Surgical Instrument Service Company, Inc. v. Intuitive Surgical, Inc.

Background

The court held a pretrial conference on November 25, 2024, and heard arguments on the parties’ motions in limine. A motion in limine is a request to limit testimony, documents, or arguments before trial. The court emphasized that such rulings concern trial management and may be changed during trial.

Surgical Instrument Service Company’s motions

Surgical Instrument Service Company, referred to as SIS, filed five motions. The court granted stipulations resolving motions 2 and 3. It denied motion 4, subject to revival at trial if Intuitive Surgical failed to provide a sufficient foundation for lay-witness testimony.

The court granted motion 1 in part by excluding testimony, documents, and arguments concerning the Food and Drug Administration’s Section 510(k) clearance framework, the meaning and application of “remanufacturing,” and whether SIS’s or other third parties’ EndoWrist activities constituted remanufacturing or required clearance. The court also granted motion 1 to exclude evidence and arguments about Intuitive Surgical’s website announcement that customers who bought certain FDA-cleared remanufactured EndoWrists would not violate their contracts.

The court explained that Section 510(k) clearance evaluates whether a device is equivalent to an already approved device, rather than determining whether the device is safe. The court therefore found a substantial risk that the evidence would confuse the jury or lead it to treat regulatory compliance as proof of safety. Intuitive Surgical could still present other evidence about the safety of repaired EndoWrists, including testing, engineering data, and appropriate expert testimony.

The court also granted motion 5. It excluded evidence and arguments concerning the FDA clearance framework; Intuitive Surgical’s FDA clearance of EndoWrists; whether that clearance required compliance with Intuitive Surgical’s use limits; whether the clearance showed that those limits related to patient safety; and whether the clearance established the number of times an EndoWrist could be used from an engineering or failure perspective. Intuitive Surgical could still argue that use counters and use limits were safety features warranting protection, but it could not validate those arguments through the Section 510(k) process.

The court further stated that Intuitive Surgical could not rely on its website announcement as an attempt to privately enforce the Food, Drug, and Cosmetic Act or to excuse its business conduct. The court noted that it had previously ruled that neither party could use the case to enforce that regulatory statute.

Intuitive Surgical’s motions

Intuitive Surgical filed five motions. A stipulation resolved motion 5. The court did not reach motion 1 because it granted a stipulated briefing schedule concerning an evidentiary proffer.

The court denied motion 2, which sought to bar SIS from introducing or referencing two Deutsche Bank analyst reports and from having SIS’s experts rely on the reports’ authors’ opinions. Assuming proper foundation, SIS could offer the reports for the non-hearsay purpose of showing Intuitive Surgical’s awareness of the competitive threat posed by third-party refurbishment of EndoWrist instruments. The reports could not be offered to prove the truth of their contents. The court also declined to restrict SIS’s experts’ testimony based on their reliance on the reports, explaining that experts may rely on material that is not itself admissible evidence.

The court granted motion 3. It barred both SIS and Intuitive Surgical from introducing or referring to other lawsuits and settlements involving Intuitive Surgical, because the litigation history would likely be more prejudicial than helpful. The court also required references to other litigation or settlements to be redacted from documents and deposition designations.

The court granted motion 4, which sought to bar SIS from offering evidence or arguments about the period after November 10, 2022, the close of fact discovery, except for recently produced financial records and responses to requests for admission. The court added four conditions: the prohibition did not cover the limited information produced under the court’s order; SIS’s damages expert could use updated schedules based on later-produced financial data; the expert could testify about SIS’s lost profits in the “but-for” world through 2026; and post-November 10, 2022 information disclosed in expert reports and explored during later expert depositions was not covered by the prohibition.

Disposition and effect

The order resolved or addressed the parties’ evidentiary motions for trial. SIS’s motions 1 and 5 were granted, motion 4 was denied subject to possible revival, and motions 2 and 3 were resolved by stipulation. Intuitive Surgical’s motion 2 was denied, motions 3 and 4 were granted, motion 5 was resolved by stipulation, and motion 1 was not reached. The order did not decide the merits of the antitrust claims.