Is Intuitive Planning New Robosurgery System Launch Amid Lawsuits, Recalls?
By Ryan Brinks
A new lawsuit and a recall have been added atop a stack of existing issues facing Intuitive Surgical's da Vinci robotic surgical system for gallbladder, gastro-esophageal, and laparoscopic operations. Meanwhile, there are reports that company could be taking steps to bring a new platform to market.
The City of Birmingham Relief and Retirement System brought the suit, accusing Intuitive Surgical of fiduciary failures and insider trading by its executives, according to a new ValueWalk report.
The shareholder derivative complaint alleged that Intuitive leadership “‘grossly under-report adverse events and complications caused by da Vinci’ surgical device, mis-characterized the events it reported by improperly classifying many situations as ‘benign category’ instead of a ‘serious injury or even death’,” according to the article. It also claims that Intuitive executives hid from the FDA at least three recall warnings that the device could malfunction and burn internal tissues, and participated in insider trading of $113 million of company stock.
Intuitive Surgical admitted to being named in at least 50 da Vinci lawsuits as of October 2013, according to a recent press update issued by law firm Bernstein Liebhard LLP. Injury Lawyer News noted last month that a Georgia woman had filed a lawsuit in California, after enduring life-threatening injuries and an invasive emergency surgery to correct problems allegedly caused by the da Vinci robot during her hysterectomy.
The bulk of the lawsuits contend that injuries resulted from da Vinci defects and/or surgeon training issues.
While sales of the robot dropped in the fourth quarter of 2013, Bernstein Liebhard pointed out there was a 12 percent rise in da Vinci procedures over that same period.
Intuitive has also dealt with a several recalls in recent months. Last week, the company announced a voluntary recall of certain lots of its Single-Site 5mm Reusable Curved Cannulae, since they can become damaged during use if installed improperly.
Yet the embattled manufacturer doesn't appear deterred from launching additional robotic surgery platforms. The Wall Street Transcript reported that Intuitive Surgical has filed for a trademark on a new system.
“There are some subtle signs that things could be moving in the direction of a new system launch,” said J.P. Morgan analyst Tycho Peterson in the article. “Overall, there is a huge underpenetrated opportunity for robotic surgery, and they are going to be the ones best positioned to capitalize on it over the next couple of years.”
He added that since its last product launch, Intuitive Surgical has spent more than $700 million on research and development.
Image credit: Intuitive Surgical Systems