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Court Rules Medical Device Maker Had Duty to Warn Hospital

The Washington Supreme Court recently ruled that medical device manufacturers have a duty to warn hospitals about any risks associated with their products. While the decision is not binding in this state, California courts often look to the decisions of their sister courts when addressing novel issues of law.

Medical device manufacturers have a duty to warn doctors of any known risks associated with their device. The rationale behind the duty is that physicians should understand the risks associated with the product and be able to make an informed decision regarding whether to use it. Doctors then have a duty to warn patients of any risks associated with the device so they can also make an informed decision. When either the manufacturer or the doctor neglect to provide the proper warnings and the failure results in injury, the patient may have a product liability claim.

The Washington lawsuit, Taylor v. Intuitive Surgical Inc., involved whether a medical device manufacturer owed a duty to warn the hospital that purchased the device. The suit involved a robotic surgical device known as the "da Vinci System," which surgeons across the country use to perform robot-assisted laparoscopic surgeries. The victim in the case, Fred Taylor, suffered serious complications after undergoing prostate surgery using the device. He died four years later. According to court documents, Taylor "was not an optimal candidate" for using the robotic device due to his weight and prior abdominal surgeries. Nonetheless, Taylor was the doctor’s first surgical patient using the medical device.

In the medical product liability lawsuit that followed, the manufacturer argued that since it warned the physician who performed the surgery, it had fulfilled its legal obligation. Washington’s highest court disagreed. Because the doctor is often not the product purchaser, the Washington Supreme Court held that medical device makers must also warn hospitals.

“Hospitals need these warnings to credential the operating physicians and to provide optimal care for patients. In this case, the trial court did not instruct the jury that the manufacturer had a duty to warn the hospital that purchased the device. Consequently, we find that the trial court erred.”

The Washington Supreme Court appears to be the first to impose such a duty. As California product liability lawyers, we will continue to monitor this legal development.

If you or someone you love has suffered serious harm due to a defective medical device, don’t hesitate to contact a San Diego product liability lawyer at the Law Offices of Robert Vaage for a free consultation.