Source: s3://data.kl3m.ai/documents/govinfo/USCOURTS/USCOURTS-azd-2_15-md-02641/USCOURTS-azd-2_15-md-02641-2/pdf.json

Nature of Suit Code: 365
Nature of Suit: Personal Injury - Product Liability
Cause of Action: 28:1332 Diversity-Product Liability

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WO 

IN THE UNITED STATES DISTRICT COURT 

FOR THE DISTRICT OF ARIZONA 

IN RE: BARD IVC FILTERS PRODUCTS 

LIABILITY LITIGATION 

This Order Relates to: All Actions 

MDL No. 2641 

 Defendants C. R. Bard, Inc. and Bard Peripheral Vascular Services, Inc. (“Bard”) 

seek a protective order to prevent Plaintiffs from using the December 15, 2004 report of 

Dr. John Lehmann. Doc. 306. The issues are fully briefed (Docs. 379, 412), and the 

Court heard oral argument on January 29, 2016 (Doc. 507). The Court concludes that no 

additional discovery or evidentiary hearing is necessary to resolve this issue. For the 

following reasons, the Court will grant Bard’s motion. 

I. Background. 

 The facts in this section are taken largely from testimony given in an evidentiary 

hearing in Alexander v. Bard, No. 3:12-CV-05187-O-BK (N.D. Tex. June 11, 2014). See 

Doc. 319-2 at 7-137. The Court will explain later in this order why it finds the testimony 

credible. 

 Dr. Lehmann is a consultant who has provided different services to Bard at 

different times. Beginning in late 2003, Dr. Lehmann was retained to serve as Bard’s 

acting director of medical services. Doc. 319-2 at 93, 107-08. Dr. Lehmann served in 

this capacity until Bard hired Dr. David Ciavarella to replace him in May 2004. 

Docs. 319-2 at 93-94; 412-1 at 6. As acting medical director, Dr. Lehmann reviewed and 

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approved documents, prepared health hazard evaluations (“HHE”) and remedial action 

plans (“RAP”), responded to queries from various medical divisions, and assisted in 

Bard’s hiring of Dr. Ciavarella. Doc. 319-2 at 93-96. In this role, Dr. Lehmann drafted 

two HHEs that are particularly relevant to this dispute: the March 10, 2004 HHE 

(Doc. 445-1 at 4-15), and the April 27, 2004 HHE (Doc. 414 at 3-15), both of which 

address Recovery Filter migration events. The Law Department occasionally asked Dr. 

Lehmann in his capacity as acting medical director to review medical records for 

particular cases. Doc. 319-2 at 30. Once Bard hired Dr. Ciavarella, Dr. Lehmann did not 

work on anything related to the Recovery Filter until the Law Department retained his 

services in November 2004. Id. at 102. 

 In early 2004, Bard began receiving notices of adverse events associated with the 

Recovery Filter. For example, in February 2004 Bard learned of a patient death related to 

the migration of a Recovery Filter. Docs. 319-2 at 40-41; 445-1 at 5. In April, Bard 

learned of a second migration death associated with the filter. Doc. 414 at 4. Bard’s 

assistant general counsel, Donna Passero, began to receive letters demanding 

compensation from lawyers and patients who had experienced such adverse events. Doc. 

319-2 at 25. In June, Passero responded to a letter that raised possible product liability 

and medical malpractice claims. Doc. 319-2 at 28-29. In July, Bard notified its 

insurance carrier of potential claims involving the Recovery Filter. Docs. 319 at 27-29; 

319-2 at 29, 91. These potential claims led the Law Department to retain Dr. Lehmann to 

conduct a broad risk assessment of the Recovery Filter. Doc. 319-2 at 38-39. 

 The Law Department retained Dr. Lehmann as a consultant in November 2004. 

Id. at 2-3, ¶ 6, 93. On November 15, 2004, Dr. Lehmann and Judith Reinsdorf, Bard’s 

General Counsel, executed a consulting agreement. Docs. 319-2 at 3, ¶ 8, 36, 94; 335 at 

3-9. The agreement said that Dr. Lehmann’s services would be provided in “anticipation 

of litigation.” Doc. 335 at 3, ¶ 1. Dr. Lehmann’s work for the Law Department was 

unlike the work he had performed as acting medical director; he was retained to provide a 

broad assessment of the risks associated with Bard’s Recovery Filter to assist the Law 

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Department in advising Bard on the extent of its legal exposure. Doc. 319-2 at 31-32, 96. 

Dr. Lehmann reviewed relevant medical literature, examined the Recovery Filter 

complaints Bard had received up to that point, analyzed data from the FDA’s adverse 

event reporting database (known as “MAUDE”), reviewed bench testing data for the 

Recovery Filter and its competitors, and prepared a written report of his findings. 

Docs. 319-2 at 97-98; 335 at 9. During this investigation, and at Passero’s direction, Dr. 

Lehmann communicated with “a small and limited number of Bard employees for the 

purpose of obtaining and providing information in order to” complete his work. 

Doc. 319-2 at 3, ¶ 10.

 On December 15, 2004, Dr. Lehmann submitted his report (“Report”) to Passero. 

Docs. 319-2 at 3, ¶ 11, 98, 104-05; 335 at 3, ¶ 2, 11. The Report contained a header on 

every page stating that it was “[p]rivileged and confidential,” “[a]ttorney work product,” 

and “[p]ursuant to contract.” See, e.g., Doc. 335 at 13. Passero distributed the Report to 

five Bard employees, including Bard’s general counsel. Doc. 319-2 at 3, ¶ 11, 36, 83. 

Eventually, the Report was distributed to approximately 12 Bard employees.1

 See id. at 

140-41, ¶¶ 3-4. Passero testified that she distributed the Report internally because it 

recommended that Bard immediately and urgently address several issues. Id. at 37; see 

also id. at 3, ¶ 11. Passero instructed the recipients “that the report and associated 

materials were confidential and that any further distribution of the report should be 

limited to only those employees or consultants who need the report to perform their 

proper job functions.” Id. at 3, ¶ 11, 83. There is no evidence that the Report was 

distributed to anyone other than Bard employees. 

