Trump v. Intuitive Surgical Inc.

Background

Candy Trump brought claims under California law against Intuitive Surgical, Inc., alleging negligence, design-defect and failure-to-warn product-liability claims, manufacturing-defect strict liability, and punitive damages. The claims arose from a July 9, 2012 hysterectomy during which her surgeon used Intuitive’s da Vinci robotic surgery system, including Hot Shears Monopolar Curved Scissors (the “MCS”) and a tip-cover accessory (the “TCA”). Trump later experienced pelvic pain and bleeding. Intuitive recalled the MCS model used in the surgery in May 2013 after testing identified a potential for micro-cracks that could cause insulation failure and unintended electrical burns.

Intuitive moved for summary judgment, arguing that Trump had no evidence that a defective MCS or TCA was used during her surgery and could not prove that a defect caused her injury. Summary judgment is a decision before trial available when the evidence shows no genuine dispute over a fact that could affect the outcome and the moving party is entitled to judgment under the law.

TCA Claims

The court granted summary judgment on Trump’s product-liability claims to the extent they concerned defects in the TCA. Trump did not respond to Intuitive’s arguments about the TCA and focused instead on alleged defects in the MCS. The court stated that failure to oppose a motion alone is not enough to justify summary judgment, but concluded that Intuitive’s arguments and evidence were sufficient and did not reveal a genuine factual dispute about the TCA.

MCS Manufacturing-Defect Claim

The court denied summary judgment on the manufacturing-defect claim involving the MCS. Intuitive argued there was no direct evidence that the MCS used in Trump’s surgery had micro-cracks. The court explained that California law permits a manufacturing defect to be shown through circumstantial evidence.

The court found a genuine dispute based on the report of Dr. Helen Salsbury, who used a process of evaluating and ruling out possible causes and concluded that Trump most likely suffered a thermal injury to her vaginal cuff caused by stray electricity from the da Vinci system. The court also relied on the recall of the MCS model and evidence that the relevant micro-cracks were not visible without magnification. The court therefore denied summary judgment on whether the MCS had a manufacturing defect.

MCS Design-Defect Claim

The court denied summary judgment on the design-defect claim involving the MCS. Intuitive argued that California law does not allow strict-liability design-defect claims against manufacturers of prescription medical devices. The court agreed with that legal rule but concluded it did not resolve Trump’s claim because she did not allege a strict-liability theory for the design-defect claim.

The court explained that California applies an ordinary-negligence standard to a prescription medical-device manufacturer’s design-defect liability. Intuitive also argued that Trump’s expert reports should be excluded under the rule governing expert evidence. The court rejected that argument because it had already denied Intuitive’s motions seeking to exclude the opinions of Salsbury and Roger Odell. It therefore denied summary judgment on the MCS design-defect claim.

MCS Failure-to-Warn Claim

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

Intuitive also argued that Trump lacked evidence that her surgeon would have acted differently if given a different warning. The court concluded that direct evidence was not required and that causation could be shown through circumstantial evidence. It therefore denied summary judgment on the MCS failure-to-warn claim.

Causation and Negligence

Intuitive argued that Salsbury’s opinion on causation was unreliable and should be excluded. The court rejected that argument because it had already found the report sufficiently reliable. The court stated that Intuitive could question Salsbury about possible alternative causes at trial, but those issues concerned the weight of the opinion rather than whether it could be considered.

The court found a genuine dispute over whether an MCS defect caused Trump’s injury and denied summary judgment based on alleged lack of causation evidence. Because Intuitive’s argument about the absence of evidence of an MCS defect also formed the basis for its challenge to the negligence claim, the court denied summary judgment on the negligence claim on that ground as well.

Disposition

The court granted Intuitive Surgical, Inc.’s motion for summary judgment on Trump’s product-liability claims concerning the TCA. It denied the motion in all other respects, including as to the MCS manufacturing-defect, design-defect, and failure-to-warn claims, the causation argument, and the negligence claim addressed on the same basis.