A Texas man has filed a product liability lawsuit that alleges he suffered bowel damage, infections and other complications from a robotic prostatectomy involving the use of the a da Vinci surgical robot.
The complaint (PDF) was filed by David and Lorie Garlich in U.S. District Court for the Northern District of Texas on August 23, naming the robot’s manufacturer, Intuitive Surgical, as the only defendant.
Intuitive Surgical’s da Vinci robot has been used with increasing frequency at hospitals throughout the United States in recent years, being promoted as a less-invasive form of surgery that results in reduced recovery time.
Amid growing reports of individuals experiencing problems following robotic surgery that are caused by burns, tears and other internal injuries, concerns have surfaced about whether the robot is over-used and whether it provides sufficient benefits over traditional procedures in many different applications.
The Garlichs are the latest of a growing number of individuals nationwide to file a da Vinci robotic surgery lawsuit against Intuitive Surgical. The complaints allege that Intuitive Surgical has withheld information about the risk of problems with the da Vinci robot, particularly involving electrical arcing that can cause burns to patients’ internal organs.
According to the lawsuit, David Garlich underwent a robotic prostatectomy in November 2012 at University of Texas Southwestern. His bowels were damaged during the surgery, resulting in severe infection, septic shock, abdominal compartment syndrome, kidney failure, acidosis and other injuries. As a result of the injuries following the da Vinci surgery, Garlich has had to undergo multiple additional surgical procedures and has been hospitalized a number of times due to the complications.
“Defendant sold its device through a calculated program of intimidation and market management, forcing hospitals and physicians to purchase it in order to appear to be competitive and creating an apprehension in their minds that if they did not obtain this technology, they would lose business to competitors,” the lawsuit claims.
He is seeking compensation for chronic pain, kidney disease, medical costs, loss of function, emotional distress and permanent injury. He will also require further medical treatment, according to the lawsuit. His wife is suing for loss of consortium and emotional, mental and physical distress.
Da Vinci Concerns On the Rise
In May, Intuitive Surgical issued a warning to health care providers about problems with the da Vinci robot cauterizing scissors, which are known as “Hot Shears”, indicating that the components may develop micro-cracks that allow electrosurgical energy to “leak” to nearby tissue and cause thermal injury or burns to internal organs.
Although some critics argued that the company should have recalled the da Vinci robots, the company did not take such an action and began shipping replacement components last month that are reportedly not prone to develop these micro-cracks.
In July, it was reported that a Class 2 da Vinci robot recall was issued after it was discovered that about 30 of the surgical systems were not properly tested before being distributed. Although all of the robots were subsequently tested in the field and no problems were discovered, concerns emerged about how the factory testing was not in compliance with UL standards.
During a conference call that month, Intuitive Surgical’s CEO Gary Guthart furthered the da Vinci robot controversy when he told investors that the FDA has issued a warning letter to the company about problems with the manufacturing of the company’s only product. That letter, suggests that Intuitive Surgical may have known that the da Vinci had problems with electricity arcing from the surgical instruments as early as October 2011.
Garlich’s lawsuit accuses the company of product liability, negligence, fraud, breach of warranty, unjust enrichment and loss of consortium. The lawsuit seeks compensatory and punitive damages.