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FDA
FDA Consumer
magazine
November-December 2003 Issue
By Linda Bren
When a surgeon couldn't remove part of a medical device stuck in a patient with a serious heart condition, the device maker's sales representative recommended breaking the product's handle--a procedure that was not approved by the Food and Drug Administration.
The unapproved handle-breaking technique was just one of the problems uncovered by federal investigators that led to the prosecution of Endovascular Technologies Inc. (EVT) of Menlo Park, Calif. In June 2003, EVT pleaded guilty in U.S. District Court in San Francisco to nine counts of misbranding medical devices and one count of making false statements to the FDA.
The company agreed to pay $92.4 million--the largest amount ever paid for failing to report medical device malfunctions to the FDA--to settle criminal and civil charges. The guilty plea followed a three-year investigation by special agents of the FDA's Office of Criminal Investigations (OCI) and the FBI.
EVT, a subsidiary of Indianapolis-based Guidant Corp., manufactured the Ancure Endograft System. The Ancure device is used to treat an abdominal aortic aneurysm, a weak spot in the wall of the large artery that carries blood from the heart to branch arteries throughout the body. The device consists of a delivery system and an implant. In a minimally invasive operation, a surgeon makes a small incision in the patient's groin, inserts a tube (catheter) through the artery, and implants a graft into the aorta in the abdomen. The graft stays in the body permanently, but the delivery catheter is removed.
Under federal law, companies are required to submit to the FDA a Medical Device Report (MDR) of any incident in which its device caused, or may potentially cause, harm to a patient.
EVT submitted 172 MDRs to the FDA during a 19-month period from September 1999, when the FDA approved the device, until March 2001, when the company withdrew it from the market. In March 2001, EVT admitted that it had failed to submit an additional 2,628 MDRs out of a total of 7,632 medical devices sold. Among the unreported incidents were 12 deaths and 57 emergency operations performed when the device's delivery system became stuck in the patient's body.
"Medical device manufacturers have a serious responsibility to report deaths and injuries associated with their products to the FDA," says Kim Rice, special agent in charge of the OCI field office in the Washington, D.C., area. "By failing to file thousands of MDRs, EVT hid the true extent of problems with their device from patients, doctors, and the public."
The FDA first became aware of allegations of fraud and coverup in October 2000 after receiving an anonymous letter from seven EVT employees. The "Anonymous Seven" described ethical, legal, and safety problems concerning the Ancure device.
FDA's OCI agents identified and questioned the Anonymous Seven. Upon further investigation, the OCI agents, with assistance from the FDA's medical device experts, concluded that many of the complaints in the Anonymous Seven's letter were accurate and that EVT was significantly out of compliance with FDA regulations and its own internal policies.
The seven employees had vocalized their concerns loudly to company management, says the OCI case agent. "Management wouldn't listen, so they wrote a letter to the FDA in an act of frustration," she says. The letter was also sent to EVT's parent company, Guidant.
Once aware of the letter and the FDA investigation, Guidant conducted its own investigation. Guidant's investigation confirmed most of the problems outlined in the Anonymous Seven's letter, says the case agent. The company admitted during the plea that it had intentionally failed to file thousands of MDRs.
After withdrawing the Ancure device from the market in March 2001, Guidant and EVT reintroduced the device in August 2001 with FDA-approved modifications in the device's warnings to customers and instructions to doctors. On June 16, 2003, Guidant announced that it would stop making the Ancure Endograft System.
Guidant and the FDA assure patients with Ancure device implants that they are not at risk as a result of this decision or the plea agreement. The problem, since corrected, was with the Ancure delivery system and not the implant itself. Patients should continue with routine monitoring and follow-up visits to a doctor, according to the FDA.
The criminal investigation is continuing. The guilty plea resulted in a financial hit to the company, but did not penalize individual company representatives, says Rice. "We're trying to see if we have sufficient evidence to prosecute one or more top-level people who directed these illegal activities within the company."