Nearly 100 lawsuits have been filed by patients who claim they were injured by a da Vinci Surgery System robot.
U.S. Securities and Exchange Commission records show robot manufacturer Intuitive Surgical, Inc. set aside $17.4 million to deal with da Vinci and other product liability lawsuits as of March 31, 2018.
In its most recent annual report, Intuitive said it faced 98 lawsuits and a large number of additional claims could be filed.
The company has also reported it has settled several other cases. Those settlements remain confidential.
The lawsuits claim people suffered wide-ranging da Vinci robotic surgery complications, including electrical burns to organ damage and death.
The active cases have been filed in both federal and state courts.
An attempt by the plaintiffs to consolidate those cases into a multidistrict litigation failed in 2012. The U.S. Judicial Panel on Multidistrict Litigation said not enough suits had been filed to warrant a consolidation.
Leading Robotic Surgery Manufacturer Sued
Lawsuits name Sunnyvale, Calif.-based Intuitive Surgical, Inc. as a defendant. The company dominates the robotic surgery field and describes itself as “the global leader in robotic-assisted, minimally invasive surgery.” As manufacturer and marketer of the da Vinci Surgical System, the company says its mission is to “extend the benefits of minimally invasive surgery to those patients who can and should benefit from it.”
The company designed surgical robotic technology to improve surgeon performance and reduce patient recovery times. The system gives surgeons magnified, high-definition 3D views of the surgical field and more precise handling of surgical instruments. The robot can move in ways not achievable by human hands. Furthermore, surgeries are performed through smaller incisions, meaning faster healing and less blood loss.
But the company has issued multiple recalls and has been forced to make some modifications along the way following an increase of medical device reports (MDRs) to the U.S. Food and Drug Administration.
A 2013 FDA survey of 11 surgeons who used the device found inconsistent training and low awareness of recalls. All 11 said they experienced technical problems.
Intuitive Settled 3,000 Suits in 2014
In April 2014, Intuitive said it set aside $67 million to settle roughly 3,000 claims related to the da Vinci Surgical System. Some claims dated back to 2012. After an extensive mediation, Intuitive said it would be more cost-effective to settle than litigate.
All of the claims stemmed from complications involving two parts of the robot: Monopolar Curved Scissors and instrument tip covers. Intuitive has recalled both parts since the earlier lawsuits.
|Name of Plaintiff||Da Vinci Surgery Performed||Injury|
|Erin Izumi||Endometriosis surgery||Colon and rectum torn/additional procedures and temporary colostomy (a piece of the colon is diverted to an artificial opening in the abdominal wall)|
|Patricia Mayfield||Hysterectomy||Painful abscess/additional surgery|
|Kimberly McCalla||Hysterectomy||Bleeding in pelvis from laceration to main artery/death|
|Jennifer Silvestrini||Thyroid removal||Extensive scarring on neck requiring plastic surgery to repair/possibility of subsequent surgeries|
|Erika Starr||Not specified||Bowel perforation/ thermal burns/infection|
|Michelle Zarick||Hysterectomy||Bowel prolapse through vagina/massive infection with cysts and adhesions/additional open surgery/ removal of right fallopian tube|
Arcing, Insulation Failure
Shawn Todd filed suit against Intuitive after alleging she suffered internal burns while undergoing a partial hysterectomy. She was then hospitalized for weeks.
- Todd was held down following the robotic surgical procedure as needles were shoved into her kidneys, which had failed, because doctors couldn’t get anesthesia to work
- Todd’s ureters (the part of the body that carries urine from the kidneys to the bladder) had been burned
- Todd said the burns were caused by “arcing” from the da Vinci system
The majority of plaintiffs involved in litigation against Intuitive complained of injuries incurred as a result of malfunctions causing leaks of electrical currents and arcing. Arcing is when sparks from a surgical instrument land in a patient’s body, causing burns. Insulation failure is known to cause arcing when protective covers are cracked or damaged in other ways.
A surgeon would rarely be aware of arcing during a procedure. It would likely take several days for a patient to complain of symptoms and for the injury to be detected. Plaintiffs allege that they experienced perforations, infections, abscesses and other heat-related damage that required additional procedures to correct due to arcing during their procedures.
Other devices used in robot-free procedures can also cause arcing. But a study in the American Journal of Obstetrics & Gynecology in 2011 said “robotic instruments have a significantly higher incidence and prevalence of [insulation failure] compared with laparoscopic instruments.”
Underreporting Adverse Events Claimed
Some lawsuits claim reports of problems are artificially low because surgeons and patients aren’t aware of problems until days after procedures. Sonya Melton’s attorney says her case is part of the underreporting trend.
