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

CourtDistrict Court, N.D. California
DecidedDecember 11, 2024
Docket3:21-cv-03496
StatusUnknown

This text of Surgical Instrument Service Company, Inc. v. Intuitive Surgical, Inc. (Surgical Instrument Service Company, Inc. v. Intuitive Surgical, Inc.) is published on Counsel Stack Legal Research, covering District Court, N.D. California primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Surgical Instrument Service Company, Inc. v. Intuitive Surgical, Inc., (N.D. Cal. 2024).

Opinion

1 2 3 4 UNITED STATES DISTRICT COURT 5 NORTHERN DISTRICT OF CALIFORNIA 6 7 SURGICAL INSTRUMENT SERVICE Case No. 21-cv-03496-AMO COMPANY, INC., et al., 8 Plaintiffs, ORDER RE MOTIONS IN LIMINE 9 v. Re: Dkt. Nos. 290, 292, 293, 296, 296, 301, 10 INTUITIVE SURGICAL, INC., 302, 303 11 Defendant.

12 13 The Court held a pretrial conference in this antitrust case on November 25, 2024. The 14 Court heard argument on the parties’ motions in limine at the conference. Having carefully 15 considered the arguments advanced at the hearing, together with the parties’ papers and the 16 relevant legal authority, the Court rules on the motions in limine as follows. 17 I. LEGAL STANDARD 18 “A motion in limine is a procedural mechanism [that is used] to limit in advance” of trial 19 the scope of “testimony or evidence in a particular area” that will be permitted at trial. United 20 States v. Heller, 551 F.3d 1108, 1111-12 (9th Cir. 2009). Though not explicitly authorized by the 21 Federal Rules of Evidence (FRE), the practice of ruling in limine on evidentiary issues is based on 22 the “district court’s inherent authority to manage the course of trials.” Luce v. United States, 469 23 U.S. 38, 41 n.4 (1984). “[I]n limine rulings are not binding on the trial judge, and the judge may 24 always change [their] mind during the course of a trial.” Ohler v. United States, 529 U.S. 753, 25 758 n.3 (2000) (emphasis removed). “A motion in limine is not the proper vehicle for seeking a 26 dispositive ruling on a claim, particularly after the deadline for filing such motions has passed.” 27 Hana Financial, Inc. v. Hana Bank, 735 F.3d 1158, 1162 n.4 (9th Cir. 2013). 1 II. SURGICAL INSTRUMENT SERVICE COMPANY, INC.’S MOTIONS IN LIMINE 2 Plaintiff Surgical Instrument Service Company, Inc. (“SIS”) filed five motions in limine. 3 The Court granted stipulations resolving SIS’s motions in limine #2 and #3. See ECF 308, ECF 4 309. 5 At the conference, the Court denied SIS’s motion in limine #4 subject to revival at trial if 6 Defendant fails to lay a sufficient foundation for lay witness testimony. 7 The Court discusses SIS’s remaining motions in limine, #1 and #5, together because the 8 Court’s reasoning regarding introduction of evidence of the Food and Drug Administration 9 (“FDA”) regulatory framework bears on each motion. In its motion in limine #1, SIS moves to 10 exclude all testimony, documentary evidence, and argument related to (1) the FDA’s Section 11 510(k) regulatory framework and procedures for clearance of medical devices for commercial 12 marketing, (2) the meaning, scope and application of the regulatory term “remanufacturing,” 13 (3) whether SIS or other third parties’ EndoWrist activities constitute “remanufacturing” or require 14 510(k) approval; and (4) the meaning, scope, application and effect of Intuitive’s announcement 15 on its website that buying FDA-cleared remanufactured EndoWrists does not violate its contracts. 16 In its motion in limine #5, SIS moves to exclude all testimony, documentary evidence, and 17 argument related to (1) the FDA’s regulatory framework and procedures for clearance of medical 18 devices for commercial marketing [same as in #1] , (2) Intuitive’s FDA 510(k) clearance of 19 EndoWrists [similar to #1], (3) the contention that Intuitive’s FDA 510(k) clearance of 20 EndoWrists requires adherence to Intuitive use limits; (4) the contention that Intuitive’s FDA 21 510(k) clearance of EndoWrists is evidence that those use limits ensure or relate to patient safety; 22 and (5) the contention that Intuitive’s FDA 510(k) clearance of EndoWrists is evidence of the 23 actual number of times an EndoWrist can be used from an engineering/failure perspective. 