Cooley v. C.R. Bard, Inc.

• Court: District Court, S.D. California
• Decided: June 26, 2023
• Docket: 3:22-cv-01754
• Status: Unknown

Opinion

1 2 3 4 5 6 7 8 UNITED STATES DISTRICT COURT 9 SOUTHERN DISTRICT OF CALIFORNIA 10 11 LINDA COOLEY, Case No.: 3:22-cv-1754-MMA-KSC

12 Plaintiff, ORDER REGARDING DISCOVERY 13 v. DISPUTE

14 C.R. BARD, INC. et al.,

15 Defendants. 16

17 I. Introduction 18 On May 17, 2023, counsel for all parties called Chambers with a discovery dispute. 19 See Doc. No. 23. Counsel spoke with the Court’s staff at great length, and the Court set the 20 matter for hearing with directions to lodge the discovery requests at issue for the Court’s 21 review. Id. The Court held a telephonic hearing with counsel on June 7, 2023. Doc. No. 24. 22 Based on the information provided to the Court’s staff, the parties’ lodgments, and the 23 arguments made during the hearing, the Court understands plaintiff seeks an order 24 compelling further responses from defendants to plaintiff’s first Request for Production 25 (“RFP”) numbers 7, 8, and 11. The Motion is granted in part and denied in part as explained 26 in this Order. 27 //// 28 1 II. Factual Background 2 This is a personal injury case, one of thousands of products liability cases filed 3 against defendants C.R. Bard, Inc. and Bard Peripheral Vascular, Inc. (collectively “Bard”) 4 based on Bard’s development and sale of retrievable inferior vena cava (“IVC”) filters. See 5 generally Doc. No. 1 ¶¶ 9-59. Plaintiff’s doctor implanted Bard’s first generation IVC 6 filter, the Recovery filter, in plaintiff in 2005. Id. ¶ 60. In the intervening years, Bard 7 introduced five successive generations of its IVC filters into the market: the G2 Filter, the 8 G2 Express Filter, the Eclipse Filter, the Meridian Filter, and, most recently, the Denali 9 Filter. Only the Denali filter remains on the market. In November 2020, plaintiff discovered 10 the filter had fractured. See id. At present, plaintiff alleges fragments of the filter have 11 lodged themselves in her heart, lung, and spine. See id. 12 The vast majority of the Bard IVC filter cases, which involved every generation of 13 Bard filter, were consolidated for common discovery purposes in a Multi District Litigation 14 (“MDL”) proceeding before Judge David G. Campbell in the District of Arizona. See In 15 re Bard IVC Filters Products Liability Litigation, No. MDL 15-2461; see also Doc. No. 16 15-1. MDL discovery closed in 2017, and Judge Campbell issued a comprehensive remand 17 order, the final version of which the parties to this case attached to their Joint Discovery 18 Plan on April 26, 2021. See Doc. No. 15-1. 19 Because this case was not filed until the MDL had closed and the final remand order 20 issued, it was not eligible for inclusion in the MDL proceedings. Accordingly, this Court 21 is not bound by the MDL orders. At the same time, the Court considers the MDL 22 proceedings and orders entered therein highly persuasive because Judge Campbell, as the 23 judge presiding over the MDL, had great familiarity with the facts surrounding the Bard 24 IVC filter litigation and the applicable law. His orders reflect careful examination of the 25 arguments advanced by all parties, resulting in sound determinations. The Court thus 26 believes it prudent to avoid reinventing the wheel to the greatest extent practical here. 27 Fortunately, in an admirable show of common sense, the parties to this matter generally 28 concur, as they have agreed between themselves to make use of the MDL common 1 discovery, and to limit local discovery in this case (as much as is practicable) to case 2 specific issues. The parties, however, do not agree in all respects, which brings us to the 3 narrow disputes now at issue which the Court must resolve. 4 III. Analysis of the Parties’ Discovery Dispute 5 Plaintiff moves to compel further responses to RFP Nos. 7, 8, and 11. A party 6 seeking discovery may move the Court to issue an order compelling production. Fed. R. 7 Civ. P. 37(a). This Court has broad discretion to permit or deny discovery. Hallett v. 8 Morgan, 296 F.3d 732, 751 (9th Cir. 2002). Discovery must be “relevant to any party's 9 claim or defense and proportional to the needs of the case.” See Fed. R. Civ. P. 26(b)(1). 10 Ninth Circuit case law does not clearly answer the question of whether the party seeking 11 discovery bears an initial burden of demonstrating the relevance of that discovery, or 12 whether the party resisting discovery must make a showing of irrelevance to sustain an 13 objection. See Fei Fei Fan v. Yan Yao Jiang, 2023 U.S. Dist. LEXIS 6544, at *5-6 (D. Nev. 14 Jan. 13, 2023); V5 Techs v. Switch, Ltc., 334 F.R.D. 306, 309-10 (D. Nev. 2019). It is 15 settled, however, that if the information sought is relevant, the party resisting discovery 16 bears the ultimate burden of convincing the Court that the discovery sought should not be 17 permitted. See V5 Techs, 334 F.R.D. at 309 (citing Blankenship v. Hearst Corp., 519 F.2d 18 418, 429 (9th Cir. 1975)). 19 The essential nexus of the parties’ disagreement over the RFPs at issue is whether 20 they are relevant and proportional to this matter, particularly in light of the vast swaths of 21 common discovery available to the parties following the MDL. The Court will address each 22 RFP in turn. 23 (A) Request for Production No. 7 24 Plaintiff’s RFP No. 7 states:

