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In re Bard IVC Filters Products Liability Litigation

United States District Court, D. Arizona

February 11, 2016

IN RE BARD IVC FILTERS PRODUCTS LIABILITY LITIGATION This Relates to: All Actions

David G. Campbell United States District Judge

Order 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 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 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 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).

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.

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 ...


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