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Guidant to Pay $296 Million Penalty for Failure to Report Defibrillator Safety Problems to FDA

By Paul Napoli

The U.S. Department of Justice has announced that Guidant LLC, a subsidiary of Boston Scientific Corporation, has pleaded guilty to criminal violations of the Federal Food, Drug and Cosmetic Act for the company's actions regarding the short-circuiting failures of three models of its implantable cardioverter defibrillators.

Patients use implantable cardioverter defibrillators to prevent sudden cardiac death by detecting and treating abnormal heart rhythms. These surgically implanted medical devices monitor the electrical activity of the patient's heart and when needed, deliver an electrical shock to the heart to restore the heartbeat to normal. Failure of a cardioverter defibrillator to detect and treat deadly electrical rhythms can cause a patient to die within minutes.

Guidant's Cardiac Rhythm Management division, headquartered in Arden Hills, MN, produced the defibrillators. Federal authorities charged the company in Minnesota's federal district court on February 25, 2010. The guilty plea agreement was filed with the court on March 11, 2010.

Under the terms of the plea agreement with the Justice Department to resolve the charges, Guidant pleaded guilty to withholding information from the U.S. Food and Drug Administration (FDA) regarding catastrophic failures in some of its lifesaving devices. Specifically, Guidant admitted to: (1) making a materially false statement in a required submission to the FDA with regard to the Ventak Prizm 2DR device; and (2) failing to notify the FDA of a "correction" to the Contak Renewal devices, which the company made to reduce a risk to health caused by the devices. Because of these offenses, the agreement calls for Guidant to pay a combined criminal penalty in excess of $296 million. District Court Judge Donovan W. Frank must still approve the plea agreement.

'Guidant's guilty plea today is about accountability,' said Assistant Attorney General Tony West, who heads the Justice Department's Civil Division. 'This successful prosecution serves as an important wake up call to all those who seek to withhold vital information about public health and safety. We will continue our efforts to prosecute those who jeopardize public health by evading their reporting obligations to the FDA.'

'The guilty plea today should serve as a reminder and deterrent to those who would break the laws requiring honesty and cooperation with government regulators whose mission is to protect the health and safety of the public,' said Frank J. Magill, Acting U.S. Attorney in this case for the District of Minnesota. 'The health care laws are as important as ever. When medical device and pharmaceutical companies fail to live up to their legal obligations, serious criminal consequences will follow.'

'Today's entry of a guilty plea by Guidant LLC and the proposed resolution would represent the largest criminal penalty ever imposed on a device manufacturer for violating the Food Drug and Cosmetic Act,' said Commissioner of Food and Drugs Margaret A. Hamburg, M.D. 'The FDA will continue to commit enforcement resources to seeking this type of criminal resolution and stiff sanctions when device manufacturers fail to adhere to the statutory and regulatory requirements that exist to ensure the safety and efficacy of their products.'The medical device manufacturer's admission of criminal wrongdoing is the result of a four-year investigation by the FDA's Office of Criminal Investigations into Guidant's handling of short-circuiting failures of three models of its implantable cardioverter defibrillators: the Ventak Prizm 2 DR (Model 1861) and the Contak Renewal (Models H135 and H155).

If you or a loved one suffered injury or a loved one died due to a defective medical device, you may be entitled to compensation for your injury, a loved one's injury or wrongful death. Please contact Napoli Bern Ripka, LLP at 888-529-4669 to discuss your options for filing a claim and recovering compensation for your medical expenses, lost wages and pain and suffering.

Originally posted at InjuryBoard by Paul Napoli

Full post as published by New York City Personal Injury Lawyer on April 11, 2010 (boomark / email).