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Medical Device Manufacturers: Duty to Warn Not Satisfied by Warning Doctors

February 16, 2017

Overview

In a case of first impression, Washington’s Supreme Court recently ruled that medical device manufacturers owe an independent duty to warn the hospital that purchased the device. See Taylor v. Intuitive Surgical, Inc., 2017 Wash. LEXIS 200 (Wash. S.Ct. Feb. 9, 2017).  This duty to warn is in addition to the medical device manufacturers’ duty to warn the physician who actually uses the device.  The Washington Supreme Court found that the Washington Product Liability Act (“WPLA”), RCW 7.72 et seq., requires medical device manufacturers to warn the product purchaser, which, in the case of medical devices, will often be hospitals or medical facilities.  And, surprisingly, the Court ruled that the learned intermediary doctrine does not apply in this circumstance.  This decision is clearly a detour from the prior general understanding of a manufacturer’s duty to warn in these situations.

Taylor underwent a surgery to treat prostate cancer at Harrison Medical Center during which his physician used a robotic surgical device called the “da Vinci System.” Taylor suffered complications during surgery, and following the surgery, his quality of life was poor.  He died four years later, and a physician testified that his death was hastened by the surgical complications.

The da Vinci System was manufactured by Intuitive Surgical, Inc. (“ISI”). It is a complex medical device, and it must be used by a trained, experienced surgeon.  Each physician must undergo training from ISI, including two proctored surgeries using the device.  In addition, ISI provided a user’s manual to physicians that contained various warnings related to the device’s use.  Each hospital determines its own credentialing process.  Harrison Medical Center purchased the da Vinci System, and provided credentials after a physician performed the two proctored surgeries.

The Washington Supreme Court was asked to decide whether the medical device manufacturer owed a duty to warn the hospital that purchased the da Vinci System. The Court ruled it did in a seeming departure from traditional product liability law.  The Court relied upon the following language of the WPLA: “[a] product is not reasonably safe because adequate warning or instruction were not provided with the product…”  (Emphasis in original.) (Citing RCW 7.72.030(1).)  Relying on the phrase “with the product,” the Court determined the statute requires a manufacturer to provide the warning to the purchaser of the product—which here was the hospital.

The medical device manufacturer’s duty to warn was not satisfied by warning the doctor. The Court found that the manufacturer also had a duty to warn the hospital as the product purchaser.  Pointing out that hospitals owe certain duties to patients, the Court reasoned that the hospital also needed to know the dangers associated with the products it purchased so that it can design its credentialing process.  The Court noted “where the product is an extremely complex and inherently dangerous medical device, it is logical that hospitals would need warnings.”  The Court’s decision was based squarely on the text of the WPLA, and held that the “manufacturer’s duty to warn hospitals is embedded in the text of the WPLA itself.”

In another surprising turn, the Court ruled that the learned intermediary doctrine did not apply. Traditionally, manufacturers of medical devices and pharmaceuticals could satisfy their duty to warn by delivering adequate warnings to the physician.  Not so any longer in Washington.  The Court rejected application of the learned intermediary doctrine “because the WPLA imposes a separate and distinct duty for the manufacturer to provide warnings to the purchaser of the product.”  It ruled that the physician is not a learned intermediary between the manufacturer and the hospital.  According to the Court, hospitals cannot fulfill their duties to patients without knowing the risks associated with the products it purchased.  

The Court’s reasoning related to the learned intermediary doctrine will likely leave many scratching their heads. In the context of prescription drugs, a manufacturer can discharge its duty to warn consumers about the risks associated with its drugs because the physician is responsible for and in the best position to pass those warnings onto the patient.  Likewise, with medical devices, a device manufacturer should be able to discharge its duty to warn (here, the purchaser) by warning the physician because the physician is best able to determine the device’s benefits and risks for a particular patient.  Instead, the Washington Supreme Court held:

Since the learned intermediary doctrine underscores the importance of patient safety, it would be illogical if the doctrine was used to excuse another avenue to achieve that goal. If patient safety is the goal, then it requires all hands on deck. While doctors are recognized as the gatekeepers between the manufacturer and the patient, the hospital is the gatekeeper between the physician and the use of the da Vinci System since the hospital clears surgeons to use it.  Thus, the hospital must have warnings about its risks and no tort doctrine should excuse the manufacturer from providing them.

The opinion was signed on to by six justices, with three dissenting. While the dissent agreed that the WPLA requires manufacturers to warn purchasers of the dangers of their products, it disagreed that the claimant could invoke the duty owed to the hospital.  It noted that if the device manufacturer breached this duty, the hospital could have a claim against the manufacturer, not the claimant.

This ruling will impact the way medical device manufacturers operate in Washington. The opinion creates an obligation for medical device manufacturers to warn not only physicians as to the risks of the devices, but also hospitals or medical facilities that use the devices.  It also sounds a warning bell for the future of the learned intermediary doctrine in Washington.

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