United States: Washington State Creates Device Manufacturer Duty To Warn Hospitals

Last Updated: February 28 2017
Article by Michelle Yeary

A hospital? What is it? It's a big building with patients, but that's not important right now. Airplane, 1980. It's also a big building filled with doctors and that is important right now. Those doctors are learned intermediaries between prescription drug and device manufacturers and the patients. A manufacturer's duty to warn runs to the doctor and it then becomes the doctor's responsibility to use his/her medical expertise to counsel his/her patient and advise the patient of the risks of the recommended treatment, therapy, drug, device, etc. This is drug and device products liability law 101.

Well, now in Washington, device manufacturers (not sure how this will impact prescription drugs) have another duty to warn – the 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). In a bizarre decision, the Washington Supreme Court creates what we believe is a unique, separate duty by device manufacturers to provide warnings to a hospital. Nowhere in the opinion does the court cite any precedent for this alternative warning claim, because there isn't any. They also hold that the learned intermediary doctrine does not apply to this unprecedented duty. And then the court also refused to apply a negligence standard to plaintiff's traditional failure to warn claim under comment k. Surely you can't be serious. I am serious . . . and don't call me Shirley.

The device at issue in Taylor was a robotic surgical device used for laparoscopic surgeries, including prostatectomies such as the one performed on plaintiff. Id. at *3. It is a complex medical device for which the manufacturer requires surgeons undergo training, including performing at least two proctored surgeries before being credentialed to use the system and recommends surgeons choose "simple cases" for their initial unproctored procedures. Id. at *4-5. The manufacturer also specifically warned surgeons not to use the device for prostatectomies on obese patients or on patients who had undergone prior lower abdominal surgeries and advised that the patient should be in a steep head down position during the procedure. Plaintiff Taylor was the first unproctored procedure for his surgeon and his surgeon opted to use the device despite plaintiff being obese and having had prior abdominal surgery. The surgeon also did not place plaintiff in the downward position due to his weight. Id. at *5-6. Plaintiff's surgeon conceded plaintiff was not an optimal candidate for using the device. Id. at *6.

Plaintiff brought suit against the surgeon, the hospital, and the manufacturer, then settled with the surgeon and hospital before trial. At trial against the manufacturer, the jury found the manufacturer was not negligent in providing warnings to the surgeon. Id. at *7-8. As noted above, the warnings seem detailed and clear. On appeal, plaintiff argued that the trial court erred in not instructing the jury that the manufacturer had a duty to warn the purchasing hospital and erred in applying a negligence standard to the failure to warn claim.

The court based its creation of a duty to warn hospitals on its reading of the Washington Products Liability Act ("WPLA") to require manufacturers to warn "purchasers" of dangerous products. The court acknowledges that the WPLA does not "explicitly" state a duty to warn purchasers, but infers such a duty because the WPLA requires that warnings must be provided "with" products. Id. at *11-12. "With" means next to, in the company of, alongside. If anything, "with" is about proximity of location and/or timing of providing the warning. It's not about who the warning goes to. Under Washington state law, for prescription medical products, the warning goes to the doctor. Washington, like every other state, provides that product manufacturers have a duty to warn consumers about risks inherent in their products. In the context of prescription drugs and devices, Washington, like every other state, provides that a manufacturer fulfills that duty by providing adequate warnings to physicians who are the learned intermediaries between manufacturers and patients. And while hospitals may have an independent duty of care to patients, id. at *13, the hospital is not involved in the decision to use or prescribe any particular drug or device with any particular patient. (We recognize exceptions apply to certain treatments which require hospital approval, but that is not the norm and not the situation presented by this case). That decision rests with the physician. Which is why even if the WPLA could be read to require a separate warning to the hospital as the purchaser of the device, as to the plaintiff, the surgeon remains an intermediary. The learned intermediary doctrine isn't about who paid for the product or who has possession of the product – it's based on a recognition that doctors are in the best position to convey warnings to their patients about prescription drugs and devices.

The court also seems to lose focus on what duty is at issue. It is the duty owed to the plaintiff to be warned about the risks of the device. That duty is satisfied by warning plaintiff's doctor. That duty is the only duty at issue in a suit brought by a patient against a manufacturer. This unprecedented duty to warn the hospital is at best a duty owed to the hospital, not the plaintiff. See dissent, id. at *37 (Plaintiff Taylor has no claim to enforce a duty owed by manufacturer to hospital).

Creation of a duty to warn hospitals raises another question for us at least in Washington. Prescription drug/device manufacturers have a duty to warn doctors under the learned intermediary rule. Washington is one of the few states in the country that allows doctors to sue for reputational and expense damages caused by defective drugs/devices.  So if there is a duty to warn hospitals, does that mean that hospitals can bring the same kind of suits against our clients? We'll have to think about that some more.

And that brings us to the court's second unsupported ruling – refusing to apply a negligence standard to plaintiff's failure to warn claim under comment k. The court claimed it didn't have to, but it should be noted that it has in every previous case. In discussing those prior cases, the court had to re-characterize the holdings or point to dictum to reach its result. Id. at *26-28. The court reasoned that it was strictly applying comment k because comment k says it provides an exception to strict liability when a proper warning is given. So, the question of whether the manufacturer properly warned must first be assessed under a strict liability standard before the comment k exception can be applied. The court said that to apply a negligence standard before determining whether the exception applies, "would allow the exception to swallow the rule." Id. at *25-26. But think about what this ruling does. It applies strict liability to the failure to warn claim to determine whether negligence should be applied to the failure to warn claim. It makes no sense.

What does make sense is that for prescription drug and device products, comment k provides a negligence standard. For drugs and devices, the question is whether the manufacturer failed to warn doctors about risks it knew or should have known about. That "rings of negligence." Rogers v. Miles Labs., Inc., 802 P.2d 1346 (Wash. S.Ct. 1991). The negligence standard is built in to the very issue to be decided – did the manufacturer act reasonably given its state of knowledge about the risks of its unavoidably unsafe product. We thinks it's clear and the courts in Washington up until now have thought that it was clear. So we think this is departure for this court, and one we'll have to watch closely. Looks like I picked the wrong week to quit sniffing glue.

This article is presented for informational purposes only and is not intended to constitute legal advice.

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