Parker Waichman LLP Reviews Allegations and Recent News Highlighting the Risks of Robot-Assisted Surgery with Intuitive’s da Vinci System

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The New York Times has reported about the lawsuit of one woman whose husband sustained severe injuries after undergoing a routine prostatectomy with the da Vinci surgical robot; he suffered from incontinence, kidney and lung damage, sepsis and stroke, allegedly due to complications from his robot-assisted surgery. According to the NYT, the Plaintiff’s surgery was performed by a doctor who had never operated the da Vinci without supervision; Parker Waichman LLP is reviewing recent news regarding the da Vinci surgical robot, and warns patients to be fully aware of the risks.

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Not only is surgery with the da Vinci more costly, but recent reports suggest that they are not even as good as other well-established alternatives.

Parker Waichman LLP, a national law firm dedicated to protecting the rights of victims injured by defective medical devices, is discussing the risks of robot-assisted surgery in light of allegations reported March 25, 2013, by the New York Times. According to the NYT article, Josette Taylor is suing Intuitive Surgical Inc. after her husband Fred E. Taylor suffered severe complications, including incontinence, kidney and lung damage, sepsis and stroke, after undergoing surgery with the da Vinci surgical robot. The NYT reports that for surgeon Dr. Scott Bildsten, it was the first time performing the operation without any supervision. Recent reports from ACOG and the Massachusetts Board of Registration in Medicine have emphasized the high cost of surgery with the da Vinci and warned about the potential for serious complications, especially considering the high learning curve required to become proficient at using the system.

“Intuitive Surgical Inc. has aggressively marketed this so-called innovative technology at the cost of patient safety,” says Gary P. Falkowitz, a Managing Attorney at Parker Waichman LLP. “Not only is surgery with the da Vinci more costly, but recent reports suggest that they are not even as good as other well-established alternatives.” Parker Waichman LLP offers free legal advice to patients who suffered alleged injuries that may have been caused by the robotic system and is actively seeking cases.

“We are the old school, where you trust the doctor,” Mrs. Taylor said to NYT. She said that after the surgery, her husband’s lifestyle was so limited that he used to cry about being “trapped in this body.” Although Mr. Taylor survived his injuries, he died last year.

Surgeons who perform procedures with the da Vinci sit several feet away from the patient at a video game-like console while using hand controls and foot pedals to guide mechanical arms equipped with surgical tools. A 3-D camera and high definition display is used to visualize what is going on inside the patient.

The NYT reports that Taylor’s lawsuit has brought to light a substantial amount of seemingly-condemning evidence for Intuitive. One email from a regional sales manager dated May 31, 2011, for instance, encouraged sales staff to not let supervised surgery or hospital certifications get in the way of promoting da Vinci, which is the only approved surgical robot in the United States. “Don’t let proctoring or credentialing get in our way,” the email stated. Another email in December from a sales representative told hospitals to give greater leniency for credentialing requirements, stating that five unsupervised surgeries before performing procedures along with the da Vinci was “on the high side” and may lead to “unintended consequences.” Emails that have come to light in Taylor’s lawsuit also suggested that Intuitive employees pushed surgeons to use the da Vinci even if they were planning to use another method for patients.

NYT also reports that, according to legal depositions in the Taylor case, sales people were frequently in the operating room instructing newly trained surgeons on what to do. The sales representatives even appeared to have access to operating room schedules and were told to “partner” with surgical teams to “review and select appropriate cases.”

According to the NYT article, Intuitive told the U.S. Food and Drug Administration (FDA) in 2000 that surgeons would have to take a 70-item exam and undergo three days of hands-on training in order to be trained for the da Vinci. Despite these claims, however, the exam had been reduced to 10-items and the hands-on training to one day by 2002.

On March 14th, the American Congress of Obstetricians and Gynecologists (ACOG) issued a statement warning consumers to not let aggressive marketing overshadow the risks of robot-assisted surgery. According to the news release, there is no good evidence to show that procedures with the da Vinci surgical robot are even as good as less invasive, far cheaper alternatives. ACOG, a group that represents 56,000 physicians, is not the only organization to express concerns about the safety and efficacy of robot-assisted surgery. This month the Massachusetts Board of Registration in Medicine has also highlighted the potential for serious complications in an advisory. The advisory stated that, in light of growing reports of injuries associated with the da Vinci, there should be more oversight for surgeons and patients should be better informed about the risks. The Board cited examples of patients who had suffered bleeding, adhesions and damage to the bowel and ureter; in one case, a piece of rectal tissue was mistakenly left inside a patient’s abdomen.

Parker Waichman LLP continues to offer free legal consultations to victims of da Vinci surgical robot injuries. If you or a loved one experienced surgical burns, perforated or torn organs, torn blood vessels or other injuries associated with the da Vinci surgical robot, please contact their office by visiting the firm's da Vinci Surgical Robot Lawsuit page at Free case evaluations are also available by calling 1 800 LAW INFO (1-800-529-4636).

Parker Waichman LLP
Gary Falkowitz, Managing Attorney
(800) LAW-INFO
(800) 529-4636

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