Three months ago, I posted an article on my Litigation & Trial blog titled, “Player Piano” Robotic Surgeries Put Women’s Lives At Risk, discussing the Da Vinci surgical robot, which is marketed as a safer alternative to other types of hysterectomies. By my count, there are now more than 4,500 complaints about the Da Vinci surgical robot in the FDA’s MAUDE (“Manufacturer and User Facility Device Experience”) Database – 50 or so of them involving the death of the patient – and 30 lawsuits against the manufacturer, Intuitive Surgical, Inc.
Since my post, there have been three main developments. First, the FDA is taking a closer look at worrisome number of patient, doctor, and hospital complaints about the machine. Second, the media is taking a closer look at the real risks of using the robot. Third, the company finally admitted a problem, though they don’t admit nearly enough, and they aren’t taking any real steps to make it safer.
The first two developments are great news, though we’re not holding our breath that anything will come of them. The FDA is often way too late to address problems with medical devices, like how they were years behind on the DePuy and Stryker metal-on-metal hip implant debacles, and how they still haven’t recognizes the scope of the vaginal mesh erosion epidemic. Both products are shockingly still on the market, despite having injured hundreds of thousands of patients.
Focusing on the third point, the company recently admitted in a letter to users that certain batches of “EndoWrist Monopolar Curved Scissors” (the electronic scalpel used with the robot) might develop tiny cracks that can allow electricity to escape from the device, burning patient’s organs. Unsurprisingly, they don’t admit anyone was actually injured by it: “our analysis shows only one complaint of injury associated with [one of the broken electronics couples], however, laboratory testing did not detect any energy leakage from this instrument.” We know better – the Da Vinci robot routinely burns patients.
A few months ago, an investment advisory firm, Citron Research, scoured the MAUDE database for details on the Da Vinci robot and found numerous extraordinary reports of inexplicable perforation, tearing, and burn injuries. Doctors reported the device, for example:
We’ve heard that from our clients and from reports from doctors. One general surgeon told me that the majority of Da Vinci injuries weren’t really perforation injuries – as in, the robot accidentally cutting tissue or organs it shouldn’t have – but rather monopolar cautery injuries, or rather an injury caused by the use of electric current to cut the patient’s tissue.
And that’s one of the key problems with the robot:the injuries it causes have less to do with the way in which the robot was operated than with the inherent design of the robot. All surgery is dangerous. While electrosurgery has benefits over the use of the traditional scalpel (the heat and electricity cauterize the wound as they cuts, thereby preventing bleeding), it also has numerous risks. These are risks that surgeons train over the course of years to reduce. The Da Vinci robot, no matter how sophisticated it may seem, simply doesn’t have the ability to mitigate those risks through advanced technique.
The tragic part is that patient’s aren’t trading some risks for other benefits: the Da Vinci robotic surgery hasn’t been proven to be any safer or more effective than any other form of laparoscopic surgery, a/k/a minimally invasive surgery. The benefits of the robotic surgery extolled by Intuitive Surgical are usually just the same benefits of traditional laparoscopic surgery, in which the patient is cut as little as possible, and the surgeon tools are then manipulated inside their body. The use of laparoscopy for hysterectomies has been growing for a generation now, and its benefits are frequently extolled in medical journals. The same goes for all of the major procedures the Da Vinci is marketed for, like radical prostatectomy, colectomy, cystectomy, nephrectomy, myomectomy, endometriosis resection, sacrocolpopexy, and gastric bypass – none of these procedures benefit any more from the use of the robot as compared to an experienced surgeon using a laparoscopic approach.
So how did this happen? Based on the research patients’ lawyers have done, most of the lawsuits include verbatim these allegations:
Defendant has promoted its device as (a) safe, and (b) safer than other comparative methods of surgery including, in the case of hysterectomies, laparoscopy, vaginal surgery and open surgery.
Defendant utilizes prominent websites aimed at consumers, seeking to create demand for the use of its robotic device by patients who consult surgeons.
Defendant sold it device through a calculated program of intimidation and market management, forcing hospitals and physicians to purchase it in order to appear to be competitive, and creating a fear in their minds that if they did not have this technology they would lose business to competitors.
Defendant reinforced its calculated program, as stated in the preceding paragraph, by placing, on its website for potential patients, names of certain physicians who had performed 20 surgeries with the device.
Plaintiff’s lawyers like me have been on top of that for a while, and it was nice to see the editors of the Journal of the American Medical Association agree, with their editorial arguing that “Consumer advertising of expensive devices should be subjected to the same scrutiny as that of new and expensive medications.”
As the plaintiffs also allege:
The use of defendant’s robotic device in surgery presents substantial risks of complications and injuries, including de-vascularization of the vaginal cuff impeding healing, partial thermal injury burns to bowel, post-surgical abscesses, tears, dehiscences, bleeding, hematomas, sepsis, and fistulas.
More specifically, defendant’s robotic device can cause damage to the bowel, blood vessels, arteries, ureters, bladder and vaginal cuff.
Indeed. All of this is why, two weeks after my blog post went up, the President of the American Congress of Obstetricians and Gynecologists (ACOG) issued a statement noting “the outcome of any surgery is directly associated with the surgeon’s skill,” and urging patients “to separate the marketing hype from the reality when considering the best surgical approach for hysterectomies.” Maybe robots are taking over increasingly sophisticated jobs – but this is one job they’re not ready to do, not by a long shot.
Since 1958, The Beasley Firm has fought for injured patients and consumers, obtaining over $2 billion in awards for our clients through hundreds of multi-million dollar settlements and jury verdicts. If you or a loved one were injured in a robotic surgery, contact our lawyers for a free and confidential consultation by by calling the firm.
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