For nearly 20 years, reports of widespread failures of more than 100 medical devices leading to scores of serious personal injuries were concealed from the public in a federal database about which few patients, doctors or regulators knew.
Earlier this year, a Kaiser Health News investigation revealed more than 5.7 million medical device-related injuries among patients across the U.S. Reports of those were filed through an internal FDA “alternative summary reporting” archive, rather than the more heavily-scrutinized public database known as MAUD. That database is used by physicians, public health advocates, medical device engineers and our own South Florida medical device litigation attorneys to identify patterns of problems with medical devices that put patients at risk. KHN reported that not even the FDA’s own commissioner was aware of the database, which included a voluminous list of devices like breathing machines, surgical staples, implantable defibrillators, breast implants, tooth implants and and in-heart balloon pumps.
And that wasn’t even the only “secret” database. The FDA also had a “registry exemption” that device manufactures could request to use for reporting injuries resulting from more controversial medical devices, such as pelvic mesh. Another allowed for “litigation complaint summary reporting,” where medical device manufacturers could send a single injury report that might detail thousands of pending lawsuits predicated on similar patient injuries. Continue reading