Did C.R. Bard Really Forge a Signature on an FDA Filing?

Chris Newmarker

September 4, 2015

3 Min Read
Did C.R. Bard Really Forge a Signature on an FDA Filing?

A former C.R. Bard regulatory affairs specialist tells NBC News that she did not sign an application for a blood clot filter she thought was problematic. And yet the signature appears to be there. The company describes her claims as "flatly untrue."

Chris Newmarker

The plot appears to have thickened in an NBC News investigation into problems related to the Recovery blood clot filter that C.R. Bard sold in the early part of the last decade.

NBC claims the filter, placed inside the vena cava to catch blood clots, was associated with 27 deaths and a couple hundred non-fatal problems--but Bard never recalled it.

Back in 2002, Bard hired veteran regulatory specialist Kay Fuller to help win approval for the Recovery, but she voiced concerns about the device after a small study raised red flags. Fuller tells NBC that Bard officials didn't seem to want to hear her concerns, so she resigned and privately alerted FDA.

And yet Fuller's name was signed onto an FDA application for the device. "That's not my signature," Fuller told NBC News after being shown a copy of the paperwork. NBC reports a sampling of Fuller's handwriting from the same time period is markedly different. Check out the full NBC story here.

The company in a written statement to NBC described the claims as "flatly untrue."

Bard filters undergo a thorough battery of testing in compliance with federal law, and are evaluated by FDA before reaching the market, Bard told Qmed in a statement. "They are implanted by physicians only after careful consideration of the risks and benefits of the device in light of each patient's condition."

FDA said in a statement shared with Qmed: "While we cannot confirm nor deny the existence of an investigation, the FDA takes very seriously any complaints about 510(k) forgeries and device safety issues. ... To help us achieve our mission, we have established pathways and guidelines that we expect the medical device industry to follow and will take action to protect the public health as appropriate."

Bard replaced Recovery with a newer model in 2005, but NBC says there are still about 20,000 people with one inside of them. 

FDA points out that since the Recovery's time, it has issued safety communications, one in 2010 and an update in 2014, advising the public of problems observed with IVC filters, including device migration, filter fracture, embolization, perforation of the IVC, and difficulty removing the device. FDA has recommended that physicians consider removing implanted filters in some patients, and has required filter manufacturers to engage in additional post-market surveillance.

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Chris Newmarker is senior editor of Qmed and MPMN. Follow him on Twitter at @newmarker.

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