Federal law enforcement officials have leveled criminal charges against Guidant LLC, a medical device manufacturer that Justice Department officials say knowingly sold defective defibrillator implants to consumers and then tried to cover up attempts to correct the defect.
Department of Justice (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 which in some cases resulted in death.
Guidant LLC is a subsidiary of Boston Scientific, which announced last November that it intends to pay $296 million in connection with the charges against Guidant. A DOJ press release announcing the charges indicates that Boston Scientific is likely to enter a guilty plea in connection with the charges.
ICDs are implants that monitor patients for abnormal heart rhythms and deliver electric shocks to keep the heart beating at the proper rhythm. The DOJ charges claim that Guidant was aware as early as 2002 that the Ventak Prizm 2 DR had the potential to suffer an electric arc, which could short-circuit the device, making it unable to provide life-saving heart rhythm corrections when the patient needed it.
The DOJ accuses the company of changing the design to fix the problem, and then lying to the FDA about the design changes to cover up the fact that there was a problem. The company continued to find problems with its defibrillators, and prosecutors say the company sent product updates to physicians that it did not send to FDA, as required by law, and even after other problems with other ICDs developed, the company did not issue a warning about the failures until June 2005.
The FDA determined that the warnings constituted Class 1 medical device recalls, the most serious category of recalls, which indicate that a product has the probability of causing serious injury or death.
“The government charges that Guidant committed serious crimes by undermining the FDA’s role to guard the American public against potentially dangerous medical devices,” said Assistant Attorney General Tony West in the DOJ statement. “Our message is clear: We will vigorously prosecute individuals and organizations who put profit over public health and safety by violating the law.”
The DOJ has put up a website for those who have been implanted with Guidant ICDs. The site contains case-related information, and notices of court events and hearings. The website is http://www.justice.gov/civil/ocl/Cases/Guidant/index.htm.