Blog : Dangerous Drugs & Devices

IVC filters failures and Bard’s cover up: Part 2

kedwards

We already know that IVC Filters are dangerous. We also already know that the manufacturers knew of the dangers but did nothing to protect the public. But did medical giant CR Bard, in order to obtain approval for their product, go so far as to forge a doctor’s signature on an application to the FDA?

Shockingly, that’s exactly what the second part of an NBC Nightly News investigation into IVC Filters revealed. Watch the video at the bottom of this page to see the signatures for yourself.

In 2002, Bard’s initial application for approval of the Recovery Filter was denied by the FDA. As part of its second attempt, Bard hired Kay Fuller, a senior regulatory affairs specialist, to assist with the application. Fuller brought her concerns to Bard officials and requested additional information after a clinical trial highlighted the product’s potential dangers. But instead of remedying the problems or giving Fuller the data she requested Fuller says Bard officials threatened to fire her if she didn’t stop asking questions.

Fuller refused to sign off on the application and left the project. Yet somehow her signature appeared on a critical FDA filing.

“That signature’s not mine,” Fuller told NBC, adding that she had no knowledge that her signature was included until recently. The FDA declined to comment on NBC’s report and Bard officials refused to be interviewed.

The NBC story also put a human face on the deeply tragic consequences of Bard’s greed. Gloria Adams, 55, was implanted with a Recovery Filter after suffering a brain aneurism. A week into her recovery a piece of the filter punctured her heart, killing her.

About 250,000 filters are implanted every year and many are never removed. If you or a loved one have been injured by an IVC Filter, you may be entitled to compensation. Contact us to find out more.

This article is part two of Oxner Permar + Richardson’s series on Inferior Vena Cava (IVC) filters.