UPDATED: 5-24-13 Jury finds Intuitive NOT GUILTY. Scroll to end to see details.
One of robotics’ biggest stars, Intuitive Surgical (NASDAQ:ISRG), and their da Vinci robotic surgical systems, is receiving a lot of unfavorable media attention – including a 4-part “exposé” by MSNBC – because:
- A month-long suit alleging injuries tied to the robot surgery used in a 2008 procedure to remove a patient’s prostrate claims that the surgeon was not adequately trained.
- A recent JAMA article showed that although the number of robotically assisted hysterectomy procedures is up, their effectiveness is the same as laparoscopic methods but their costs are about $2,000 higher per procedure.
- The FDA recently initiated a probe asking surgeons at numerous hospitals to identify complications with the da Vinci machines.
- Intuitive sends note out about a scissor instrument known as Hot Shears saying the instrument could develop small, invisible cracks, which can potentially cause a leak of electricity that can burn patients. It describes precautions to take before using the instrument but also says an additional message will be sent once a replacement instrument is available.
PLAINTIFF: That Intuitive Surgical designed a watered down training program to make it easier for them to sell systems to hospitals thereby compromising surgical quality which, in this case, led to complications which caused the man to die. They further claim that the lack of training and steep learning curve caused mistakes which led to kidney failure, brain damage, permanent incontinence, the need to wear a colostomy bag, and ultimately, heart failure and death.
DEFENDENT: That injuries suffered by the obese and medically-troubled patient occurred after the robotic systems was unplugged and not in use; the injuries happened after the robotic surgery was completed. That training, supervision and case selection warnings are and were adequate but in this case not heeded.
- One firm is investigating potential claims against the board of Intuitive because the FDA MAUDE database of adverse events involving medical procedures is “significantly understated in terms of da Vinci-related complications.”
- Another class action suit has been filed alleging that officers and directors of Intuitive violated SEC provisions and issued materially false and misleading statements highlighting the purported safety and effectiveness of the da Vinci system, concealed at least 10 lawsuits, and therefore are responsible for artificially inflating stock prices during the class action period.
- A third class action suit has been filed almost identical to the one above.
As Intuitive begins to defend itself in the Taylor case, multiple witnesses testified that heart disease, not a failed robotic procedure, killed the patient. Further, Taylor’s arteries were 50 to 90% blocked and he had bypass surgery in 2002. Another witness testified that Taylor’s health risks prior to the prostate surgery – diabetes, high blood pressure, high cholesterol and his obesity (280# on a 5’8″ frame) – ultimately caused his heart to stop.
Intuitive sends note out to customers about a scissor instrument known as Hot Shears saying the instrument could develop small, invisible cracks, which can potentially cause a leak of electricity that can burn patients. It describes precautions to take before using the instrument but also says an additional message will be sent once a replacement instrument is available.
Three additional law firms (Ryan & Maniskas, Rigrodsky and Long, and Hagens Berman Sobol Shapiro) filed class action suits alleging that ISRG issued a series of false or misleading statements to investors and thereby failed to fully disclose to investors the financial impact of safety problems with its da Vinci Surgical System.
PLAINTIFF: Intuitive is to blame for injuries stemming from a 2008 robot-assisted prostate removal because of Intuitive’s inadequate training which was streamlined and compromised by the company’s agressive efforts to sell their robots.
DEFENDENT: Intuitive’s warnings to not use the da Vinci device for complicated procedures went unheeded by plaintiff’s urologist and that person is responsible for plaintiff’s injuries. During the course of the trial Intuitive said that the urologist knew the path he was on was unduly risky but proceeded nevertheless. It was also disclosed that the plaintiff had previously sued and settled claims again the urologist and the hospital but those documents and the settlement details were secret.