25 Produce all DOCUMENTS AND ESI EVIDENCING or RELATING to any 26 request made by the Food and Drug Administration for YOU to conduct post- market surveillance of the Recovery Filter, G2 Filter, G2 Express Filter, 27 Eclipse Filter, Meridian Filter and/or the Denali Filter; and DOCUMENTS 28 and ESI, including communications, plans, reports, or other information YOU 1 submitted to the Food and Drug Administration in response.

3 Counsel for the parties explain this request concerns the Predicting the Safety and 4 Effectiveness of Inferior Vena Cava Filters (“PRESERVE”) study, which observed the 5 relative safety and effectiveness of multiple IVC filters from multiple manufacturers, 6 including the Denali filter produced by Bard. The PRESERVE study was instigated, at 7 least in part, at the insistence of the FDA, which plaintiff’s counsel describes as an 8 “unusual” circumstance that demonstrates the dangerous nature of removable IVC filters 9 generally, and Bard’s products in particular. The study itself has been published, and the 10 results are available to the public.1 11 Plaintiff does not dispute that the results of the study are available to her, and she 12 does not seek to compel Bard to produce the actual study. Rather, she contends Bard should 13 produce all correspondence between Bard and the FDA, or between Bard and any other 14 parties related to the study; and Bard should also produce documents created and circulated 15 internally that pertain to the PRESERVE study. The main thrust of plaintiff’s argument is 16 that subsequent generations of Bard’s IVC filters, including the Denali filter, can be offered 17 into evidence as reasonable and feasible alternative designs to the Recovery filter 18 implanted in plaintiff. 19 As a threshold issue, Bard argues the study, and all ancillary documents, are 20 irrelevant to plaintiff’s claims because plaintiff was implanted with the first-generation 21 Recovery filter, which had been off the market for more than a decade prior to the 22 introduction of the Denali filter that was the subject of the PRESERVE study. Bard 23 suggests plaintiff has all the information she needs because she has access to the study, and 24 her expert witnesses can use and refer to the PRESERVE study in their reports and when 25 they testify. As argued, collecting, reviewing, and producing ancillary documents that 26

