PRODUCTS LIABILITY GUIDE: Products Liability Law,
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ZyprexaGUIDANT : Guidant Corporations Ancure Endograft System
EndoVascular Technologies, a subsidiary of Guidant Corporation, recently agreed to pay $92.4 million to settle criminal and civil charges, including 10 counts of fraudulently shipping a misbranded product and making a false statement to the Food and Drug Administration. The $92.4 million is purportedly the largest penalty ever given for failing to report a faulty medical product to the FDA.
Guidant has plead guilty to covering up malfunctions of its Ancure Endograft System, used to treat abdominal aortic aneurysms, which may have led to 12 deaths and 57 emergency surgeries nationwide.
The criminal complaint alleges that Guidant reported only 172 cases of malfunction since the product was introduced in September of 1999, but the company actually had records of 2,628 incidents where the device malfunctioned.
The device was withdrawn from the market in March of 2001 after the FDA and Guidant received seven anonymous letters from employees warning about the device. Patients with the devices currently implanted are not at risk and should not be alarmed because the malfunction only occurs during the insertion of the device.
The devices were used to keep weak artery walls from rupturing and were once considered groundbreaking because surgeons inserted the device through an artery in the leg which is much less invasive than having to cut open a patient's abdomen.
Since its withdrawal, Guidant has modified the stent-graft and the FDA reports that the devices are safe now and being sold on the market once again.
