The Core Issue in the Zarick Lawsuit - Zarick Part II
The crux of the suit is a product liability claim that daVinci is defective in design and that ISRG failed to exercise "reasonable care" in designing and commerciallizing the product, and that ISRG did not properly warn of the risks, dangers and adverse side effects. They assert that using monopolar rather than bipolar electrosurgery is a "defect" and that this choice is responsible for avoidable risks and complications. They also allege a failure of "due care" in design of insulation, and failure of adequate pre-clinical testing, "intra-operative surveilance" and post-market studies to identify, fix and warn of the risks and complications.
This is an interesting claim, one that seems to rely completely on the claim that a bipolar electrosurgery mode "should" have been designed rather than a monopolar mode. There are those who claim that bipolar is superior for avoiding certain risks of distant adjacent tissue damage, but monopolar is still the most widely used, and bipolar is unable to produce certain surgical effects. There are a few clinical studies supporting the superiority of bipolar modes, but the majority show no superiority and meta studies have been done that show no superiority.
There is enough support to justify filing the lawsuit. I doubt that ISRG will be able to win a summary judgment to dismiss the suit. But this will not be an easy case to win on the merits. And this explains why they added so many ancillary claims. To win, they must convince the jury that ISRG is a bunch of greedy (and even evil) people who don't care what horrendous damage daVinci does to innocent young women. And that is what they are diligently attempting to get the media to say (with some success, we must admit, with their success with WSJ and Bloomberg).
I rate the likelihood of their winning pretty low, but juries have been bamboozled by even weaker cases in the past.
We use monopolar cautery every day in open and laparoscopic surgery. Bipolar cautery is not commonly used and usually must be used on much lower settings. it is not practical to use bipolar cautery routinely.
That lawsiut sounds absurd and could easlly be shot down by an expert witness- a surgeon.
these are common standard assertions in products liability and medical malpractice cases. the people who make hip joint replacements for example were sued with identical claims. Jury's understand that the result in a particular case is almost random and never guaranteed. large jury verdicts that you read about in the newspaper are famous precisely because they are unusual rather than common. ISRG will survive and thrive