da Vinci Robot Injuries Were Hid from FDA, Class Action Lawsuit Says

Top Class Actions’s website and social media posts use affiliate links. If you make a purchase using such links, we may receive a commission, but it will not result in any additional charges to you. Please review our Affiliate Link Disclosure for more information.

Intuitive Surgical Inc. has been hit with a class action lawsuit from shareholders who allege the company made misleading statements concerning its flagship product, the da Vinci Surgical System, including “concerted efforts to conceal da Vinci’s internally-known defects and the injuries caused to patients, including death.”

Intuitive Surgical is currently facing dozens of da Vinci robot lawsuits filed by patients, or on behalf of patients, who were severely injured following robotic hysterectomy and robotic prostatectomy procedures.

“Throughout the Relevant Period, Intuitive received thousands of injury and defect reports related to surgeries using da Vinci. The most dangerous injuries arose from burns to internal organs caused by the discharge of electricity (usually in the form of sparks), caused by the robot’s instruments inside the patient,” the shareholders allege in the Intuitive Surgical class action lawsuit.

“Despite the severity and multitude of reports, defendants systematically underreported these injuries and their seriousness to the United States Food and Drug Administration (the “FDA”). As the reports continued to increase, however, the FDA finally initiated an investigation in 2013, which culminated in the issuance of a warning letter on July 16, 2013 (the “FDA Warning Letter”). The FDA Warning Letter concluded that Intuitive had concealed information from the FDA, secretly recalled defective parts, and ignored known injuries to patients in its design process of critical da Vinci instruments.”

The da Vinci Surgical System is a surgical robot designed to allow surgeons to perform laparoscopic surgery more precisely. However, there have been allegations and product liability lawsuits alleging that the robotic surgery system was more dangerous than good old fashioned laparoscopic surgery. The allegations hold that the tools connected to the surgical robot can inadvertently damage other organs, leading to complications.

The da Vinci class action lawsuit argues that the same alleged actions that led to robotic surgery patients being harmed also endangered shareholder profits. The class action lawsuit alleges that Intuitive Surgical modified several cutting tools on the surgical system without telling the U.S. Food and Drug Administration (FDA), and took other steps to conceal the hazards associated with the da Vinci robot. The class action further alleges that these risks endangered lives and made the company’s stock unprofitable.

The Intuitive Surgical Antitrust Class Action Lawsuit is Robert Bert, Derivatively and on Behalf of Intuitive Surgical Corporation, versus Gary S. Guthart et al, Case No. 4:14-cv-00515-YGR, filed in the United States District Court for the District of California.

da Vinci Robot Lawsuits Grow

The da Vinci robot class action lawsuit comes at a time when Intuitive Surgical is facing other da Vinci robot lawsuits, filed by patients and their survivors who suffered from surgical complications after having da Vinci robot surgery. These lawsuits make many of the same allegations and assertions found in the shareholder lawsuit — that Intuitive concealed the risks of da Vinci surgery complications and manufactured a defective product that caused burns, nicks and tears to internal organs and arteries.

If you or a loved one were injured during da Vinci robotic surgery, you may be able to pursue compensation for your injuries. Obtain a free case evaluation at the Da Vinci Robot Surgery Class Action Lawsuit & Robotic Surgery Lawsuit Investigation.