II. Legal Standard. 

 “A party or any person from whom discovery is sought may move for a protective 

 

1

 The record does not clearly establish how the remaining Bard employees received the Report. Presumably, the individuals to whom Passero gave the Report passed it along to others. See Doc. 319-2 at 3, ¶ 11. The record is similarly unclear as to the identities of the 12 Bard employees who received the Report, although Bard’s briefing suggests that it is the 12 individuals named in Robert Carr’s February 3, 2014 affidavit. See Doc. 306 at 9, 16; see also Doc. 319-2 at 140-41, ¶¶ 3-4. 

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order in the court where the action is pending.” Fed. R. Civ. P. 26(c)(1). Rule 26(c) 

authorizes a district court to grant a protective order where “good cause” is shown. See 

San Jose Mercury News, Inc. v. U.S. Dist. Ct., 187 F.3d 1096, 1103 (9th Cir. 1999). 

“[T]he party seeking protection bears the burden of showing specific prejudice or harm 

will result if no protective order is granted.” Phillips v. G.M. Corp., 307 F.3d 1206, 

1210-11 (9th Cir. 2002) (quotation marks and citations omitted).

III. Analysis. 

 Bard argues that (1) the Report is protected from disclosure by the work product 

doctrine; (2) Plaintiffs have not shown a substantial need for the Report, or that they will 

experience an undue hardship in obtaining substantially equivalent information; and 

(3) Bard did not waive the Report’s work-product protection. The Court will explain 

why it agrees with these three assertions. 

 A. The Report is protected work product. 

“Ordinarily, a party may not discover documents and tangible things that are 

prepared in anticipation of litigation or for trial by or for another party or its 

representative (including the other party’s attorney, consultant, surety, indemnitor, 

insurer, or agent).” Fed. R. Civ. P. 26(b)(3)(A) (emphasis added). Courts in the Ninth 

Circuit use the “because of” test to determine whether dual purpose documents were 

prepared in anticipation of litigation: 

In circumstances where a document serves a dual purpose, that is, where it 

was not prepared exclusively for litigation, then the “because of” test is 

used. Dual purpose documents are deemed prepared because of litigation if 

in light of the nature of the document and the factual situation in the 

particular case, the document can be fairly said to have been prepared or 

obtained because of the prospect of litigation. In applying the “because of” 

standard, courts must consider the totality of the circumstances and 

determine whether the document was created because of anticipated 

litigation, and would not have been created in substantially similar form but 

for the prospect of litigation. 

United States v. Richey, 632 F.3d 559, 567-68 (9th Cir. 2011) (quotation marks and 

citations omitted). 

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 Before the start of this MDL, Passero and Lehmann testified in an evidentiary 

hearing in the Alexander case cited above. See Doc. 319-2 at 7-137. Attorneys who are 

part of the Plaintiffs’ Steering Committee in this MDL participated in the hearing and 

cross-examined Passero and Lehmann. Id. at 9. Bard relies on affidavits, documentary 

evidence, and testimony from the Alexander hearing to show that the Report was created 

because of anticipated litigation. See Doc. 306 at 9-13. 

 Documents confirm that, beginning in early 2004, Bard and its legal counsel began 

receiving notices that the Recovery Filter was associated with adverse events, including 

several deaths. See Docs. 319 at 14-25 (letters and emails involving lawyers and patients 

who had experienced adverse events associated with the Recovery Filter); id. at 31-80 

(Bard complaint files for patients who had experienced adverse events associated with the 

Recovery Filter); 319-1 at 1-230 (same). Bard received several threats of litigation. 

Doc. 319 at 14-16 (February 3, 2004); id. at 20-21 (June 7, 2004); id. at 23 (June 15, 

2004). In July 2004, Bard notified its insurance carrier of potential claims relating to the 

Recovery Filter. Docs. 319 at 27-29; 319-2 at 29, 91. Plaintiffs do not dispute this 

documentation. 

 Ms. Passero stated in an affidavit and during her testimony in Alexander that these 

events caused the Law Department to retain Dr. Lehmann as a consultant to conduct a 

broad risk assessment. Doc. 319-2 at 2 (¶¶ 6-7), 32. Dr. Lehmann confirmed this fact in 

his testimony. Id. at 93-95. 

 The consulting agreement was executed by Dr. Lehmann and Bard’s general 

counsel, and provided that Dr. Lehmann would report directly to, and take directions 

from, attorney Passero and the Law Department. Docs. 319-2 at 3, ¶ 9, 36, 94; 335 at 3-

9. The agreement stated that Dr. Lehmann’s services were being retained in “anticipation 

of litigation.” Doc. 335 at 3, ¶ 1. Dr. Lehmann’s Report was submitted directly to 

Passero. Docs. 319-2 at 3, ¶ 11, 98, 104-05; 335 at 3, ¶ 2, 11. The Report contained a 

header stating that it was “[p]rivileged and confidential,” “[a]ttorney work product,” and 

“[p]ursuant to contract.” See, e.g., Doc. 335 at 13. 

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 Plaintiffs argue that the Report was prepared in the ordinary course of business. 

See Doc. 379 at 12-19. They assert that Bard’s regular business includes remedial actions 

and “significant obligations to investigate and to report product failures, including 

conducting comparisons to competitor products.” Id. at 13. Plaintiffs point to Bard’s 

Regulatory Affairs Manual (Doc. 445-2 at 11-26, 35-53) and various statutes and 

administrative regulations as proof of these obligations. See Doc. 379 at 5-6, 13-14. 

Plaintiffs contend that Bard’s Regulatory Affairs Manual establishes that Dr. Lehmann 

was a member of Bard’s Product Assessment Team when he was serving as acting 

medical director. Id. at 13-14. Even if this is true, Plaintiffs fail to link this fact to Dr. 

Lehmann’s work in preparing the Report – work that was conducted months later and in 

his capacity as a consultant for the Law Department. 

