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By: Irvin Jackson | Published: April 30th, 2013
A class action lawsuit has been filed against Intuitive Surgical, the makers of the da Vinci Surgical System, alleging that investors were misled about the safety and effectiveness of their surgical robot, which is the company’s only product.
The complaint was filed in the U.S. District Court for the Northern District of California last week, seeking class action status to include all shareholders of Intuitive Surgical Inc. who purchased stock between October 19, 2011 and April 18, 2013.
According to allegations raised in the da Vinci robot class action lawsuit, Intuitive Surgical violated federal securities laws by making material false and misleading statements about their product. The company allegedly concealed information about the risk of da Vinci robotic surgery complications, which have reportedly caused individuals to suffer severe burns, tears and other internal injuries.
The investors claim that Intuitive Surgical failed to disclose the number of problems following da Vinci surgery and the number of patient deaths, including withholding information on adverse events from the FDA. As a result of the actions, the company allegedly exposed itself to hundreds of millions of dollars in possible liability lawsuits, as well as potential criminal charges.
According to a press release issued by the law firm that filed the case, investors who wish to be a lead plaintiff in the class action lawsuit have until June 25 to notify the court, but that deadline does not limit investors from participating in the claim.
Product Liability Lawsuits over da Vinci Robot
In addition to the investor claims, Intuitive Surgical also faces a mounting number of da Vinci robot lawsuits filed on behalf of patients who have experienced severe and sometimes fatal injuries following robotic surgery where the device was used.
The da Vinci Surgical System is a complex robot that can be used in a number of surgical procedures to provide a less invasive surgery, which reduces recovery time. The device 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.
Since it was introduced in 2000, use of the da Vinci robot-assisted surgical system has increased dramatically throughout the United States amid aggressive marketing and promotions by the manufacturer, Intuitive Surgical. However, concerns have also emerged about the risk internal injuries and death, leading the FDA to launch a probe earlier this year into the safety of the da Vinci surgical robot.
The da Vinci robot costs between $1 million and $2.25 million for a hospital to purchase, depending on the model. It then costs another $140,000 a year in maintenance and between $1,500 and $2,000 for replacement parts after every robotic surgery.
Concerns have surfaced that Intuitive Surgical has created artificial demand for robotic surgical procedures, despite questions about whether it provides long-term benefits or superior outcomes. Many doctors and hospitals have reported feeling pressured to purchase the device to stay competitive with other facilities that offer it, but they are also then in a position where they must start using the machine as soon as possible and as often as possible to make up for the costs.
According to a report released earlier this year by Citron Research, an investment analysis firm, the da Vinci may be linked to more than 80 deaths. The analysts criticized the company for trying to downplay adverse event reports, abuse event reporting systems put in place by the FDA to protect consumers, and said that it appears that there is little to no benefit in using the da Vinci for most of its prescribed uses. The report warned that as additional information surfaces about the problems with the da Vinci robot, Intuitive Surgical’s stock price will continue to drop dramatically.