Mendoza v. Intuitive Surgical, Inc.

Background

Donna Mendoza brought negligence, products-liability, and strict-liability claims against Intuitive Surgical, Inc., alleging that defects in the company’s da Vinci robotic surgery system caused injuries during or after her October 12, 2011 hysterectomy. The system used a Hot Shears Monopolar Curved Scissors instrument, or MCS, and a tip cover accessory, or TCA. Mendoza experienced severe abdominal pain shortly after surgery and was diagnosed with a small-bowel obstruction three days later.

Intuitive Surgical moved to exclude the expert opinions of Dr. Helen Salsbury and Roger Odell under Federal Rule of Evidence 702. That rule permits qualified experts to testify when their opinions are relevant, based on sufficient information, produced by reliable methods, and reliably applied to the case. The court explained that weaknesses in otherwise admissible expert evidence generally affect the weight given to the testimony rather than its admissibility.

Dr. Salsbury’s Opinions

Salsbury, an obstetrician and gynecologist, intended to testify that Mendoza’s complications resulted from a thermal bowel injury caused by stray electricity from the MCS and defects in the MCS and TCA. Salsbury used a differential diagnosis, meaning that she considered possible causes, ruled out causes lacking plausible support, and identified the most likely remaining cause.

The court found that Salsbury did not include adhesive disease or a defect in another electrosurgical instrument, called the EndoShears, among the potential causes in her formal analysis. But the court concluded that this omission did not make her opinion unreliable. Salsbury had considered several other potential causes, and the court found that adhesive disease and an EndoShears defect were not so obviously supported by the record that failing to address them required exclusion. The court noted that the surgeon had reported no bowel injury or bowel adhesions and had used the EndoShears away from the bowel. Intuitive Surgical could question Salsbury about these issues at trial.

The court also rejected the challenge to Salsbury’s opinion about product defects. Although Salsbury lacked information about the condition of the specific MCS and TCA used in Mendoza’s surgery, she relied on medical literature and documents concerning recalls involving the same types of alleged defects—cracking and insulation failure. The court further found Salsbury qualified to offer an opinion that Mendoza’s injury arose from a product defect similar to previously reported da Vinci system defects because of her experience performing hundreds of robotically assisted hysterectomies and her extensive experience with the system.

The court therefore denied Intuitive Surgical’s motion to exclude Salsbury’s opinions about both causation and product defects.

Mr. Odell’s Opinions

Odell, an electrical engineer, intended to testify that the MCS was defectively designed because it lacked active electrode monitoring, or AEM, and coaxial shielding and monitoring of the device shaft. AEM is intended to detect insulation failure or excessive electrical coupling and help prevent unintended burns from electrical energy escaping the instrument.

Intuitive Surgical argued that Odell’s opinion was unreliable because AEM had a low hospital-adoption rate, no comparative studies showed that the MCS was safer with AEM, Odell relied on adverse-event reports, and he improperly repeated opinions from two other experts. The court rejected these arguments. It found that Odell cited literature, an independent medical-device evaluation organization, statements from a medical-device manufacturer, studies and reports about insulation failures, and other evidence showing that at least part of the medical community viewed AEM as making the MCS safer.

The court also found that Odell did not merely repeat the other experts’ opinions. He used their reports for limited purposes and combined them with additional evidence. His use of adverse-event reports likewise did not require exclusion because those reports were not his only source of information. Intuitive Surgical could challenge Odell’s reliance on the reports and other materials at trial.

The court denied Intuitive Surgical’s motion to exclude Odell’s opinion concerning alleged defects in the MCS.

Odell’s TCA Opinion and Disposition

Intuitive Surgical also challenged Odell’s opinions concerning alleged defects in the TCA. Mendoza did not address those arguments in her opposition and stated that she would not offer or ask Odell about the TCA unless Intuitive Surgical opened the door at trial. The court therefore granted Intuitive Surgical’s motion to exclude Odell’s opinions concerning defects in the TCA.

Judge Lucy Koh’s final disposition was to deny Intuitive Surgical’s motion to exclude Salsbury’s opinions concerning causation and defects in the da Vinci system, deny Intuitive Surgical’s motion to exclude Odell’s opinion concerning defects in the MCS, and grant Intuitive Surgical’s motion to exclude Odell’s opinion concerning defects in the TCA.