The product liability lawsuits allege that the Sunnyvale, Calif.-based company was negligent in its construction and sale of the Da Vinci surgical robot. Three of the patients claim they were injured during hysterectomy procedures using the device; 1 later died. The 4th was undergoing a Da Vinci thyroid procedure when the machine allegedly malfunctioned.
The plaintiffs – Jennifer Silvestrini of Louisiana; Gilmore McCalla of New York; Gwendolyn Jones and Amos Jones Jr. of Alabama; and Patricia Mayfield of Mississippi – want their cases and "any and all additional related actions that may be brought … against similar defendants" removed to the U.S. District Court for Southern Mississippi, under Judge Carlton Wayne Reeves, "or alternatively, to the Northern District of California," according to court documents.
Robot dies during thyroidectomy
Silvestrini’s lawsuit, filed in the U.S. District Court for Eastern Louisiana last October, alleges that the Da Vinci robot used in her thyroidectomy surgery died during the procedure. When the surgical team was unable to re-start the device – and unable to raise the Intuitive Surgical rep their contract said would be on tap 24-7 – Silvestrini’s procedure was converted to a conventional laparoscopic thyroidectomy, according to court documents.
Silvestrini "has been caused to suffer an extensive, unattractive scar on her neck which will require plastic surgery revision at significant cost. … Further still, plaintiff avers that there were remnants left of the thyroid more extensive than would have been the case had the robot not malfunctioned and the Intuitive Surgical, Inc. technician been available as had been contracted for; plaintiff has been advised that she now faces the prospect of one or more further surgeries, which otherwise would have been unnecessary," according to the lawsuit. "Prior to admission, the patient (and her family) had made a careful study of the benefits of such robotic surgery over traditional, more invasive, surgery. The patient chose the robotic surgery because it was represented to her as safe and far less invasive with far less residuals."
Problems with monopolar power?
The other 3 cases involved allegedly botched hysterectomies. In 1, the father of a 24-year-old woman who died 2 weeks after her procedure claims that the da Vinci system burned an artery and intestines during his daughter’s surgery, further accusing the surgeon and the hospital of carelessness for not discovering the damage.
McCalla claims that the surgical robot contains dangerous design flaws, including un-insulated surgical arms that may allow electrical currents to jump to healthy internal organs and tissue.
The Da Vinci device excises tissue using monopolar power, which delivers high-current but rapidly dissipating electricity to the tissue the surgeon wants to remove. A pointed electrode delivers the energy, which quickly dissipates beyond the target tissue and is returned to the device via a large return electrode.
But the technique depends on good electrical contact between the patient and the return electrode to prevent the current from arcing through healthy tissue, which can result in 3rd-degree burns. At least 1 law firm speculates that insulation in the Da Vinci’s robotic arm may wear away over time, creating the potential for just such a scenario.
Few lawsuits until now
Before the 4 cases filed since last October, there have been few other product liability lawsuit against Intuitive over the Da Vinci device since it initially hit the market more than a decade ago. In 2010, the company dodged 1 such case after a federal appeals court cleared it of any liability for a Pennsylvania man’s erectile dysfunction following a Da Vinci prostatectomy.
In 2010, Daniel O’Brien sued Intuitive after the Da Vinci device used in his pancreatic and islet cell transplant also allegedly died and was unable to be re-started, according to court documents. The conventional operation that followed left him with a 14-inch scar across his abdomen and a host of other troubles, according to court documents. That case was dismissed after Judge Gary Feinerman of the U.S. District Court for Northern Illinois ruled that O’Brien failed to prove that the device caused his injuries.
Thomas and Joan Dulski also sued Intuitive that year, alleging that the Da Vinci device caused his prostatectomy to go awry and he wound up with a perforated colon. The case was dismissed last year after a mediation bid failed, according to court documents.
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