 It is true that the statutes and regulations impose on Bard certain obligations: to 

maintain complaint and adverse event files (see 21 C.F.R. §§ 820.198, 803.1), investigate 

and report to the FDA certain product failures (see 21 C.F.R. § 820.198), undertake 

certain duties with respect to misbranded or adulterated devices (see 21 U.S.C. §§ 321, 

331, 351, 352, 360), and perform quality audits (see 21 C.F.R. § 820.22). But these laws 

do not impose an obligation to conduct the extensive and comparative statistical and 

bench testing data analyses undertaken by Dr. Lehmann and memorialized in the Report. 

Both Passero and Dr. Lehmann testified that the Report was an unusual undertaking, 

prepared in anticipation of litigation and unrelated to Bard’s regulatory obligations. See

Doc. 319-2 at 33-34, 38, 93-98, 108-10, 113-17. Even considering and crediting 

Plaintiffs’ evidence, the Court finds these assertions largely unrebutted. The Report was 

a more extensive and detailed analysis than Bard normally created. The evidence does 

not support Plaintiffs’ assertion that the Report was prepared in the ordinary course of 

Bard’s business. It supports a finding that the Report “would not have been created in 

substantially similar form but for the prospect of litigation,” Richey, 632 F.3d at 568, 

which satisfies the Ninth Circuit’s work product test.2

 

2

 At oral argument, the Court asked Plaintiffs to cite the specific statute or 

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 Plaintiffs also argue that the Report was used for Bard’s business purposes, and 

that there is no evidence it was used for litigation purposes. Doc. 379 at 14-15. Plaintiffs 

identify three internal Bard documents that contain information from the Report: the 

December 12, 2004 HHE, the January 4, 2005 RAP, and a December 9, 2004 draft of the 

January RAP. Id. at 14. A review of these documents confirms that the Report was used 

in creating them. Bard also admitted this fact during oral argument and in its reply brief. 

Doc. 412 at 7. But use of the Report to create internal HHEs and RAPs does not deprive 

the Report of work product protection. To the contrary, the “because of” test is directed 

at documents that serve both litigation and business purposes. See Richey, 632 F.3d at 

567-68 (“In circumstances where a document serves a dual purpose, that is, where it was 

not prepared exclusively for litigation, then the ‘because of’ test is used.”). The Court 

must determine whether “the document was created because of anticipated litigation, and 

would not have been created in substantially similar form but for the prospect of 

litigation.” Id. at 568. As discussed in this order, the evidence supports such a finding. 

 Plaintiffs also cite no authority for their argument that Bard must show the Report 

was actually used in litigation. The test is whether the Report was “prepared in 

 regulation that they claim required Bard to produce the Report. Plaintiffs cited 21 C.F.R. 

§ 820.22. The Court has closely reviewed this regulation, as well as related regulations, and concludes that § 820.22 did not require Bard to create the Report. First, § 820.22 focuses on quality systems. Id. (“Each manufacturer shall establish procedures for quality audits and conduct such audits to assure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system.”) (emphasis added). “Quality system” is defined as “the organizational structure, responsibilities, procedures, processes, and resources for implementing quality management.” Id. § 820.3(v). This suggests that the quality audits mentioned in § 820.22 

are focused on ensuring that manufacturers have proper quality assurance procedures in place and are, in fact, following those procedures. Second, the FDA’s comments in the 

preamble to the regulation confirm that this is the purpose of § 820.22. See 61 Fed. Reg. 52602, 52614 (Oct. 7, 1996) (“Quality audit[s] are for an internal audit and review of the 

quality system to verify compliance with the quality system regulation. The review and evaluations under § 820.22 are very focused. During the internal quality audit, the manufacturer should review all procedures to ensure adequacy and compliance with the regulation, and determine whether the procedures are being effectively implemented at all times.”). Third, the regulatory structure indicates that § 820.22 is focused on procedures and processes, rather than on a particular product’s safety. The regulation is located in Subpart B “Quality System Requirements,” and not in other subparts that more directly address the subject matter of the Report, such as Subpart G “Production and Process Controls,” Subpart I “Nonconforming Product,” or Subpart J “Corrective and Preventative Action.” 

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anticipation of litigation,” not whether it was used in litigation. Fed. R. Civ. P. 26(b)(3) 

(emphasis added). Requiring parties to show that a document was used in litigation 

would likely invade both the work product protection and the attorney-client privilege. 

 Plaintiffs similarly argue that the Report does not mention litigation, legal 

analysis, or litigation strategy. But work product protection is not limited to legal 

analysis or litigation strategy – it includes “documents and tangible things that are 

prepared in anticipation of litigation . . . for another party or its representative,” including 

by its “consultant” or “agent.” Id.; see Richey, 632 F.3d at 567 (“The work-product 

doctrine covers documents or the compilation of materials prepared by agents of the 

attorney in preparation for litigation.”). Thus, a purely technical analysis of a Bard filter 

prepared by one of Plaintiffs’ consulting experts in anticipation of litigation would be 

work product regardless of whether it included litigation strategy or legal analysis. 

Indeed, when work product must be disclosed under Rule 26 for substantial need, courts 

are directed to withhold “mental impressions, conclusions, opinions, or legal theories of a 

party’s attorney or other representative concerning the litigation,” making clear that work 

product includes more than this kind of legal analysis. Fed. R. Civ. P. 26(b)(3)(B). 

Plaintiffs contend that the Report is not work product because litigation was not 

“imminent.” Doc. 379 at 16-17. But Plaintiffs cite no authority for the proposition that 

work product protection applies only when litigation is imminent. The test is whether 

litigation was reasonably anticipated, and the adverse events and litigation threats of 2004 

clearly satisfied this requirement. 

Plaintiffs also argue that Bard did not reasonably anticipate litigation when it 

retained Dr. Lehmann because Bard had not yet implemented a litigation hold on 

documents and electronically stored information. Id. at 16. But even if Bard failed to 

implement a timely litigation hold as Plaintiffs contend – an issue the Court does not 

decide at this time – that fact would not prove that litigation was not reasonably 

anticipated. Parties can fail to comply with preservation obligations in the face of 

reasonably anticipated litigation. Plaintiffs do not dispute that deaths and injuries from 

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the Recovery Filter had been reported in 2004, that Bard had received demands for 

compensation, or that Bard had put its insurance carrier on notice of possible claims. The 

totality of the circumstances clearly shows that litigation was reasonably anticipated.

