The Star Tribune has published an article about medical device makers and their publication of adverse events concerning their products. According to the Star Tribune, companies like Johnson & Johnson, Zimmer, and Stryker can either bury these stats or publish them well after the companies have launched their medical devices.
“Makers of medical devices, from heart valves to drug pumps, are required to tell the U.S. Food and Drug Administration whenever they learn that a product may have injured someone. Those reports are usually available to patients and their doctors. But a Star Tribune analysis of recently obtained data shows that the FDA has accepted late reports that cover hundreds of thousands of incidents, sometimes years after the fact, and has created a program that lets device makers keep the details out of view. For example, the FDA let Illinois-based Baxter International put 75,000 unreported malfunctions of its Colleague drug pump into a confidential report while publicly disclosing only a single, brief summary. The FDA kept the number of events confidential until the Star Tribune challenged that decision.”
It turns out that the real culprit is the FDA itself, which is supposed to be the consumer watchdog and keep consumers safe from unscrupulous medical device companies seeking profits over consumer safety. Now, we need a watchdog for the watchdog. Congress needs to fix this and ensure that these existing loopholes allowing companies to either bury their findings or report them late are closed tightly.
It is appalling that medical device makers are allowed to withhold critical information from medical professionals and consumers, all with the blessing of the FDA.
Dr. David Challoner, who led an Institute of Medicine team that studied adverse-event reporting problems in 2011, said he had never heard of retrospective summary reporting.
“That’s a loophole you’ve identified,” Challoner said. “It should not happen. The fact that [overdue adverse event reports] can be reported in summary, without details, is inappropriate and, at least in my understanding of the basic congressional intent of reporting, outside the boundaries.”