On June 12, 2003, Guidant Corporation and its subsidiary EndoVascular Technologies, one of the nation’s leading medical device manufacturers, pleaded guilty to 10 felonies in a San Francisco federal court, admitting that it lied to the FDA and hid thousands of serious health problems, including 12 deaths, caused by one of their products, the Ancure Endograft System used around the country by doctors to surgically correct their patients’ abdominal aortic aneurysms. This case resulted in $92.4 million in criminal and civil penalties, which The New York Times claims is the biggest penalty ever imposed against a medical device manufacturer for failing to report problems to the FDA. Presently, many people are walking around with these potentially “ticking time-bombs” in their bodies and they don’t even know it.

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Throughout the period Ancure was first on the market (19 months), 2,628 of the 7,632 devices that were sold had malfunctioned in the insertion process and were unreported to the FDA. 57 cases required emergency surgery to correct any complications involved in the procedure. 12 patients died. It is estimated that over 18,000 patients worldwide have been implanted with Ancure devices. With a failure rate of one third, there could have been over 6,000 defects resulting in injury or death.

It is important to point out that the FDA does not test new medical devices independently and relies solely on companies to provide honest results of clinical trials.

Background
Guidant introduced the Ancure Endograft System in 1999 as a less-invasive alternative to surgery. It was used to strengthen the aorta, or the main vessel that comes from the heart, as it passes through the abdomen. People at risk of heart disease are susceptible to a life-threatening abdominal aortic aneurysm, which is a weakening or complete rupture of the aorta.

Less than four months after the device was on the market, a patient had died after an Ancure device became lodged in the patient’s body. An EndoVascular sales representative monitored the emergency surgery and instructed the doctor to break off the handle of the device and remove the catheters housed within the delivery system piece by piece. This happened in numerous cases and the procedure had not been approved by the FDA at the time. Top management officials failed to notify the FDA that their insertion device was defective.

In July 2000, the FDA made regulatory inspections at EndoVascular and asked for any malfunctions regarding the Ancure device. EndoVascular turned over only 172 reports, but months later, after an investigation took place, employees admitted to the FDA that there had been many more problems that were unreported.

In March 2001, the device was recalled when Guidant told the FDA it hadn’t reported manufacturing changes, device malfunctions and “severe vessel damage” linked to the insertion of the device. It was then reintroduced in August 2001.

Presently, the FDA says that the problems related only to the system for implanting the device, not to its performance once implanted.

Investigation
The affiliated companies now face at least 10 product liability lawsuits pending against Guidant by families who say their loved ones died from the implant or by people who say they were injured during the procedure. According to The Times, as part of the settlement agreement, EndoVascular Technologies agreed to waive the attorney-client privilege, meaning employee statements to company lawyers during the investigation will now be available as potential evidence.

Complete a FREE Consultation Form online

Free Case Evaluation!
If you have this device in your body or if you were already injured by it, contact the Villari law firm now for a free consultation because time may be of the essence to protect your legal rights. Complete a FREE Consultation Form online or Call Us today toll free at 1-888-729-2901!