DoJ files suit against Guidant, Bos Sci for selling defective ICDs
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The DoJ alleges that Guidant sold the Ventak Prizm 2 and the Renewal 1 and 2, even though the company knew the devices were defective. Despite fixing the defect in these lines of devices, according to the complaint, the company continued to sell its remaining stock of defective devices.
The government's complaint alleges that Guidant hid the problems with their defibrillators from patients, doctors and the FDA. In February 2010, Guidant pleaded guilty to misleading the FDA about the problems in the devices. A district court in Minnesota accepted the company's plea on Jan. 12, 2011. Guidant was acquired by Boston Scientific in 2006.
"Patients with serious heart conditions who depend on these devices should not have to second-guess whether they are safe and effective," said Tony West, Assistant Attorney General for the Justice Department's Civil Division. "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."
The DoJ alleges that Guidant knew as early as April 2002 that the Prizm 2 contained a potentially life-threatening defect. The government's complaint also alleges that Guidant knew as early as November 2003 that the Renewal 1 and 2 contained a similar, potentially life-threatening defect.
Yet, the DoJ alleges, Guidant not only continued to sell the defective products, but also issued a misleading communication to doctors that misinformed them about the nature of the defect.
The company did not fully disclose the problem in the devices to doctors and the FDA until May 2005, after first being contacted by a reporter, according to the DoJ complaint. The company subsequently recalled the devices shortly after a front-page article about the defects appeared in the New York Times.
The United States joined a lawsuit filed under the qui tam, or whisteblower, provisions of the False Claims Act by James Allen, who allegedly received one of the defective devices. Under the act's qui tam provisions, a private citizen, known as a "relator," can sue on behalf of the United States and share in any recovery. The case is United States ex rel. Allen v. Guidant LLC et al., No. 11-CV-22 (D. Minn.).