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

[[COURTLISTENER_SUBOPINION {"id":"10760613","type":"100trialcourt","part":"other","author":null,"source_field":"html_with_citations"}]]
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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.  And here, perhaps to an even greater extent than in the product liability 
10   cases, evidence regarding the regulatory scheme and either side’s compliance threatens to itself 
11   create a “mini-trial” that would greatly distract the jury.  The Court accordingly GRANTS the 
12   portions of SIS’s motion in limine #1 to exclude all testimony, documentary evidence, and 
13   argument related to (1) the FDA’s Section 510(k) regulatory framework and procedures for 
14   clearance of medical devices for commercial marketing, (2) the meaning, scope and application of 
15   the regulatory term “remanufacturing,” and (3) whether SIS or other third parties’ EndoWrist 
16   activities constitute “remanufacturing” or require 510(k) approval.   
17        The fourth part of SIS’s motion of limine #1 merits separate discussion as it relates to 
18   Intuitive’s announcement on its website that buying FDA-cleared remanufactured EndoWrists 
19   does not violate its contracts.  See Rosa Decl. ¶ 45 (ECF 137-2) (quoting in part from Intuitive’s 
20   March 2023 website announcement, “Intuitive will not void its service contract with, cease doing 
21   business with, or consider it a breach of contract by a customer in the United States who chooses 
22   to purchase remanufactured instruments that have been remanufactured by a third party pursuant 
23   to and in compliance with a 510(k) clearance or equivalent granted by the FDA.”). The 
24   announcement cannot be presented to the jury without contextualizing its reference to 510(k) 
25   clearance, which would require presenting additional evidence that would turn into a sideshow 
26                                                                         
27                                                                         
1   likely to distract and confuse the jury.1  The Court therefore GRANTS SIS’s motion in limine to 
2   exclude the exclude all testimony, documentary evidence, and argument related to the meaning, 
3   scope, application and effect of Intuitive’s announcement on its website that buying FDA-cleared 
4   remanufactured EndoWrists does not violate its contracts.2            
5        This same reasoning generally applies to SIS’s motion in limine #5.  Accordingly, the 
6   Court GRANTS SIS’s motion in limine #5 to exclude all testimony, documentary evidence, and 
7   argument related to (1) the FDA’s regulatory framework and procedures for clearance of medical 
8   devices for commercial marketing [same as in #1], (2) Intuitive’s FDA 510(k) clearance of 
9   EndoWrists [similar to #1], (3) the contention that Intuitive’s FDA 510(k) clearance of 
10   EndoWrists requires adherence to Intuitive use limits; (4) the contention that Intuitive’s FDA 
11   510(k) clearance of EndoWrists is evidence that those use limits ensure or relate to patient safety; 
12   and (5) the contention that Intuitive’s FDA 510(k) clearance of EndoWrists is evidence of the 
13   actual number of times an EndoWrist can be used from an engineering/failure perspective.  
14   Intuitive may not present evidence that the use counters/use limits were required pursuant to the 
15   FDA’s regulatory approval, but Intuitive may present argument and evidence that the use 
16   counters/use limits constituted a safety feature that warranted protection.  Intuitive argues that it 
17   must still be permitted to advance the use limits and other safety concerns as part of its pro-
18   competitive rationale.  Intuitive may do so, though not by validating those safety concerns through 
19   the 510(k) scheme because 510(k) clearance does not address product safety.   
20        Through its oppositions to SIS’s motions in limine #1 and #5, Intuitive aims to relitigate 
21   the role the regulatory framework played in SIS’s market participation.  This issue was already 
22                                                                         

23                                                                         
    1 The Court further finds that the announcement demonstrates an attempt to privately enforce the 
    Food, Drug and Cosmetic Act (“FDCA”), which the Court earlier determined is prohibited as a 
24                                                                         
    matter of law.  See Order re Cross MSJs (ECF 204) at 12-14.  Intuitive may not rely on its 
    announcement, an improper attempt to privately enforce the FDCA by requiring compliance with 
25                                                                         
    a regulatory scheme unenforced by the FDA, to excuse its business conduct. 

