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.
Medtronic got permission to summarize more than 1,000 incidents in patients who got its Infuse bone graft. Medtronic previously had been warned four times in five years for not reporting problems with its products.
The FDA gets so many reports beyond the usual 30-day deadline that it has created a “retrospective summary reporting program” for them. No written description of the program is available on the FDA’s website, no law explicitly authorizes it and there is virtually no public paper trail of its existence.
The Star Tribune reported on Medtronic’s Infuse summary in April. Additional analysis since then shows that the FDA has allowed retrospective summaries dating to 2005 from at least two dozen medical device makers, comprising more than 130,000 overdue “adverse events,” as the FDA calls them.
That total jumped to more than 300,000 last month after the Star Tribune successfully challenged FDA decisions that kept some adverse event totals confidential by classifying them as corporate trade secrets. The FDA allowed one summary to be filed without including how many events there were.
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.”