FDA Covers for Device Makers, Keeps Injuries Under Wraps

Jane Akre
October 20, 2016
FDA Office of the Commissioner, Silver Spring, MD

FDA Office of the Commissioner, Silver Spring, MD

Medical Device News Desk, October 20, 2016 ~ The system is supposed to be transparent. Medical device makers are required to alert the U.S. Food and Drug Administration (FDA) when their products injure consumers or malfunction.

The FDA then theoretically alerts doctors who alert consumers. In rare cases, such as pelvic mesh, the FDA will actually issue a public health notification.

That is not happening, according to an investigation by the Minneapolis Star Tribune. Its analysis, based on data from the FDA, shows the agency has created programs that allow manufacturers to keep injury reports out of view of the public.

One example is Baxter International.

The Illinois-based company put 75,000 malfunctions of its Colleague drug pump into a report, kept out of the eyes of the public while a brief summary was issued. When the Star Tribune challenged the decision, the FDA revealed the actual number of injuries.


Medical device manufacturer Medtronic, maker of the Infuse bone graft, was given permission to summarize adverse event reports numbering more than 1,000 malfunction and potentially product-related injuries related to Infuse in a three- sentence summary about six years after they were due.

This was allowed even though Medtronic had been warned four times previously for not reporting problems.

Medtronic said the failure to report was unintentional.

The Star Tribune filed a Freedom of Information Act request with the FDA, which took more than one year to fulfill. It showed more than 40 patients out of 100 who had the Infuse placed in the neck had trouble swallowing. The company had these reports back in October 2007. Nine months later, after receiving adverse reports from others sources, the FDA warned that Infuse can cause swelling near the airways.

LifeScan, a Johnson & Johnson company finally reported 186,000 potential malfunctions in its diabetic blood meters in 2006. The reports went back two years and had not previously been reported to the FDA.

The program is called the retrospective summary reporting program and it was created because so many companies fail to issue their reports in the required 30-day deadline. The newspaper reports there is no description of the program on the FDA’s website, so the public would not know of its existence. There is no punishment for failing to report in a timely manner.

The FDA has allowed injury or adverse event summaries, from as far back as 2005, to be entered into the program. At least 2 companies have issued more than 130,000 overdue adverse event reports. To date that number is now more than 300,000, after the Star Tribune investigation.

Dr. David Challoner, MD

Dr. David Challoner, MD

Dr. David Challoner, who led an Institute of Medicine team that studied adverse-event reporting problems in 2011, told the Star Tribune 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.”

While the FDA declined an interview request, a spokesperson by e-mail said that the medical community already understand the issues well and additional documentation would just waste resources.

Often the devices mentioned in the summaries are controversial. For example Baxter Colleague pump has been recalled. Vaginal mesh implant reports are submitted late. There are in excess of 100,000 defective product cases filed against seven makers of these products.

Madris Tomes, who used to work with the FDA and now runs the website Device Events told the paper “Physicians might change their minds if they knew how many problems there really were.”

Rules for posting a quarterly summary of adverse events, called Alternative Summary Reporting, is designed for companies that acquire another and find unreported issues. A full report must be obtained through a Freedom of Information Act request which can take up to a year to fulfill.

Minnesota’s U.S. senators expressed criticism of the secret program earlier this week, reports the Star Tribune.

Sen. Amy Klobuchar says the retrospective summary reports “stands in the way” of keeping the public informed. “All patients deserve to know the risks and side effects of a medical procedure and a medical device.”

Sen. Al Franken says he’s been pushing to revamp the medical device reporting system. ##

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