 Plaintiffs argue that the Report was prepared in the ordinary course of business 

because “Dr. Lehmann’s work was well underway long before he was given a contract 

with the Law Department.” Doc. 379 at 17. While there is no dispute that Dr. Lehmann 

worked as Bard’s acting medical director in late 2003 and early 2004, Dr. Lehmann 

testified in the Alexander hearing that this role terminated on the hiring of Dr. Ciavarella 

in May 2004 and that, other than occasional communications with Dr. Ciavarella, he 

performed no work for Bard until November 2004. Doc. 319-2 at 93-98. Dr. Lehmann 

also testified that the work he performed as acting medical director was substantially 

different from the work done to produce the Report. Id. Plaintiffs present no direct 

evidence to contradict this testimony. Plaintiffs instead identify several documents as 

indirect evidence that Dr. Lehmann’s work as acting medical director was related to his 

Law Department work that culminated in the Report: the March 10, 2004 HHE (Doc. 

445-1 at 4-15); an April 15, 2004 email (Doc. 443-1 at 5-8); and the April 27, 2004 HHE 

(Doc. 414 at 3-15). 

 Dr. Lehmann’s testimony directly addressed the differences between these HHEs 

and the Report. Dr. Lehmann testified that: HHEs were prepared pursuant to Bard’s 

regulatory obligations, while the Report was not; the purpose of HHEs was to “guide 

potential market actions or corrections,” while the purpose of the Report was to provide 

guidance on Bard’s risk and overall exposure from adverse events associated with the 

Recovery Filter; HHEs considered a product’s risks and benefits, while the Report 

considered only the Recovery Filter’s risks; HHEs each focused on a single adverse event 

involving migration, while the Report dealt with all adverse events associated with the 

Recovery Filter; and the Report involved detailed statistical analysis personally 

performed by Dr. Lehmann, while HHEs did not. See Doc. 319-2 at 96-98. The Court’s 

close review of the HHEs and the Report confirms these distinctions. 

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 The four-page HHE dated March 10, 2004 was prepared by Dr. Lehmann after the 

February 2004 death of a patient due to the migration of a massive blood clot and a 

Recovery Filter to the patient’s heart.3

 Doc. 445-1 at 5. The HHE focused on this single 

adverse event and discussed the placement of the filter, the patient’s risk factors, the 

autopsy report, and other medical evidence. Id. at 5-6. The HHE included a short review 

of other Recovery Filter migration complaints. Id. at 6. The HHE then addressed the 

following subjects: human exposure to the problem, general consequences, population 

exposed to risk, mitigating or predisposing factors, nature and seriousness of the risk, 

likelihood of occurrence, likelihood of harm, whether the product is essential to health, 

whether there are available alternatives, whether the problem must be corrected 

surgically, whether the problem is expected and within an acceptable statistical range, 

whether the problem can be field corrected, whether the problem is obvious to the user, 

whether the product can continue to be used with proper warnings, and whether the 

device is used only by specially-trained health care professionals. See id. at 6-8. The 

HHE concluded that “[t]here have been 3 migrations of the Recovery VC Filter in which 

the device ended up in or near the heart, with one fatality, in an estimated 6,402 sales 

through March 2, 2004, for a rate of 0.05%.” Id. This is the only statistical calculation in 

the HHE, and includes a warning that comparative assessments using data from “the 

MAUDE database do not yield reliable quantitative estimates.” Id. With respect to 

whether the problem is expected and within an acceptable statistical range, the HHE 

stated that “[e]stimates based on MAUDE and sales data suggest that there is no 

significant difference in the rates of these complications between devices, including the 

Recovery” Filter. Id. at 8. 

 The Report has a broader focus. It contains statistical analyses relating to selected 

types of adverse events associated with the Recovery Filter and other filters on the 

market, including rates of reported filter fractures, caval perforation, filter movement, 

filter embolization, and filter embolization deaths. Doc. 335 at 13. Using MAUDE data, 

 

3

 The April 27, 2004 HHE is similar to the March HHE in all relevant respects. 

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actual sales data for the Recovery Filter, and estimated sales data for other filters, the 

Report calculates and compares adverse event reporting rates for the Recovery Filter and 

seven other types of filters. Id. at 19-20. The Report then uses the reporting rates to 

calculate relative risks for each of the eight filters for different types of adverse events. 

Id. at 21-27. The Report also reviews Bard’s bench testing data that was used to 

determine migration resistance for each of the eight filters, and compares the bench data 

to the frequency of adverse events reported in the MAUDE data base. Id. at 31-33. The 

Report concludes that “[t]his data and analysis provides two significant signals (MAUDE 

rates and bench test data) that further investigation of the Recovery VCF filter 

performance in relation to migration and fracture is urgently warranted.” Id. at 16. This 

is a different focus than the HHEs. True, there are some similarities between the HHEs 

and the Report, but the documents clearly serve different purposes and their substantial 

differences corroborate Dr. Lehmann’s testimony that the Report was a different 

undertaking than the work he did as acting medical director. 

In the April 15, 2004 email relied on by Plaintiffs, Dr. Lehmann stated that 

“[c]omparison with other filters is problematic in many ways, and we should avoid / 

downplay this as much as possible.” Doc. 443-1 at 5. Plaintiffs argue that this statement 

shows that Dr. Lehmann performed the same work as acting medical director that he did 

in preparing the Report. But the fact that Dr. Lehmann – or others within Bard – did 

some comparisons with other filters while he was acting as Bard’s medical director does 

not prove that the detailed statistical analysis and evaluation of bench-testing results 

contained in the Report were done before his contract with the Law Department or for 

another reason. Nor have Plaintiffs cited any authority for the proposition that work 

product is not entitled to protection if it is similar in some way to work the person has 

done before. Rather, the test is whether the Report “would not have been created in 

substantially similar form but for the prospect of litigation.” Richey, 632 F.3d at 568. 

