Did Forged Signature Clear Way for Dangerous Blood-Clot Filter?
In the first part of an NBC News investigation into the Recovery blood-clot filter, we revealed that the device, which is implanted in thousands of people, was associated with 27 deaths and hundreds of other non-fatal problems after it received FDA clearance. In the second part of the report, a former insider at medical giant C.R. Bard raises questions about how the device got that clearance.
In 2002, medical giant C.R. Bard recruited Kay Fuller, a veteran regulatory specialist, to help secure FDA clearance for its Recovery blood clot filter, after the agency had turned down a previous application.
The Recovery, a one-and-a-half-inch metal trap, was designed to sit inside a major vein, the vena cava, and block blood clots from traveling to the heart or lungs, where they could be deadly.
In an exclusive interview with NBC News, Fuller said that she had serious concerns about the Recovery. A small human clinical trial raised red flags, and the company did not give her important safety performance test results, she said.
But when she voiced her concerns, she said, Bard officials didn’t seem to want to hear them.
“It was basically, you know, if you continue to pursue these questions, that I was going to be asked not to be on the team,” Fuller said. “And I was shocked.”
Fuller says she told her boss she would not sign the application until the issues were resolved. Bard submitted its application to the FDA with what appears to be Fuller’s signature on it.
Above, the signature on C.R. Bard’s FDA application, which Kay Fuller says she did not sign. Below, what Fuller says is her actual signature.
“That’s not my signature,” Fuller told NBC News when shown a copy of the paperwork. A sample of her signature from that time is markedly different from the one on the application. “I will tell you I did not sign it,” Fuller said, adding that her name was signed on the application without her knowledge.
Fuller has since resigned from Bard, but not before reporting her safety concerns to the FDA. “I never knew what they did after that,” she said.
The FDA won’t say if it acted on Fuller’s tip and denied requests for an interview. In a statement, it said it “takes very seriously” any complaints about “forgeries and device issues.”
Bard executives also declined to be interviewed but said any suggestion the New Jersey-based company submitted forged documents to the FDA is “flatly untrue.”
About a quarter of a million blood clot filters are implanted in patients like Gloria Adams and Dodi Froehlich each year, most without incident. Eleven companies sell them in the U.S., but Bard’s Recovery filter stood out early as a risky device.
After receiving FDA clearance, Bard sold about 34,000 patients Recovery filters. Records show that over the course of a decade, the filter was associated with 27 deaths and several hundred non-fatal problems.
You can read the entire full length story here.