Robotic Surgery Controversy Deepens

davinci-controversy

We’ve long written about robotic surgery devices, specifically, the da Vinci, which is manufactured and marketed by Intuitive Surgical Inc. The state-of-the-art system has been the focus of an increasing number of lawsuits and death and injury reports and is at the center of a growing dispute over the technology and how it is marketed and used.

In robotic-assisted surgery, a surgeon sits at a console operating four robotic arms. Those arms manipulate small tools that are inserted into the patient’s body via tiny incisions. The system also utilizes a small, lighted camera that displays the surgical area in 3-D video. Some 70 deaths have been linked to robotic surgical systems since 2009, as well as at least 10 lawsuits in the last 14 months.

Some argue that robotic surgery creates less scarring, pain, and blood loss; decreased complications; shorter hospital stays; and quicker recovery, when compared to traditional open surgery in which a larger incision is made and the healing time is longer. Critics say it is the minimal invasiveness of the procedures and not the robotics that offer the advantage.

In one case, said The New York Times, a male patient, 67, underwent a routine, robotic prostatectomy in 2008. His five-hour surgery took more than 13 hours and left him incontinent and reliant on a colostomy bag. This led to kidney and lung damage, sepsis, and stroke; he died in 2012, said The Times, which noted that the surgeon involved, Dr. Scott Bildsten, had not used the da Vinci before that surgery. Documents provided to The Times by the patient’s estate reveal aggressive marketing tactics and point to quality issues related to physician training on the da Vinci, which is used in nearly 1,400 United States hospitals. Last year, about half a million procedures were performed by robotic surgery worldwide.

Hospitals set credentialing standards—training requirements—for doctors who will operate the robotic system; however, Intuitive documents reveal that its sales reps were very close to the process, presenting themselves as da Vinci experts, and working toward reduced standards so that training could be eased for busy surgeons, all to increase use of the da Vinci and its sales, said The Times.

In one email, an Intuitive Western regional sales manager urged sales staff to push surgeons to switch traditional surgery cases to robotic surgeries. “Don’t let proctoring or credentialing”—supervised surgery and hospital certification—“get in our way,” said The Times. A year later, in 2009, the same rep prompted a hospital to ease credentialing requirements writing that the mandate that surgeons conduct five supervised operations using the da Vinci before operating unsupervised was “on the high side” and could lead to “unintended consequences.”

Other emails suggest that Intuitive’s sales team pushed surgeons to use the da Vinci when they were planning on a different surgical method. In a 2010 email, an Intuitive clinical sales director urged the sales team to “scrub” surgeon schedules and have procedures moved up so that the quarterly goal would be met. “Let’s bring it home!” she wrote. “Be sure you scrub all schedules, identify cases on Thursday and Friday that can be moved up,” she added, according to The Times. Sale staff compensation was associated with a quarterly quota of operations filing.

In 2010, a clinical sales director wrote to his team, “Be proactive in finding cases to convert. Be prepared to challenge each trained surgeon every time you see a lap or open case. Be unsatisfied with the thought of ending a day without a converted case,” according to The Times. A “lap” is a laparoscopic procedure, another minimally invasive surgery. Sales reps were often in operating rooms, had operating room schedule access, and were urged to “partner” with surgical teams “to review and select appropriate cases,” court documents indicated, said The Times.

Meanwhile, in Massachusetts, health officials announced that mounting robotic injury reports prompted the state to seek improved training oversight and patient disclosure concerning the technology’s possible risks. The U.S. Food and Drug Administration (FDA) is now seeking information from surgeons at key hospitals regarding complications seen with the da Vinci and the surgeries robotic surgery devices are best and least suited for. A 2011 study revealed that hospital web sites often overstate the benefits of robotic surgery; none described risks and sites often utilized stock images or text provided by Intuitive. Most recently, The American College of Obstetricians and Gynecologists (ACOG) issued a statement advising women that robotic surgery is not the ideal option when undergoing routine hysterectomy.

Personal injury lawsuits allege the da Vinci Surgical Robot has caused severe internal injuries, including burns, tears, and other complications, some of which had resulted in death or chronic pain and disability. Among other things, da Vinci Surgical Robot lawsuits fault the aggressive marketing tactics used by Intuitive to convince hospitals to purchase the expensive surgical robot, and allege that a combination of design flaws inherent in the robot, coupled with poor physician training on the device, have resulted in serious injuries.

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