After examining the HHEs and the April 2004 email, and comparing them with the 

Report, the Court finds that they do not undercut the testimony of Dr. Lehmann that the 

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Report was prepared at the behest of the Law Department and would not have been 

created in substantially similar form otherwise. 

Finally, Plaintiffs cite language from the December 2004 draft RAP which states 

that Dr. Lehmann “was commissioned by Corporate Senior Management to provide an 

independent study of the risk/benefit of the [Recovery Filter] in bariatric patients.” 

Doc. 379 at 9 (emphasis added by Plaintiffs). Plaintiffs argue that this proves Dr. 

Lehmann was hired by the business, not by the legal department, to prepare the Report. 

But Dr. Lehmann’s consulting contract was signed by Judith Reinsdorf, Bard’s Vice 

President, General Counsel, and Secretary. Doc. 335 at 8. She clearly qualified as 

“Corporate Senior Management,” as stated in the draft RAP. She also was Bard’s lead 

in-house lawyer. The Court cannot conclude that the statement in the draft RAP is 

somehow inconsistent with the fact that the Report was prepared at the request of the 

Law Department and in anticipation of litigation.4

 In summary, the Court finds that the clear threat of litigation in 2004, Dr. 

Lehmann’s retention by the Law Department in November of that year, the contract he 

signed with Bard’s general counsel, the scope of work be performed under the contract, 

and the clear labeling of the Report as work product all support a finding that the Report 

was prepared because of anticipated litigation. Dr. Lehmann testified that his work in 

late 2003 and early 2004 as acting medical director was different than the work he did 

under the contract, and the documents cited by Plaintiffs do not undercut that testimony. 

To be sure, there are some general similarities between the HHEs and the Report, and the 

Report was used for some business purposes, but these facts do not contradict the clear 

evidence that the Report “would not have been created in substantially similar form but 

for the prospect of litigation.” Richey, 632 F.3d at 568. The Court finds no evidence to 

support Plaintiffs’ suggestion that the work product label for the Report was some kind of 

 

4

 What is more, this language did not appear in the January 4, 2005 final version of the RAP. See Doc. 306-1 at 43-44 (“As part of the ongoing evaluation of [the Recovery Filter], Bard requested an independent study of the risks and benefits of the [Recovery Filter], with an emphasis on its use in bariatric surgery and trauma patients.”). 

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grand ruse, implemented to hide unfavorable information. Based on the totality of the 

circumstances, the Court concludes that the Report was prepared “because of” anticipated 

litigation and is protected by the work-product doctrine. Fed. R. Civ. P. 26(b)(3)(A); 

Richey, 632 F.3d at 567-68. 

 B. Plaintiffs have not shown substantial need or undue hardship. 

 Work product protection is not absolute. A protected but otherwise discoverable 

document may be obtained in discovery if “the party shows that it has substantial need 

for the materials to prepare its case and cannot, without undue hardship, obtain their 

substantial equivalent by other means.” Fed. R. Civ. P. 26(b)(3)(A). The Advisory 

Committee has made clear that a “special showing” is required. See Bickler v. Senior 

Lifestyle Corp., 266 F.R.D. 379, 384 (D. Ariz. 2010) (citing Fed. R. Civ. P. 26(b)(3) 

advisory committee’s note (1970)). 

Bard argues that Plaintiffs have full access to all of the data analyzed in Dr. 

Lehmann’s Report and that their experts can – and already have in some of the 

consolidated cases – perform the same analysis. Plaintiffs do not disagree, but instead 

attempt to show their substantial need by arguing this: 

Yes, Plaintiffs can analyze the same data Dr. Lehmann did. Plaintiffs in 

other cases have even hired experts to do the same work. But Plaintiffs 

should not be required to present the evidence in this cumbersome fashion 

and incur the expense and delay associated with hiring an independent 

expert simply to show what Bard knew as of December 2004 and 

communicated to several high-ranking officials in its corporation. The 

Report does all of that. Why waste days of trial (in every MDL case 

remanded for trial) with the concomitant strain on judicial and party 

resources to employ, prepare, present, and depose experts, along with the 

inevitable Daubert hearing exercise, when all that same information is in 

one report provided to several Bard employees primarily used to comply 

with Bard’s reporting requirements to the FDA? 

Doc. 379 at 28. 

The Court finds this argument wholly unpersuasive. Plaintiffs essentially concede 

that they can create the substantial equivalent of the Report through their own experts, 

but argue – in this substantial and well-funded MDL proceeding – that they should not be 

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put to the time and expense of retaining their own experts. If this were a sufficient 

“special showing” to overcome work product protection, Bickler, 266 F.R.D. at 384, the 

protection would be lost in every case where the opposing side would have to expend 

meaningful resources to obtain the substantial equivalent of the work product. This is not 

the law. See, e.g., Fletcher v. Union Pac. R.R. Co., 194 F.R.D. 666, 671 (S.D. Cal. 2000) 

(citing 8 Charles Alan Wright & Arthur R. Miller, Federal Practice and Procedure § 

2025, at 374, n.15 (3d ed. 2015)) (finding “mere[] expense or inconvenience” insufficient 

to constitute undue hardship). 

Plaintiffs asserted during oral argument that there is a fact they cannot prove 

through their own experts: that Bard knew of Dr. Lehmann’s unfavorable conclusions. 

But Plaintiffs’ briefing on this issue suggestions otherwise: “Plaintiffs should not be 

required to . . . incur the expense and delay associated with hiring an independent expert 

simply to show what Bard knew as of December 2004.” Doc. 379 at 28 (emphasis 

added). What is more, Plaintiffs’ briefing includes many cites to evidence they claim 

shows that Bard knew about the problems arising from its filters, including a statement in 

which Dr. Lehmann, in his role as acting medical director, allegedly was urging Bard to 

downplay the problem. See Doc. 443-1 at 5 (“Bottom line: good filter, severe case, bad 

outcome, deep regret. This is the simple story we should repeat again and again. 

Comparison with other filters is problematic in many ways, and we should avoid / 

downplay this as much as possible.”). Plaintiffs asserted in oral argument that Dr. 

