Trump v. Intuitive Surgical Inc.

Background

Candy Trump sued Intuitive Surgical, Inc., alleging negligence, products liability, and strict liability claims arising from alleged defects in the company’s da Vinci robotic surgery system. Trump alleged that she suffered a torn vaginal cuff, abdominal pain, vaginal bleeding, improper healing, and related medical treatment after a July 9, 2012 hysterectomy using the da Vinci system, monopolar curved scissors, and a tip cover accessory.

Intuitive Surgical moved to exclude the expert opinions of Dr. Helen Salsbury and Roger Odell under Federal Rule of Evidence 702 and the standards associated with Daubert. Those standards require expert testimony to be relevant and reliable, based on sufficient facts or data, reliable methods, and reliable application of those methods.

Salsbury’s Opinions

Salsbury, an obstetrician and gynecologist, intended to testify that Trump’s complications resulted from thermal injury to the vaginal cuff caused by stray electricity from the da Vinci system’s monopolar curved scissors. Salsbury used a differential diagnosis, a method in which an expert considers possible causes, rules out causes that lack plausible support, and identifies the most likely remaining cause.

Intuitive Surgical argued that Salsbury’s analysis was unreliable because she did not adequately consider smoking, surgical menopause, low body mass index, chronic constipation, bacterial vaginosis, and sexual intercourse as possible causes. The court concluded that Salsbury sufficiently addressed smoking and intercourse and could rely on her extensive clinical experience as a gynecologist. The court also held that an expert need not eliminate every possible cause when the expert has considered numerous potential causes. Any shortcomings went to the weight of her opinion, meaning how persuasive it was, rather than its admissibility, meaning whether she could testify.

The court also considered Salsbury’s opinion that Trump’s injury indicated a defect in the da Vinci system. Intuitive Surgical argued that Salsbury lacked information about the specific scissors and tip cover used in Trump’s surgery and was not qualified to address their design or manufacture. The court found that Salsbury properly relied on medical literature and product-recall documents concerning defects similar to those alleged in the case, including cracking and insulation failure. It also found that her experience with hundreds of robotically assisted hysterectomies and the da Vinci system qualified her to offer the opinion.

The court therefore DENIED Defendant’s motion to exclude Salsbury’s opinion concerning the cause of Trump’s injury and DENIED Defendant’s motion to exclude Salsbury’s opinion concerning defects in the da Vinci system.

Odell’s Opinions

Odell, an electrical engineer, intended to testify that the da Vinci system was defectively designed because it did not include active electrode monitoring or coaxial shielding and monitoring of the device shaft. Intuitive Surgical argued that active electrode monitoring had a low adoption rate, that comparative studies were lacking, that Odell improperly relied on adverse-event reports, and that he merely repeated the opinions of two other experts.

The court rejected those arguments as grounds for exclusion. It found that Odell relied on evidence indicating that at least part of the medical community viewed active electrode monitoring as effective, including literature, independent medical-device evaluations, statements from a medical-device manufacturer, studies, and reports about insulation failures. The court also found that Odell did not rely exclusively on the other experts’ reports and combined those reports with additional evidence. His use of adverse-event reports likewise did not require exclusion because those reports were not his sole source of information.

The court therefore DENIED Defendant’s motion to exclude Odell’s opinion concerning defects in the da Vinci system’s monopolar curved scissors.

The defendant also challenged Odell’s opinions about defects in the system’s tip cover accessory. Trump stated that she would not offer or ask Odell about the tip cover accessory unless the defendant opened the door at trial. Because Trump did not oppose exclusion of those opinions, the court GRANTED Defendant’s motion with respect to Odell’s opinions concerning the tip cover accessory.

Ruling

Judge Lucy H. Koh DENIED Defendant’s motion to exclude Salsbury’s opinions concerning causation of Trump’s injury and defects in the da Vinci system; DENIED Defendant’s motion to exclude Odell’s opinion concerning defects in the system’s monopolar curved scissors; and GRANTED Defendant’s motion to exclude Odell’s opinion concerning defects in the system’s tip cover accessory.