Because of a little-known federal exemption program, death data about heart devices sits in inaccessible FDA files that can take up to two years for the public to see under open-records laws.
A retired Oakland, Calif., physician is among the patients citing the once-hidden Food and Drug Administration data in a suit.
The FDA reveals that 56,000 malfunctions associated with surgical staplers weren’t reported through its traditional public reporting system.
The Food and Drug Administration allowed one company to send 50,000 reports of harm or malfunctions to an internal database even as patients worried about faulty defibrillators lodged in their hearts.
In the wake of a KHN investigation, the agency will no longer let device makers file reports of harm outside a widely used public database.
In the wake of a KHN investigation, Scott Gottlieb says releasing the records is in the public interest.
For almost two decades, device makers have sent reports of incidents to databases hidden from public view.
The FDA said it might reclassify the widely used devices featured in a recent Kaiser Health News investigation.
The Food and Drug Administration has let medical device companies file reports of injuries and malfunctions outside a widely scrutinized public database, leaving doctors and medical sleuths in the dark.
In the wake of a KHN/USA Today Network investigation, Leapfrog will check the safety and quality of outpatient centers.