The digital age has rendered formal memoranda explicitly requesting or reflecting legal advice nearly obsolete. Instead, employees and counsel send and receive hundreds or thousands of informal e-mails that implicitly request or reflect legal advice. The result is a corresponding increase in the volume of documents withheld based on the attorney-client privilege during litigation. Unfortunately, courts have reacted to the increase in privilege claims by increasingly raising the bar required to establish the privilege.
Drug and medical device companies, as well as their litigation counsel, are well-positioned to shape the changing landscape of the attorney-client privilege. With minor adjustments to how employees communicate with counsel, to how privileged communications are presented during litigation, and to how arguments about privilege are made to the court, companies can protect the privilege and help to reverse its recent erosion.
A. Narrowing of the Attorney-Client Privilege in Drug and Medical Device Litigation
Historically, courts and state legislatures have adopted various definitions of the attorney-client privilege, which generally can be distilled to five elements: (1) a communication (2) made in confidence, between (3) an attorney and (4) a client, for (5) the purpose of obtaining or providing legal advice or assistance. See Weinstein & Berger, Weinstein's Evidence Manual §18.03 (2d ed. 2009); see also In re Vioxx Products Liability Litigation, 501 F. Supp. 2d 789, 795 (E.D. La. 2007). In the context of drug and medical device litigation, the first four elements are easy to satisfy. The trouble arises when courts analyze the fifth element regarding whether the purpose of the communication was to obtain or provide legal advice or assistance, as opposed to business advice, for instance. In instances where the communications appear to have a mixed business-legal purpose, courts have applied the attorney-client privilege only when the communication is "primarily" or "predominantly" legal in nature. See, e.g., Vioxx, 501 F. Supp. 2d at 796.
The dramatic rise of e-mails claimed as privileged in drug and medical device litigation has led courts to narrow the attorney-client privilege for fear that upholding privilege would encourage companies to funnel communications through their legal departments. The upshot of these courts' rulings is as follows:
- Held To Be Privileged:
- E-mails and attachments addressed solely to an attorney with limited circulation and asking a legal question.
- E-mails addressed to attorneys and non-attorneys where legal advice is sought, and the non-attorneys are simply being notified (usually via cc:) about the nature of the legal services sought.
- The attorneys' responses to legal questions.
- E-mails forwarding legal advice to other non-attorneys if the recipients needed the advice in order to fulfill their corporate responsibilities.
- Held Not To Be Privileged:
- E-mails and attachments addressed to attorneys and non-attorneys for review, comment, and approval, because the primary purpose of the communication is not to obtain legal advice since the advice was sought from all.
- Attorneys' comments related purely to technical, scientific, promotional, management, or marketing matters that do not appear to be related to legal assistance. Document-by-document proof via affidavit, demonstrating that the responses are primarily legal, however, could make these communications privileged. But general argument that the drug and medical device industry is highly regulated is insufficient proof that the primary purpose of the communication is legal.
- E-mails forwarding legal advice to other non-attorneys who did not need the advice in order to fulfill their corporate responsibilities.
In re Vioxx Products Liability Litigation, 501 F. Supp. 2d 789 (E.D. La. 2007); see In re Seroquel Products Liability Litigation, No. 6:06-md-1769, 2008 U.S. Dist. LEXIS 39467 (M.D. Fla. May 7, 2008) (adopting guidelines set forth in Vioxx); In re Avandia Marketing, Sales Practices and Products Liability Litigation, 07-md-01871-CMR, 2009 U.S. Dist. LEXIS 122246 (E.D. Pa. Oct. 2, 2009), adopted by 2009 U.S. Dist. LEXIS 113562 (E.D. Pa. Dec. 7, 2009) (same).
