “Accordingly, we are extremely dismayed by the U.S. Attorney General’s decision to enter into a plea agreement with Guidant LLC, rather than prosecute the company and the individuals responsible for this egregious act.”

The Obama Administration seems to agree, and is pushing for more prosecutions of individual executives. However, the DOJ officials indicate that they can only bring charges that they believe they can reasonably win with the evidence at hand, and say that it is rare to have such evidence at hand in these kinds of cases. DOJ has not said it will not pursue criminal charges against Guidant executives in addition to the fines against the company itself, but said that it is much easier to prove a case against a drug or medical device company, than one or a handful of individuals at that particular company.