NBC News recently opened an investigation into the Recovery filter by C.R. Bard, Inc., a medical device designed to help decrease a patient’s risk of blood clots hitting the lungs or heart. Reports from hundreds of patients about serious medical issues after implantation, as well as at least 27 deaths, show that the device may cause more harm than good.
When patients or doctors argue that a medical device is defective, one of the first questions asked is about how such a product made it to the general market. Many are calling the approval process into question as it relates to the Recovery filter, since further research has highlighted the serious risks associated with implantation.
C.R. Bard’s march toward approval for this device started back in 2002, when the company hired a regulatory specialist by the name of Kay Fuller to help them obtain clearance from the Food and Drug Administration (FDA). The FDA had already rejected one of Bard's applications. The device is a small metal trap, designed for implantation inside a patient's inferior vena cava to stop blood clots from entering the heart or lungs.
Fuller has since shared her own concerns with the device as a result of a small clinical trial early on. She said she was not allowed to see the results of that vital performance test, raising red flags for her. When she shared those concerns with officials at Bard, she felt they did not want to hear what she had to say. According to Fuller, the company made it clear that she would not be a part of the process unless she let the issue go. Her response was to deny signing the document for the FDA application. The FDA application, however, bears her name on the signature line.
When Fuller had the chance to review the document, she was firm in her belief that it was not her signature and provided a sample of her signature to NBC News as proof. There was a notable difference in the two signatures. Fuller shared her concerns about the device with the FDA, but resigned from her position at Bard. Once C.R. Bard obtained regulatory clearance to market the Recovery filter, it was implanted in at least 34,000 patients.
If you or someone you love has suffered the consequences of the Bard IVC Recovery filter, contact premier Boca Raton defective device attorneys at Osborne & Associates Law Firm, P.A. for a consultation. We can be reached by phone at (561) 293-2600 or contact us online. Our attorneys have more than 50 years of combined experience helping injured victims throughout South Florida recover the compensation they deserve.
See the NBC News story by clicking the links below.
Part 1 - Did Blood-Clot Filter Used on Thousands of Americans Have Fatal Flaw?
Part 2 - Did Forged Signature Clear Way for Dangerous Blood-Clot Filter?
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