Boston Scientific subsidiary, Guidant LLC was convicted and sentenced today to three years probation and fined more than $296 million ($42,079,675 through forfeiture) for fraudulently concealing information about its defibrillators from the FDA. “Implantable cardioverter defibrillators are lifesaving devices used to detect and treat abnormal heart rhythms that can result in sudden cardiac death,” says DoJ:
“The devices, once surgically implanted, continually monitor the electrical activity in a patient’s heart for deadly arrhythmias and deliver an electrical shock to the heart in an effort to return the heartbeat to normal rhythm. If they fail to operate properly when needed, a person can die within minutes.”
According to the allegations in the indictment, “Guidant made decisions at various junctures to conceal information from the FDA and medical professionals regarding the device failures.” Only after three people died, did the company report the problems, says DoJ:
“The Justice Department’s sentencing memorandum filed with the court explains how Guidant decided to continue to implant hundreds of defective Renewal devices, even after the company had decided to stop shipping them from the factory due to the seriousness of the health risk they represented. Guidant developed a strategy to mitigate the health risk while not raising FDA concerns about the problem. This strategy included the company advising its sales representatives to tell physicians that ‘nothing was broken’ with the Renewal, and falsely telling the FDA that changes it proposed to the device in response to the electrical short-circuiting ‘were not being done to correct device flaws that threaten patient safety’ but were rather ‘to improve process throughout.’
“The safety and integrity of critical medical devices is assured only by close FDA oversight,” said First Assistant U.S. Attorney John Marti of the District of Minnesota. “This agency can only perform its mandated duty when medical device manufacturers provide the agency with timely and accurate information. When Guidant withheld important information, patient safety was jeopardized.”
To report healthcare fraud, contact Frohsin & Barger.