27 1 The Court was easily able to access the results of the study at 28 1 relate to the PRESERVE study is disproportionate to the needs of the case given the low 2 probative value of anything likely gleaned from any such documents. Bard argues that 3 Judge Campbell, who provided over the MDL and had the greatest familiarity with the 4 common discovery conducted in that proceeding, issued exactly such an order in his own 5 cases. See Kathleen A. Shea v. C.R. Bard, Inc. et al., 2:16-cv-03088-DGC, Doc. No. 16 at 6 3 (D. Ariz. August 7, 2020). 7 Plaintiff may well be able to offer the design of the Denali filter as a reasonable, 8 feasible alternative to the original Recovery filter; and if that is the case, the PRESERVE 9 study may be a useful repository of information on which plaintiff’s expert(s) may rely. 10 But having access to the study itself provides plaintiff with sufficient information. 11 Expanding discovery to Bard’s participation in the PRESERVE study is minimally 12 relevant, if at all, to this case because the PRESERVE study exclusively tracked patients 13 implanted with the Denali filter, which is five generations removed from the filter placed 14 in plaintiff. Plaintiff has not convinced the Court that the production of Bard’s ancillary 15 communications (whether internal or with third parties) will do anything to advance the 16 merits of the case. Rather, the discovery sought is not proportional to the needs of this 17 case. The Motion to Compel further responses to RFP No. 7 is therefore DENIED. 18 (B) Request for Production No. 8 19 RFP No. 8 states: 20 Produce all DOCUMENTS AND ESI EVIDENCING or referring to all data analysis or trends of adverse events that were reported to YOU regarding the 21 Recovery Filter, G2 Filter, G2 Express Filter, Eclipse Filter, Meridian Filter 22 and/or the Denali Filter, including any studies, research or documents prepared to reflect any analysis or trend. 23

24 This RFP essentially seeks discovery of any documentary evidence in Bard’s 25 possession that relates in any way, shape, or form to failures and other adverse events for 26 all of Bard’s IVC filters. As the Court understands it, an “adverse event” occurs when the 27 filter fails to perform as intended, for example, if a portion of the filter breaks off while 28 1 implanted in the patient or if the filter “migrates” along the patient’s vena cava, regardless 2 of whether it causes any particular injury to a patient. 3 The parties agree Bard has produced the following categories of information 4 pertinent to adverse events: (1) Trackwise data; (2) fracture reports; and (3) Quality 5 Management Board Reviews (“QMBRs”). As the Court understands based on the parties’ 6 explanations, Trackwise is a software program Bard uses to track the various failures and 7 adverse events attributed to its IVC filters when Bard receives patient complaints, which it 8 maintains in Trackwise complaint files. Bard contends the entire system itself is not 9 suitable for production and inspection without imposing an extraordinary burden on Bard, 10 but it has produced a spreadsheet of data exported from Trackwise. Bard argues the export 11 is sufficient, but plaintiff characterizes the export as containing some, but not all, of the 12 data in Bard’s complaint files. More specifically, plaintiff suggests the exported 13 spreadsheet excludes some of the supporting documentation—e.g., communications from 14 patients and physicians or relevant medical records—included in Bard’s complaint files.2 15 However, plaintiff is generally satisfied with the Trackwise data because Bard’s reports, 16 including the fracture reports and (to a lesser extent) QMBRs, that have already been 17 produced contain sufficient adverse event data. There remain some narrow disputes 18 concerning Bard’s reports. 19 20

