OLYMPIA, Wash. (Legal Newsline) - Washington state’s Supreme Court earlier this month ruled that under the state’s product liability laws, manufacturers have a duty to warn hospitals, not just physicians, about the dangers of their medical devices.

In Taylor v. Intuitive Surgical Inc., the state’s high court said the trial court failed to instruct the jury that the manufacturer had a duty to warn the hospital that purchased the device at issue.

The high court found that the trial court erred, and vacated the defense verdict and remanded the case for trial.

According to the Feb. 9 majority opinion, written by Justice Susan Owens, manufacturers have a duty to provide warnings to consumers about the risks of their products under the state’s Product Liability Act, or WPLA.

In this case, the court was asked to decide whether the manufacturer owed a duty to warn the hospital that purchased the device. The company, Intuitive Surgical, contends that since it warned the physician who performed the surgery -- Dr. Scott Bildsten -- it had no duty to warn any other party.

“We disagree because the doctor is often not the product purchaser,” Owens explained in the 31-page opinion. “We find that the WPLA requires manufacturers to warn purchasers about their dangerous medical devices.

“Hospitals need these warnings to credential the operating physicians and to provide optimal care for patients.”

Intuitive is the manufacturer of a robotic surgical device called the “da Vinci System,” which surgeons use to perform laparoscopic surgeries. Intuitive manufactures and markets the da Vinci System to medical centers, including Harrison Medical Center, which purchased the device in this case.

The device is used for robotic laparoscopic surgeries, which are minimally invasive because surgeons remotely operate on the person by inserting the robotic instruments into the patient through small incisions.

After receiving informed consent, Bildsten performed a robotic prostatectomy on plaintiff Fred Taylor to treat his prostate cancer using the da Vinci System on Sept. 9, 2008.

Taylor, who was not in good health ahead of the surgery, according to the court’s opinion, suffered various complications from the procedure, which a doctor testified led to his death four years later.

Taylor filed a lawsuit against Bildsten, partner Dr. John Hedges and Harrison Medical Center a year after his surgery. He later added Intuitive.

After he died, his wife, Josette Taylor, proceeded with the lawsuit as personal representative of his estate.

Before trial, Josette Taylor settled with Bildsten, Hedges, their private practice and the hospital. Intuitive was the only remaining defendant.

Josette Taylor proceeded against Intuitive for claims of product defect, breach of warranty, breach of contract, violation of the state’s Consumer Protection Act, negligence and product liability under WPLA.

The trial court granted summary judgment in favor of Intuitive on all claims, except for Taylor’s failure to warn claim under the WPLA.

“Since the product is owned and maintained by the purchasing hospital, it follows from the text of the statute that the purchaser is owed product warnings with the product it purchases,” Owens wrote for the majority.

“Especially here, where the product is an extremely complex and inherently dangerous medical device, it is logical that hospitals would need warnings.”

The Washington State Hospital Association, which filed an amicus brief in support of Intuitive, argued the hospital is not in the best position to determine what procedure should be performed.

“However, just because the physician is in the best position to make a decision regarding a patient’s treatment, the hospital is not completely absent from the process,” Owens wrote.

And while the hospital, as an entity, did not have a one-on-one relationship with Taylor -- Bildsten did -- the court said hospitals must maintain a “high standard of care” for the benefit of their patients.

“As it pertains to the da Vinci System, hospital personnel are actively involved in credentialing doctors to use the device,” Owens noted in the opinion. “The hospital simply cannot maintain the high standard that the law requires by excusing manufacturers from the duty to provide them information about devices that they own. Knowing the risks of the da Vinci System is necessary in order to allow hospitals to impose stricter credentialing processes as needed.

“Certainly an airplane manufacturer does not only supply a user’s manual to the pilots -- the airline owner needs a copy as well. It is in the best interest of all parties for warnings to be provided, but particularly for patients, who trust that their safety is a priority.”

Chief Justice Barbara Madsen, in her dissent, said she agreed with the majority that strict liability governs inadequate warning claims on dangerous medical products and that Intuitive had a duty to warn Harrison Medical Center of the dangers of the da Vinci System when the hospital purchased the device.

However, she contends that even though the duty exists, it is not a duty that was “owed” to the petitioner in this case.

“Therefore, the trial court did not err by not instructing the jury on lSI’s duty to warn Harrison,” Madsen wrote.

She continued, “Here, lSI would owe this duty to Harrison. So if lSI breached this duty, Harrison would presumably have a claim against lSI. But Taylor has no claim to enforce a duty owed to another. Taylor cannot invoke a duty owed to Harrison to recover damages from lSI.”

Simply put, Taylor cannot recover for an alleged breach of a duty that was owed to another, Madsen said.

From Legal Newsline: Reach Jessica Karmasek by email at jessica@legalnewsline.com.

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