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In re Avandia Marketing

December 7, 2009

IN RE: AVANDIA MARKETING, SALES PRACTICES AND PRODUCTS LIABILITY LITIGATION


The opinion of the court was delivered by: Rufe, J.

MDL No. 1871

THIS DOCUMENT APPLIES TO: ALL ACTIONS

MEMORANDUM OPINION AND PRETRIAL ORDER No. 84

The Defendant, SmithKline Beecham Corporation d/b/a GlaxoSmithKline (GSK), has filed a Motion Appealing the Eighth Report and Recommendation of the Special Master as to Documents Withheld Pursuant to the Attorney-Client Privilege and/or the Work Product Doctrine ("R & R # 8").*fn1 After considering Defendant's Motion to Appeal, Plaintiffs' Response in Opposition, Defendant's Reply, and Plaintiffs' Sur-reply, and pursuant to this Court's power pursuant to 28 U.S.C. § 636(b)(1)(C) to make a de novo determination of proposed recommendations to which objections are made, the Court approves and adopts the recommendations contained in R & R #8 for the reasons set forth below.

PROCEDURAL HISTORY

The Special Master and the parties to this case have spent much of the past year trying to resolve a discovery dispute over Defendant's assertion of attorney-client privilege or work-product protection for tens of thousands of documents. Defendant submitted approximately 120 documents to the Special Master for in camera review. Defendant objected to the Special Master's rulings on many of these documents, and also objected to his proposed comprehensive guidelines for applying attorney-client privilege or work product protection that the Special Master set forth in his Seventh Report and Recommendation to the Court. The Court did not adopt the recommended comprehensive guidelines, as the Court found them inapt for the litigation, and directed the parties to meet with the Special Master again to try to resolve the dispute. As a result of the Special Master's meetings and discussions with the parties, the number of documents for which privilege is claimed has been reduced from 120 to 25. The Special Master rejected Defendant's claim of attorney-client privilege and/or work-product protection as to each of these documents in R & R #8. The documents for which privilege and/or protection is claimed have also been submitted to this Court for in camera review, and the Court has reviewed each individual document carefully to determine whether privilege or work-product doctrine applies.

DISCUSSION

Attorney-Client Privilege

The attorney-client privilege exists to foster disclosure and communication between the attorney and the client. Nevertheless, because the privilege obstructs the search for the truth and because its benefits are, at best, "indirect and speculative," it must be strictly confined within the narrowest possible limits consistent with the logic of its principle.*fn2

Pennsylvania law controls the privilege issues in this case. The Pennsylvania rule regarding confidentiality is codified at Pa. Const. Stat. Ann. §5928, which states:

In a civil matter counsel shall not be competent or permitted to testify to confidential communications made to him by his client, nor shall the client be compelled to disclose the same, unless in either case this privilege is waived upon the trial of the client.

Determining whether this rule applies can be complicated in the corporate setting, where in-house counsel serve as both business advisors and legal advisors to corporations. In such situations, the federal courts have interpreted Pennsylvania law to require the party asserting the privilege to demonstrate that the primary purpose of the communication was to gain or provide legal assistance.*fn3

The privilege applies only if. . .[the communication was made] for the purpose of securing primarily either (i) an opinion on law or (ii) legal services or (iii) assistance in some legal proceeding.*fn4

Defendant contends that the primary purpose requirement refers to the primary reason the document is sent to the attorney, not to the primary purpose of the document itself. This Court finds no support for such an interpretation in the cases applying Pennsylvania law, including in the Ford case cited by Defendant in support of its position, and finds such an interpretation inconsistent with the requirement that privileges must be narrowly construed. Nevertheless, the Court's analysis of the documents at issue in this case does not rest on the construction of the term "primary purpose."

Drafts of documents circulated to counsel for comments on legal issues may be considered privileged if they were prepared or circulated for the purpose of obtaining a legal opinion and they contain confidential information or legal advice not included in the final version.*fn5 Even in these cases, the Court may find that only the portions of the draft reflecting the legal advice are privileged. However, if the attorney is primarily evaluating the business ramifications of a document or other communication, it will not be privileged.*fn6 "Courts have remained firm in denying privileged status to documents that contain essentially technical or business data and are not primarily legal in nature."*fn7 The party claiming the privilege must clearly show that a document is legal in nature or that it renders legal advice.

The attorney-client privilege does not shield documents merely because they were transferred or routed through an attorney. Otherwise non-privileged communications between corporate employees do not attain privileged status when counsel is copied on the correspondence.*fn8

Therefore, the corporation asserting the privilege must demonstrate that the communication was made for the express purpose of securing legal and not business advice.*fn9

Work-Product Doctrine

Federal Rule of Civil Procedure 26(b)(3) governs attorney work product doctrine. Generally, a party may not discover documents that are prepared in anticipation of litigation, unless they are otherwise discoverable and the requesting party demonstrates a substantial need for the materials to prepare its case and cannot obtain the equivalent information by other means.*fn10 Even when work product documents are discoverable, "mental impressions, conclusions, opinions, or legal theories of an attorney or other representative of a party concerning the litigation" are protected against disclosure.*fn11

The Third Circuit has held that only documents that were prepared or obtained because of the pending or threatened litigation are protected from disclosure.*fn12 That is, the "primary motivating purpose behind the creation of the document [must be] to aid in possible future litigation."*fn13 Work product prepared in the ordinary course of business is not immune from discovery.*fn14 For example, documents prepared by a corporation as part of efforts to ensure compliance with federal regulatory agencies or maintain a positive public image for its products, and not because of possible litigation, are not protected by work-product doctrine.*fn15

The party asserting the work-product privilege has the burden of proving that the protection is applicable.*fn16

Analysis of Documents

With these legal principles in mind, the Court will review the documents presented for in camera review.

