A drug and device manufacturer’s duty to warn is one concept that all pharmaceutical attorneys probably thought they understood. And they were probably right until February 9, 2017, when the Washington Supreme Court ripped the duty wide open – exposing drug and device manufacturers to unprecedented liability.

For those unfamiliar with a drug and device manufacturer’s duty to warn, here are the cliff notes: a manufacturer has a duty to warn prescribing physicians. Those physicians, as learned intermediaries between the manufacturer and the patient, have a duty to provide the warnings to their patients through the informed consent process.

In a surprising departure from this well-settled law, the Washington Supreme Court recently held that a manufacturer has a duty to warn hospitals about the dangers of their products. In Taylor on behalf of Taylor v. Intuitive Surgical, Inc., the plaintiff brought suit against, among others, Intuitive Surgical Inc. (“ISI”), the manufacturer of the da Vinci System, a robotic surgical device used to perform laparoscopic surgeries.

Plaintiff underwent a robotic prostatectomy to treat his prostate cancer using the da Vinci System but suffered complications during the procedure. He eventually filed suit against ISI, claiming that ISI had a duty to warn the hospital about the dangers associated with the da Vinci System. During trial, the court refused to instruct the jury that ISI had a duty to warn the hospital. The jury returned a verdict in favor of ISI, finding that ISI was not negligent in providing warnings or instruction to the physician. Plaintiff appealed, arguing that the court erred in refusing to give his requested jury instruction. The Court of Appeals disagreed and affirmed the verdict. Plaintiff appealed again; this time successfully.

The Washington Supreme Court, reversing the trial court and the Court of Appeals, and relying on the Washington Product Liability Act (“WPLA”), held that “manufacturers have a duty to warn hospitals about the dangers of their products.” The Court, admitting that this duty is not explicitly stated in the text of the WPLA, relied on the language in the WPLA requiring that warnings be provided “with” products. According to the Court, this requires that warnings be provided to the purchaser of the product. In this instance, the purchaser is the hospital. The court further held that the learned intermediary doctrine does not apply here “because it pertains to the manufacturer’s duty to warn only the patient, not the product purchaser.” The Court vacated and remanded the case, finding that the trial court “erred by declining to give the jury an instruction on ISI’s duty to warn” the hospital.

A patient/plaintiff in the State of Washington is now entitled to a jury instruction stating that a manufacturer has a duty to warn a hospital – even when the hospital is not a party to the litigation and had no duty to warn the patient. This is apparently true even in cases, like we have here, where the manufacturer provided thorough warnings and training to a physician; and where the physician properly obtained informed consent from the patient.  Disregarding these traditional safeguards, the Washington Supreme Court will allow a plaintiff to recover from a manufacturer for the manufacturer’s failure to warn a hospital. Does a patient/plaintiff even have standing to recover for this conduct? That is a question that has yet to be answered and that the Washington Supreme Court tacitly (or intentionally) failed to address.

This case promises to have far reaching consequences for drug and device manufacturers. Although it involved complicated and expensive surgical equipment (priced between $600,000 and $2,500,000) that is purchased and maintained by hospitals, the Court’s decision consistently refers broadly to “medical products,” without defining the term. The Court’s decision should be limited to high-cost, complex medical equipment purchased and maintained by a hospital; however, its imprecise language provides an opening for plaintiffs to argue that all “manufacturers of medical products” have a duty to warn hospitals – regardless of the “medical product” at issue. Courts will have to determine who a “purchaser” is when it comes to commonly used “medical products,” like hip and knee implants, surgical mesh, and sutures – products that are commonly stocked by hospitals, but have traditionally fallen within the learned intermediary doctrine. This will be a developing issue that must be monitored by all attorneys working within the pharmaceutical space.