As patient complaints mount in lawsuits against Intuitive Surgical (NSDQ:ISRG) and its da Vinci robot-assisted surgical platform, physicians and researchers are shifting some of the blame to the FDA’s postmarket surveillance systems as an inadequate tool for protecting the public.
Sources cited in a recent Bloomberg report varied in calling FDA’s medtech surveillance "a disaster" and generally riddled with conflicts of interest, some framing the embattled Intuitive Surgical as a mere "poster child" for larger problems at the federal watchdog agency.
Intuitive has been under a microscope in recent months as patient injury lawsuits have helped to spur a flurry of adverse event reports tied to the da Vinci system. Growing complaints have drawn the ire of some activist investors and prompted a lot of media attention, despite Intuitive’s claims that adverse events have been in decline compared with growing utilization of the technology.
"Our overall adverse event rates are not only extremely low, but they are declining," Intuitive spokeswoman Angela Wonson told MassDevice.com today. "The true measure of a device’s safety is measured through clinical data. Large, peer-reviewed population studies validate the safety and effectiveness of robotic-assisted surgery."
The increase in reports have been tied to changes in the company’s own policies as well as to the popularity of lawsuits, which have encouraged patients to call lawyers who, in turn, have filed formal complaints that Intuitive Surgical is obligated to report to the FDA. Some of those reports include patient complaints that had gone unfiled for years, according to Bloomberg, a discovery that is shifting some of the concern onto the FDA and its monitoring authority.
Medtech companies are required to report adverse events to the FDA, but doctors and hospitals report on a voluntary basis. Many of the recently reported adverse events are tied to procedures performed years ago, ones which Intuitive Surgical says it was unaware of until they were filed alongside lawsuits.
"The adverse event reporting system is a disaster," University of Florida health affairs vice president emeritus David Challoner told Bloomberg. "Every link in the chain has a reason not to report."
Challoner previously chaired the Institute of Medicine’s 2011 report on the FDA’s medtech review programs, recommending that the agency scrap altogether the less-stringent 510(k) pathway that allows some high-risk medical devices onto the market without undergoing clinical trials.
It’s not the 1st time that the FDA has been criticized for its medtech postmarket surveillance programs. Patient safety critic Dr. Robert Hauser last year called for such monitoring activities to be stripped from the FDA entirely, saying that a single agency with the authority to review and approve devices and the obligation to monitor and recall devices was inherently riddled with conflicts of interest.
"The FDA is being asked to approve devices and then to be responsible for monitoring performance for devices and drugs," Hauser said. "Right away, you have a conflict because the group that approved the drug is going to question the group that is now criticizing the drug.
"They’re all in 1 agency, and I doubt that the lines of authority, responsibility, accountability are clear. How objective can a group be, inside the agency, when it’s discussing, potentially, the performance of another group inside the agency?"
The FDA’s surveillance programs often come under fire when medical device issues gain public attention, such as the ongoing lawsuits metal-on-metal hip implant recalls or the firestorm over Medtronic’s (NYSE:MDT) recalled Sprint Fidelis pacemaker leads.
Intuitive Surgical supports measures to bolster the postmarket surveillance system, but isn’t too keen on the notion that it’s recent legal troubles make it a "poster child" for the FDA’s monitoring issues. University of Michigan Ann Arbor surgical outcomes expert John Birkmeyer granted Intuitive the title in speaking with Bloomberg about spottiness in monitoring, saying that "robotic surgery didn’t invent the genre but it certainly is the poster child for what the concerns are."
"It is inappropriate for anyone to assign ‘poster child’ status for a decades-old issue of under-reporting to one surgical device without evaluating reporting for all forms of surgery," Intuitive’s Wonson told us. "As we’ve stated publicly in the past, we support a more robust and standardized system for reporting adverse events. We take our responsibility to report very seriously. Any information regarding an adverse event that is brought to our attention where the use of da Vinci cannot be ruled out as causing or contributing to the injury is reported as an MDR in accordance with FDA regulations."
The FDA has taken some steps to bolster its surveillance activities, making progress on the Unique Device Identifier program, which would mandate that devices carry unique bar-codes that allow simpler and more robust tracking, and the agency has also launched a smartphone app designed to encourage adverse event reporting.
Meanwhile, the shift in rhetoric away from Intuitive Surgical may ease some of the pressure on the company, which has seen its shares tank some 24% over the last 6 months. ISRG stock has gained a few points in recent weeks, up about 1% since last month.
ISRG shares were down about 1% as of 3:45 p.m. today, trading at $380.24.