Document #1 AVMDLZ00140748-00140781

Document #1 is a September 26, 2001 e-mail from attorney Robert McRae to Margaret Kreider, with a copy to another attorney (Kurt Henjes) and ten non-attorney employees, in which he writes only "looks good" (regarding the attached draft prescribing information for Avandamet). The GSK privilege log describes this document as "Regulatory documents containing legal advice from Rob MacRae, Esq. regarding communications with a government authority, and sent to Kurt Henjes, Esq. for the purpose of obtaining legal advice regarding communications with a governmental authority."

The Court finds that this e-mail message is not covered by attorney-client privilege. The e-mail from McRae does not provide any substantive advice which would be confidential. Therefore, while this comment does render legal advice, it is not protected (although the attachment it comments upon could be privileged). Although the e-mail is copied to another attorney, Henjes, it does not ask him to provide any legal advice, and therefore the Court cannot find that a primary purpose of the e-mail was to request legal advice, despite GSK's characterization in its privilege log.

An earlier e-mail in the chain, dated September 25, 2001, was sent by non-lawyer Margaret Kreider to various employees, including two attorneys, with the draft prescribing information. She asks for final comments or revisions on that document. The primary purpose of that e-mail is to solicit comments about the prescribing information. By sending the e-mail to two attorneys, she may be seeking direction from the legal department about whether there are "adequate directions for use" and "adequate warnings,"*fn17 which is arguably legal and not technical advice. However, the e-mail message does not contain any confidential information. Therefore, this communication is not privileged.

Turning finally to the attachment, which contains the draft prescribing information, it appears that most of the information in this document was already published in prescribing information for other GSK drugs. Such information would not be confidential. However, even looking at the document as a whole, the Court finds that the Defendant has not proved that the attached draft prescribing information contains confidential information or legal advice not included in the final (non-confidential) version. Examining the edits made to the prescribing information document itself, some of which may have been made by legal counsel, although the Defendant does specifically so allege, the Court finds no confidential information or legal advice which is not found in the final version released to the public. Therefore, the attachment is also not privileged.

Work-product doctrine does not apply to the e-mail or the attachment because it was produced in compliance with federal regulations, and not because of pending or threatened litigation.

Document #1 should be produced to the Plaintiffs' Steering Committee without redaction.

Document #2: AVMDLZ00094684, 94685, 94703

Document #2 is a July 26, 2007 e-mail from GSK employee Amy Ebel to Margaret Kreider, with copies to various other employees including one attorney. Attached are two documents with proposed prescribing information for Avandia. The e-mail refers to a meeting earlier that day at which the recipients of the e-mail agreed on "boxed warning" language. The e-mail directs their attention to the edits in the boxed warning, and asks for an e-mail formalizing the earlier approval. One attorney is among the recipients who are asked to provide formal approval of the attachment. Defendants characterize this document as "Regulatory documents sent to Stuart Greer, Esq. for the purpose of obtaining legal advice regarding communications with a governmental authority."

The Court finds that there is no confidential information in the e-mail which requests review and approval. Therefore, the e-mail is not subject to attorney-client privilege.

The boxed warning language in the attached document is nearly identical to the final boxed warning label approved by the FDA and distributed publically. The changes made were not substantive edits, and the draft boxed warning label contains no confidential information excluded from the final version.*fn18 Therefore, neither the e-mail not the attachment are privileged documents.

Work-product doctrine does not apply to the e-mail or the attachment because it was produced in compliance with federal regulations, and not because of pending or threatened litigation.

Document #2 should be produced to the Plaintiffs' Steering Committee without redaction.

Document #3: AVMDLZ00061220-61225

This set of documents dated July 26, 2007 consists of four e-mails from recipients of the e-mail discussed above (Document #2). The first, from Dr. Alexander Cobitz to Amy Ebel (both non-attorneys), says "AGREED." The second, from Willa Phyall to Amy Ebel (both non-attorneys) is specifically addressed to Amy and suggests striking the words "100 count bottle" for consistency with an Avandia prescribing information form previously submitted to the FDA. The third, from Lauren Karak to Amy Ebel (both non-attorneys) says "Amy, I am ok with this text, Best Regards, Lauren." The fourth, from Dr. Eric Dube to Amy Ebel (both non-attorneys) read "I approve." There were no attachments to these emails, but the earlier e-mail from Amy Ebel to Margaret Kreider, which was discussed above (Document #2) and determined to be non-privileged, was included in each of these messages. Copies of each of these messages were sent to other ...


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