News | November 09, 2009

Boston Scientific to Pay $296 Million Settlement for Guidant FDA Violations

November 9, 2009 – Boston Scientific Corp. said Friday it reached an agreement in principle with the U.S. Department of Justice (DOJ) related to product advisories issued by its Guidant subsidiary in 2005. The alleged conduct and product sales occurred prior to Boston Scientific’s 2006 acquisition of Guidant.

Boston Scientific had previously disclosed an investigation by the U.S. Attorney’s Office in Minneapolis into alleged violations of the Food, Drug, and Cosmetic Act by Guidant. Under the terms of the agreement, Guidant will plead to two misdemeanor charges related to failure to include information in reports to the U.S. Food and Drug Administration (FDA), and Boston Scientific will pay $296 million on behalf of Guidant.

“We are pleased this investigation has been resolved,” said Ray Elliott, president and CEO of Boston Scientific. “Guidant and its employees acted in good faith and believed they complied with applicable laws and regulations. We elected to resolve this matter so we could put it behind us and devote our full energies and resources to developing our innovative technologies.”

The only products involved in the investigation were the VENTAK PRIZM 2, the CONTAK RENEWAL and the CONTAK RENEWAL 2 cardiac resynchronization therapy defibrillators, which were the subjects of the 2005 product advisories.

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