Last month, the FDA announced Class II recalls of two different components of the da Vinci surgical system, which uses robots to perform procedures, and the agency has released new training and credentialing recommendations for hospitals and doctors using the devices. The recalls—which involve instrument arms that can become stuck and part of the robot hand that can detach—are the latest in a series of regulatory and legal woes for Intuitive Surgical Inc. (ISI), the da Vinci maker.
With more than 70 products liability cases filed against the manufacturer in federal courts and dozens of others filed in state courts, ISI is now defending itself against its insurance carrier, Illinois Union Insurance Co. That company is trying to rescind products liability coverage over allegations that ISI concealed its potential risk for additional lawsuits. Plaintiff attorneys handling the products liability cases said the increasing numbers of lawsuits and recalls highlight the da Vinci robots’ safety issues.
In December, the FDA announced a Class II recall of 1,386 da Vinci systems following ISI’s urgent device notification regarding complications with the instrument arms, which may suddenly stall and become stuck due to abnormal friction. Class II recalls are issued when a product “may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.” In one reported incident, this friction led to the robot making an imprecise cut during the transection of a urethra, and in two other cases, the doctors had to stop using the robot mid-procedure and switch to alternative surgical methods.
The FDA also issued a Class II recall following ISI’s urgent device recall for certain lots (manufactured between 2007 and 2011) of da Vinci EndoWrist needle drivers—which hold and guide the surgical instruments—because the drivers’ jaw inserts can detach. ISI has reported 82 incidents related to damaged or detached needle driver jaw inserts, including 27 incidents where the inserts fell off during surgery. In one case, a device fragment was not retrieved during surgery after falling into the patient, so a second operation was required to remove it.
These recalls, combined with an increase in the number of adverse event reports submitted to the FDA in 2013—3,697 reports involving death, injury, or malfunction as of early November, compared with 1,595 in 2012—prompted the agency to call for hospitals and doctors to engage in additional training before using the robots. The FDA recommends that all surgeons be appropriately credentialed; it also said users should understand that there are different da Vinci models, and doctors should be trained on each one.
There is some debate over the source of the reporting spike, but medical researchers and attorneys agree that underreporting adverse events is a problem. In September, Johns Hopkins researchers published a study in the Journal for Healthcare Quality that said robot surgery complications were underreported and that a standardized robotic device reporting system should be created.
“There’s always an issue with underreporting whenever you have a potentially defective device or product on the market,” said Louisville, Ky., attorney Jennifer Moore, who is representing plaintiffs in the products liability lawsuits against ISI. She said the number of reported adverse events is on the rise in part because the robots are being used for a variety of different surgeries, including hysterectomies, prostatectomies, gastric bypasses, and cardiac procedures. “We’re seeing a spike in the types of surgeries the instruments are being used for. With the continued use, marketing, and selling of the robots, we may see an increase in the number of patients who are injured,” Moore said.
Earlier this year, the FDA announced it was surveying doctors about the challenges they face when using the da Vinci systems. It released its final report in November, but it surveyed only 11 surgeons; nonetheless, 10 of the 11 respondents reported problems with the robot arms. Moore questioned the small sampling.
“There is no question that this investigation should delve deeper into the robots’ safety and determine whether the robots should be used in hospitals,” said Moore. “There were approximately 400,000 surgeries using the robot [in 2012], so we know it is being used every single day in hospitals in cities and rural areas across the country. . . . We don’t think you can get an accurate sampling based on such a small number.”
The number of lawsuits against ISI continues to skyrocket. Along with the products liability cases that have been filed, two federal shareholder class actions are pending, as Trial News previously reported.
In October, Illinois Union filed a lawsuit demanding rescission of the products liability coverage policy it issued to ISI in March. It alleges that ISI concealed the existence of tolling agreements that froze the statute of limitations until after the policy was issued and that ISI has no idea how many products liability lawsuits may be filed. Illinois Union said it would not have issued the policy if it had had an accurate risk assessment. (Illinois Union Ins. Co. v. Intuitive Surgical, Inc., No. 5:13-cv-04863 (N.D. Cal. filed Oct. 21, 2013).)
Moore said the ultimate goal is to protect people from being injured by the robots.
“It’s not just one pocket of the country where the da Vinci robots are being used. We are trying to get to the bottom of this and make sure that when a company promotes a product or a device as heavily as Intuitive Surgical has, that it’s safe for consumers. What we are finding out is that it’s not always safe,” she said.