May 20, 2016, PLLR E-Newsletter | The American Association For Justice

May 20, 2016, PLLR E-Newsletter

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Da Vinci manufacturer settles claim alleging botched hysterectomy

Closeup of saline drip with patient lying in background at operation room

The plaintiffs alleged that the robotic system was defectively designed and manufactured in that microscopic cracks in the insulation could permit electricity to leak out and damage the patient’s surrounding tissue. The parties settled confidentially. Zarick v. Intuitive Surgical, Inc.
 

On Feb. 3, 2009, Michelle Zarick underwent a hysterectomy in which the surgeon used the da Vinci robotic surgical system, manufactured by Intuitive Surgical, Inc. During the procedure, which is designed to provide for less invasive surgery, laparoscopic instruments are inserted into the patient’s abdomen. The surgeon sits at a console and views the surgical field inside the patient though a high-definition 3D image. When the surgeon operates joystick-like controls, robotic arms move the surgical instruments inside the patient.

About five weeks postsurgery, Zarick, 37, experiencing light vaginal bleeding after intercourse. Soon after, she felt a “pop,” and saw that part of her intestines were protruding from her vagina.

Zarick was rushed to the hospital for emergency surgery. During the procedure— which entailed a hip-to-hip incision—the surgeon noted that Zarick had a massive infection, which was so severe that her right fallopian tube and ovary had to be removed. The surgery also revealed necrotic tissue and a small bowel evisceration adjacent to the suture line where the vaginal cuff had been sewn closed during the hysterectomy. Zarick suffered severe pain and spent six weeks recuperating from the emergency procedure. She continues to suffer pelvic pain and has a diminished her sex life. The botched surgery also damaged her rectal muscles.

Zarick and her husband sued Intuitive, alleging that the robotic system was defectively designed and manufactured in that there were problems with the insulation covering the electrified scissors attachment used to cut and cauterize tissue. Specifically, the plaintiffs contended that microscopic cracks in the insulation could permit electricity to leak out and damage the patient’s surrounding tissue. Here, plaintiffs asserted, the location of necrotic tissue, which was discovered adjacent to the vaginal cuff sutures, showed that there had been inadvertent electrical arcing during her hysterectomy.

The plaintiffs alleged that Intuitive was aware of the problem as early as 2007 but continued selling the system and failed to warn users until 2011. They also alleged that Intuitive placed financial interests ahead of patients by failing to conduct adequate premarket testing of the system and selling it to surgeons without ensuring that they received proper training.

Intuitive denied that the system was defective and argued that Zarick developed complications because she failed to follow the surgeon’s instructions to wait six to eight weeks before having sexual intercourse.

The plaintiffs reportedly sought $250 million for emotional distress and $50 million for economic damages.

The parties settled for a confidential amount before trial.

Citation: Zarick v. Intuitive Surgical, Inc., No. 1-12-CV-237723 (Cal. Super. Ct. Santa Clara Cnty. Apr. 2016).

Plaintiff counsel: Mark J. Geragos and AAJ member Ben J. Meiselas, both of Los Angeles; and Francois M. Blaudeau, Birmingham, Ala.

Comment: There are reportedly more than 20 lawsuits pending in the United States against Intuitive for injuries caused by the da Vinci system. The Zarick case was reportedly the second to go to trial.