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Ebert v. C.R. Bard, Inc.

United States District Court, E.D. Pennsylvania

April 24, 2014

C.R. BARD, INC., ET AL., Defendants.



In this products liability case, the parties disagree about whether a report written by Dr. John Lehmann for the defendants in late 2004 should be produced in discovery. This report was inadvertently disclosed in other cases involving the same or similar product. The plaintiff in this case is represented by the same law firm as the plaintiffs in the cases in which the report was inadvertently disclosed. The plaintiffs in those cases were court-ordered to "immediately and diligently" return or destroy any copies of the report they had received inadvertently. The plaintiff in this case now wants to use Dr. Lehmann's report, though it was never produced to her counsel in discovery.


a. Factual Background

Melissa Ebert alleges that she suffered an injury from the implantation of the defendants' G2 inferior vena cava (IVC) filter.[1] An IVC is a venous interruption device designed to prevent pulmonary embolism by filtering blood to prevent material like blood clots from blocking the main artery of the lung or one of its branches. The defendants obtained FDA clearance for the Recovery IVC filter through the 510(k) pre-market notification process based upon an already approved predicate device called the Simon Nitinol Filter (SNF).[2] The pre-market approval process required Bard to demonstrate that the Recovery IVC Filter device was the "substantial equivalent" to and has the same or better safety profile than the SNF-the device that was currently on the market. The defendants then obtained FDA clearance for the G2 IVC filter through the 510(k) process based upon the Recovery IVC Filter.[3]

The plaintiff claims that, unlike the safety profile for the SNF, the next two generation of filters-the Recovery and G2 IVC filters-were substantially less safe. She argues that the report shows that the defendants had actual knowledge that the subsequent devices were not the substantial equivalent, yet they still continued to market and sell these devices to members of the public, including the plaintiff.[4]

Other products liability cases against Bard related to its IVC filters have been filed throughout the United States. The first was filed in February 2004.[5] In November 2004, Bard retained Dr. John Lehmann, a former Bard medical affairs consultant, to prepare a litigation consultant report.[6] Dr. Lehmann signed a contract to perform work for Bard's law department, which was intended to serve both as legal advice concerning the IVC filters and to assist the law department with anticipated and ongoing litigation.[7] Dr. Lehmann was also instructed by counsel for Bard to convey the results of his investigation to the law department and to those whom the law department may direct.[8]

Dr. Lehmann conducted his investigation in November and December of 2004 and submitted his final report in December 2004.[9] In preparing his report, Dr. Lehmann spoke with a small, limited number of Bard employees in accordance with specific tasks he was required to carry out under his contract.[10] The law department subsequently distributed the report to a small select number of employees outside of the law department but within the company.[11] These employees were instructed that the report was confidential and that further distribution of the report was limited only to those who needed the report to perform their job functions.[12]

Subsequently, the defendants used the Lehmann Report to create a Remedial Action Plan and Health Hazard Evaluation.[13]

b. Relevant Procedural History The plaintiff in this case is represented by lawyers from the Philadelphia office of Lopez McHugh. Lopez McHugh's California office represents plaintiffs in other cases against Bard related to the IVC filters in several other jurisdictions.[14] In other cases, Lopez McHugh and Bard agreed to a protective order that enabled Lopez McHugh to use any documents produced in those cases in all of the cases in which Lopez McHugh was involved.[15] The purpose of that order was to allow for effective and efficient use of judicial resources.[16]

On December 14, 2012, Bard inadvertently disclosed to plaintiff's counsel twelve privileged documents including the litigation consultant's report in those other cases.[17] On December 21, 2012, Bard requested a "clawback" of those inadvertently produced, privileged documents in accord with the protective orders in those other cases.[18] On January 23, 2013, Bard's attorney sent the Lopez attorneys a letter with redacted images of the clawed-back documents, to replace the clawed-back documents. The letter also reminded the attorneys of their obligation to destroy or return the clawed back documents.[19]

Subsequently, the parties litigated the issue of whether the report was privileged or protected in those other cases. A California state court denied the clawback request in an unpublished order with no explanation or analysis.[20] The United States District Court for the District of Nevada, on the other hand, determined that Dr. Lehmann's litigation consultant report was protected from discovery by the work-product doctrine and attorney-client privilege in a nearly 70-page opinion.[21]

