According to a recent ProPublica article, the FDA failed to protect millions of people who used tainted breathing machines, particularly those manufactured by Philips Respironics. Despite receiving numerous complaints about a dangerous defect in the devices, including the popular DreamStation for sleep apnea, the FDA did not issue alerts to doctors or patients over the course of a decade.
The FDA allowed the company to submit reports years later without penalty and concealed the original dates from the public. The investigation also revealed that other leading device makers submitted hundreds of thousands of late reports to the FDA, leaving regulators and the public without safety information. Criminal charges for delays like this are rare, and the FDA's enforcement has been criticized.