Wrongful deaths lead to increased scutiny over robotic surgeries

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Robotic surgeries dramatically increased in popularity with surgeons last year. Nearly 400,000 surgeries using the da Vinci robotic system were performed in 2012–three times the number performed in 2008. The Food and Drug Administration (FDA) is investigating increased reports of problems, including several wrongful deaths. The FDA has received reports of incidents involving the robotic system, such as a robotic hand that would not release tissue it grasped during surgery and a patient who was hit in the face by a robotic arm as she lay on an operating room table. Since early last year, the FDA has received reports of at least five deaths.

Nearly 1,400–1 out of 4–hospitals in the U.S. have at least one da Vinci system at a cost of $1.45 million each. Service agreements cost $100,000 or more annually.

Surgeons are divided over use of the robotic systems.  Some surgeons believe robotic procedures result in less bleeding and shorter hospital admissions iwhen compared to conventional laparoscopic surgeries. In addition, advocates cite the steadiness of the robotic hands and reduction of surgeon fatigue.

Dr. Martin Makary, a surgeon at Johns Hopkins, who co-authored a soon to be released research paper, believes that problems associated with the robotic surgery system are underreported. Dr. Makary states that some cases involve “catastrophic complications.”

Makary does not believe the increase in robotic surgery is warranted and he blames aggressive advertising by hospitals in attempt in attract patients, as well as da Vinci’s manufacturer, Intuitive Surgical Inc. The da Vinci robotic system is the company’s only product and is the only robotic system approved by the FDA for soft tissue surgery. Other robotic systems have been approved by the FDA for neurosurgery and orthopedics, as well as other procedures.

Last year, a jury awarded $7.5 million in a medical malpractice lawsuit to the family of a Chicago man who died in 2007 following robotic spleen surgery. That lawsuit alleged that surgeons inadvertently perforated the man’s intestines, causing wrongful death. It was the first time one of the surgeons had used the robotic surgical system. The plaintiff’s attorney described use of the robotic surgery system for an ordinary surgery as “overkill.” One expert witness likened the use of the robotic system in that case was like “using an 18-wheeler to go to the market to get a quart of milk.”

For more information, contact the Ohio wrongful death lawyers at Clark, Perdue & List.

Source: Associated Press, “Robot hot among surgeons but FDA taking fresh look,” Lindsey Tanner, April 9, 2013.