Intuitive Accused of Concealing Complication Reports from FDA in Recent da Vinci Robot Lawsuit
Intuitive shareholders have filed a da Vinci robot lawsuit that accuses the company of under-reporting patient complications to the U.S. Food and Drug Administration (FDA), from which they also concealed certain recall information.
According to a MassDevice.com report on March 25, the shareholder derivative lawsuit was filed by the City of Birmingham Relief and Retirement System, and alleges that Intuitive and its board of management failed to comply with FDA regulations about the safety of its da Vinci Surgical System.
Among other things, the da Vinci robot lawsuit asserts that “Defendants caused the company to grossly underreport adverse events and complications caused by da Vinci; mischaracterize the events that it did report by improperly classifying many events as in the benign category of ‘other,’ rather than as a ‘serious injury’ or even ‘death.’ Attorneys further allege that the FDA was not made aware of at least three da Vinci robot recalls that had been issued by Intuitive, who is currently facing dozens of product liability lawsuits from patients who allege cut ureters, surgical burns and tears to arteries, bowel injuries and even death caused by use of the device.
Insurance Company Files da Vinci Robot Lawsuits against Intuitive, Looks to Cease Coverage
According to the recently-filed shareholder claim, Intuitive CEO Gary Guthart, CFO Marshall Mohr and chairman and former CEO Lonnie Smith are accused of $113 million in insider trading of ISRG stock. And that’s not all. Intuitive is also under fire from at least two insurance companies who cover use of the da Vinci Surgical System.
The first case was filed by the Illinois Union Insurance Co., who sued Intuitive in November 2013 for only disclosing information about 25 lawsuits that involved the da Vinci, and concealing information about certain “tolling agreements” that occurred in several others. Navigators Insurance Co. filed similar claims against the company, and said they were looking to rescind policy coverage of the da Vinci Surgical System.
According to a recent filing with the U.S. Securities and Exchange Commission, at least 76 da Vinci lawsuit claims have been filed against Intuitive. These cases similarly allege the company’s failure to warn about side effects that may stem from the healthcare aid, which was FDA-approved in 2000 to aid in minimally-invasive gynecologic, urologic and laparoscopic procedures.
Call a Lawyer to File a da Vinci Lawsuit against Intuitive
The attorneys at Bernstein Liebhard LLP are standing by to answer any questions you have regarding da Vinci robot lawsuits. Call the Firm now at (877) 779-1414.