Intuitive Surgical faces a new product liability lawsuit brought by an Ohio woman who indicates that she suffered bowel perforation, thermal burns and other internal injuries that were allegedly caused by the use of monopolar scissors with the da Vinci surgical robot.
The complaint (PDF) was filed by Erika Starr and her husband Nick Griffith in the U.S. District Court for the Southern District of Ohio on March 12, claiming that the Monopolar Curved Scissors and other da Vinci robot components are defective and caused her injuries by allowing electricity to arc outside of the surgical field.
Starr underwent da Vinci robot surgery on March 13, 2013, indicating that she suffered a bowel perforation and thermal burns during the procedure, which has left her with severe and permanent injuries, serious physical and mental pain and suffering, medical expenses and lost wages, as well as impaired future earning ability.
Approximately two months after Starr’s surgery, Intuitive Surgical issued a warning to health care providers about problems with da Vinci robot monopolar scissors, also known as “Hot Shears,” indicating that the components may develop micro-cracks that allow electrosurgical energy to “leak” to nearby tissue and cause thermal burns or injuries to internal organs.
The lawsuit accuses the company of designing and manufacturing defective medical devices and then using bullying tactics to force hospitals to use them.
“Defendant Intuitive 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 a fear in their minds that if they did not have this technology they would lose business to competitors,” the complaint states.
The allegations are similar to those raised in a number of other da Vinci surgery lawsuits being pursued by individuals throughout the U.S. who have suffered burns, tears and other internal injuries, which often do not surface until hours or days after surgery.
Starr claims that Intuitive Surgical had information that something was wrong with the da Vinci robot as early as October 2011, when it responded to reports of arcing through damaged tip covers that caused patient injuries. The company issued a field correction that month to hospitals, with recommendations on proper use of the Tip Cover Accessory and instructing which types of generators should be used with the monopolar instruments.
Da Vinci Surgery Complications
The da Vinci Surgical System is a complex, remote control robot featuring four arms that are controlled by a surgeon through the use of hand and foot controls while sitting at a console, providing a virtual reality representation of the patient’s internal organs. It has been heralded as a breakthrough technology, resulting in smaller incisions and quicker recovery times.
The surgical robot system has been purchased by thousands of hospitals throughout the United States in recent years, and it has been used for a number of different urologic, laparoscopic, gynecologic and non-cardiovascular thoracoscopic surgical procedures and thoracoscopically assisted cardiotomy procedures.
A growing number of product liability lawsuits are being filed against Intuitive Surgical on behalf of individuals who have experienced injuries following procedures where the robot was used. According to allegations raised in the complaints, Intuitive Surgical sold the surgical system without ensuring proper training and instructions for surgeons, and without providing adequate warnings for consumers about the risk of da Vinci surgery complications.
The complaints allege that safer alternative designs were available, including other methods to cut, burn and cauterize tissue, such as bipolar energy and harmonic scalpel, which could reduce the risk of serious and potentially life-threatening injuries suffered during robotic surgery.