Mendoza v. Intuitive Surgical, Inc.

Background

Donna Mendoza sued Intuitive Surgical, Inc. under California law, alleging negligence, products liability based on design defect and failure to warn, strict liability based on manufacturing defect, and punitive damages. She alleged that defects in Intuitive Surgical’s da Vinci robotic surgery system caused injuries during her October 12, 2011 hysterectomy. The surgeon used the system’s Hot Shears Monopolar Curved Scissors, or MCS, along with a required tip-cover accessory, or TCA.

Mendoza experienced severe abdominal pain several days after the surgery and later underwent a bowel resection. In May 2013, Intuitive Surgical announced that internal testing had identified a potential for tiny cracks in the MCS shaft. The company stated that such cracks could cause insulation failure and allow electrical energy to reach tissue, potentially causing unintended burns. Intuitive Surgical recalled the MCS model used during Mendoza’s surgery.

Summary-judgment standard

Summary judgment is a decision before trial that is appropriate when the evidence shows no genuine dispute over facts that could affect the result and the moving party is entitled to judgment under the law. The court must view disputed evidence in the light most favorable to the party opposing the motion.

Tip-cover claims

Intuitive Surgical argued that Mendoza had offered no evidence that the TCA used during her surgery was defective. Mendoza did not respond to those arguments and focused instead on alleged defects in the MCS. The court held that Intuitive Surgical’s own papers supported judgment and did not reveal a genuine factual dispute concerning the TCA. The court therefore granted Intuitive Surgical’s motion for summary judgment on Mendoza’s products-liability claims insofar as they concerned defects in the TCA.

MCS manufacturing-defect claim

The court denied summary judgment on the claim that the MCS had a manufacturing defect. A manufacturing defect is a product that differs from the manufacturer’s intended result or from otherwise identical products. The court held that Mendoza had presented enough circumstantial evidence to create a genuine factual dispute, even without direct evidence that the specific MCS used in her surgery contained micro-cracks.

Mendoza’s expert, Dr. Helen Salsbury, performed a differential diagnosis, meaning she considered possible causes of the injury and ruled out alternatives. Salsbury concluded that Mendoza’s complications and later procedures were caused by a thermal bowel injury resulting from the da Vinci system. The court also considered the later recall of the MCS model and Intuitive Surgical’s statement that the micro-cracks were not visible without magnification. The court concluded that a jury could determine whether the MCS used in Mendoza’s surgery had a manufacturing defect.

MCS design-defect claim

The court denied summary judgment on Mendoza’s MCS design-defect claim. Intuitive Surgical argued that California law does not permit strict-liability design-defect claims against manufacturers of prescription medical devices. The court agreed with that legal principle but found that Mendoza had not asserted her design-defect claim under a strict-liability theory. Instead, California law applies an ordinary-negligence standard to a prescription medical device design-defect claim. The court held that Intuitive Surgical’s argument failed because it depended on excluding Mendoza’s expert reports, and the court had already denied Intuitive Surgical’s motions seeking to exclude those experts under the rules governing expert evidence.

MCS failure-to-warn claim

The court denied summary judgment on Mendoza’s failure-to-warn claim concerning the MCS. Mendoza identified the alleged warning failure as Intuitive Surgical’s failure to warn physicians about micro-cracks or the increased risk of injury from compromised insulation. The court stated that the adequacy of a warning is generally a question for the jury.

The court also rejected Intuitive Surgical’s argument that Mendoza lacked evidence that the surgeon would have acted differently if given a different warning. The court held that causation in a defective-products case may be proven through circumstantial evidence and that the absence of direct evidence did not justify summary judgment.

Causation

Intuitive Surgical argued that the undisputed evidence showed Mendoza did not suffer a thermal injury and that Salsbury’s medical-causation opinion was unreliable. The court found a genuine factual dispute about whether Mendoza suffered a thermal injury. Salsbury relied on the delayed development of Mendoza’s bowel-related symptoms and the absence of a noted mechanical bowel injury during surgery, among other considerations.

The court also held that Salsbury’s report was admissible and sufficiently reliable. It stated that Intuitive Surgical could question Salsbury about other possible causes, including adhesions and a defect in another surgical instrument, at trial. The court therefore denied summary judgment based on an alleged lack of admissible evidence that an MCS defect caused Mendoza’s injury.

Disposition

The court granted Intuitive Surgical’s motion for summary judgment on Mendoza’s products-liability claims concerning the TCA. The court denied the motion for summary judgment in all other respects, including the claims and arguments concerning the MCS and causation. Judge Lucy H. Koh signed the order on June 10, 2020.