Duty To Warn – New Rules To Impact Medical Device Manufacturers

A recent decision in the Supreme Court of the State of Washington may have changed the procedural landscape for medical device manufacturers.

Taylor v. Intuitive Surgical Inc, was a case centered around a medical device manufacturer, Intuitive Surgical, Inc. (“Intuitive”) which sold a medical device used in laparoscopic surgeries, known as the da Vinci System robotic device, to Harrison Medical Center (“Harrison). Harrison credentialed some of its physicians to perform surgery with the device. Experts testified at trial that even a skilled surgeon would have to perform between 150 to 250 procedures with the da Vinci System before being able to operate the system successfully. Intuitive required that operating doctors perform two proctored surgeries with the device but hospitals were permitted to impose their own training requirements prior to credentialing.

However, Intuitive’s warning practices were called into question during the case. More specifically, whether Intuitive owed a duty to warn Harrison that purchased the device as opposed to only owing a duty to the doctors.

Intuitive issued various warnings to users of the device, including:

• Advising surgeons not to perform prostatectomies on obese patients (Body Mass Index of less than 30);
• Advising surgeons not to perform prostate procedures on patients who have already undergone surgeries on their lower abdomen; and
• Advising surgeons that it was unsafe for a patient to be in a tilted, head down, position during a procedure.

However, the surgeon who performed a prostatectomy on the plaintiff did so while the plaintiff had a body mass index of 39. Additionally, the plaintiff had previously undergone three lower abdominal surgeries. The plaintiff suffered complications because of the surgeon’s decisions to go against Intuitive’s warnings.

Intuitive argued that since it warned the doctor who performed the actual surgery, it did not have a duty to warn Harrison and the trial court agreed, finding that Intuitive was not negligent in providing warnings to the operating physician.

The plaintiff appealed, claiming that the trial court erred by failing to instruct the jury that Intuitive had a duty to warn Harrison. However, the appeals court did not agree and found that the trial court applied a negligence standard to the claim of an inadequate warning. Washington’s Supreme Court ruled differently.

The court found that Intuitive did indeed owe a duty to warn Harrison because it was the hospital that was the purchaser of the device, not the doctor. The Court referenced the Washington Product Liability Act which required device manufacturers to warn purchasers about their dangerous medical devices. The court reasoned that such a warning allows hospitals to properly credential the operating doctors and to provide optimal care for patients.

As a result, the court created a new duty to warn hospitals in addition to the operating physicians.

Medical malpractice can have devastating effects that last a lifetime. If you have been injured by a physician’s neglect, attorneys Charles Gilman and Briggs Bedigian will work to get you the full compensation to which you are entitled. Call 866-849-9899 today or contact them online for a free case evaluation. They handle cases in Maryland, Pennsylvania, and Washington, D.C.