When news broke of an internal FDA database of medical device injuries so secret that few within the agency even knew of its existence, the discovery obviously led to the raising of a multitude of questions. Why was an agency tasked with keeping American families safe allowing the companies it was supposed to be regulating to hide reports of injuries caused by their devices? Why was such a database even created? And, how many injuries could have been prevented or lives could have been saved if medical professionals and their patients had all the information they needed to make decisions about care? How large-scale can the amount of harm go when close to 6 million reports of device failure and injury are kept from those that need to see them most?
Three lawsuits filed against Medtronic may shine the first few rays of light on the impact. Medtronic, a leading medical device manufacturer, is facing litigation filed by three plaintiffs who say that the staplers used during their medical procedures failed and that the company knew there were problems with the devices, hid the risks, and sold them anyway.
Kaiser Health News’ reporting on the secret FDA database showed that while public reporting indicated just 84 injuries tied to Covidien surgical staplers, close to 10,000 incident reports related to the same stapler existed behind the database’s walls. Medtronic acquired Covidien in 2015 and, according to a report in the StarTribune, had been “warned” four times in just five years for failing to report problems with its devices and continuing to sell them to unwitting providers.
Among the Medtronic stapler failures alleged in the new lawsuits are staples that failed to properly close once placed and holes being left in organs and tissues when a staple was never left in place to begin with. The results for the patients were additional surgeries to try to correct the issues as well as the onset of severe infection and cardiac problems.
“Had these incidents been accurately reported, it is highly likely that public notice, FDA scrutiny, and product recalls would have preceded [my client]’s surgery,” argues one attorney in the filing, “and…the devices would have been appropriately recalled before being used on [my client] by her unsuspecting surgeons.”
