|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.
“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.”
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.
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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- 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
- 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.
- 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.
- Intuitive Surgical, Inc. (2014, December 12). da Vinci Surgery. Retrieved from http://www.davincisurgery.com/
- 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
- 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
- Greenberg, H. (2013, April 19). Patients scarred after robotic surgery. CNBC. Retrieved from http://www.cnbc.com/id/10062694