B. Protecting the Attorney-Client Privilege Moving Forward
Despite the fact that the drug and medical device industry is pervasively regulated, and that legal advice is crucial to ensure regulatory compliance and to reduce the risks of pending and future litigation, the district courts in Vioxx, Seroquel, and Avandia have raised the bar for the attorney-client privilege to a seemingly unreachable height for the vast majority of communications. Indeed, the courts seem to have denied privilege for nearly all communications concerning FDA approval; correspondence pertaining to FDA review or approval; wording of package inserts; product advertising; promotional materials concerning labeling; oral promotional activities, including presentations to physicians, and distribution of scientific articles or textbook chapters to physicians; and press releases.
These decisions signal a shift in the way that courts likely will analyze the attorney-client privilege in drug and medical device litigation in the future. Although companies should continue to advance the pervasive-regulation argument when plaintiffs challenge privilege logs, corporate and litigation counsel should also incorporate some of the guidelines presented in the Vioxx, Seroquel, and Avandia decisions to diminish the blow in the event that courts reject pervasive regulation and litigation avoidance as sufficient bases to maintain the privilege.
1. Protecting the Privilege at the Corporate Level
Simply cc:ing corporate counsel on an e-mail or including corporate counsel on the To: line of an e-mail to several non-attorneys is not, according to the Vioxx, Seroquel, and Avandia decisions, sufficient to ensure that the attorney-client privilege will be upheld because the primary purpose of the communication is not to obtain legal advice.
Therefore, company employees must strive to adjust the ways that they structure their e-mails to make their intent clear that the primary purpose of the communication is to seek legal advice:
- The attorney should be the only person on the To: line of an e-mail seeking legal advice. If non-attorneys are part of the communication, they should be cc:ed.
- Because intent of the author is critical to determining whether the primary purpose of the communication is to obtain legal advice, in addition to listing the attorney as the only person on the To: line, the first line of the e-mail should read: "Attorney-client privilege: communication primarily intended to obtain legal advice."
These suggestions are particularly important when the communication involves attorney input regarding categories of correspondence that Vioxx and its progeny found insufficient to support privilege, such as FDA approval, correspondence pertaining to FDA review or approval; wording of package inserts; product advertising; promotional materials concerning labeling; oral promotional activities, including presentations to physicians, distribution of scientific articles or textbook chapters to physicians; and press releases. Moreover, template affidavits should be constructed that reflect the legal purpose behind communications regarding each of these issues. These affidavits can later be tailored as needed for particular documents that are subject to privilege challenges.
2. Protecting the Privilege During Litigation
Privilege challenges start with challenging the Rule 26(b)(5) privilege log. The key targets: entries listing many non-attorneys as direct recipients of the communication and an attorney as one of the cc: recipients; entries listing an attorney as one of many direct recipients; and entries listing no attorney at all (presumably because the attorney-client communication took place earlier on the e-mail string).
Privilege logs can be greatly improved with minor changes:
- In future litigation, corporate counsel's implementation of the suggestions set forth above will result in the recipient field containing only an attorney with others listed in the cc: field. Until then, defendants should consider, as appropriate under the relevant law governing the litigation, adding a separate "Attorney" field to the privilege log that identifies the attorney front-and-center rather than among the other recipients.
- The field on the log that describes the communication to the attorney should make clear that the primary purpose and intent of the communication was to obtain legal advice. The description of the document also should be as specific as possible without revealing the substance of the communication. For example, instead of "e-mail requesting legal advice regarding marketing material," the description might say, "e-mail sent to counsel for the primary purpose of requesting legal advice regarding marketing material's compliance with FDA regulations."
- For entries that do not contain an attorney because the communication with the attorney took place earlier in the e-mail string, the log entry's description should capture the privileged communication and say that the later recipients of the privileged communication needed the communication in order to fulfill their corporate responsibilities.
Courts are still reacting to the relatively recent shift to e-mail as the primary mode of corporate communication and its impact on the attorney-client privilege. These suggested changes in how corporate communications are structured and how privilege logs are composed aim to protect the privilege by addressing the issues raised by the courts in Vioxx, Seroquel, and Avandia. The goal is to improve the chances that the court will find that the primary intent of the communication was to obtain legal advice and/or that the privilege log was sufficiently specific to establish all elements of the attorney-client privilege without the need for in camera review of each document.
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