Mendoza v. Intuitive Surgical, Inc.

Background

Donna Mendoza moved to exclude several categories of evidence before trial in her product-liability action against Intuitive Surgical, Inc. Intuitive filed one motion concerning evidence or argument about other claims, complaints, or incidents. The court applied Federal Rule of Evidence 403, which allows exclusion of relevant evidence when unfair prejudice, confusion, or other listed concerns substantially outweigh its value.

The opinion states that Mendoza claims her injuries were caused by a malfunctioning defective product. The parties stipulated to Indiana law for Mendoza’s product-liability claims, which include negligence and strict liability. Causation was a disputed factual issue.

Mendoza’s Motion in Limine No. 1: Informed-Consent Evidence

Mendoza sought to exclude the informed-consent documents she signed before surgery and her conversations with Dr. Howard Marcus about surgical risks. She argued that she had not brought an informed-consent claim and that the evidence was irrelevant and unfairly prejudicial because her claim concerned an allegedly defective product and a risk about which she was not warned.

The court denied without prejudice the motion. It held that Mendoza’s medical-malpractice authorities did not decide whether informed-consent evidence could be admitted for purposes other than rebutting a medical-malpractice claim, including purposes related to product-liability claims. The court also held that admissibility could depend on Mendoza’s or Dr. Marcus’s trial testimony. For example, the evidence might be usable for impeachment, meaning to challenge a witness’s testimony. Because it was not yet clear whether Intuitive would offer the evidence or for what purpose, the court deferred the issue until trial.

Mendoza’s Motion in Limine No. 2: Known-Risk Evidence

Mendoza sought to exclude testimony, statements, or suggestions that she had been informed about the nature and risks of a robotically assisted hysterectomy. More specifically, she challenged evidence that bowel injuries were a known risk of the surgical procedure, regardless of the surgical method used.

The court denied the motion. It found the evidence relevant because Intuitive’s experts planned to offer non-conclusory testimony that Mendoza’s history of adhesions—bands of scar-like tissue—could have caused the bowel injury without negligence by the surgeon and without a malfunction of Intuitive’s instruments. The court also found that the evidence’s relevance outweighed potential unfair prejudice. Excluding it could lead the jury to assume that the alleged product defect was the only possible cause, preventing the jury from weighing the disputed causation evidence.

Mendoza’s Motion in Limine No. 3: Tolling Agreement

Mendoza sought to exclude all evidence or reference to the parties’ agreement to pause the statute of limitations for potential product-liability litigation concerning her injuries. She argued that the agreement was irrelevant and unfairly prejudicial and that Federal Rule of Evidence 408 barred it as related to compromise discussions.

The court granted the motion because the agreement was irrelevant to the only purpose Intuitive identified: supporting the defense of laches, an equitable defense based on unreasonable delay. The court held that laches was unavailable in this action because Mendoza sought only monetary relief for product-liability claims, and those claims were governed by a statute of limitations. The court therefore did not reach Mendoza’s separate arguments about unfair prejudice or Rule 408.

Intuitive’s Motion in Limine: Other Complaints and Reports

Intuitive sought to exclude evidence or argument about legal claims, complaints, or incidents other than complaints about the surgery involved in this case. The court described Mendoza’s planned evidence as primarily formal reports submitted to the Food and Drug Administration, called Medical Device Reporting reports or MedWatch reports. Mendoza indicated that she might offer evidence of other lawsuits only if Intuitive misled the jury in a way that the evidence could rebut.

The court granted Intuitive’s motion as to the content of Medical Device Reporting reports. It relied on 21 U.S.C. § 360i(b)(3), which states that qualifying reports generally may not be admitted or otherwise used in a civil action between private parties, subject to the statute’s conditions. The court concluded that Mendoza had not addressed that statute or shown that her proposed reports fell outside its scope. Because the statutory bar resolved the issue, the court did not need to decide Intuitive’s hearsay or Rule 403 arguments.

The court denied without prejudice Intuitive’s motion as to other complaints, including evidence of other lawsuits, because ruling on that broader category before the evidence was offered at trial would be premature.

Disposition

The court ruled as follows: Mendoza’s Motion in Limine No. 1 was denied without prejudice; Mendoza’s Motion in Limine No. 2 was denied; Mendoza’s Motion in Limine No. 3 was granted; and Intuitive’s motion was granted as to the content of Medical Device Reporting or MedWatch reports but denied without prejudice as to other complaints.