Lehmann’s report would make this point even more credibly, but the Court cannot 

conclude that enhanced credibility satisfies the special showing required to overcome 

work product protection. See Baker v. Gen. Motors Corp., 209 F.3d 1051, 1054 (8th Cir. 

2000) (“A party also does not demonstrate substantial need when it merely seeks 

corroborative evidence.”). 

It is undisputed that Plaintiffs have access to the same data that Dr. Lehmann 

relied on in creating the Report. Docs. 306 at 14; 379 at 28. Further, “Plaintiffs in other 

cases have even hired experts to do the same work.” Doc. 379 at 28; see Doc. 319-2 at 

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143-64 (expert report of Dr. Michael Freeman). Plaintiffs have not made the showing of 

substantial need or undue hardship required to overcome the Report’s work product 

protection. 

 C. Bard did not waive the Report’s work product protection. 

 Plaintiffs argue that Bard waived any claim to work product protection by 

(1) internal distribution of the report to 12 Bard employees, (2) disclosure of the report in 

the Phillips trial in the District of Nevada, (3) attempting to use work product protection 

as both a sword and a shield, and (4) using the Report in furtherance of a crime or fraud. 

See Doc. 379 at 20-27. The Court will address each argument separately. 

 1. Internal distribution of the Report. 

 “Courts have recognized that work product protection may be lost when the 

disclosure substantially increases the opportunity for potential adversaries to obtain the 

information.” Bickler, 266 F.R.D. at 384 (quotation marks and citation omitted). Bard 

contends that its distribution of the Report to 12 internal employees did not substantially 

increase the opportunity for Plaintiffs to obtain the Report. The Court agrees. 

 Passero distributed the Report to five people, including Bard’s general counsel, 

with instructions that it was confidential and distribution “should be limited.” Doc. 319-2 

at 3, ¶ 11, 36-37. Passero testified that she distributed the report internally because the 

Report recommended that Bard promptly take certain steps and she thought it important 

to give it “to people who would know what to do with that information.” Id. at 37. 

Eventually, the Report was distributed to a total of 12 Bard employees. See Doc. 319-2 

at 140-41, ¶¶ 3-4. 

 Plaintiffs argue that the Report was circulated without restrictions. They cite 

deposition testimony of Dr. Ciavarella that “he received the Report ‘without restriction’ 

as to its use,” and that he was “never instructed that the Report was secret or prepared in 

anticipation of litigation.” Doc. 379 at 10 (emphasis by Plaintiffs). Plaintiffs’ Exhibit 5 

contains several pages of Dr. Ciavarella’s deposition transcript, but none of them contains 

this testimony. See Doc. 445-2 at 1-9. The Court therefore cannot consider Ciavarella’s 

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statement in context. But even if it was made as quoted by Plaintiffs and is accepted as 

true, the Court cannot conclude that one high-level employee’s receipt of the Report 

without Passero’s restrictions substantially increased the risk that the Report would be 

distributed outside of Bard. Every page of the Report was labeled “[p]rivileged and 

confidential” and “[a]ttorney work product.” Doc. 335 at 13-46. In addition, Bard’s 

internal policies state that communications between Bard’s legal counsel and its 

employees are to be kept confidential, as are documents created in anticipation of 

litigation. Doc. 319-2 at 2, ¶ 5. 

 The Court concludes that Bard’s internal distribution of the Report to 12 

employees did not substantially increase the opportunity for Plaintiffs or others outside of 

Bard to obtain the Report. Bickler, 266 F.R.D. at 384. 

 2. Disclosures of the Report in the Phillips trial. 

 Courts have been willing to preserve a document’s work product protection where 

an earlier disclosure of the document was compelled. Bickler, 266 F.R.D. at 384 (citation 

omitted); see also Shields v. Sturm, Ruger & Co., 864 F.2d 379, 382 (5th Cir. 1989) 

(“When a party is compelled to disclose privileged work product and does so only after 

objecting and taking other reasonable steps to protect the privilege, one court’s disregard 

of the privileged character of the material does not waive the privilege before another 

court.”). In Phillips v. Bard, No. 3:12-CV-344-RCJ-WGC (D. Nev. Feb. 2, 2015), the 

Report was admitted into evidence during trial over Bard’s work product objection. See

Doc. 306-1 at 150-55; 159-60. Bard argues that this compelled disclosure did not amount 

to waiver. The Court agrees. 

 Bard took reasonable steps to protect the Report’s confidential nature during the 

Phillips trial. Bard objected to the Report’s use at trial, argued against its admission 

during a hearing in the middle of trial, and objected again when the Report was actually 

introduced in evidence. See Doc. 306-1 at 150-55, 159-60. The Court is not persuaded 

by Plaintiffs’ argument that “Bard failed to timely request that [the] Report (and other 

trial exhibits) be sealed.” Doc. 379 at 27. Bard actively opposed the use of the Report 

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during trial and moved to seal the Report at the conclusion of the trial. Doc. 412 at 15. 

Bard’s compelled disclosure was not a waiver of its work product protection. Bickler, 

266 F.R.D. at 384; Shields, 864 F.2d at 382.

 3. Sword and shield argument. 

 The attorney-client privilege and work product protection may not be used as both 

a sword and a shield. “Where a party raises a claim which in fairness requires disclosure 

of the protected communication, the privilege may be implicitly waived.” Columbia 

Pictures Television, Inc. v. Krypton Broad. of Birmingham, Inc., 259 F.3d 1186, 1196 

(9th Cir. 2001) (quotation marks and citations omitted). 

 Plaintiffs assert that Bard has selectively quoted the Report in several documents, 

including the December 17, 2004 HHE (Doc. 306-1 at 52-56) and the January 4, 2005 

RAP (id. at 39-50). Both the HHE and the RAP do repeat the Report’s findings that the 

Recovery Filter was experiencing significantly higher reporting rates of adverse events 

than comparable filters. See id. at 44, 53. The documents also convey some of the 

Report’s limitations, such as the lack of reliable data and the need to conduct follow-up 

research. See id. But Plaintiffs do not show how this use of the Report constitutes a 

sword. The sword-shield rulings stand for basic fairness – a party should not be allowed 

to use work product affirmatively to gain some advantage in litigation, and at the same 

time withhold the work product from scrutiny by asserting the work product protection. 

