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Medical Device Manufacturers Have Duty to Warn Hospitals


The manufacturer of a robotic surgical device for laparoscopic surgeries required that surgeons perform two supervised surgeries as part of training on the device. The manufacturer provided to doctors a user’s manual that contained various warnings related to the device. The manufacturer advised surgeons not to perform prostatectomies on obese men. The manufacturer stated patients should have a body mass index (BMI) of less than 30. The manufacturer also advised doctors not to perform prostate procedures on men who previously underwent lower abdominal surgeries. Finally, the manufacturer warned that it was unsafe for the patient not to be in a steep Trendelenburg position (tilted with head downward) during the procedure.

 

A surgeon had 15 years of experience performing open prostatectomies, having performed between 80 and 100 such procedures. He was also experienced with hand-assisted laparoscopic procedures, in which the surgeon operates with one hand outside of the patient’s body and the other hand assisting the instruments inside of the body. The surgeon had performed two supervised robotic prostatectomies before performing his first unsupervised procedure.

 

The surgeon performed his first unsupervised robotic prostatectomy on a 280 pound man with a BMI of 39. The man had undergone three prior lower abdominal surgeries. During the surgery, the surgeon did not position the man in the steep Trendelenburg position due to his weight.

 

During the surgery, the man suffered complications. The surgeon became aware that the man’s rectal wall was lacerated and converted the procedure to an open surgery. Another surgeon came in to fix the rectal tear.

 

The man’s quality of life was poor after the surgery. The man suffered respiratory failure requiring ventilation, renal failure, and infection. The man was incontinent and had to wear a colostomy bag. The man also suffered neuromuscular damage and could no longer walk without assistance. Approximately four years after the surgery, the man died.

 

A year after the surgery, the man sued the surgeon, his medical practice, the hospital, and the manufacturer. After the man died, the estate proceeded with the lawsuit. Prior to trial, the state settled with the surgeon, his medical practice, and the hospital. The case proceeded against the manufacturer for claims of product defect, breach of warranty, breach of contract, violation of Washington’s Consumer Protection Act (ch. 19.86 RCW), negligence, and product liability under the Washington Product Liability Act (WPLA) (ch. 7.72 RCW). The Superior Court of Washington, Kitsap County, granted summary judgment in favor of the manufacturer on all claims except for the failure to warn claim under the WPLA.

 

At trial, the estate’s expert testified that the procedure’s complications hastened the man’s death. The manufacturer’s expert told the jury that in his opinion the surgeon was negligent in performing the man’s surgery.

 

The jury returned a verdict in favor of the manufacturer. Specifically, the jury found that the manufacturer was not negligent in providing warnings or instruction to the surgeon.

 

The Court of Appeals of Washington, Division 2, affirmed. The appellate court held that the trial court did not err because the manufacturer failed its duty to warn by warning the surgeon.

 

The Supreme Court of Washington reversed. The court held that Washington law imposes a duty on manufacturers of medical devices to warn hospitals about the products’ dangers and the learned intermediary doctrine was not applicable.

 

Washington law imposes a duty on manufacturers of medical devices to warn hospitals about the products’ dangers. The court reasoned that although the text of the statute does not specify to whom warnings should be provided, the statute requires that warnings be provided with products, and, as the medical device was owned and maintained by the purchasing hospital, it followed that the hospital was owed product warnings with the product it purchased. The hospital had a credentialing process clearing doctors to use the robotic surgical device; it follows that the hospital needed product warnings in order to design a credentialing process that would keep patients as safe as possible. The manufacturer’s duty to warn purchasing hospitals is not excused when a manufacturer warns doctors who use the devices because hospitals need to be informed of the dangers of their own products, which cannot be accomplished simply by the manufacturer’s warnings to the doctor who uses the product. The trial court erred in failing to instruct the jury that the manufacturer had a duty to warn the hospital that purchased the device.

 

The learned intermediary doctrine was not applicable. The manufacturer’s duty to warn the hospital was not met by providing warnings to the doctor using the product. Under the learned intermediary doctrine, manufacturers of medical products can satisfy their duty to warn patients of the risks of their products by providing those warnings to the doctors prescribing the products. Washington’s law imposed a duty for the manufacturer to provide warnings to the purchaser of the product, separate and distinct from the manufacturer’s duty to warn doctors. The doctor is not a learned intermediary between the manufacturer and the hospital. Hospitals have an independent duty to ensure a device is used safely and can meet that duty only if they are informed of the risks of using the device.

 

The Supreme Court of Washington reversed the trial court’s entry of judgment in favor of the medical device manufacturer.

 

See: Taylor v. Intuitive Surgical, Inc., 2017 WL 532497 (Wash., February 9, 2017) (not designated for publication).

 

See also Medical Law Perspectives, October 2015 Report: Unclean, Unsterile, Unsafe: Risks of Injury from Unsterilized Medical Equipment

 

See also Medical Law Perspectives, June 2014 Report: Physician and Manufacturer Risks for Pain Pump Injuries: Malpractice, Negligence, and Products Liability

 

See also Medical Law Perspectives, April 2012 Report: Using Medical Devices Off-Label: False Claims, Overpromotion, Malpractice, and Other Dangerous 

 

 

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