Instead of acting as a tough federal watchdog that protects and informs patients about problems with medical devices−from heart valves to drug pumps−the federal Food and Drug Administration all too often has served as an industry lap cat offering late, lax oversight in reporting safety woes, a new report finds. The Minneapolis Star-Tribune and former agency official Madris Tomes (photo right) deserve credit for blowing the whistle on the gaping bureaucratic loophole that lets device makers report problems almost at their leisure, and to do so in a way that hides issues from public view.
By law, the paper says, makers are supposed to file safety incident reports with the FDA within 30 days of occurrence. But the agency not only fails to enforce that requirement, it has created a process of Orwellian double-speak, allowing “retrospective reporting.” Device makers in this process tell the agency about hundreds of thousands of safety incidents, sometimes years after they occurred. Further, the FDA allows the companies to detail the incidents, in some cases tens of thousands of them, in confidential reports. The only notice the public gets is via terse summaries, “marker reports,” of the much longer documents.
Tomes, since leaving the agency, has created a search engine, Device Events, that helps outsiders track agency information on medical devices’ performance. Using that tool, it still took Star-Tribune reporters almost a year to pry from the FDA information barely hinted at in marker reports.
Reporters found that a drug-pump maker stashed 75,000 malfunctions of its device into a confidential study, which then was reported in a terse summary the FDA made public. The maker of a device that dealt with fecal incontinence summarized hundreds of malfunctions, crammed them into a report that then was noted only with another brief “marker report.” This occurred, even though regulators twice had formally warned the firm about failures in its disclosures. The newspaper looked at a decade of records involving adverse events involving a local maker of a bone graft system, finding that more than 300,000 incidents had gone through the retrospective reporting and marker report process. The Star-Tribune obtained the information only after wrangling with the feds and seeing the maker keep confidential some of the adverse events by persuading regulators public disclosure of them would give away trade secrets.
Policy-makers and federal legislators expressed chagrin at how the FDA has allowed device makers to circumvent laws passed by Congress to improve safety by requiring greater disclosure. “That’s a loophole you’ve identified,” Dr. David Challoner, who led an Institute of Medicine team that studied adverse-event reporting problems in 2011, told the paper. “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.” David Durenberger, a former Republican senator from Minnesota and co-sponsor of a 1990 law on how the FDA tracks devices once marketed, told the paper he does not remember Congress giving any allowance for retrospective summaries or overdue injury reports: “I find it hard to believe that the law provides for reporting and leaves that kind of a loophole. t defies what I intended.”
The FDA declined to respond in detail to the news report, saying only that requiring more of device makers would use up valuable resources and clog up the agency with excess information. The bureaucrats insisted the information involved isn’t revealing, major, and that physicians typically already are aware of issues disclosed in the reports. But the newspaper points out a case in which a device maker failed to report 100 incidents of complications tied to its neck implant, including 40 in which patients complained of swallowing problems. The company didn’t report the issues, which it knew about in 2007, until 2013. In that year, based on other reporting, the FDA warned that implanting the device in the neck can cause swelling that put patients and their airways at risk.
I’ve written about device-maker scandals that have claimed patient lives, and, after the fact, where it has come to light that federal regulators all too readily sat back and waited for the companies and hospitals to provide critical information. As someone with lots of experience successfully pursuing lawsuits involving defective products, I know that it’s madness or stupidity for regulators to expect companies, except in rarest cases, to fess up about problems with their wares−and medical device makers are showing they are not going to be corporate exceptions in disclosure.
Although journalists deserve kudos for digging into the government bureaucracy to ferret out woes like these late, skimpy disclosures about medical devices, lawmakers overseeing the FDA need to get busy and correct what look like unacceptable practices. The agency is supposed to work for us. It is infuriating to think that patients might be harmed due to regulatory laxity. Further, it would be maddening then to know that bureaucrats would abet those who might block the pursuit of justice via malpractice suits based on full, complete safety information — and how it might have been ignored.