Hasbrook & Hasbrook is evaluating possible legal claims on behalf of people who have experienced tragic results after undergoing robotic surgery.
According to a recent study by the Journal for Healthcare Quality, 71 deaths and 174 nonfatal injuries were reported to the FDA during 2000 to 2012 related to the use of the da Vinci Robotic Surgical System. Many of those outcomes have led to legal actions, with approximately 50 robotic surgery lawsuits now filed across the country against Intuitive Surgical, Inc., of Sunnyvale, CA, which designed, manufactures and markets the da Vinci robotic surgery devices.
Plaintiffs allege that robotic surgery caused intestinal tears, bowel injuries, punctured blood vessels, ureter injuries and surgical burns, and that the adverse effects have sometimes led to a patient’s death.
The Da Vinci Robotic Surgical Systems were first used in U.S. hospitals in 2000 and are the only multipurpose robotic surgery devices in use in the U.S. for general surgeries. The system costs $1.5 million to more than $2 million and includes:
- A surgeon’s console, from which a surgeon manipulates instruments attached to robotic arms,
- A patient-side cart, and
- A vision system which gives the surgeon a high-definition 3D view of the procedure.
The console translates the surgeon’s natural hand movements into micro-movements of surgical instruments positioned laparoscopically inside the patient.
About 2000 da Vinci Surgical Systems are in use across the country. The number of surgeries using the technology has increased from a few thousand surgeries per year 10 years ago to 450,000 procedures in 2012, according to Intuitive Surgical’s website.
A primary complaint in lawsuits against Intuitive Surgical is that the company has failed to provide adequate training to surgeons who use the system. Josette Taylor sued Intuitive Surgical on behalf of her deceased husband, Fred Taylor, who had surgery to remove his cancerous prostate gland in 2008 and died four years later.
Josette Taylor filed her lawsuit in 2009 in Washington State Superior Court for Kitsap County. In April, it became the first robotic surgery lawsuit to go to trial.
According to the suit, the urologist who performed the surgery had done 100 successful traditional prostatectomies. However, Taylor was the surgeon’s first patient using robotic surgery unassisted. After operating for seven hours, with multiple complications, the surgeon abandoned the robotic device and completed the surgery by traditional means. However, Taylor required post-operative emergency care to repair a rectal laceration.
The jury found that the manufacturer was not negligent in its training program. The jury did, however, conclude that Taylor’s death was due to medical error. The surgeon, who was also named in the lawsuit, settled with the plaintiff out of court.
The Risks of Robotic Surgery
The da Vinci Surgical System is a robotic-assisted form of laparoscopic surgery and is used in such procedures as hysterectomies, prostatectomies, gall bladder removal and gastric bypasses. Its use is now expanding to lung, colon, pancreas and heart surgeries, including heart bypass and valve repairs.
The manufacturer claims the system is even less invasive than traditional laparoscopic surgery, while providing surgeons with greater precision and dexterity, rivaling that of open surgery. A less invasive surgery can result in a shorter hospital stay for the recovering patient, and a claim of “greater precision” suggests an increased likelihood of a positive outcome.
However, two recent studies, one by Columbia University researchers and the other by researchers at Johns Hopkins Medical School, question the value of robotic surgery. Both studies contend that there is so far little evidence that robotic surgery delivers significant benefits over traditional laparoscopy.
Medical consultant Matt Garabrandt contends that although robotic surgery has its place, it should be limited to certain “complex cases.” However, Garabrandt says, robotic surgery has been the subject of aggressive marketing and media coverage, causing many patients to request it. A hospital’s ability to advertise robotic surgery has resulted in “competitive gains for hundreds of hospitals over the years,” said Garabrandt. Plus, after a hospital invests as much as $2 million or more to acquire the robotic surgery system, it wants to recover its investment. All these factors may combine to push the use of robotic surgery, despite its increased risks, in many cases that do not merit its use.
More Injury Lawsuits are Expected
The Journal for Healthcare Quality study cited at the top of this page reported another significant finding. Researchers who studied FDA reports over a 12-year period also searched legal databases for the same time frame, and cross-indexed legal actions with FDA reports. They found eight lawsuits in which the adverse effects claimed by plaintiffs were not properly reported to the FDA.
In five of the cases, no FDA report was filed, and in the other three, the filing occurred as much as 2½ years after the fact. Those statistics indicate the probability that there are more deaths and injuries due to robotic surgery than have so far come to light.
In an effort to minimize its legal exposure, Intuitive Surgical has entered into tolling agreements with some prospective plaintiffs. A tolling agreement stops the clock on the statute of limitations, allowing parties more time to negotiate a claim without litigation. Disclosure of these tolling agreements is certainly another indication that more robotic surgery lawsuits are in store.
If You were Hurt by a Robotic Surgery Procedure in Oklahoma, Our Attorneys can Help
If you or a loved one has undergone robotic surgery and experienced a serious adverse effect, contact our Hasbrook and Hasbrook law office for a free consultation. You may contact us by telephone (866-416-4737), email (firstname.lastname@example.org) or use our website contact form.