For more information or confidential assistance
800-306-3180
se habla español

Lawsuit Alleges da Vinci Robot Prostatectomy Caused Severe Burns

scales of justiceRichard Pohly has filed a lawsuit against the manufacturer of the da Vinci robot, claiming the device left him with permanent and disabling injuries.

The plaintiff further states that the manufacturer was fully aware of the risks associated with their product, but failed to alert the medical community and general public. In addition, the company is charged with failing to take steps to reduce those risks by issuing a recall or making changes that would have made da Vinci surgery safer for patients.

Complaint filed in California court

Richard Pohly filed his complaint in U.S. District Court for the Northern District of California on September 9, 2015. The plaintiff chose this particular court for filing because two similar cases were already before the court. Both previous cases had been filed by insurance companies on behalf of their injured clients and both involved injuries caused by the da Vinci robotic system. The defendant in all three of these cases is Intuitive Surgical Inc., the manufacturer of the da Vinci robot.

Pohly states in his complaint that he underwent a prostatectomy using the da Vinci robotic system on July 31, 2012. The procedure was performed at the University of Texas Southwestern Medical Center (UT) in Dallas, Texas. Pohly asserts that at the time of his surgery, neither he nor his surgical team were aware of the risk for potential burning of tissue and organs from stray electrical energy emitted from the device.

During Pohly’s surgery, stray electrical energy was emitted from the da Vinci robot, which resulted in internal burning and severe rectal injuries. Pohly’s surgeon was unaware of the burns at the time of the procedure. It was not until after the procedure that Pohly realized the complications were caused by the da Vinci device.

Pohly claims that his thermal injuries have caused him “physical pain, mental anguish, emotional distress, disfigurement and physical impairment.” The injuries have required extensive medical treatment and surgeries, which have caused the plaintiff substantial pain and expense. Pohly claims his injuries have affected his business opportunities and have left him with a lower quality of life overall.

Allegations company knew of risks

Pohly’s da Vinci robot lawsuit against Intuitive Surgical alleges the company knew about the risks associated with their device for some time, but continued to actively market the robotic system as the “most effective and least invasive treatment option for a wide range of complex conditions.” Despite these claims on the company’s website, Pohly insists in his complaint that the defendant could not have known their product was the most effective, since no large-scale, randomized trials had been performed on the device at that time.

As the robotic system continued to be used in operating rooms across the country, reports of serious complications, including thermal injuries, raised concerns among the medical community. In August 2011, the American Journal of Obstetrics and Gynecology published a study that found a significant number of insulation failures with the device, which could lead to thermal injuries or internal burning. The study also concluded that robotic devices like the da Vinci had a higher rate of insulation failure than laparoscopic instruments.

FDA launches investigation

In April 2013, after a spike in adverse reports involving the da Vinci robotic system, the FDA launched an investigation into the device to determine its safety. At that time, the number of surgical complications associated with the da Vinci system had increased 34 percent between 2011 and 2012. The FDA survey also followed a number of additional studies performed on the robotic system, which found the device to be costlier, without offering significant benefits over laparoscopic procedures.

In his complaint, Pohly is seeking both compensatory and punitive damages for pain and suffering, medical expenses and other non-economic losses.

  1. Journal of Clinical Oncology, Comparative Effectiveness of Robotic versus Laparoscopic Hysterectomy for Endometrial Cancer, http://jco.ascopubs.org/content/30/8/783.full
  2. Medscape, FDA Investigates Robotic Surgery System after Adverse Event Spike, http://www.medscape.com/viewarticle/803339
  3. The American Congress of Obstetrics and Gynecology, http://www.acog.org/About-ACOG/News-Room/News-Releases/2013/Statement-on-Robotic-Surgery
  4. U.S. National Library of Medicine, Robotic Instrument Failure: Initial Report of a Potential Source of Patient Injury, http://www.ncbi.nlm.nih.gov/pubmed/20846712