The use of data and conclusions from the Report in internal Bard documents, such as the 

RAPs and the HHEs, does not amount to such affirmative use, and fairness therefore does 

not demand disclosure of the full document. 

 Plaintiffs also point to representations that Bard made to “the FDA and the 

medical community that the Recovery [Filter] failed at the same rate as competition 

models while knowing from the Report that this was not true.” Doc. 379 at 21-22 (citing 

Doc. 443-1 at 5-8). For support, Plaintiffs cite an April 15, 2004 email from Dr. 

Lehmann. Doc. 443-1 at 5-8. But this email does not support Plaintiffs’ position. At the 

time, Dr. Lehmann could not have known from the Report that the Recovery Filter was 

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failing at higher rates than its competitors because the Report had not been created – it 

was not issued for another eight months. What is more, making a public statement 

contrary to what is contained in work product does not constitute use of the work product 

as a sword. The work product is not used at all in such a communication. The work 

product may contradict the public statement, but the sword-shield basis for waiver does 

not turn on impeachment value; it turns on the unfairness of using a document to make an 

affirmative assertion for one’s advantage while simultaneously withholding the document 

from scrutiny. Dr. Lehmann’s email did not do that. 

 4. Crime-fraud exception. 

 The attorney-client privilege and work product protection do not apply to 

communications made or work done in furtherance of a crime or fraud. In re Grand Jury 

Proceedings, 87 F.3d 377, 381 (9th Cir. 1996); United States v. Zolin, 491 U.S. 554, 562-

63 (1989); In re Richard Roe, Inc., 68 F.3d 38, 40 n.2 (2d Cir. 1995) (work product). A 

party that invokes the crime-fraud exception must show that: (1) “the client was engaged 

in or planning a criminal or fraudulent scheme when it sought the advice of counsel to 

further the scheme,” and (2) the work product was sufficiently related to and was made in 

furtherance of the intended, or present, continuing illegality. In re Napster, Inc. 

Copyright Litig., 479 F.3d 1078, 1090 (9th Cir. 2007) (quotation marks and citations 

omitted), abrogated on other grounds by Mohawk Indus., Inc. v. Carpenter, 558 U.S. 100 

(2009). 

 Plaintiffs argue that the crime-fraud exception can be established merely by 

showing “reasonable cause” to believe that the legal services were used to promote an 

unlawful scheme. Doc. 379 at 22. But the case law cited by Plaintiffs concerns grand 

jury proceedings, and the Ninth Circuit has noted that there is reason to apply a lower 

standard in such proceedings – which require speed and simplicity – than in civil cases. 

In re Napster, 479 F.3d at 1094. The Ninth Circuit has held that a party in a civil case 

must establish the crime-fraud exception by a preponderance of the evidence when 

challenging attorney-client communications. Id. at 1094-95 (“For several reasons, we 

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conclude that in a civil case the burden of proof that must be carried by a party seeking 

outright disclosure of attorney-client communications under the crime-fraud exception 

should be preponderance of the evidence.”). Plaintiffs do not address this holding, nor do 

they provide reason for the Court to conclude that a different standard should apply to 

work product protection. The Court concludes that the preponderance of the evidence 

standard should be applied to this work product challenge.5

 In an opening footnote on this issue, Plaintiffs cite a recall of another Bard product 

in 1990, criminal charges brought in 1993 against Bard related to other products, two 

MDL proceedings against Bard, and Bard’s settlement of a qui tam lawsuit. Doc. 379 at 

23-24 n.15. Plaintiffs provide no evidence linking these events to this case. Moreover, 

the crime-fraud exception does not apply to past conduct. Zolin, 491 U.S. at 562-63. 

 Plaintiffs assert that Bard committed a “cover up of adverse testing, injuries, and 

deaths associated with its filters,” which they contend is both fraudulent and criminal. 

Doc. 379 at 24. Plaintiffs produce the following evidence: Bard learned of the first 

reported death associated with the Recovery Filter in February 2004; in response, Bard 

formed a Crisis Communication Team; in April 2004, a Bard executive emailed Dr. 

Lehmann expressing concern about the Recovery Filter’s mortality rate; in July 2004, 

Bard issued an HHE that showed the Recovery Filter had a failure rate 28 times higher 

than other filters; the Report showed high rates of adverse events associated with the 

Recovery Filter; and witnesses have testified about the Recovery Filter’s high rate of 

adverse events. Id. at 24-25. Plaintiffs assert that Bard committed fraud by not reporting 

this information to the FDA, doctors, and patients, and by failing to issue a product recall.

 Bard presents contrary evidence and arguments. Doc. 412 at 13. Bard notes that 

 

5

 The Court finds that the four reasons given by the Ninth Circuit for adopting the preponderance standard for challenges to attorney-client communications apply as well to work product: (1) the importance of the work product protection has been recognized since Hickman v. Taylor, 329 U.S. 495 (1947); (2) the prima facie standard is not 

inconsistent with a preponderance standard; (3) Federal Rule of Evidence 104(a) applies to admissibility questions regarding work product and calls for a preponderance standard; and (4) the problem of limited access to proof is mitigated by the possibility of in camera 

review as well as the substantial need exception to work product protection. See In re 

Napster, 479 F.3d at 1095-96.

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the two deaths, which led to creation of the Crisis Communications Team, were both 

reported to the FDA. Doc. 319 at 32, 44. In addition, the adverse outcome rates set forth 

in the Report were based on adverse events in the MAUDE database, which is maintained 

by the FDA. Doc. 335 at 14. Bard thus asserts that FDA was fully aware of the deaths 

and adverse events Plaintiffs rely on for their fraud allegations. Bard also cites evidence 

of additional adverse-event-rate disclosures to the FDA in October 2004. Doc. 412 at 13. 

Bard further cites evidence that migration rates for the Recovery Filter were well below 

rates reported in medical literature for all IVC filters (Doc. 412 at 12), and that the overall 

adverse event rates for the Recovery Filter were small (id.). Finally, Bard notes that the 

FDA, which is aware of Recovery Filter adverse event rates, has never suggested that the 

Recovery Filter be recalled. Id. at 13. 

