Approximately 13 years ago, an American company called Intuitive Surgical, Inc. first introduced the world to the concept of a robotic surgeon when it released the innovated da Vinci Robotic Surgical System. The idea behind the da Vinci robotic surgical system was to create a machine with increased dexterity and flexibility that allow surgeons to perform complex operations by only making a few small incisions.
The da Vinci robotic surgeon was designed to give patients a minimally invasive option when it comes to undergoing certain surgical procedures for complex conditions such as bladder and prostate cancer, kidney disease and coronary artery disease. Surgeons control the da Vinci surgical system from a console that allows them to use tools much smaller than their own hands, which allows for the procedures to be less invasive.
Being that the da Vinci surgical systems were such an innovative concept at the time of their inception, Intuitive Surgical’s stock value surged when the company announced the release of the product. However, the company’s stock has taken a beating after reports of numerous complications resulting from surgical procedures began to surface.
Thousands of hospitals and medical facilities across the United States currently operate da Vinci rotobic surgical systems, with each of the systems costing upwards of $2 million. According to a study published in the Journal for Healthcare Quality on August 27, 2013, the U.S. Food and Drug Administration (FDA) has received 245 reports of adverse events related to the da Vinci robotic surgical system between January 2000 and August 2012.
Lawsuits Regarding da Vinci Surgical Systems
But Dr. Martin Makary, MD, the lead author of the aforementioned study, says that his research team uncovered several additional cases of injury and/or death related to the da Vinci surgical systems that were either not reported to the FDA or were reported hundreds of days after the incidents actually occurred.
“We think that based on the sample, the 245 reported cases represent a small fraction of the true events out there,” says Dr. Makary, who is the associate professor of surgery at Johns Hopkins University in Baltimore. “The number of reported cases seems very low, given the discussion of these events in the surgical community.”
Earlier in 2013, the FDA surveyed a group of physicians and medical providers about the pros and cons of using the da Vinci surgical system on patients after the administration noticed a 34 percent increase in the number of adverse events being reported to the FDA database. While the FDA says the results of that survey are still being reviewed, the American College of Obstetricians and Gynecologists announced it had concluded that the da Vinci surgical system “is not the only or the best minimally invasive approach” to these procedures.
Aside from surgical complications resulting from these procedures, accidental electrical burns are noted to be a recurring problem for patients who have been subjected to the use of a da Vinci surgical system. In a report filed with the Securities and Exchange Commission (SEC) in 2013, Intuitive Surgical admitted to being a defendant in approximately 30 product liability lawsuits and that plaintiffs’ attorneys are pushing heavily to attract more patients who could possibly bring personal injury claims against the company.
Reasons for Underreported da Vinci Surgical Cases
When a patient gets injured as a result of a da Vinci surgical procedure, from a legal and patient rights perspective it is important to determine whether the injury was a result of user error or because of a defect with the device. Dr. Makary believes one reason for the underreported cases may be that injuries appear to be a result of user error – meaning the injury was the physician’s fault – when in reality it actually resulted from an issue with the da Vinci surgical system.
But the system and protocol for reporting adverse events is also partly to blame for the underreporting of injury and death cases, according to Dr. Makary. Because the MAUDE reporting system – which is used to track adverse events in the da Vinci surgical systems – is not standardized or timely, many doctors are either unaware of their obligations to report adverse events or not incentivized to be accurate in their reporting.
“Until we build a better system, underreporting will be a problem with every medical device,” adds Dr. Makary.
Interested in contacting an attorney about a potential da Vinci surgical system lawsuit? Call Davis Law Group, P.S. at 206-727-4000 today or contact us online here.