The Da Vinci Surgical system is a robotic surgical tool that is designed to facilitate complex surgeries in a minimally invasive way while still giving the surgeon 100% control over the procedure. The system offers magnified vision that provides surgeons a three-dimensional, high-definition view, inside the patient's body; an ergonomically designed console where the surgeon sits while performing an operation; a patient-side cart where the patient is positioned during surgery; and wristed medical instruments that bend and rotate far greater than possible for the human hand. This allows the surgeon's movements to be translated into smaller, precise actions of tiny instruments inside the patient's body.
The da Vinci Surgical system was approved by the Food and Drug Administration (FDA) in 2000 after a company called Intuitive Surgical created a robot that could increase a surgeon's precision during various types of complex surgeries including:
- Head and Neck
The robot is expensive, costing anywhere from $1 million to $2.25 million while hospitals must pay approximately $140,000 in annual maintenance costs. Despite the high price, robot-assisted surgeries are on the rise. Between 2007 and 2011, the use of robots in surgery increased 400%. Intuitive's profits have been on the rise since surviving scrutiny by regulators over its disclosures. Sales have rebounded since a 2013 slump when regulators questioned surgeons about an increase in problematic event reports and the FDA warned about the company's transparency on product corrections.
While the da vinci system is undoubtedly an advance in technology, there is skepticism as it relates to just how much benefit the robotic device provides to already skilled surgeons. It has been suggested that the technology is merely form over substance and that it has yet to be proven that the system is superior to traditional surgery. In addition to the uncertainty that surrounds the da vinci system, the robotic device carries with it several possible complications, including:
- Nerve pain
- Added time under anesthesia
- Breathing problems
- Internal scarring
Medical device recalls fall under three different types of classifications; Class I, Class II, and Class III. A Class I recall is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. A Class II recall is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. A Class III recall is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
Da vinci manufacturer, Intuitive, issued a Class II recall of its robotic surgical system which warned consumers that the system could potentially stall during procedures which would place patients in danger of temporary or medically reversible health problems with the possibility of serious complications. At the time of the recall, it was believed that the issue affected 1,386 devices which performed over 55,000 operations all over the world. While the recall did not remove the device from the marketplace, it did serve to have patients inform surgeons about the issue in an effort to have the devices inspected and repaired.
In 2013, Intuitive faced a lawsuit claiming it was negligent in recommending that surgeons were capable of performing a surgical procedure alone with the system after training one or two times prior to attempting a solo effort. A jury agreed with Intuitive as it found that the company was not responsible for any injuries that stem from claims of inadequate training.
In 2016, a product liability lawsuit with claims in excess of $300 million was filed in against Intuitive Surgical, Inc. in California state court by a woman who claimed the robotic system caused internal injuries after a hysterectomy was performed. More specifically, the plaintiff argued that an electrical surge impacted a scissor that was attached to the robot, causing an injury to her bowel. A two-week trial took place but a settlement was reached before a verdict could be rendered. In addition to the most recent lawsuit, the manufacturer is facing approximately 86 additional lawsuits spread across 22 states.
An insurance dispute is also an ongoing battle for Intuitive as Illinois Union and Navigators Specialty Insurance Co. claim that Intuitive disclosed just 24 claims while hiding 734 others, when it applied for insurance coverage from the companies. Had the insurance companies known about the additional claims, coverage would not have been provided. If a judge eventually decides that the insurers are correct in their claim that Intuitive purposefully concealed claims, the policies provided by the insurers could be rescinded and Intuitive would be left with only self-insurance for a period of one year.
If you have suffered adverse health effects as a result of a faulty medical device, it is possible that you may be entitled to compensation. Consulting with an experienced and skilled medical device attorney is the first step to receiving the justice that you deserve. Since 2004, the law firm of Jeremy Rosenthal has focused exclusively on personal injury law and makes it their priority to put your best interest first while supplying you with first class legal representation. Call (303) 825-2223 today to schedule a consultation.