 Given the parties’ conflicting evidence and allegations, the Court cannot find by a 

preponderance of the evidence that Bard engaged in fraudulent or criminal conduct. 

Plaintiffs have failed to carry their burden of proving the crime-fraud exception. 

IV. Additional discovery or evidentiary hearing. 

 If the Court is inclined to reject their arguments, Plaintiffs ask for additional 

discovery and an evidentiary hearing. The Court declines this request for two reasons. 

 First, this issue has already been litigated in many state and federal courts that 

preceded this MDL. Thirteen court decisions have found the Report to be protected work 

product.6

 Four have found the Report subject to discovery.7 The Court does not find 

 

6 Alexander v. Bard, No. 3:12-CV-05187-O-BK (N.D. Tex.); Barkley v. Bard, No. 

CV2011-021250 (Ariz. Super. Ct.); Carr v. Bard, 297 F.R.D. 328 (N.D. Ohio 2014); 

Cason v. Bard, No. 1:12-CV-01288-MHS (N.D. Ga.); Ebert v. Bard, No. 5:12-CV01253-LS, 2014 WL 1632155 (E.D. Pa. Apr. 24, 2014); Jones v. Bard, No. 3:13-CV00599-K (N.D. Tex); Kilver v. Bard, No. 1:13-CV-01219-MMM-JEH (C.D. Ill.); Leus v. 

Bard, No. 13-CV-00585-W-GAF (W.D. Mo.); Peterson v. Bard, No. 3:13-CV-00528-

JJR-RLB (M.D. La.); Phillips v. Bard, 290 F.R.D. 615 (D. Nev. 2013) (Cobb, M.J.); 

Rackliff v. Bard, No. CV2011-021206 (Ariz. Super. Ct.); Stesney v. Bard, No. CV2012-

006103 (Ariz. Super. Ct.); Towlson v. Bard, No. CV2011-022334 (Ariz. Super Ct.). 

7 Giordano v. Bard, No. 37-2011-00069363-CU-PO-EC (Cal. Super. Ct.); Payne v. Bard, No. 6:11-CV-01582-ORL-37GJK (M.D. Fla.); Phillips v. Bard, No. 3:12-CV00344-RCJ-WGC (D. Nev.) (Jones, J.); Tillman v. Bard, No. 3:13-CV-00222-J-34JBT 

(M.D. Fla.). 

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these four decisions persuasive. In one, Giordano v. Bard, the California Superior Court 

denied Bard’s attempt to clawback the inadvertently produced Report without providing 

any comment or analysis. Doc. 306 at 4-5 n.2. In two others – Tillman v. Bard and 

Payne v. Bard – Magistrate Judge Toomey of the Middle District of Florida applied the 

more rigorous “primary purpose” work product standard, which protects “documents 

prepared principally or exclusively to assist in anticipated or ongoing litigation.” See 

Doc. 443-1 at 110-132. The fourth case, Phillips v. Bard, actually involved two 

conflicting decisions in Nevada Federal District Court. After briefing and a hearing, 

Magistrate Judge Cobb held that the Report was protected work product. See Doc. 306-1 

at 120-24, 133, 139-141. During trial, the plaintiff in Phillips sought to place the Report 

in evidence, Bard objected, and District Judge Jones – without the benefit of briefing – 

overruled the objection. Id. at 152-54. Thus, the four decisions which found the Report 

discoverable either were made without explanation, applied a different legal standard 

than the Ninth Circuit’s “because of” test, or were made without briefing. 

 Moreover, the fact that the Report has been litigated more than 15 times in a wide 

range of courts shows that it has been the subject to ample discovery and argument. And 

as noted above, it was the subject of an evidentiary hearing in Alexander v. Bard, in the 

Northern District of Texas. The plaintiff’s lawyers in that hearing are members of the 

Plaintiffs’ Steering Committee in this MDL. See Doc. 319-2 at 7. Bard was represented 

by the same lawyers who are representing it in this MDL. See id. at 8. 

 Given this prior litigation history, the Court cannot conclude that Plaintiffs have 

been disadvantaged in any way by a lack of discovery or opportunity to develop their 

arguments. See Fed. R. Civ. P. 26(b)(2)(C)(ii). 

 Second, the evidence the Court has considered in making this decision does not 

suggest that an evidentiary hearing is needed. The testimony of Passero and Lehmann is 

consistent with the documentary evidence. Plaintiffs have presented no evidence that 

causes the Court to think this is a difficult evidentiary issue requiring in-person 

credibility determinations. In short, this is not a close question. The Court therefore will 

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deny Plaintiffs’ request for additional discovery and an evidentiary hearing. There are 

more relevant and productive tasks to be completed in this MDL. 

V. Effect of this ruling on prior rulings in other cases. 

 The parties agree that this Court’s ruling should not affect any prior rulings on this 

issue in other cases. See Docs. 306 at 21-23; 379 at 29-30. The Court agrees. This 

ruling shall operate prospectively only, and shall apply in all MDL cases where the issue 

has not previously been decided. 

VI. Conclusion. 

 The Court finds that Bard will suffer specific prejudice or harm if Plaintiffs are 

permitted to use a Report entitled to work product protection in discovery or at trial. 

Bard has shown good cause for a protective order. San Jose Mercury News, 187 F.3d at 

1103; Phillips, 307 F.3d at 1210-11. 

 IT IS ORDERED: 

 1. Defendants’ motion for a protective order (Doc. 306) is granted. Dr. John 

Lehmann’s December 15, 2004, report is protected work product pursuant to Federal 

Rule of Civil Procedure 26(b)(3). Plaintiffs may not use or rely on the report in any 

pending or future case in this MDL. This order shall not affect any transferor courts’ 

previous orders regarding the discoverability or use of Dr. Lehmann’s report. 

 2. Defendants’ unopposed motion to seal (Doc. 413) is granted. The Clerk is 

directed to accept for filing under seal the document lodged on the Court’s docket as 

Doc. 414. 

 Dated this 11th day of February, 2016. 

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