The Da Vinci robotic device or machine is manufactured by Intuitive Surgical, Inc. of Sunnyvale, CA. It generally consists of a console in the surgical suit which remotely operates various arms which are inserted into the patient. These arms contain parts for cutting, cauterizing and the like. Another arm has a camera so that the surgeon can see what is going on.
Generally, two types of surgery make up the majority of the uses of the robot: hysterectomy and prostatectomy. However, other types of surgery have been assayed on the da Vinci, some of which could be considered in the experimental category.
It has been estimated that there are some 2000 of these machines in use in the United States, which is increasing in numbers through continuing sales. These machines sell for as much as $1.5 to $2 million, depending on their configuration. There is also a significant annual maintenance fee. If your client had robotic surgery, it was most likely the Da Vinci although some operative notes may fail to mention that the robot was used.
The robotic system is a medical device receiving a 510(k) approval by the FDA in 2000 and, fortunately not Class III approval. So far, Intuitive Surgical, Inc has not asserted a pre-emption defense.
BASIS OF LIABILITY
The asserted bases of liability in this new litigation have been both related to the machine and the training. As to the machine, a major design flaw is the use of monopolar current which permits arcing—the passage of electricity into adjacent tissue. This can cause burning. The McCalla case filed in New York involves a 24 year old woman who had a hysterectomy. She was then found to have an artery burn which deprived her intestines of blood, and she died. McCalla vs. Intuitive Surgical, Inc., S.D.N.Y, Civil Action No. 1-12-CV-02597.
Hospitals promoting this machine to the public, and the manufacturer as well, assert that there is a lower risk of bleeding, infections, and other complications when the robot is used compared to other surgical approaches. However, it appears there are few, if any, studies which compare outcomes where the patients were randomly selected, which is the gold standard way of comparing possible treatments. In other words, the generally accepted method of performing proper studies is through randomly selected patients.
There are several peer-reviewed medical articles which report that, to the contrary, there is a higher incidence of injuries with the robot, compared to other surgical methods.
*Cormier et al, Electrocautery-Associated Vascular injury During Robotic-Assisted Surgery, Ob.Gyn. Vol. 120, part 2, August 2012, p. 491.
*Espada et al., Insulation failure in robotic and laparoscopic instrumentation: a prospective evaluation, Am J of Ob Gyn, August 2011, p. 121.el.
*Wright et al, Robotically Assisted vs Laparoscopic Hysterectomy Among Women With Benign Gynecological Disease, JAMA, Vol. 309, No. 7, 2/20/13, p. 689.
There are also several books on the subject:
*Patel ed., Robotic Urologic Surgery (Springer 2012)
*Ghavamian ed., Complications of Laparoscopic and Robotic Urological Surgery (Springer 2010)
There are also possible situations where the machine breaks down, such as an arm detaching or software failing, which could then lead to conversion to open surgery instead of the robotic surgery.
The second major theory of liability relates to training and credentialing. Information has suggested that, while Intuitive Surgical, Inc states that it gives full training to hospitals which buy its machine, it may actually skimp on it. This would potentially allow a surgeon with little training on the machine, let alone in laparoscopy, march into surgery, and possibly get overwhelmed by its technicalities, improperly utilize the robot and even have to call for help.
In fact, it would make one ask the question: what if the training of the trainer of the robot? Does the trainer have a medical degree, or even a biomedical engineering degree, so that he/she can communicate effectively with the surgeon he/she is trying to train? How many surgeries does it take for the surgeon to become proficient? Who performs the surgery while the surgeon who is being trained is learning? Is it the non-medical trainer who probably doesn’t even have a medical license and who can’t legally perform surgeries in a hospital?
Also, what if the sales people for Intuitive Surgical, Inc were given incentives for talking a doctor into using the robot machine even if the doctor lacks adequate experience or the cost outweighs the benefits in minor surgery? If a hospital has purchased the expensive system, does it feel compelled to overuse it for economic reasons?
In February, the FDA initiated a study into the true incidence of injuries. In March the American Congress of Obstetricians and Gynecologists warned gynecologists not to use the robot for simple (non-cancer) hysterectomies. And the Massachusetts State Medicine Board of Registration similarly cautioned it members against overuse, no doubt out of fear of increasing suits and malpractice premiums.
Intuitive Surgical, Inc. claims that the Da Vinci System can be used in several surgical specialties including:
- • Urology
- • Gynecology
- • Cardiothoracic
- • General Surgery
- • Colorectal
- • Head & Neck
And that the Da Vinci Surgery can be used to treat a wide range of conditions, including:
- • Bladder Cancer
- • Colorectal Cancer
- • Coronary Artery Disease
- • Endometriosis
- • Gynecologic Cancer
- • Heavy Uterine Bleeding
- • Kidney Disorders
- • Kidney Cancer
- • Lung Cancer
- • Mitral Valve Prolapse
- • Obesity
- • Prostate Cancer
- • Throat Cancer
- • Uterine Fibroids
- • Uterine Prolapse
If you have undergone surgery with the use of the Intuitive Surgical, Inc. machine, and encountered serious, unexpected injuries or complications, a lawyer may have to analyze the case to determine which of four possible situations may explain the serious injuries or complications: was the doctor at fault; was the machine at fault; were both the doctor and machine at fault; and, lastly, neither were at fault (just a bad outcome but a known, unavoidable risk).
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