Two Minneapolis doctors who were the first to speak out about a potentially deadly defect in a popular model of heart defibrillator made by the Guidant division of Boston Scientific Corp. have asked a federal judge to reject a $296 million plea agreement that would settle the case.
In an April 12 letter made public Monday, Minneapolis Heart Institute doctors Barry Maron and Robert Hauser urged U.S. District Judge Donovan Frank to reject the proposed plea "on behalf of the patients who died or suffered pain and mental anguish as the direct result of Guidant's illegal and unethical behavior." Frank could rule on whether to accept the plea by the end of the week.
Five years ago, the two cardiologists made national news when they publicly voiced their concerns about a Guidant-made implantable cardioverter defibrillator (ICD) after their 21-year-old patient, Joshua Oukrop of Grand Rapids, Minn., collapsed on a Utah biking trip and died. His Guidant Ventak Prizm 2 defibrillator had short-circuited.
ICDs are stopwatch-sized devices implanted in the chest that shock an errantly beating heart back into rhythm, often warding off sudden cardiac death.
Oukrop'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 (FDA)," the doctors' letter states. The doctors said they are willing to meet with the judge, or respond to questions.
Guidant ultimately recalled several models of defibrillators and pacemakers because a small number had the potential to malfunction. Despite the recall, Natick, Mass.-based Boston Scientific forged ahead with its purchase of Guidant for $27 billion, in one of medical technology's biggest deals ever. Guidant's cardiac rhythm management division is based in Arden Hills and employs about 2,000 people.
In January, Guidant pleaded guilty to two federal criminal charges, including making false statements to the FDA regarding modifications made to the design of the Ventak Prizm defibrillator that affected the device's safety and effectiveness. Guidant also pleaded guilty to failing to promptly notify regulators of a correction made in 2005 to the Contak Renewal defibrillators. Medical device companies are required to first contact the FDA about substantive changes to a product's design.
In addition, Boston Scientific agreed to pay a $296 million fine on behalf of Guidant. If approved by the judge, the criminal penalty would rank as the largest ever in medical technology for violating the U.S. Food, Drug and Cosmetic Act.
"To allow a repeat offender, like Guidant, to escape with a fine (that is entirely borne by the shareholders of Boston Scientific) does not hold the guilty parties fully accountable and inevitably undermines patient safety," the doctors wrote.
U.S. Justice Department officials could not be reached for comment Monday, nor was a spokesman for Boston Scientific available.
Reached in Munich on Monday, Hauser said he and Maron decided to write the letter after reading court documents spelling out the terms of the plea. "I just got very upset reading it, it brought it all back to me," Hauser said. He said the plea does little to discourage medical device companies from thwarting the law and putting patients at risk.
Charles Zimmerman, a Minneapolis attorney representing patients implanted with the device, applauded the doctors for writing the letter. "This is quite unusual and extraordinary, that they care enough and have the commitment to come forward, " he said. Zimmerman and other plaintiffs' attorneys also oppose the plea, saying their clients deserve restitution.
Janet Moore • 612-673-7752