Though a number of companies manufacture and sell surgical robots in the United States, Intuitive Surgical has been the primary target of product liability lawsuits in recent years. Around 100 such claims have already been filed and at least 700 more are believed to have been placed on the back burner pursuant to a tolling agreement with some plaintiffs’ counsel. To date, only two product liability cases against Intuitive have gone to trial. The jury returned a defense verdict in the first case and the second was settled while the jury was deliberating. These cases serve as a great source of important takeaways for other companies that are either currently selling surgical robots in the United States, or are considering doing so.
One of the issues debated in these cases was surgeon training. Though plaintiffs frequently bring up purported training deficiencies, in my experience those arguments generally do not often carry very much weight with jurors. However, emerging technologies, like robotic surgery, present a unique context in which training may take on added importance.
One takeaway regarding training program design and implementation that can be drawn from the Intuitive litigation and recent trends in the surgical robot space concerns the use of independent educational firms. Several court filings referenced Intuitive’s representations to the FDA that the company would partner with Medical Education Training Associates (“META”) to evaluate physician learning needs and develop and refine its learning curriculum. Intuitive, however, apparently did not do so. Instead, the company contracted META only to assist with sales-related training.
Given the jury’s ultimate ruling in favor of the defense, it seems that they did not hold this fact against Intuitive. That does not mean, however, that surgical robot manufacturers would not benefit from entering into such partnerships with independent educational firms when designing training programs.
For example, not only would such a partnership benefit prospective patients, but the addition of independent input to a company’s learning curriculum could lend it added credibility. Going above and beyond the minimum statutory and regulatory requirements may also earn the company some favor with judges and jurors. Finally, by teaming up with an independent educational firm, a robotic surgery company might increase its chances of securing a third-party source from which to obtain a defense and indemnification, or with which to share liability, in the event of litigation.
While this is by no means an exhaustive list of the benefits of partnering with an independent educational firm to evaluate physician learning needs and develop and refine a company’s learning curriculum, it highlights some of the most obvious reasons for doing so. Ultimately, though, it’s up to each company to decide whether such a conservative approach makes sense given its respective business priorities.