Boston Scientific Corp.’s Guidant unit is facing federal criminal charges that it failed to fully disclose problems with its <"http://www.yourlawyer.com/topics/overview/guidant_defibrillators">implantable defibrillators to the U.S. Food & Drug Administration (FDA). According to the Associated Press, the charges are part of a previously announced settlement agreement.
The Boston Globe is reporting that Boston Scientific and the U.S. Justice Department have signed a plea agreement that will be filed with the U.S. District Court in St. Paul, Minnesota at a later date. The company agreed in November to plead to the charges and pay $296 million to resolve the investigation.
According to the charges filed in federal court, Guidant violated the Food, Drug and Cosmetic Act by concealing information from the FDA about catastrophic short-circuiting failures in three models of its implantable cardiverter defibrillators. The company discovered problems with one of the products in 2002 and became aware of problems with two others in 2004, the department said.
Three safety alerts were issued about these defibrillators in June 2005. The FDA later determined these were Class I recalls, which are the most serious type of device recall because there is a reasonable change the devices could cause serious health problems or death. According to the Wall Street Journal, malfunctions in the products were linked to multiple deaths
According to the Boston Globe, federal prosecutors have alleged that Guidant executives knew about the problems and changed the design of its implantable defibrillators years earlier, falsely telling the FDA its design changes did not affect safety or effectiveness.
Boston Scientific, which acquired Guidant in 2006, did not admit guilt in the settlement
In 2007, Boston Scientific agreed to pay $240 million to settle more than 8,000 lawsuits claiming Guidant hid defects in defibrillators, which are devices that shock the heart back into regular rhythm.