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DoJ Joins Whistleblower Suit Against Guidant & Boston Scientific; Faulty Defibrillators Put Lives at Risk, Says Tony West

February 4, 2011

According to whistleblower James Allen, Guidant knowingly sold him a defective cardiac device that threatened his life. The Department of Justice apparently agrees. The Department of Justice intervened in the False Claims Act lawsuit on behalf of the United States in the whistleblower lawsuit against Boston Scientific Corp. and “related Guidant entities under the False Claims Act for conduct relating to certain of its cardiac devices,” according to DoJ. The DoJ Complaint alleges that:

“Guidant sold cardiac devices, the Ventak Prizm 2 and the Renewal 1 and 2, even though Guidant knew the devices were defective. Despite Guidant’s fixing the defect in these lines of devices, the company continued to sell their remaining stock of defective devices anyway.”The devices at issue are implantable cardioverter defibrillators, which are designed to deliver therapy to prevent sudden cardiac death. The devices are surgically implanted into patients’ chests. When they detect an irregular heartbeat, the devices send an electrical pulse to the heart to “shock” it back to normal rhythm.”

Guidant — which was acquired by Boston Scientific in 2006 — pled guilty to related criminal charges early last year and was sentenced to pay nearly $300 million last month. Tony West, Assistant Attorney General for the Justice Department’s Civil Division, stated that the economic harm to the healthcare system and taxpayers caused by the company’s fraud was compounded by the physical harm to patients who had the defective devices implanted in their chests. “When a medical device manufacturer conceals problems with its products, as is alleged here, not only is taxpayer money wasted, but lives are put at risk.” Boston Scientific appears undaunted by the lawsuit, issuing a statement that it is not likely to have “a significant financial impact” on the company.

To report Medicare fraud, contact Frohsin & Barger.

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