A woman and her husband are seeking $300 million in damages in a product liability lawsuit against the maker of a robotic surgical system that she says nearly killed her and caused her excruciating pain and suffering, as well as lifelong medical ailments.
In Zarick v. Intuitive Surgical Inc., plaintiff alleges the surgical system caused her severe internal injuries when doctors relied on it to perform a hysterectomy.
This case is one of the first to go trial against this defendant, which characterizes itself as the worldwide leader in minimally-invasive, robot-assisted surgery. These procedures are conducted with a surgeon sitting at a console near the patient, looking through a viewfinder and moving a joystick-like controller to move the robotic arms of the device. This particular device alone is used in some 200,000 surgeries a year.
Plaintiff reports that the system botched her 2009 surgery, causing her intestines to protrude through her vagina. She was rushed to a nearby emergency room and was forced to undergo a high-risk surgery that required a hip-to-hip incision. Plaintiff, 44, and her husband are asking for $50 million in economic damages and another $250 million for emotional distress, pain and suffering, loss of consortium and loss of life enjoyment.
As to what exactly went wrong during the surgery, plaintiff alleges the electric scissors used by the robot aren’t adequately insulated. These scissors are used to slice and cauterize human tissue. But without proper insulation, plaintiff alleges, that electricity can surge through the device, inflicting damage to the tissue surrounding the procedure – including the bowels.
That’s reportedly what happened to plaintiff. She alleged the second surgery she underwent was invasive and extremely painful. It permanently damaged her rectal muscles and has had irreparable and permanent harm on her sex life.
Plaintiff alleges the robot maker did not adequately test these devices before they started aggressively marketing them to doctors. Further, plaintiffs assert the company actively concealed information about the safety of these devices from the U.S. Food & Drug Administration (FDA).
The surgery she had initially undergone was one of several options she had to treat benign cysts in her uterus. She was persuaded by her doctor to undergo surgery in the first place because she was assured the robots were extremely safe and the recovery time would be quick. At no time was she told that the devices had been determined by the FDA to be dangerous or that executives with the company were “on notice that the device was causing a health crisis” across the U.S.
In 2000, the FDA had cleared the robots for use in surgeries for both adults and children. However in 2013, regulators launched an investigation into the allegedly defective medical devices after a reported spike in the number of “adverse medical events.” In all, the devices have been associated with at least 70 deaths, according to Bloomberg News.
Defendant manufacturer, which raked in more than $2 billion in revenue just in 2012 sales, argues the system is not defective. Instead, the company asserts plaintiff was negligent for her own injuries because she engaged in sexual intercourse five weeks after surgery – instead of waiting the six-to-eight weeks her physician had recommended.
This case is being closely watched because there will likely be many more to follow.
Contact the Carolina injury lawyers at the Lee Law Offices by calling 800-887-1965.
$300M Trial Begins Over Intuitive’s Allegedly Defective Robotic Surgical System, April 7, 2016, By David Siegel, CVN
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