June 21, 2013 – Earlier this month, a Washington state jury ruled that Intuitive Surgical Inc., the company that manufactures the da Vinci Robot, was not negligent in training a physician who seriously injured a patient during a prostatectomy surgery. Yet despite the seemingly favorable outcome for Intuitive, the company continues to face a litany of problems over the controversial robotic surgical system both inside and outside of the courtroom. In recent years, the da Vinci Robot has been repeatedly linked to complications including surgical burns, bleeding, sepsis, punctured organs and blood vessels, bowel injuries, and death.
Da Vinci Robot Recall March 25, 2014: Intuitive Surgical has issued a nationwide recall for certain cannulae components used with the da Vinci Robot, due to the risk that the parts may be damaged during use and could be hard to replace. To date, at least one patient has experienced injuries that may have been caused by a damaged cannula, which occurred when the tube rotated and punctured the patient’s abdomen.
What’s the Problem?
In 2008, Dr. Scott Bildsten performed a prostate removal surgery on Fred Taylor using the da Vinci Robot. As a result of the procedure, Taylor suffered kidney failure and brain damage, and died last year from heart failure allegedly caused by his injuries. The prosecution claimed that Intuitive:
- improperly marketed the da Vinci Surgical Robot;
- failed to provide proper warnings regarding its use;
- failed to adequately train Bildsten and his medical team.
In Intuitive’s defense, attorneys attempted to pin the blame on Bildsten, who was using the surgical robot unsupervised for the first time. The doctor reportedly reached a confidential settlement with Taylor’s estate before the case went to trial. After five weeks of testimony, the jury reached a 10-2 verdict.
Yet despite the victory for Intuitive, many familiar with these issues have said that the verdict will do little to affect future da Vinci Robot lawsuits. This is because the vast majority of the other cases involve product defects in the monopolar scissors and insulation defects in the shaft and other parts of the device that have caused patients a variety of serious injuries. However, the issue of inadequate training is likely to come up in other cases.
Two weeks before the verdict, Intuitive sent a letter to its customers stating that certain 2009 and 2010 da Vinci Robots’ cautery monopolar scissors may develop microscopic cracks that have the potential to leak electrical energy and burn tissue during surgical procedures. The company said that replacements would be available soon, but it did not issue a recall for the parts. This specific defect is alleged in a number of da Vinci Robot lawsuits currently pending against Intuitive.
The problem with the cautery scissors has been reported to the U.S. Food & Drug Administration (FDA), which is currently in the process of reviewing it. The administration was already investigating the da Vinci Robot due to an abnormally large number of adverse event reports (AER) associated with the devices, which have included instances of:
- Surgical Burns to Arteries or Organs
- Peritonitis (painful and tender inflammation of the lining of the abdomen)
- Excessive bleeding
- Burning of nearby organs including the intestines
- Punctured blood vessels, organs or arteries
- Burns and/or tears of the intestines
- Severe bowel injuries
- Punctured or cut ureters
- Vaginal cuff dehiscence (reopening of the incision made to remove the uterus and cervix during a hysterectomy)
- Additional Surgical Procedures Following Robot Surgery
- Wrongful Death
While Intuitive continues to fight dozens of da Vinci Robot Lawsuits in courthouses around the country, a group of shareholders is now accusing the company of securities fraud.
In April, a plaintiff filed a da Vinci class action lawsuit in federal district court in California on behalf of all investors who bought Intuitive Surgical shares between Oct. 2011 and Apr. 2013. The class action alleges that the company’s officers and directors made false and misleading statements regarding the robot’s safety and effectiveness in violation of the Securities Exchange Act of 1934 and SEC Rule 10b-5. The lawsuit claims these false statements concealed problems with the device and misled investors about the company’s financial prospects, causing Intuitive stock to trade at inflated prices, and that executives sold shares of personally held stock for nearly $220 million in proceeds.