Manufacturer Sued For Death Arising From Surgical Robot

Fri, 04/06/2012 - 7:46am

/PRNewswire/ -- The father of his deceased 24 year old daughter has commenced a lawsuit in New York against Intuitive Surgery, Inc., the maker of the da Vinci surgical robot, alleging that the device caused her death.

In his complaint, filed by the firm of Rheingold, Valet, Rheingold, McCartney & Giuffra LLP of New York City, Gilmore McCalla asserts that when his daughter was having a hysterectomy in a Bronx hospital in August 2010, the robot caused burns to an artery and her intestines, which led to her death two weeks later.

The complaint alleges design flaws in the da Vinci robot, including un-insulated surgical arms and use of electrical current which can jump to healthy internal organs and tissue. It also alleges that physicians are not properly trained on the device, and that Intuitive Surgery has failed to run randomized tests as to complications with its robot.

The McCalla complaint, filed in the federal court in New York City on April 4, 2012, 12civ2597, also asserts that the manufacturer has suppressed reports of complications, and has oversold the merits of its da Vinci robot to hospitals considering buying it. The machine costs of upwards of $2 million to purchase and then has a sizeable annual maintenance cost.

McCalla is also asserting, in separate litigation, that the surgeon operating the robot and the hospital where the procedure was being done were careless, in part in not discovering the damage done by the robot.

The da Vinci robot is operated remotely from a console by a surgeon. Several arms are placed into the patient, for burning away tissue in order to remove the diseased organ, and also for a camera.

Numerous complications have been reported in medical journals with the use of the da Vinci robot in various types of surgery, not only hysterectomies as in the McCalla case but also other gynecologic surgery, and prostate surgery. The common types of injuries are tears and burns, to blood vessels, intestines, uterus and vaginal cuff dehiscence. Often these injuries are delayed in their appearance after the actual surgery.

Intuitive Surgery, Inc., is headquartered in Sunnyvale, CA. It is currently the sole manufacturer of surgical robots in the country. Its stock is traded on the NASDAQ exchange under the letters ISRG. Recent annual earnings were more than $1.75 billion and its balance sheet showed more than $3 billion in assets.

The cost for performing robotic surgery greatly exceeds the type of laparoscopic or open surgery it replaces, and there has been debate in the medical literature whether the extra costs -- whether paid by insurance companies, the government or patients -- is justified because of claimed better outcomes with the device. The complaint alleges that Intuitive Surgery has not sponsored any comparative safety tests where patients are selected prospectively as compared to just looking at results.

In evaluating the cost-benefit ratio in the use of expensive robotic surgery, some medical groups have questioned the use of robotic surgery. These include the American College of Obstetricians and Gynecologists; and the Kaiser Foundation.

In certain instances where there are complications while performing robotic surgery, it may be necessary to sue both the robot manufacturer and the surgeon, who may have been careless in operating the machine. That is the true of the McCalla litigation. However, often the surgeon has not been properly trained by Intuitive Surgery on the use of the machine and so may not realize that burns and tears are being inadvertently caused.

Rheingold, Valet, Rheingold, McCartney & Giuffra LLP is a plaintiffs law firm in New York handling national litigation involving defective medical drugs and devices. Currently it is involved in mass litigation involving the NuvaRing birth control device, the Yaz birth control pill, the DePuy ASR metal-on-metal hip replacements, femur fractures in Fosamax users, among other suits. The firm also handles medical malpractice cases.


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