According to a new investor research report, an in-depth analysis of adverse events involving complications following da Vinci robotic surgery has identified more than 80 deaths, as well as thousands of other injuries, that were associated with use of the surgical robot.
Citron Research, an investment analysis and research firm, released a report (PDF) last week on Intuitive Surgical, the manufacturer of the da Vinci Surgical System, identifying more than 4,600 adverse event reports filed with the FDA.
The group indicates that the identified problems are likely “just the tip of the iceberg,” and suggests that the number of robotic surgical procedures involving the da Vinci machine will dramatically drop over the coming year and new sales will “flatline” amid increased awareness about the risk of complications and a mounting number of da Vinci robotic surgery injury lawsuits filed by individuals who suffered serious and sometimes fatal injuries.
The report is a follow up to prior information (PDF) released by Citron Research last month, which predicted that Intuitive Surgical’s stock price, which has seen a 52-week high of more than $590 a share, will drop to $350 before eventually falling to $250 over the next 18 months.
Disturbing Trends in da Vinci Death Reports
The da Vinci Surgical System is a complex, remote-controlled robot that has been heavily marketed and increasingly used in recent years for a number of surgical procedures to provide a less invasive surgery, which reduces recovery time. The robot is controlled by a surgeon looking at a virtual reality representation of the patient’s internal organs and manipulating its four metal arms with hand and foot controls.
Citron Research has compiled a complete list of all of the complaints made to FDA’s Manufacturer and user Facility Device Experience (MAUDE) database (excel format), which records adverse event reports linked to medical devices.
The analysis found what Citron considered a number of disturbing trends, including a high rate of da Vinci robotic surgery deaths and injuries that occurred following what are typically considered routine surgery, as well as a tendency by Intuitive Surgical to make “clearly unfathomable” assertions that the reported complications had nothing to do with the da Vinci robot.
Among the reports are 89 incidences involving the death of a patients undergoing da Vinci robotic surgery, but Citron notes that at least two of those reports may be duplicates.
“Some of these deaths are clearly incidental, while others are extremely troubling with regard to injuries apparently caused during the surgery,” states the report. “The point is that very serious, and sometimes lethal outcomes are the result, patients lives hang in the balance, and are exposed to these risks in what are very often the most routine types of surgeries being performed.”
In one case, a patient died due to an artery injury following a da Vinci hysterectomy. The patient had an infection following the surgery and was given a blood thinner, and bled out into the body cavity due to arterial damage caused by a burn, according to the report.
Intuitive Surgical indicated in the adverse event report that there is no way to determine if the da Vinci system contributed to the patient’s death, while the Citron Research report suggests that it is the only way the burn could have occurred, as internal arteries do not burn by themselves, and the patient had no other incidents that could account for the injury.
“Some of these records are truly disturbing,” the report notes. “There is no other way for a burn in an arterial wall to occur except from the da Vinci equipment.”
Attempt to Shift Blame for da Vinci Surgery Injuries to Hospitals, Doctors
Citron Research indicates that Intuitive Surgical, which submitted most of the reports and repeatedly added its own comments that seem to absolve the da Vinci of any responsibility, was submitting the reports in a poor attempt at avoiding legal liability.
“After surveying patterns in these 4,600 MAUDE records, as we became deeply disturbed at abuses of the da Vinci machine, we also became disturbed by the abuses of the MAUDE database itself,” Citron warns. “Beyond the burns, perforations and lacerations that appear far too many times, over 90% of the reported incidents are reported by Intuitive Surgical, which inserts in every possible instance, including some that are clearly unfathomable….that the complications or problems resulting from the surgery had nothing to do with the da Vinci device, and/or that the machine appears to be functioning without error.”
Citron Research predicts that the tactic will not work and that problems with the da Vinci will become painfully obvious in the near future, causing Intuitive Surgical’s stock value to be cut in half during 2013. It also predicted that the company is hurting itself by trying to blame da Vinci complications on its own customers in adverse event reports to the FDA.
The report was the second in a two-part analysis by Citron Research, the first part of which was released in late December. It came at the same time as Intuitive Surgical was releasing its 2012 Q4 earnings reports, showing a 18% growth in sales, fueled in part by an emerging Japanese market.
Some investors predict that Intuitive Surgical’s stock will hit $600 per share this year, but Citron warns that will proceed a precipitous descent as the problems with the da Vinci robot come to light, as that is the only product for the manufacturer.
Mounting da Vinci Surgery Lawsuits
A growing number of product liability lawsuits are being filed against Intuitive Surgical on behalf of individuals who have experienced injuries following procedures where the robot was used.
According to allegations raised in the complaints, Intuitive Surgical sold the surgery system without ensuring proper training and instructions for surgeons, and without providing adequate warnings for consumers about the risk of problems from the da Vinci robot.
Plaintiffs also allege that safer alternative designs were available that do not use monopolar energy to cut, burn and cauterize tissue. In addition, plaintiffs claim that the electrical current may pass outside the surgical field as a result of problems with insulation on the arms, which may become worn or torn in places.