Product Liability -- 2017



Taylor v. Intuitive Surgical, Inc.   (Washington State Supreme Court)

Learned intermediary duty to warn

This case involves Intuitive Surgical's duty to warn about risks from its robotic surgical device call the "da Vinci System," used for laparoscopic surgeries. The intermediate appeals court ruled that the company did not need to notify the hospital that bought its device about risks, but that it properly notified the doctor who used it. The patient's estate appealed to the Washington Supreme Court.

The NAM filed an amicus brief arguing against expanding the learned intermediary duty to warn. Plaintiffs want manufacturers to warn not only the physician, but also the hospitals, and want liability against the manufacturer when a doctor makes a mistake while using the manufacturer’s medical device. Our brief argued that not only is that outside the scope of the health care rules, it’s out of line with the rest of the country, and that there are strong policy reasons to reject the plaintiff’s theory.

On Feb. 9, 2017, the Washington Supreme Court ruled against the company. If said that the company has a duty to warn the hospital as that bought the device, as well as the doctor who used it. If found that a Washington law requires warnings "with the product," meaning when delivered to the hospital, and that the learned intermediary doctrine only applies to warnings that are owed to patients, not hospitals.

The ruling expands the liability for medical device manufacturers, who will now need to expand their efforts to warn about risks to hospitals as well as physicians.


Related Documents:
NAM amicus brief  (April 22, 2016)

 


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