Davinci Surgery Lawsuits

Why Should You File a Lawsuit?

If you or a loved one was injured during da Vinci surgery, you may decide to file a lawsuit against Intuitive for compensation for medical bills, lost time from work and permanent injuries, among other damages. Attorneys are acting on behalf of injured patients because they feel the da Vinci is a faulty and “unreasonably dangerous” product that caused serious injuries and deaths.

According to multiple court filings, some of the claims leveled at Intuitive include:
Manufacturing a defective product
Failing to warn and place adequate warnings
Failing to adequately test the machine before selling
Failing to provide adequate training to surgeons and hospitals
Selling unsafe products knowingly
Failing to monitor and report complications

Plaintiffs also accuse Intuitive of promoting the da Vinci robot even though it knew the “monopolar current had increased risk of serious injury and/or death,” despite the fact “safer and more effective methods of treatment were available.”

Intuitive told CNBC that monopolar energy instruments are also used in traditional surgery methods, and “the da Vinci surgical system deploys monopolar energy in a safe and effective way when used as indicated.” In May 2012, however, the company released new tip covers for its instruments and asked doctors to begin using them immediately. Many of the arcing problems occurred near the tip covers, but the problem continues despite the replacement.

Specific da Vinci Litigation

Kimberly McCalla’s father, Gilmore, filed a claim against Intuitive after his 24-year-old daughter died from massive internal bleeding. According to his claim, her bleeding was caused by the da Vinci device. Kimberly went in for a routine hysterectomy and died 13 days later from a laceration of a main artery that happened during the robotic surgery.

“Blood was flowing from her leg, from between her legs,” McCalla told CNBC. “And two nurses were there around her, catching the blood with a bottle.”

Erin Izumi sued Intuitive after she went in for routine surgery to treat endometriosis and spent weeks in the hospital with a torn colon and rectum. She had to undergo several corrective surgeries and received a temporary colostomy.

Erika Starr and her husband, Nick Griffith, filed a lawsuit after Starr, then 38, suffered “bowel perforation and/or thermal burns and subsequent infections that caused severe and permanent injuries.”

FDA Warnings

The U.S. Food and Drug Administration (FDA) send Intuitive a warning letter that listed four separate federal violations related to the da Vinci. All involved failures to inform the FDA about faulty equipment and misleading information. Intuitive’s clients, such as doctors and hospitals, received corrections about the system after complaints and medical device reports revealed several risks to patients.

The FDA listed several errors including:

Damaged tip covers injured patients

Wrong instructions about proper accessories and generators

da Vinci was promoted for use in thyroid surgery, but the company eventually indicated the device it wasn’t cleared for use during these procedures

Instructions failed to provide information about properly inspecting, flushing and transporting the system

Original manual listed pediatric patients as suitable for trans-oral surgeries, but this recommendation was later reversed

Between January 2010 and December 2011, Intuitive received more than 134 complaints from doctors and filed 83 of these reports with the FDA. These filings covered instrument “tip cover issues.” According to Intuitive, new tip covers were approved in 2011, and it sent an “important product notification” to doctors and hospitals to use the new covers immediately. The company maintains the original covers were not defective.

Questionable Marketing Methods

People who entered into litigation because of the da Vinci Surgical System also accuse the company of marketing their product too aggressively and of urging doctors to perform the surgery even if surgeons were not trained properly.

A 2010 study of robotic surgical systems zeroed in on the da Vinci and concluded that the robotic system increased the cost of surgical procedures, required extensive maintenance and demanded more operating time. Study authors Dr. Gabriel Barbash and Dr. Sherry Glied also estimated that a surgeon would have to conduct between 150 and 250 procedures before being qualified to operate the device.

Internal emails from Intuitive show sales representatives often influence and pressure hospitals and doctors, The New York Times reported. In one email, a company rep told a hospital in Montana that requiring surgeons to do five supervised surgeries before performing surgery alone was “on the high side” and threatened “unintended consequences.” The hospital said it would probably “decrease the requirement to three.”

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  1. Barbash, G. and Glied, S. (August 19, 2010). New Technology and Health Care Costs – The Case of Robot-Assisted Surgery. The New England Journal of Medicine, 363, 701-704. Retrieved from http://dx.doi.org/10.1056/NEJMp1006602
  2. Starr and Griffith v. Intuitive Surgical, Inc. (2014, March 12). United States District Court, Southern District of Ohio. Case 1:14CV225. Retrieved from http://www.aboutlawsuits.com/wp-content/uploads/2014-03-12-Starr-Complaint.pdf.
  3. Fox, M. (2013, June 14). NBC News. Electrical burns may burst surgical robot’s bubble. Retrieved from http://www.nbcnews.com/health/health-care/electrical-burns-may-burst-surgical-robots-bubble-f6C10321766.
  4. Intuitive Surgical, Inc. (2014, December 12). da Vinci Surgery. Retrieved from http://www.davincisurgery.com/
  5. U.S. Food and Drug Administration. (2013, July 16). Warning letter to Gary S. Guthart. Retrieved from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm363260.htm
  6. Rabin, R.C. (2013, March 25). Salesmen in the surgical suite. New York Times. Retrieved from http://www.nytimes.com/2013/03/26/health/salesmen-in-the-surgical-suite.html?pagewanted=all
  7. Greenberg, H. (2013, April 19). Patients scarred after robotic surgery. CNBC. Retrieved from http://www.cnbc.com/id/10062694