26                                                                         
    2 The Court additionally finds that admission of this website announcement, made in the period 
    following the close of fact discovery and prior to summary judgment briefing in this case, would 
27                                                                         
    prove inequitable in light of the Court’s grant of Intuitive’s motion to exclude most fact evidence 
1   resolved at summary judgment.  The Court denied Intuitive’s motion, which asserted that SIS 
2   could not establish antitrust causation because the regulatory framework interfered with SIS’s 
3   market participation rather than Intuitive’s allegedly anticompetitive conduct.  See Order re Cross 
4   MSJs (ECF 204) at 16 (discussing In re Wellbutrin XL Antitrust Litig. Indirect Purchaser Class, 
5
868 F.3d 132, 165-66
(3d Cir. 2017); Modesto Irrigation Dist. v. Pac. Gas & Elec. Co.,
309 F. 
6
Supp. 2d 1156, 1170 (N.D. Cal. 2004)).  The Court stated that neither party could aim to enforce 
7   the FDCA through this case.  See Order re Cross MSJs (ECF 204) at 12-14.  Yet Intuitive seems to 
8   do exactly that – to establish that SIS failed to obtain 510(k) clearance as if it was required.  
9        In sum, though Intuitive argues that SIS distorts the record by trying to avoid discussing 
10   FDA clearance in a case about medical devices and safety, it is Intuitive that distorts the gravamen 
11   of the case.  This antitrust case is about allegedly anticompetitive conduct.  And, again, Intuitive 
12   mischaracterizes the import of 510(k) clearance, which the Supreme Court has recognized is not 
13   concerned with safety.  For these reasons, among the others discussed above, the Court GRANTS 
14   SIS’s motions in limine #1 and #5.                                    
15   III.  INTUITIVE SURGICAL, INC.’S MOTIONS IN LIMINE                    
16        Intuitive Surgical filed five motions in limine.  The Court granted a stipulation resolving 
17   Intuitive’s motion in limine #5.  See ECF 326.  The Court additionally granted a stipulated 
18   briefing schedule regarding an evidentiary proffer related to Intuitive’s motion in limine #1, and 
19   the Court therefore does not reach that motion in this order.  The Court takes up the remaining 
20   three motions.                                                        
21        A.   Intuitive’s Motion in Limine #2                             
22        Intuitive moves for an order prohibiting: (1) SIS from either introducing into evidence or 
23   referencing the Deutsche Bank analyst reports dated January 27, 2020 and February 20, 2020 (the 
24   “Reports”); and (2) SIS’s experts from incorporating the opinions of the Reports’ authors as part 
25   of those experts’ own opinions.                                       
26        Intuitive argues that the reports themselves constitute inadmissible hearsay, including 
27   multiple layers of hearsay in their reference to unidentified “surgeons and supply chain 
1   expert testimony where they opine on, among other things, hospital demand for third-party 
2   repaired EndoWrists, the safety risk posed by those repairs, and whether FDA approval is required 
3   for such repairs.  See Fed. R. Evid. 701 & 702.  SIS opposes Intuitive’s requested exclusion.   
4        The Court DENIES Intuitive’s motion to exclude the Reports because they may prove 
5   admissible for a non-hearsay purpose.  Assuming proper foundation, SIS may proffer the Reports 
6   to show that Intuitive was aware of the competitive threat posed by third-party activities 
7   refurbishing EndoWrist instruments discussed in the Reports.  The Court otherwise finds the 
8   hearsay exceptions identified by SIS inapplicable to the Reports, and no party may proffer the 
9   Reports for the truth of their contents.  See Fed. R. Evid. 803(3), 803(6), 803(17).   
10        To the second part of this motion, Intuitive improperly attacks SIS’s experts’ reliance on 
11   the Deutsche Bank reports because experts need not rely on admissible evidence in forming their 
12   opinions.  The Court finds that this portion of Intuitive’s motion simply amounts to a collateral 
13   attack on the Court’s Daubert rulings on Lamb and Bero, and the Court declines to limit the 
14   experts’ testimony in this way.                                       
15        B.   Intuitive’s Motion in Limine #3                             
16        Intuitive moves for an order: (1) prohibiting Plaintiff SIS from introducing evidence that 
17   Intuitive has been sued by other parties in other cases or referring to other litigations and 
18   settlements involving Intuitive, including the litigation and settlement in Restore Robotics LLC v. 
