In its opinion filed on February 9, 2017, the Supreme Court of the State of Washington (“Washington Supreme Court”) stated, “Manufacturers have a duty to provide warnings to consumers about the risks of their products pursuant to the Washington product liability act (“WPLA”), chapter 7.72 RCW. In this case, a manufacturer sold a surgical device to a hospital, which credentialed some of its physicians to perform surgery with the device. The manufacturer’s warnings regarding that device are at the heart of this case. We are asked to decide whether the manufacturer owed a duty to warn the hospital that purchased the device.”
The Washington Supreme Court stated, “The manufacturer argues that since it warned the physician who performed the surgery, it had no duty to warn any other party. We disagree because the doctor is often not the product purchaser. 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. In this case, the trial court did not instruct the jury that the manufacturer had a duty to warn the hospital that purchased the device. Consequently, we find that the trial court erred. We vacate the defense verdict and remand for retrial.”
According to the Washington Supreme Court’s written opinion:
Intuitive Surgical Inc. (“ISI”) is the manufacturer of a robotic surgical device called the “da Vinci Surgical System,” which surgeons use to perform laparoscopic surgeries. ISI manufactures and markets the da Vinci Surgical System robotic device to medical centers, including Harrison Medical Center, which purchased the device. 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. Since laparoscopic procedures use small incisions through the skin, the recovery times are much shorter and the surgeries result in fewer complications than alternative methods.
Presently, the da Vinci Surgical System is used in about 84% of prostatectomies in the United States. The da Vinci Surgical System was used for the first time in 1997. In 2000, the United States Food and Drug Administration (“FDA”) cleared the da Vinci Surgical System for certain surgeries, and it was cleared for prostatectomies in 2001. The da Vinci Surgical System is not used on a patient unless a physician allows for its use. Even with expertise in open surgery, a skilled surgeon would still need training and experience to operate the da Vinci Surgical System successfully, and confidence with the device is not achieved until a surgeon has completed 150 to 250 procedures.
As part of its training, ISI requires that surgeons perform two proctored surgeries, but hospitals enforce their own requirements for credentialing surgeons to use the da Vinci Surgical System. Harrison Medical Center provided credentials after those two proctored procedures while other hospitals in Washington provided credentials after three or four proctored surgeries.
lSI recommends that surgeons choose simple cases for initial unproctored procedures. lSI provided a user’s manual to doctors, containing various warnings related to the device. Three warnings are particularly relevant to this case. First, as part of its training, ISI advised surgeons not to perform prostatectomies on obese persons. ISI provided body mass index (“BMI”) guidelines stating patients should have a BMI of less than 30. Second, ISI advised not to perform prostate procedures on persons who previously underwent lower abdominal surgeries. Third, ISI warned that it was unsafe for the patient not to be in a steep Trendelenburg position (tilted with head downward) during the procedure.
Facts Particular To This Case
Dr. Scott Bildsten had 15 years of experience performing open prostatectomies, having performed between 80 and 100 such procedures prior to the decedent’s surgery. Dr. Bildsten had performed two proctored prostatectomies before performing his first unproctored procedure on the decedent.
After receiving informed consent, Dr. Bildsten performed a robotic prostatectomy on the decedent to treat his prostate cancer using the da Vinci Surgical System, on September 9, 2008. At the time of surgery, the decedent weighed 280 pounds and had a BMI of 39; Dr. Bildsten considered the decedent to be severely obese. Furthermore, the decedent had three prior lower abdominal surgeries, which went against ISI’s advice to avoid patients with prior lower abdominal surgeries.
During the surgery, Dr. Bildsten did not position the decedent in the steep Trendelenburg position due to his weight. Although Dr. Bildsten knew that the decedent was not an optimal candidate, he performed the prostatectomy as his first unproctored procedure using the robotic system.
During the surgery, the decedent suffered complications – the decedent’s rectal wall was lacerated. Dr. Bildsten converted the procedure to an open surgery, and another surgeon came in to fix the rectal tear. The decedent’s quality of life was poor after the surgery. He suffered respiratory failure requiring ventilation, renal failure (that ultimately resolved itself), and infection. The decedent was incontinent and had to wear a colostomy bag. He also suffered neuromuscular damage and could no longer walk without assistance. Approximately four years after the surgery, the decedent died. A doctor testified at trial that the prostatectomy’s complications hastened his death.
A year after the surgery, the decedent filed his Washington medical malpractice lawsuit against Dr. Bildsten, his partner, their medical practice, and Harrison Medical Center, and later named ISI as a defendant. After he died, the decedent’s wife proceeded with the lawsuit as personal representative of the decedent’s estate. Before trial, the plaintiff settled with Dr. Bildsten, his partner, their private practice, and Harrison Medical Center. ISI was the only remaining defendant.
The plaintiff proceeded against ISI 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 WPLA. The trial court granted summary judgment in favor of ISI on all claims, except for the plaintiff’s failure to warn claim under the WPLA.
The jury returned a verdict in favor of ISI, finding that ISI was not negligent in providing warnings or instruction to Dr. Bildsten. The plaintiff appealed.
The Washington Supreme Court Decision
The Washington Supreme Court held that the WPLA imposes a duty on manufacturers of medical products to warn hospitals of the products’ dangers when they purchase them. The manufacturer’s duty to warn purchasing hospitals is not excused when a manufacturer warns doctors who use the devices because hospitals need to know the dangers of their own products, which cannot be accomplished simply by the manufacturer’s warnings to the doctor who uses the product. Thus, the Washington Supreme Court concluded that the trial court erred by failing to instruct the jury there was a duty to warn Harrison Medical Center of the da Vinci Surgical System’s risks (since warnings must be provided “with” products, manufacturers like ISI have a duty to provide warnings to the purchaser of the product – in this case, Harrison Medical Center; 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).
The Learned Intermediary Doctrine
The Washington Supreme Court stated that the Learned Intermediary Doctrine (i.e., 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; the manufacturer’s duty to provide warnings to patients transfers to the doctor, who is in a better position to communicate them to the patient) does not apply to this case because the WPLA imposes a separate and distinct duty for the manufacturer to provide warnings to the purchaser of the product. Hospitals cannot meet their own duty to patients without knowing the risks of the dangerous medical products they own.
Furthermore, while doctors are recognized as the gatekeepers between the manufacturer and the patient, the hospital is the gatekeeper between the physician and the use of the da Vinci Surgical System since the hospital clears surgeons to use it. Thus, the hospital must have warnings about its risks and no tort doctrine should excuse the manufacturer from providing them.
The Washington Supreme Court further held that the usual strict liability standard applies to failure to warn claims.
The Washington Supreme Court concluded: “We find that pursuant to the WPLA, manufacturers have a duty to warn hospitals about the dangers of their products. The manufacturer’s warnings to Dr. Bildsten did not excuse its duty to warn Harrison Medical Center. As such, we find that the trial court erred in failing to instruct the jury on this duty. We vacate the jury’s defense verdict and remand for a new trial.”
Source Taylor v. Intuitive Surgical, Inc., No. 92210-1.
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