This story exposed a number of “exemptions” the Food and Drug Administration gave to makers of life-sustaining medical devices, allowing them to quietly file injury, death and malfunction reports to intra-agency databases. The public, including researchers and doctors, would expect to find those reports in a database called MAUDE. The reporting focused on tragic injuries from surgical stapler malfunctions and revealed that in a year when about 80 stapler injuries were disclosed publicly, the agency quietly collected 10,000 malfunction reports internally. The stories spurred the FDA to end its largest exemption program and open 5.7 million records to the public.
The investigation immediately triggered an uproar in the medical device industry — and at the FDA. The day after Christina Jewett’s first story ran, the FDA acknowledged that it was aware of “many more” reports of stapler-related malfunction reports that were not filed openly in the MAUDE database and came out with a wide-ranging plan to improve the safety of the staplers. Citing KHN’s work, device-safety experts called on the FDA to open up the hidden reports of harm. That triggered a tweet by FDA Commissioner Scott Gottlieb — linking to KHN’s story — that said the reports would be opened: “We’re now prioritizing making ALL of this data available.” In early May, the FDA announced it would be shuttering the “alternative summary reporting” program altogether, and, on June 21, the FDA published its entire hidden database online, revealing 5.7 million device-related injuries or malfunctions for the first time. In a single data disclosure, the FDA revealed nearly 40% of the total medical device harm reports from the past 20 years for devices used to shock the heart and open blocked vessels.
Jewett used extensive search strategies to suss out happenstance mentions of the exemption program and “alternative summary” reports from the well-known public database of device injuries. This gave her a road map of devices to focus on. She used Freedom of Information Act requests to try to get details, but her efforts to expedite those requests were denied repeatedly. So she used the power of basic reporting and persistence to nudge the FDA press office for more detailed information about the overall amount and specific number of reports that were, in effect, hidden in its internal database. The strength of the facts and human stories helped spur the agency to open millions more records.
What was the hardest part of this project?
The hardest part of this project was finding the wherewithal to persevere in the face of closed doors. Experts who spent their careers fixing medical devices and investigating breakdowns didn’t know about this data. A former FDA commissioner didn’t even know. Information about “exemptions” in the public MAUDE database was spotty and scant. The FOIA requests were in a long line of backlogs and expected to take 22 months to fill. Jewett doggedly negotiated with the press office to get a minimum amount of data to show the public that we were seeing the tip of a very important iceberg.
What can others learn from this project?
If your reporter’s sense tells you there’s a story there, keep digging. Learn that “no” often means “maybe” if you’re persistent. In other words, even if the experts don’t know about something, even if the gatekeepers are offering little detail, there are ways to get information. For example, Jewett found an old trade-news article referencing the number of these hidden reports. She gave the press office an easy enough ”ask”: Please update these numbers. That was one way she got key information for the final article.