On April 30, 2013, following Bard's clawback of these privileged documents in the other cases and the Nevada district court's decision, Bard produced over two million pages of documents and electronically stored information in this case pursuant to the terms of the Agreed Protective Order.[22] Having learned its lesson from the previous productions, Bard did not produce the twelve protected documents that had been inadvertently produced before. Bard claimed the litigation report, along with other documents, was protected and listed the report on its privilege logs (both on its original privilege log, served August 9, 2013, and on its revised privilege log, served on September 6, 2013).[23]

c. Motion for Protective Order

Pursuant to Federal Rule of Civil Procedure 26(c), the defendants request that this court enter a protective order requiring the plaintiff and plaintiff's counsel to destroy all copies of the litigation report in their possession and preclude the plaintiff or plaintiff's counsel from using the contents of the report in this case. The Litigation Consultant Report was not produced in this case, but was obtained by the plaintiff because she has counsel who was also counsel in one of the cases in which the report was inadvertently disclosed. Depositions from those other cases have been cross-noticed in this case. The plaintiff opposes this motion.[24]


Federal Rule of Civil Procedure 26(c) provides that, upon a motion by a party from whom discovery is sought and for good cause shown, the court may enter a protective order preventing discovery on certain matters. Bard claims that good cause exists because the Lehmann Report is covered by the work-product doctrine. The plaintiff argues that the Lehmann Report was not created "in anticipation of litigation" and was, instead, only meant to comply with Bard's regulatory reporting requirements.

Several courts have already found that the Lehmann Report is covered by the work-product doctrine.[25] Others have found that the work-product doctrine does not protect the report.[26] While none of these prior decisions is binding, I agree that the work-product doctrine protects the Lehmann Report.[27]

a. Work Product Doctrine[28]

The work product doctrine allows lawyers to prepare a case "without undue and needless interference." Hickman v. Taylor , 329 U.S. 495, 511 (1947). This protection extends to non-lawyers working on behalf of lawyers to prepare for litigation.[29] "Litigation consultants retained to aid in witness preparation may qualify as non-attorneys who are protected by the work product doctrine." In re Cendant Corp. Sec. Litig. , 343 F.3d 658, 665 (3d Cir. 2003)(citations omitted).

Federal Rule of Civil Procedure 26(b)(3) prevents discovery of documents "prepared in anticipation of litigation or for trial by or for another party or by or for that party's representative (including the other party's attorney, consultant, surety, indemnitor, insurer or agent)." FED. R. CIV. P. 26(b)(3)(A)(emphasis added). Rule 26(b)(4)(D) also provides that a party may not "discover facts known or opinions held by an expert who has been retained or specially employed by another party in anticipation of litigation."[30] These two rules provide separate work product protections for litigation consultants. In re Cendant , 343 F.3d at 664-65. This "general policy against invading the privacy of an attorney's course of preparation is so well recognized and so essential to an orderly working of our system of legal procedure that a burden rests on the one who would invade that privacy to establish adequate reasons to justify production through a subpoena or court order." Id. at 512.[31]

Whether a document was prepared "in anticipation of litigation" is a factual question. U.S. v. Rockwell Intern. , 897 F.2d 1255, 1266 (3d Cir. 1990)(citations omitted). The Third Circuit has explained that a document satisfies Rule 26(b)(3) if "in light of the nature of the document and the factual situation in the particular case, the document can fairly be said to have been prepared or obtained because of the prospect of litigation." Martin v. Bally's Park Place Hotel & Casino , 983 F.2d 1252, 1258 (3d Cir. 1993)(citations and quotation marks omitted).[32]

The facts show that the Lehmann Report was created because of impending litigation related to the IVC filters. The defendants received their first claim related to alleged failures in the Recovery Filter in February 2004.[33] Lehmann entered into a consulting agreement with Bard's Law Department in November 2004. The consulting agreement between Lehmann and the defendants governing his consulting services in preparing the report clearly states that he was being hired "in anticipation of litigation."[34] The tasks outlined as part of the agreement differ from those required of Lehmann by other consulting agreements entered into by him and the defendants-indicating that the purpose of his services was related to the pending litigation and they were not performed as ordinary business functions.

