On a daily basis, doctors across the country rely on disclosures from medical device manufacturers to assess the risks and benefits of medical devices they recommend for their patients. To do so, they routinely rely on the U.S. Food and Drug Administration’s (FDA) public online database known as the manufacturer and user device facility experience (MAUDE) for objective reports of adverse events associated with those devices. Now imagine that millions of adverse events were systematically hidden from the public database over the course of two decades—and the FDA was complicit in that deception. Hard to imagine but true.

A Back-Door Program for Device Manufacturers

Earlier this year, the FDA acknowledged dozens of medical device manufacturers had been granted a little-known exemption from regulations requiring the submission of adverse events for publication in MAUDE. In June, the FDA released roughly six million previously undisclosed reports it received from various manufacturers between 1999 and April 2019 through a back-door program known as alternative summary reporting (ASR). Though ASR, manufacturers of critical devices such as surgical staplers and pediatric breathing machines satisfied their obligation to notify the FDA of certain reports of intraoperative device failure or post-surgical complication without also disclosing those reports to the general public. Pursuant to 21 CFR Part 803, a manufacturer is required to inform the FDA within 30 days if it learns from any source that its device may have caused or contributed to a patient death or serious injury. A duty to report is also triggered when a manufacturer learns of a device malfunction that would be likely to cause or contribute to death or serious injury if it were to recur. The FDA voluntarily created the ASR program through a regulatory loophole, allowing some of the largest device manufacturers, including Medtronic and Zimmer, to bypass the more transparent reporting process and discreetly submit summary reports of device failures, often on a quarterly basis.

The FDA’s Explanation