Defective Product Lawyers

Defective products are more common in every day life than one might expect.  Every year, car models are recalled, boat engines revamped, children's toys plastered with warnings and proper usage stickers.  Medical devices malfunction and prescription drug medications turn out to be tainted and potentially deadly to the patient.  For these reasons, the government struggles to create a safety net of rigorous testing; unfortunately, the true dangers of products are oftentimes not realized until after the fact.  Provided below is an article on the settlement of a defective medical device product case.

June 12, 2003

In a landmark guilty plea, a major health care corporation pled guilty today in San Francisco federal court to 10 felonies and agreed to pay $92.4 million to settle criminal and civil charges that it covered up thousands of incidents in which a medical device used to treat aneurysms in the aorta malfunctioned.  Among the thousands of incidents covered up by the company were 12 deaths and dozens of invasive surgeries. 

The guilty plea represents the largest amount ever paid by a defendant for failing to report malfunctions of a medical device to the Food & Drug Administration ("FDA"), and one of the first times there have been felony convictions for such conduct.  It is also the second largest criminal and civil settlement in the history of the Northern District of California.  The guilty plea and civil settlement was announced today at a press conference by the U.S. Attorney's Office for the Northern District of California, the U.S. Department of Justice's Office of Consumer Litigation and Civil Fraud Section, the FDA and the Federal Bureau of Investigation.

The defendant, Endovascular Technologies, Inc. ("EVT"), is a wholly owned subsidiary of Guidant Corporation ("Guidant").  The subsidiary is based in Menlo Park, California.  According to Guidant's website (guidant.com), the Menlo Park facility where the Ancure device was manufactured is also listed as one of Guidant's operating facilities.  Guidant is a Fortune 500 company based in Indianapolis, Indiana.   The criminal charges relate to a medical device known as the Ancure Endograft System ("Ancure Device").  The Ancure Device treats abdominal aortic aneurysms, a potentially life threatening condition commonly associated with people with heart disease.  The Ancure Device is inserted into the patient's body during a surgical procedure.

Under federal law, a company is required to report to FDA any incident in which its medical device may have caused or contributed to a death or serious injury or the medical device experienced a malfunction that would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.

* United States Attorney Northern District of California usdoj.gov/usao/can/press/html/2003_06_12_endovascular.html