What is the Gnidant Ancure Endograft System?
The Ancure Devise was designed for use in the treatment of abdominal aortic aneurysms. An abdominal aortic aneurysm is a potentially life threatening condition involving a weak area that develops in the wall of the aorta, the artery that brings blood flow from the heart through the abdomen to the rest of the body. The Aneure Device sold by Guidant has two primary parts. The first part is a delivery catheter used to place the vascular endograft into the aorta. The delivery catheter is inserted into a blood vessel through an incision made in the plaintiffs leg. The second part of the Ancure Device is a vascular endograft placed in the patient’s aorta using a delivery system to prevent an aneurysm from rupturing. The vascular endograft consists of a woven fabric graft with an attachment system that includes hooks. The vascular endograft is designed to remain in the patient’s aorta permanently after being implanted to strengthen the weakened area in the aorta. The delivery catheter is designed to be removed from the patent after the vascular endografi is implanted. Traditionally, in order to treat abdominal aortic aneurysms, patients had to undergo invasive surgery requiring the physician to cut open the abdomen in order to reach the aorta.
Defendants began marketing the Ancure Device in the United States in 1999. On September 28, 1999, the FDA completed its review and approved the Defendants’ premarket approval application for the Ancure Device.
Defendants removed the device from the market on March 16, 2001. The company made changes and put the device back on the market in August, 2001. On June 17, 2003, Guidant Corp. announced that it will stop making the device and close the California subsidiary that made the product.
Guidant Corporation, Inc. is incorporated in Indiana, with its principal place of business in Indianapolis Indiana. The device was manufactured in Santa Clara County, California. In its first year of operation, Guidant posted a profit of 92.1 million, on sales of $892.4 million. By the year 2000, revenues reached $2.4 billion. Guidant had $612 million in net income last year.
Endovascular Technologies, Inc. is a wholly owned subsidiary of Guidant Corporation, Inc. and was incorporated in California, with its principal place of business in Menlo Park, California.
Sales Representatives of Guidant are located across the United States..
Endovascular Technologies, Inc., the wholly owned subsidiary of Guidant Corporation and the United States Department of Justice entered into a plea agreement on June 12, 2003.
Endovascular Technologies, Inc. agreed to waive indictment and plead guilty to a criminal Information charging it with one felony count of making false statements within the jurisdiction of a federal agency, in violation of 18 U.S.C. § 1001, and nine felony counts of shipping misbranded medical devices in interstate commerce, in violation of 2l U.S.C. §§331 (a) and 333 (a)(2).
The company was charged with failing to report as many as 2,600 malfunctions of the $10,000 device during surgery. According to the charges, doctors and others began to report to the company malfunctions with the delivery system soon after sales began in the US. The delivery system became lodged in the body of the patient, requiring doctors to perform surgery — opening up the abdominal cavity — simply to remove the delivery system.
According to the charges, sales representatives, who were often present when the procedure was performed, began telling doctors to break off the handle of the delivery system if it became stuck and extract it in pieces. The charges state that the solution was devised in part by the sales representatives themselves, wit no testing to prove it safe or effective. In at least one procedure, conducted in January of 2000, the handle breaking technique was unsuccessful and the patient died. Despite this, Endovascular failed to test the procedure and continued to recommend that doctors break the handle.
Under the terms of the plea agreement, Guidant agreed to make a payment of $43.4 million and an additional $49 million civil settlement to the government. The plea agreement pertained only to the delivery system of Ancure prior to the company s voluntary recall. The gross misconduct of the corporations resulted in one of the first guilty plea to criminal felony convictions.
A total of 7,632 devices were sold prior to the recall, and 2,628 reported problems.
Approximately 11,000 devices were sold after the recall.
Jon L. Gelman, Esq. currently accepts death and disability Ancure device cases. Most of these cases arise from the necessity of the doctors opening up the abdominal cavity to remove pieces of the delivery system.