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February 20th

Will More States Require Device Makers to Warn Hospitals?

  • Judicial
  • Robotics/AI

Bloomberg BNA - Courts in other states are expected to follow a recent Washington Supreme Court decision holding that medical device makers must give product warnings to hospitals, an attorney for the plaintiff says ( Taylor v. Intuitive Surgical, Inc. , 2017 BL 39492, Wash., No. 92210-1, 2/9/17 ).

“You’re going to see more courts going this way,” said the lead trial counsel for the widow of a man who died several years after a procedure involving a robotic device made by Intuitive Surgical, Inc.

It may take a few years for the next cases to work their way through state court systems, Richard Friedman told Bloomberg BNA. But “in 20 years, it will be well-established everywhere,” he said.

The decision probably opens up a new avenue for injured patients to sue medical device makers, Friedman, of Friedman Rubin in Bremerton, Wash., said.

Before this ruling, there was little or no law addressing warning obligations owed to hospitals, and this type of claim wasn’t often made, he said.

But an attorney who filed a brief in support of Intuitive SurgicaI on behalf of product makers criticized the Washington State top court ruling and downplayed its expected impact.

The decision doesn’t make sense legally, and could result in hospitals being put in a position that interferes with the doctor-patient relationship, said Phil Goldberg, who represents the Medical Device Manufacturers Association and the National Association of Manufacturers.

Goldberg, of Shook, Hardy & Bacon LLP in Washington, D.C., also told Bloomberg BNA the decision likely won’t be replicated elsewhere.

Washington Law Requires Warning

The Washington Product Liability Act requires medical device makers to warn purchasing hospitals—not just doctors—about the risks of their products, the court said Feb. 9.

“Hospitals cannot meet their own duty to patients without knowing the risks of the dangerous medical products they own,” the court said.

The court rejected Intuitive Surgical’s argument that a manufacturer’s duty to warn the hospital is met by providing warnings to the doctor who actually uses the product.

The “learned intermediary” doctrine doesn’t apply here, because Washington law imposes a separate duty on the manufacturer to warn the device purchaser, the court said.

In dissent, Chief Justice Barbara A. Madsen agreed that Intuitive Surgical had a duty to warn Harrison Medical Center of the dangers of the da Vinci robotic system.

But the plaintiff in this case shouldn’t be allowed to invoke the duty owed to the hospital to recover damages from Intuitive Surgical, Madsen said.

‘Unique’ Ruling

A prominent defense attorney agreed about the novelty of the new ruling.

“The decision is unique as far as I can tell,” according to James M. Beck of Reed Smith in Philadelphia, a co-founder of the Drug and Device Law blog.

“No other state has created a separate duty to warn hospitals where adequate warnings are provided to the treating doctor,” said Beck, who filed an amicus brief on another issue raised in the suit on behalf of the Product Liability Advisory Council, a group of defense attorneys.

The decision also could mean new claims against hospitals by patients.

“This may be the opening salvo in creating a separate and independent duty to warn owed by a hospital to a patient concerning the risks of products used in surgery,” Beck told Bloomberg BNA.

“That would also be unique, as the overwhelming majority rule is that informed consent is a duty owed by doctors, not hospitals,” said Beck.

Possible ‘Chill’ in New Products Cited

But both the Medical Device Manufacturers Association and the National Association of Manufacturers cautioned that adopting a new warning requirement could chill medical innovation and harm patients overall.

The industry groups, in a brief filed with the Washington Supreme Court before it handed down its decision, said that, if allowed to proceed, the “novel” liability theories asserted in the suit could make it more risky for device manufacturers to introduce new products.

The groups also argued that, although a hospital may purchase medical devices for use by its physicians, it’s the physician who is responsible for determining whether and how to use a device on a particular patient.

“If there is a separate duty owed to the hospital, that isn’t a duty that should flow through to the patient,” Goldberg, one of the attorneys on the product makers’ brief, told Bloomberg BNA. “If the hospital wants to say it wasn’t warned, that’s on the hospital.”

Minimally Invasive Procedures

Here, Josette Taylor filed suit after her husband, Fred, died several years after a robotic procedure that went poorly.

The suit involved the da Vinci robot, a sophisticated robotic surgery system manufactured by Intuitive Surgical.

The da Vinci system is designed for minimally invasive procedures. A surgeon uses a console to remotely control robotic arms that operate on the patient through small incisions.

Taylor settled with the hospital and doctor, proceeding to trial solely against Intuitive Surgical for failure to provide adequate warnings regarding the device.

The jury returned a verdict for Intuitive Surgical, and Taylor appealed.

The state’s top court said the trial court erred by not instructing the jury that Intuitive Surgical had a duty to warn the hospital about the da Vinci’s risks.

The court rejected Intuitive Surgical’s argument that it satisfied its obligations by warning the operating physician.

The doctor isn’t typically the purchaser, the court said. Hospitals need warnings to credential their surgeons and to provide optimal patient care.

Law and Medicine

“This is an important ruling, which brings the law in line with the reality of modern medicine,” said Friedman, the plaintiff’s attorney.

“As complex and expensive medical devices play a larger and larger role in health care, the companies profiting from selling these devices need to be responsible for warning the purchaser—the hospital,” he said.

Given the court’s rationale, the decision may only apply in the case of complex medical devices for which a separate physician credentialing process exists, although nothing in the decision explicitly says so, Beck said.

But trial courts will have to figure out what exactly a duty to warn a hospital entails, without placing a hospital in a position to interfere with the doctor/patient relationship, Goldberg said.

“It doesn’t make sense for a hospital to interfere,” he said.

No Big Logical Leap

Friedman said although it’s “a big deal” that Washington’s top court said device makers must warn hospitals, “it’s not a huge logical leap.”

The decision was based on well-settled principles of tort law—that manufacturers have a duty to warn consumers, he said.

Here, the hospital is the purchaser—the consumer, he said.

Manufacturers typically argue that they have no duty to warn the hospital, and try to blame the doctor and/or the hospital for anything that goes wrong, Friedman said.

Training Procedures

As part of its training procedures, Intuitive Surgical requires surgeons to perform two proctored surgeries, but hospitals enforce their own requirements for allowing surgeons to use the da Vinci system, the court said.

Intuitive Surgical provided a user’s manual to doctors, containing various warnings related to the device, it said.

The doctor who performed Taylor’s surgery did so even though he knew Taylor wasn’t an optimal candidate, it said.

The new trial will differ from the first trial, Friedman said.

On retrial, when Intuitive Surgical “attempts to blame the doctor, we will say ‘that’s right, and if you had properly informed and warned the hospital, this doctor would not have been allowed by the hospital to use the robot for this operation,’” Friedman said

“It will be easy for the jury to see the failure to warn the hospital.”

Intuitive Surgical spokesman Jim McGrath said he couldn’t comment on legal strategy.

But he said that the “Washington Supreme Court fails to note in its ruling that Intuitive Surgical presented evidence at trial showing that, consistent with our usual practice, we delivered the hospital’s da Vinci System with the user manual, which includes warnings and precautions about the device.”

Justice Susan Owens wrote the 6-1 opinion.

Image Credit: Pixabay