21 2 Plaintiff’s counsel suggests the supporting documents are discoverable because Bard 22 may have imprecisely translated the information contained in the supporting documents 23 into Trackwise. At this point, plaintiff’s concern is speculative at best. Bard’s counsel explains that producing all the supporting documents from every complaint file would be 24 excessive, particularly because not all complaint files are germane to plaintiff’s case, but 25 if plaintiff were able to articulate a need for a particular document or documents, counsel could meet-and-confer about having them produced. The Court directs the parties to do 26 exactly that. If plaintiff can articulate a reason why specific documents stored in Trackwise 27 but not produced in this matter are relevant to this case, as opposed to merely relevant to Bard IVC products liability litigation in general, discovery of those documents might be 28 1 Fracture reports and QMBRs are two different kinds of reports maintained by Bard 2 in the ordinary course of business. They differ in matters of form and the level of detail 3 provided, but both include information about adverse events related to Bard’s various IVC 4 filters. Plaintiff is particularly concerned with fracture reports here, which her counsel 5 characterizes as more detailed in terms of adverse event data, and therefore more useful on 6 the merits. Plaintiff first notes the production of Bard’s fracture reports ended years ago, 7 and plaintiff suspects that more recent fracture reports, or analogous documents that serve 8 the same function as fracture reports, have not been produced. Second, plaintiff seeks 9 ancillary internal documents that generally concern Bard’s internal analysis and assessment 10 of the adverse events, rather than the raw data about the adverse events themselves. 11 As to the first issue, Bard’s counsel represents that Bard stopped preparing fracture 12 reports in approximately March 2017, which explains why Bard’s document productions 13 do not include reports post-dating that time. Plaintiff’s counsel rejoins by pointing out that 14 federal regulatory compliance obligates Bard to track failure rates in its devices, and he 15 questions whether Bard simply stopped tracking fracture and failure rates, and/or whether 16 the discontinued fracture reports have been replaced by another compilation and reporting 17 process not yet produced in discovery. 18 In a show of admirable candor, Bard’s counsel acknowledged during oral argument 19 that he was uncertain whether the reporting requirement formerly satisfied by the fracture 20 reports is currently being satisfied with another reporting procedure. He suggested Bard 21 may simply be tracking fracture rates as part of its internal complaint files, the relevant 22 portions of which have been exported from Trackwise and provided to plaintiff. However, 23 after conferring with his client, Bard’s counsel was able to confirm that Bard also produces 24 and maintains Bard Quarterly Monthly Reports (“BQMRs”), which include information 25 about IVC filters and associated adverse events. Bard’s counsel represents the BQMRs are 26 a kind of antecedent to the more comprehensive QMBR, and he suggests the relevant 27 information from the BQMR is contained in the QMBR. He also suggests it would be cost- 28 prohibitive to produce BQMRs in discovery because they cover more than Bard’s IVC 1 filters, and they must be reviewed to ensure non-discoverable patient personally identifying 2 information is not inadvertently produced. Plaintiff’s counsel suggests the BQMR contains 3 more granular detail about adverse IVC filter events than the QMBR, and he suggests it is 4 a better means of discovering adverse event data than the unwieldy Trackwise exports. 5 Plaintiff argues the BQMRs are not distinguishable from fracture reports and QMBRs, and 6 they should therefore be produced. 7 The Court will follow the line of reasoning employed by Judge Campbell, who, in 8 managing cases on remand, required Bard to supplement disclosures of “adverse event 9 data,” even though it would technically constitute “common” discovery. See Kathleen A. 10 Shea v. C.R. Bard, Inc. et al., 2:16-cv-03088-DGC, Doc. No. 16 at 3 (D. Ariz. August 7, 11 2020); see also Lalond v. C.R. Bard, Inc., 1:19cv01516-DAD-BAM, 2020 U.S. Dist. 12 LEXIS 22846, at *6 (E.D. Cal. Feb. 7, 2020) (imposing identical post-remand adverse 13 event data supplementation and noting two other District Court cases adopting the same 14 rationale). Adverse event data is germane to the central issues of liability in this case, and, 15 when collected by Bard in a report or other repository (whether as a matter of regulatory 16 compliance or otherwise) is relevant and not unduly burdensome to produce in discovery. 