Bradley Thompson, a Member of the Firm in the Health Care and Life Sciences Practice in the Washington, DC office, was quoted in an article about an increase in the number of adverse events reported to the FDA regarding medical devices.
The article, “Solving the Mystery of an Increase in Adverse Events,” stated that the Government Accountability Office issued a report at the end of July showing that the number of adverse events reported to the FDA for medical devices increased to 588,161 in 2008 from 189,450 in 2004. The report fails to explain such a big increase.
Thompson noted two contributing factors. The first, he said, is probably the growth of the number of unit sales of medical devices. “It’s not just the number of types of devices sold, but actual unit increases for existing devices,” he said. “With a bigger pool of devices out there, one would expect more adverse events.” He added that much of the growth has occurred in higher-risk devices, which also have a higher incidence of adverse events.
The second contributing factor, he said, is a growing conservatism among companies on how they make judgments about what is reportable and what is not. “There’s no specific penalty for overreporting—although it’s discouraged—and there is a more definite compliance risk to underreporting,” he said, “and so, more and more companies have been reporting more events.”