U.S. Sen. Al Franken says Medtronic’s handling of a study of its Infuse Bone Graft product may have “potentially skewed the risk profile” for thousands of patients and exposed “insufficient vigilance” by the Food and Drug Administration.
Franken raised both concerns in letters delivered Tuesday to Medtronic CEO Omar Ishrak and FDA Commissioner Robert Califf. Franken said he was “writing out of concern” about a Star Tribune story that appeared Sunday about the study’s handling.
Medtronic ran a retrospective study of 3,647 Infuse patients from 2006-2008 but shut it down without reporting more than 1,000 “adverse events” to the government within 30 days, as the law required.
