Alert higher-ups about problems ranging from minor glitches to deaths of some patients implanted with a device. Employees at the Menlo Park subsidiary of medical-device giant Guidant encountered backlash from senior staff when the workers tried to alert higher-ups about problems ranging from minor glitches to deaths of some patients implanted with a device, according to a letter released by federal regulators.
Written anonymously by seven employees and directed to a Guidant executive in October 2000, the letter was also sent to the Food and Drug Administration. It played a large part in the federal investigation by the U.S. Justice Department that led to a multimillion-dollar settlement against the subsidiary announced June 12.
In the letter, the seven employees outlined a list of design flaws or quality issues surrounding the device, called the Ancure, along with medical practices they said were inadequately tested and put patients’ lives at risk.
“Many of us have had concerns for several months and we feel we have exhausted all means of resolution within our own departments, and within the division as a whole,” the employees wrote in their letter to Michael Gropp, Guidant’s chief compliance officer at the company’s office in Santa Clara.
Seven employees did not identify themselves
The seven employees did not identify themselves because “we have witnessed others who have initiated important discussions around these same topics to senior staff through the usual and proper channels, only to encounter hostility and ultimately threats to their careers,” the letter said.
The letter was released by the FDA in response to a request from the Mercury News under the Freedom of Information Act. The seven employees did not name any senior staff at the subsidiary or at Guidant in the letter.
Contacted for comment Tuesday, Guidant officials declined to respond directly to points raised in the employees’ letter.
“The company resolved its issues with the government in the plea agreement that was reached and announced on June 12. In fact, the `Anonymous Seven’ letter was discussed in great detail in the agreement. Therefore, we see no purpose in rehashing matters that have already been resolved,” Steven Tragash, a spokesman for Indiana-based Guidant, wrote in an e-mail.
Guidant voluntarily contacted the FDA in a timely manner, took the product off the market
In a separate letter Monday to the Mercury News, Tragash wrote, “Guidant voluntarily contacted the FDA in a timely manner, took the product off the market, overhauled our regulatory and compliance systems and worked tirelessly to correct the problems.”
The Ancure device was made by Guidant’s EndoVascular Technologies subsidiary, based in Menlo Park. That division pleaded guilty in June to 10 felonies involving the Ancure device, including misbranding and making false statements to government regulators. The subsidiary agreed to pay a $92.4 million fine to the government in the largest settlement of its kind to date for failing to report medical device malfunctions to the FDA, as required by law.
The Ancure was a device developed by the Guidant subsidiary to repair bulges, known as aneurysms, that can develop in the main artery leading from the heart to the rest of the body. The device was intended to be a better treatment than surgery.
A Mercury News examination has found that Ancure malfunctions that went unreported to the FDA including 12 deaths were widely known within the subsidiary. Overall, at least 75 patients died and 991 were injured after receiving the implant, and lawsuits charge that in some cases, the implant was at fault.
Among the concerns outlined in the employees’ letter:
A procedure called the “broken-handle” method for removing the outside of the device, if it became stuck in an artery, was not adequately tested.
Even so, the letter said, “Members of the sales force are currently instructing physicians to use this troubleshooting method with many of the potential risks unknown.”
Problems were reported inconsistently to the FDA. Similar complaints and outcomes were handled differently, the employees said, with the company directing some complaints to the FDA but failing to file others. The letter said one device removed from a patient in 1999 contained a broken hook, which attaches the device to the artery wall.
“An attempt was made to keep this information very quiet” and was not reported to the federal regulators as required, the workers alleged. Guidant personnel “asked to change records before and during an FDA audit, without FDA knowledge.”
The employee refused.
Concerned about these and other problems, the letter said the workers urged an internal audit.
In March 2001, after telling the FDA that its EndoVascular Technologies division had not filed 2,628 incidents of Ancure system malfunctions, Guidant suspended sales of the Ancure system. Five months later, following FDA-approved labeling changes that detailed how to remove the device’s handle from the body should it become lodged during insertion, the system was put back on the market.
Guidant officials have said Ancure is safe and any malfunctions involved the system used to implant the device inside the body.