Boston Sci pays $296M to settle with DoJ over Guidant acquisition
Boston Scientific has 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 company noted that the alleged conduct and product sales occurred prior to Boston Scientific's 2006 acquisition of Guidant.
The Natick, Mass.-based company 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 FDA, and Boston Scientific will pay $296 million on behalf of Guidant.
The company said it has updated its financial results for the third quarter and nine months ended Sept. 30, recording a third quarter charge of $294 million, on both a pre-tax and after-tax basis. This amount represents the $296 million charge associated with the agreement net of a $2 million reversal of a related accrual.
"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 Natick, Mass.-based company 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 FDA, and Boston Scientific will pay $296 million on behalf of Guidant.
The company said it has updated its financial results for the third quarter and nine months ended Sept. 30, recording a third quarter charge of $294 million, on both a pre-tax and after-tax basis. This amount represents the $296 million charge associated with the agreement net of a $2 million reversal of a related accrual.
"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."