Death and taxes are unavoidable. And if you create a popular product, so too are product liability lawsuits. In my practice, companies sometimes ask, “How soon after our surgical robot hits the market will we get sued?”
Though it is usually impossible to predict exactly when a company will get sued, reasonable assumptions can be drawn by looking at other companies’ experiences. Intuitive Surgical is arguably the leading surgical robot manufacturer in the United States. And its experience in this space is instructive. Intuitive started marketing its da Vinci surgical robot in 2000. According to the company’s regulatory filings, it was first sued for product liability in the second quarter of 2003. By then, Intuitive had sold 210 da Vinci systems and surgeons using the technology had successfully completed thousands of operations in major hospitals throughout the world.
By 2012, Intuitive noticed an uptick in the number of plaintiff’s lawyers seeking da Vinci patients. In its 2013 regulatory filings, the company noted: “We are aware of increasing efforts by plaintiff’s attorneys to solicit da Vinci patients for product liability lawsuits against the Company. The Company cannot yet estimate the impact of these solicitations.” By 2013, the da Vinci installed base had grown to 1,878 units in the United States, 416 in Europe, and 291 in the rest of the world. And the company estimated that its technology had been used in approximately 450,000 surgical procedures of various types in hospitals throughout the world. Shortly thereafter, Intuitive began receiving a large influx of claims and product liability lawsuits in the United States. As of the company’s last regulatory filings, it remains named as a defendant in numerous individual product liability lawsuits filed in various state and federal courts.
Several assumptions can be drawn from Intuitive’s experience. Once a new device exceeds the 100-200 unit installed base threshold and is used in thousands of yearly procedures, product liability litigation is likely to follow. As the device gains popularity, plaintiff’s lawyers will take notice and ramp up patient recruitment efforts. By the time the installed base crosses 1,500 units and yearly procedures reach the 400,000 mark, significant legal action alleging design and warning defects may be threatened or pending.
With that said, it is important to keep in mind that Intuitive’s experience was impacted by some adverse regulatory activity and product recalls, which likely increased the number of claims. It is also worth noting that through their work on the Intuitive litigation, the plaintiff’s bar have learned important lessons and developed strategies and work product that they can repurpose and apply to new claims against new robot manufacturers. This could reduce the time-frame necessary for gearing up and filing new claims.
To lessen their exposure, companies should not wait until the first lawsuits are filed. They should be proactive, and engage experienced legal counsel during the pre-market development phase in order to identify, assess, and mitigate future risks.