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.
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.