19   Intuitive Surgical, Inc., No. 5:19-cv-00055 (N.D. Fla.), the litigation and settlement in Rebotix 
20   Repair LLC v. Intuitive Surgical, Inc., No. 8:20-cv-02274 (M.D. Fla.), the still-pending litigation 
21   in Restore Robotics Repairs LLC v. Intuitive Surgical, Inc., No. 3:24-cv-00444 (N.D. Fla.), and the 
22   still-pending putative class action litigation against Intuitive in the matter of In re: Da Vinci 
23   Surgical Robot Antitrust Litigation, No. 3:21-cv-03825-AMO (N.D. Cal.); and (2) requiring the 
24   parties to redact any references to other litigation or settlements in any documents or deposition 
25   designations.                                                         
26        The Court GRANTS Intuitive’s motion in limine #3 because Intuitive’s litigation history 
27   will likely prove more prejudicial than probative.  The prohibitions against introducing evidence 
1   or making reference to other litigations and settlements apply to both SIS and Intuitive with equal 
2   force.                                                                
3        C.   Intuitive’s Motion in Limine #4                             
4        Intuitive moves for an order prohibiting SIS from offering any evidence or argument about 
5   the time period following November 10, 2022 (the close of fact discovery in this case), other than 
6   SIS’s recently produced financial records and responses to requests for admission.  Intuitive 
7   sought to take discovery of facts and events occurring after November 2022.  The Court denied 
8   Intuitive’s motion to compel such discovery, with two narrow exceptions, requiring SIS to: 
9   (1) produce updated financial records, and (2) respond to a small number of Requests for 
10   Admission (“RFAs”).  See Minute Entry, ECF 261.  Intuitive argues that permitting SIS to proffer 
11   evidence post-dating November 2022 outside of its limited supplemental production would violate 
12   both Federal Rule of Civil Procedure 26 and principles of fairness.   
13        Intuitive repeatedly argues that it is prejudiced by not being able to present evidence of 
14   what happened in the real world since the close of fact discovery in November 2022 because the 
15   events of the post-November 2022 period serve to undercut SIS’s damages calculations in the “but 
16   for” world.  The Court previously resolved this issue.  The limited authority presented by Intuitive 
17   does not establish that the factual events taking place since the close of fact discovery should bear 
18   on either liability or damages calculations in antitrust cases.  The Court permitted limited further 
19   discovery for the sole purpose of establishing that SIS did not compete in the market following the 
20   close of fact discovery.  Even with this backdrop, SIS responded to Intuitive’s motion by stating 
21   its non-opposition to the limitation so long as the Court added four proposed conditions.  The 
22   Court accordingly GRANTS Intuitive’s motion in limine #4 to prohibit SIS’s witnesses and 
23   lawyers from offering any evidence or argument about the time period following November 10, 
24   2022, other than SIS’s recently produced financial records and RFA responses.  The Court 
25   imposes the following additional conditions:                          
26        (1) the prohibition against offering any evidence or argument about what happened after 
27   November 2022 outside of the limited information that SIS produced in response to the Court’s 
    1          (2) SIS’s damages expert’s updated Schedules appended to his expert report based upon 
    2  || financial data produced by the parties after the close of discovery are not subject to the prohibition 
    3    against offering any evidence or argument about what the “but for” world would look like after 
    4    November 2022; 
    5          (3) SIS’s damages expert is not prohibited from testifying regarding SIS’s lost profits in 
    6 || the “but-for” world corresponding to the period after November 2022 through 2026; and 
    7          (4) information available after November 10, 2022, which is disclosed or covered in the 
    8  || parties’ expert reports and which the parties had a full opportunity to explore through the 
    9    subsequent expert deposition process are not subject to the prohibition against offering any 
   10  || evidence or argument about what happened after November 2022. 
   11          IT IS SO ORDERED. 
a    12    Dated: December 11, 2024 

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                                                         ARACELI MARTINEZ-OLTUL 
      15                                                    United States District Judge 
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