Intuitive Surgical facing lawsuits, reports of death and injury
–Since the da Vinci surgical robot received FDA approval in 2000, Intuitive’s devices — which are operated by a surgeon using joysticks, foot pedals and a 3-D viewer — have propelled the firm to a $35 billion valuation and world dominance in robot-aided surgery. But the legal claims that have come with Intuitive’s success showcase the serious risks that accompany the rewards new medical technology can bring.
Any kind of surgery carries risk: In high-income countries such as the United States, post-operative complications occur in up to 20 percent of all surgery patients, according to the U.S. National Institutes of Health. Proponents say the benefits of da Vinci systems are clear: They can be more precisely controlled, need smaller incisions, and lead to less blood loss and quicker recoveries.
In a 2014 regulatory filing, Intuitive said it was facing 3,000 product-liability claims over surgeries taking place between 2004 and 2013 when its robots performed about 1.7 million procedures. The firm set aside $67 million to settle an undisclosed number of claims. Many of the early claims related to device components that ended up being recalled by Intuitive. Product liability claims can allow consumers alleging harm to negotiate a settlement with a company without filing a lawsuit and Intuitive notes that such claims are “inherent to the medical device industry.” Its da Vinci machines have been used in more than 4 million operations.
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