Intuitive “Not Investible” Given Mounting FDA Complaints about Surgery Robot Named in da Vinci Lawsuit Filings, Analysts Say
Market analysts at Citron Research have accused the company preparing to defend a mounting number of da Vinci robot lawsuit filings of being “not investible” given the surge of complication reports that have recently stemmed from use of its remote-controlled surgery robot, according to MassDevice.com.
In a report published Oct. 3 on MassDevice.com, Citron points to a rise in adverse event filings involving the da Vinci Surgical System on the U.S. Food and Drug Administration (FDA)’s MAUDE database. Intuitive Surgical counters this argument by saying that more reports associated with its principal product do not necessarily indicate a greater number of patient injuries and/or death.
It is noteworthy to add that Intuitive Surgical’s assertions were based on its own analysis of the FDA’s database, according to the article, which federal regulators say may not be an accurate way to assess incident rates.
But the numbers don’t lie, according to Citron. “In the 1st 8 months of 2013, 2332 Adverse Event records were posted – compare to 4603 records posted in the entire 12 year period since the 1st Adverse Event tracking for da Vinci appeared in MAUDE in 2000,” market analysts said.
“It is the opinion of Citron that the only reason there is not a national outcry is because the da Vinci robot has yet to kill or injure ‘the right person’ – like the next of kin of a congress member or a celebrity.”
According to the FDA, surgical burns, cut ureters, tears to arteries, bowel injuries, infection and death are among the most common adverse event reports associated with the da Vinci robot.
Intuitive Fails to Report Robotic Surgery Complications, Receives FDA Letter
Citron points out that Intuitive’s da Vinci Surgical System has been at the center of growing scrutiny from the FDA, who sent them a Warning Letter in July 2013 after learning that adverse events associated with the device were not reported to federal regulators, and neither was information about certain corrections made to the device. The company is “not investable until it gets its house in order,” analysts said.
In less than two weeks, Intuitive Surgical is scheduled to release its earnings results for the third quarter of 2013. The conference call on October 17th will be webcast by Thomson Reuters and accessed via the company’s website. According to a recent report from StreetInsider.com, analysts saw a 24 percent drop in da Vinci sales compared to last year at this time.
Learn How to File a da Vinci Robot Lawsuit
Call the lawyers at Bernstein Liebhard LLP to find out more about filing a da Vinci lawsuit, and whether you are eligible to receive compensation for your injuries, at (877) 779-1414.