In addition, the facts show that Lehmann was serving as an agent for the law department in creating this report. The consulting agreement indicates that Lehmann was to be supervised by Donna Passero, Assistant General Counsel for Bard. The cover memo for the report, signed by Lehmann, indicates it was then sent to Passero on December 15, 2004; the final report was attached. Each page of the report is dated December 15, 2004 and is titled "Vena Cava Filters - Final Report." Each page also indicates that the report is "Privileged and confidential, Attorney work product, Pursuant to contract."[35] For these reasons, I find that the Lehmann Report is protected by the work-product doctrine under Rule 26(b)(3).[36]

b. Substantial Need to Overcome the Protection

The plaintiff argues that, despite the work-product doctrine, her "substantial need" for the report requires its production. Under Rule 26(b)(3) a party seeking discovery of materials covered by the work product doctrine must show that she has a "substantial need for the materials to prepare its case and cannot, without undue hardship, obtain their substantial equivalent by other means."[37] FED. R. CIV. P. 26(b)(3)(A)(ii). Even if a court permits disclosure of materials covered by the work-product doctrine based on the "substantial need" exception, the court must still protect against disclosure of "the mental impressions, conclusions, opinions, or legal theories of a party's attorney or other representative concerning the litigation." FED. R. CIV. P. 26(b)(3)(B)(emphasis added).[38]

The plaintiff herself admits that "the conclusions of Bard's consultant as to that data" are what she cannot recreate and that which she seeks in discovery.[39] When a document by an attorney or other representative of a party concerning the litigation includes these "mental impressions, conclusions, opinion, or legal theories, " this "opinion" work product is "generally afforded near absolute protection from discovery." In re Cendant , 343 F.3d at 663 (emphasis added). Therefore, a litigation consultant's advice based on information disclosed during private communications between a client, the client's attorney, and the consultant "may be considered opinion' work product which requires a showing of exceptional circumstances in order for it to be discoverable." Id.

The plaintiff has established no exceptional circumstances or substantial need to overcome the work-product protection. The plaintiff argues that the Lehmann Report shows that the defendant had actual knowledge that the Recovery Filter was dangerous as compared to its predicate, the SNF. She contends that since the Recovery filter was the predicate of the plaintiff's filter-the G2 filter-then the defendant's knowledge that the Recovery Filter was causing injuries somehow indicates that the G2 Filter was also dangerous because it was shown to be a "substantially equivalent" product under the FDA clearance process. The plaintiff claims that even the most rigorous analysis of the same data used by Dr. Lehmann in preparing his report by the plaintiff's own experts would not be sufficient because she would have no other way to establish Bard's actual knowledge of the IVC filter's dangers without undue hardship.[40]

This is just not the case.[41] The Remedial Action Plan and the Health Hazard Evaluation, which were created with the use of information from the Lehmann Report, have been produced in this case. They offer evidence that the defendants were aware of problems with the Recovery Filter when they developed the G2 Filter. The plaintiff, however, believes the Lehmann Report itself would serve as stronger evidence of the defendants' awareness of the Recovery Filter's dangerousness because it is more detailed. This, however, is not enough of a substantial need to overcome Rule 26's work product discovery bar.

c. Waiver

The plaintiff also argues that the work-product doctrine, if it applies, was waived because the defendants cross-noticed the depositions in this case with those in other cases, including cases in which the Lehmann Report was inadvertently disclosed. Work-product protection is waived when a client voluntarily discloses the protected documents to one's adversaries. Montgomery County v. MicroVote Corp. , 175 F.3d 296, 304 (3d Cir. 1999)(quoting Westinghouse v. Republic of the Philippines , 951 F.2d 1414, 1428 (3d Cir.1991)).

This novel "waiver by cross noticing depositions" argument has no support in any rule or case.[42] Possibly the plaintiff is trying to imply that the inadvertent disclosure of the Report in those other cases counts as a disclosure to adversaries in this case.[43] That is just silly. Following the inadvertent disclosure and Bard's subsequent invoking of the clawback provision in the parties' agreed-upon protective order, Bard made clear that the Report was not to be used by the opposing side.[44] Furthermore, courts agreed that the Report should not be used in the litigation. The defendants have made clear in this litigation, and in all other litigation, that the Report is protected by work-product and have objected to its use in those depositions.[45] As the Stipulated Protective Order clearly states, inadvertent disclosure does not waive the privilege.[46]


For the reasons stated above, I find that the Lehmann Report is protected by the work-product doctrine; neither substantial need nor waiver overcomes this protection.[47] I will grant the defendants' motion for protective order.

An appropriate Order follows.

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