17 Bard’s BQMR’s fall within the scope of adverse event data reasonably required to be 18 supplemented here after the MDL, and Bard is ordered to produce the BQMRs to plaintiff 19 in this action. 20 The ancillary, internal documents related to Bard’s analyses of its device failures are 21 another matter. Plaintiff suggests Bard had a practice of tracking the failure rates of its 22 devices and periodically evaluating those rates against predetermined guidelines to 23 determine whether to recall any of the retrievable IVC filters. Plaintiff now seeks to 24 discover all the documentary evidence of Bard’s internal deliberations about whether any 25 of its filters should be recalled. Plaintiff describes these documents as probative of Bard’s 26 ongoing duty to warn of the potential dangers associated with a fractured recovery filter 27 and whether such duty was breached in this case. The Court perceives an outcome 28 determinative flaw in this line of reasoning. 1 The parties hotly dispute whether California law imposed a duty to warn of dangers 2 that became known to Bard only after the IVC filter was placed into plaintiff. If such an 3 ongoing duty exists, plaintiff contends Bard should have warned plaintiff (or more likely 4 her physicians) of dangers inherent in the Recovery once it became aware that a large 5 number of recovery filters were fracturing and injuring patients. Bard contends no such 6 ongoing duty exists as a matter of California law, and it discharged any duty to warn when 7 it told plaintiffs doctors about all dangers known to Bard at the time the device was 8 originally sold and implanted. The Court does not need to decide the issue because, 9 assuming California law imposes a post-sale duty to warn, that duty indisputably sounds 10 in negligence, and California negligence law is axiomatically based on an objective 11 “reasonableness” standard. See Regents of Univ. of Cal. v. Superior Ct., 29 Cal. App. 5th 12 890, 904 (2018). Indeed, the post-sale duty to warn at issue here is based on section 10 of 13 the Restatement (Third) of Torts: Products Liability, which looks at whether a “reasonable” 14 seller would provide a post-sale warning. See also Restatement (Third) of Torts: Products 15 Liability, § 10 cmt. b (“The standard governing the liability of the seller is objective: 16 whether a reasonable person in the seller’s position would provide a warning. This is the 17 standard traditionally applied in determining negligence.”). 18 Thus, assuming an ongoing duty to warn applied, plaintiff can establish whether 19 Bard should have issued a warning here based solely on the raw adverse event data. What 20 Bard did with that data as a subjective matter is generally irrelevant to the ultimate calculus 21 of what an objectively reasonable seller in Bard’s position would or should have done.3 22 23 24 3 Bard’s response to the various adverse events is much more relevant to the issue of 25 breach. However, as the Court understands it, the question of duty is the focus of this case, at least as to the post-sale duty to warn, because it is essentially undisputed that Bard, 26 believing it had no such duty, issued no warnings other than those provided at the time of 27 sale. Thus, even to the extent the discovery at issue here is relevant to proving a potential breach of the post-sale duty to warn, it is cumulative and thus disproportionate to the needs 28 1 The value to this case of Bard’s internal deliberations is therefore de minimis at best, 2 production of the documents is not proportional, and Bard’s internal communications about 3 the adverse event data in its possession fall beyond the scope of discovery. Accord Shea, 4 2:16-cv-03088-DGC, Doc. No. 16 at 3 (noting the “voluminous and comprehensive fact 5 and expert discovery” conduct during the MDL and ruling “the Court will not reopen 6 general fact or expert discovery”). 7 Plaintiff’s Motion to Compel further responses to RFP No. 8 is accordingly 8 GRANTED IN PART AND DENIED IN PART. Bard must produce the BQMRs that it 9 has not yet produced, but it is not obligated to collect and produce ancillary internal 10 documents related to IVC filter adverse event data. 11 (C) Request for Production No. 11 12 Plaintiff’s RFP No. 11 states: 13 Produce all DOCUMENTS AND ESI EVIDENCING or RELATING to any communications whether by e-mail, telephone, facsimile, or verbal between 14 YOU and Plaintiff's health care providers Brian Moore, M.D., Jong Hwan 15 Yun, M.D., Sharp Grossmont Hospital in La Mesa, California, or Kaiser Permanente Zion Medical Center in San Diego, California regarding the 16 safety and/or efficacy of the Recovery Filter, G2 Filter, Eclipse Filter, 17 Meridian Filter, and/or Denali Filter.