Melton was initially unaware that her injuries may have been caused by the da Vinci system used in her minimally invasive surgical procedure. After her routine, same-day gynecological procedure to remove uterine fibroids, Melton experienced intense pain and developed pneumonia. Doctors operated again, this time performing a “full-open surgery” and finding a perforation in her small intestine. Melton later sued.
An attorney for Melton and other plaintiffs, Dr. Francois Blaudeau said problems from robot-assisted surgeries may not get reported to the FDA as an “adverse event” because sometimes symptoms develop after procedures.
Steep Learning Curve
A personal injury lawsuit (later amended to a wrongful death suit) against Intuitive in 2012 alleged the company failed to warn hospitals of robotic-surgery dangers, leading to insufficient training. The suit involved the death of a Seattle-area man, Fred Taylor, who was Dr. Scott Bildsten’s third da Vinci surgery patient and his first without supervision.
- Taylor’s prostate surgery took more than 13 hours – the procedure normally takes a fraction of that time
- Taylor suffered from a torn rectum, leading to the loss of 15 cups of blood and shock
- Taylor suffered a stroke, causing incontinence, kidney and lung damage and memory loss
- Taylor died four years after the surgery but as a direct result of the ongoing complications suffered from the robot-assisted procedure
- Bildsten stopped using robots one year after operating on Taylor
Bildsten said the “learning curve [is] so steep and lengthy that the level of comfort just took too long,” CNBC reported.
Taylor’s family lost its lawsuit at trial and on appeal. But they won a new trial in February 2017. That’s when the Washington Supreme Court ruled that the lower court should have told Intuitive that it had a duty to warn the hospital — not just the doctor — about the dangers of robot-assisted surgeries.
Studies of Robotic Surgery Training
A 2018 article in the journal Administrative Science Quarterly looked at robotic-surgery training. Author Matthew Beane conducted two studies to understand how new doctors learn to use the devices.
He reported that a system he called “shadow learning” had evolved. It was outside the norms of traditional training for surgeons. And it is often practiced without the supervision of trained doctors.
“Shadow learning practices were neither punished nor forbidden, and they contributed to significant and troubling outcomes for the cadre of initiate surgeons and the profession.”
Beane found new doctors received as little as five minutes of hands-on experience with systems like the da Vinci during a typical surgery. In traditional surgery, residents may be required to help in some way throughout procedures, gaining valuable hands-on experience.
Lawsuits also claim the standards for robot-assisted surgery training are not sufficient.
- Take one hour of online training
- Watch two robotic procedures online (four hours)
- Spend seven hours operating on a pig
- Participate in at least two surgeries overseen by a surgeon with experience in robot-assisted procedures
Individual hospitals or medical groups may have additional requirements. Some hospitals required as many as five supervised surgeries.
But company sales representatives tried to persuade hospitals to lower their training requirements, according to various news reports and internal company emails obtained through discovery.
“It’s not reasonable to believe that every surgeon across the country can be adequately trained with one pig and two proctored cases”
Tip Cover Recall
In 2011, Intuitive recalled its EndoWrist MCS tip cover — an insulator for a device that uses monopolar (single electrode) energy to cut tissue. In 2012, Intuitive initiated a second recall for all those who did not respond to the initial one.
- Avoiding instrument collisions
- Carefully installing tip covers
- Straightening wrist (of instrument) prior to removal
- Inspecting cannula (thin tube inserted into a vein or body cavity) prior to use
- Not exceeding power settings
The recall was a Class II recall, meaning use of the device may cause injuries that are temporary or treatable.
Even after the recalls, Intuitive said it was “confident that the da Vinci Surgical System deploys monopolar energy in a safe and effective way when used as indicated.”
Furthermore, NBC reported that when asked about the timing of the recalls and replacement tip cover, Intuitive responded, “We are always looking at our system and our instruments to see how we can improve the safety. I wouldn’t say we changed anything based on… lawsuits.”
The FDA received a total of 4,600 adverse events reports about the da Vinci Surgical System over a 13-year period ending in 2013. Nearly 1.5 million surgeries performed during that time using the robotic system. Blaudeau, both an Alabama gynecologist and lead plaintiffs’ attorney, said it’s possible for injuries to happen without surgeons realizing.
Certain injuries resulting from the surgeries can take several days to appear.
High-Pressure Marketing and Sales
Several claims by plaintiffs and reports by analysts have found that Intuitive may use high-pressure sales tactics and aggressive marketing techniques.
Internal company emails suggest sales — rather than need — motivated Intuitive representatives.
CNBC reported that one email reads, “Mountain West is forecasting about 285 procedures each week. We need to be at 345 procedures/week to close on our goal.”
After an email that requests the identification of cases that “can be moved up,” another email states, “Guys, it’s time to call in favors for these last 2 cases… We need to start calling our surgical champions who know our business first thing tomorrow.”
Please seek the advice of a medical professional before making health care decisions.