FDA has acknowledged that a former CR Bard employee expressed concerns about one of the company’s blood-clot filters that the agency ultimately approved, and that has been linked to 27 deaths.
That employee, Kay Fuller, told the agency that the company had not conducted a specific non-clinical test on the Recovery vena cava filter before applying for regulatory clearance in 2002, according to an NBC News investigation. In a November 2015 letter, FDA told Sen. Charles Grassley, R-IA, chair of the Senate Judiciary Committee, that Bard submitted those test results after an FDA request, and that the results satisfied the agency.
