FDA May Release Hundreds of Thousands of Adverse Event Reports to The Public

In a sharp reversal of tone from our previous article titled, “FDA Hides Millions of Adverse Reports,” outgoing FDA Commissioner Dr. Scott Gottlieb ‘tweeted’ (in part) that the agency tasked with protecting Americans from dangerous medical devices plans to release approximately 1.1 million adverse event reports to the public.

Dr. Gottlieb stated, “This is an old database where historical information wasn’t easily accessible electronically owing to the system’s age. But it’s imperative that all safety information be available to the public. We’re now prioritizing making ALL of this data available.”

Lawyers representing injured patients and medical device safety researchers have been pushing the FDA for years to release hundreds of thousands of hidden injury and malfunction reports related to approximately 100 medical devices.

These reports have been hidden from public view for about 20 years via a program that allowed manufacturers to file ‘alternative summary reports.’

The push for this information has recently come amid reports of surgical stapler malfunctions and complications.

President of the National Center for Health Research, Diana Zuckerman who has testified to Congress and the FDA about medical device safety stated, “The FDA absolutely should be making all of this information available.”

According to a recent NBC News article, Dr. Gottlieb said, “we are looking at ways to make ASR [alternative summary reporting] data received prior to 2017 more easily accessible.”

“I think that the imperative of the agency is to make as much of this information available to the public as possible,” Gottlieb said during the interview last week. “I think these databases by and large should be searchable to the public.”

For a list of medical devices that Johnson//Becker is currently investigating or pursuing litigation in, please follow this link: Medical Device Injuries.

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