UPDATED 5-21-2013: Lawyers conclude closing arguments and case given to jurors
For continuing coverage of not only the court case but also the FDA probe, the JAMA article, the product recall, and the new class action suits, click here.
Intuitive Surgical's marketing director testified that they focused on a category of urologists who have “basic or limited laparoscopic skills who currently perform” traditional prostate removals and that group is “where 80 percent of your clinical [marketing] time should be spent.”
Intuitive released their first quarter results showing surprisingly high profits and revenue. But Intuitive also narrowed their 2013 revenue projections slightly. The stock market responded with a $21.00 drop in price (4.25%).
In first day of trial in State of Washington, in their opening arguments, lawyers stated their cases: [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 a man to die. [Defendent] that injuries suffered by the obese and medically-troubled patient occurred after the robotic system was unplugged and not in use; the injuries happened after the robotic surgery was completed. Trial details here.
A suit alleging injuries tied to the robot surgery system in a 2008 procedure to remove a patient's prostate claims that the surgeon was not adequately trained and that the results of that lack of training caused mistakes which led to kidney failure, brain damage, permanent incontinence, the need to wear a colostomy bag, and ultimately, heart failure and death.
An attempt by Intuitive to have the case thrown out was denied because the state's product-liability laws require medical-device makers to properly train physicians who buy their products.
There are 12 suits of this type pending trials. But there is also a JAMA article which shows that although the number of robotically assisted procedures is up, their effectiveness is the same as laparoscopic methods but their costs are about $2,000 higher per procedure. However, when reductions in hospital stays and post-recovery work from traditional surgery are added into the mix, robotic surgery is the most cost efficient.
Also, the FDA has initiated an ongoing probe asking surgeons at numerous hospitals to identify complications with the da Vinci machines.