18 This RFP has provoked a dispute between the parties about how to search for and 19 produce responsive ESI. The parties agree that Dr. Moore implanted the Recovery filter in 20 plaintiff, and that Dr. Yun is her primary care physician. The two medical centers identified 21 in the RFP are where plaintiff has received medical care related to the Recovery filter, 22 including but not limited to the original implantation, and where she is currently receiving 23 treatment. Plaintiff wants Bard to turn over every communication in its possession that is 24 (a) pertinent to all of the retrievable IVC filters identified in the RFP; and (b) between Bard 25 and either of the doctors or medical facilities listed in the RFP, whether or not such 26 communications pertain to plaintiff. 27 28 1 There are multiple sources of ESI at issue here. Plaintiff’s first dispute concerns a 2 large volume of ESI that was collected as part of the MDL proceedings. The documents 3 are kept in a database, and they can be searched with keywords to locate responsive ESI 4 on a case-by-case basis. Bard has agreed to search these collected-but-not-produced 5 documents using a series of keywords, which includes the plaintiff, her treating physicians, 6 and the sales representatives responsible for covering the general geographic area during 7 the period when the device was implanted in plaintiff—all of which Bard’s counsel 8 represents are run using certain “anchor terms.” Plaintiff disagrees with the search terms 9 Bard has used. 10 The second prong of the dispute is that plaintiff also wants Bard to collect and review 11 ESI from other ESI custodians. Specifically, two Bard employees who held the role “Vice 12 President of Quality.” This new ESI would fall beyond the scope of the ESI that was 13 collected during the MDL proceedings. Bard objects to engaging in a second round of ESI 14 collection and estimates the costs of doing so could exceed $100,000, which it considers 15 disproportionate to the needs of the case. Plaintiff suggests Bard’s estimate of the economic 16 burden here is purely speculative and not founded on any actual evidence. Moreover, 17 plaintiff has had no opportunity to challenge Bard’s assessment here, which may well 18 include sources of financial burden (such as reviewing for privilege claims) not properly 19 included as a matter of law. 20 As to the first issue, the Court does not relish the task of refereeing disputes about 21 keyword search terms because the parties, not the Court, have a much better idea of the 22 most effective way to gather responsive documents. The thrust of plaintiff’s complaint here 23 is that Bard, particularly through its use of “anchor terms” in many search strings, is using 24 search terms that are too narrow. Plaintiff fears Bard’s keyword searches will exclude 25 information relevant to this case. Bard argues plaintiff’s keywords are too broad and would 26 return a glut of documents not relevant to this case. However, because the ESI at issue has 27 been collected and stored in a readily searchable format, Bard generally admits the burden 28 of running additional search strings is minimal. Bard is accordingly ordered to search the 1 || collected-but-not-produced ESI using plaintiff's keywords, but with the following caveat: 2 plaintiff must restrict her proposed keywords to collect information pertinent to the 3 Recovery filter, not the subsequent generations of filters. 4 As to whether Bard should engage in a second round of ESI collection to broaden 5 scope of discovery, plaintiff has not shown the Court how the information is relevant 6 || to plaintiff's injuries. Given the low relevance of this information, which is cumulative of 7 common discovery already conducted, the Court finds that conducting fact discovery 8 collect more ESI that would sweep in additional custodians is accordingly not 9 || proportional to the needs of this case. Plaintiff's Motion to Compel further responses to 10 || RFP No. 11 is accordingly GRANTED IN PART AND DENIED IN PART #4 11 IV. Conclusion 12 Plaintiff's motion to compel further responses to RFP No. 7 is DENIED. □□□□□□□□□□□ 13 |}motion to compel further responses to RFP Nos. 8 and 11 is GRANTED IN PART AND 14 || DENIED IN PART as explained in this Order. 15 ||Dated: June 26, 2023 16 Wi (Be “a 7 Hori. Karen 8S. Crawford United States Magistrate Judge 18 19 20 21 22 || 24 The Court urges the parties to be reasonable when negotiating search terms as 25 |/ordered. If plaintiff produces a voluminous list of search strings that, by design or by 5 accident, unreasonably burden Bard, Bard may yet object. But the Court expects Bard to 6 grant plaintiff some latitude, as the burden of searching the pre-collected ESI is minor, and 27 Court has spared Bard the burden of collecting ESI beyond that which has already been 28 collected. If the parties reach a bonafide dispute about search terms, they must meet and confer before contacting the Court.