24 Courts regularly exclude evidence regarding the FDA’s 510(k) clearance process based on 25 a pair of interlocking concerns. First, Section 510(k) clearance involves an inquiry into a new 26 device’s equivalence with an earlier-approved medical device, not, as Intuitive contends here, an 27 inquiry into the safety of the new product. See Meditronic, Inc. v. Lohr, 518 U.S. 470, 493 (1996) 1 Second, and because Section 510(k) clearance does not address issues of safety, any probative 2 value of the evidence related to the regulatory framework and a plaintiff’s failure to obtain such 3 clearance is greatly outweighed “by the danger of, among other things, confusing the issues, 4 misleading the jury, and wasting time.” Kaiser v. Johnson & Johnson, No. 2:17-CV-114-PPS, 5 2018 WL 1358407, at *4 (N.D. Ind. Mar. 16, 2018) (denying motion in limine to admit FDA 6 evidence and granting motion in limine to exclude FDA 510(k) evidence), aff’d, 947 F.3d 996 (7th 7 Cir. 2020). 8 Both concerns merit exclusion here. The same risk of confusing the jury applies here and 9 warrants exclusion of the regulatory evidence. Intuitive aims to present evidence of the Section 10 510(k) process to demonstrate a lack of safety for SIS serviced instruments, but Section 510(k) 11 simply is not oriented towards ensuring safety of medical devices. See Meditronic, 518 U.S. at 12 493. Although Section 510(k) clearance is clearly relevant in the context of this case and how it 13 has been litigated so far, the regulatory framework cannot be invoked to demonstrate deficient 14 product safety. The voluminous record arising from SIS’s failure to obtain Section 510(k) 15 clearance presents a substantial risk of confusing matters for the jury because the complex record 16 related to regulatory compliance could lead jurors “to erroneously conclude that regulatory 17 compliance proved safety.” In re C. R. Bard, Inc., 81 F.3d 913, 922 (4th Cir. 2016); see also id. at 18 920 (“[T]he clear weight of persuasive and controlling authority favors a finding that the 510(k) 19 procedure is of little or no evidentiary value.”). Intuitive can and should present evidence 20 concerning repaired EndoWrists’s safety, including through other available evidence, such as any 21 testing data, engineering data, and appropriate expert testimony. Intuitive cannot, however, invite 22 the jury to conclude that SIS’s failure to obtain 510(k) clearance demonstrates that SIS’s services 23 were unsafe. 24 Intuitive contends that the cases cited by SIS are unhelpful here because they considered 25 510(k) clearance in the product liability context. See Intuitive Opp. to MIL #1 at 5 n.4. But the 26 reasoning underpinning 510(k) clearance exclusion in the products liability context applies equally 27 here. Indeed, Intuitive aims to proffer 510(k) clearance evidence for the same purpose discounted 1 to MIL #1 at 1-3 with Carter v. Johnson & Johnson, No. 220CV01232KJDVCF, 2022 WL 2 4700549, at *2 (D. Nev. Sept. 29, 2022) (finding that a “mini-trial” on Section 510(k) evidence 3 “ ‘could easily inflate the perceived importance of compliance and distract the jury from the 4 central question before it,’ whether the defendants’ product was unreasonably dangerous.” 5 (citation omitted)). And here, just as in the product liability context, evidence of the 510k 6 clearance regime is ancillary to the gravamen of the claims at issue. See id. There, the regulatory 7 scheme did not resolve the issue of whether the challenged products were poorly or unsafely 8 designed; here, the regulatory scheme does not resolve the issue of whether Intuitive engaged in 9 anticompetitive conduct.

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Related

Wayman v. Southard
23 U.S. 1 (Supreme Court, 1825)
Medtronic, Inc. v. Lohr
518 U.S. 470 (Supreme Court, 1996)
Ohler v. United States
529 U.S. 753 (Supreme Court, 2000)
United States v. Heller
551 F.3d 1108 (Ninth Circuit, 2009)
Hana Financial, Inc. v. Hana Bank
735 F.3d 1158 (Ninth Circuit, 2013)
Barbara Kaiser v. Johnson & Johnson
947 F.3d 996 (Seventh Circuit, 2020)

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Bluebook (online)
Surgical Instrument Service Company, Inc. v. Intuitive Surgical, Inc., Counsel Stack Legal Research, https://law.counselstack.com/opinion/surgical-instrument-service-company-inc-v-intuitive-surgical-inc-cand-2024.