In re Restasis (Cyclosporine Ophthalmic Emulsion) Antitrust Litig.
In re Restasis (Cyclosporine Ophthalmic Emulsion) Antitrust Litig.
Opinion of the Court
In this multi-district litigation, plaintiffs have moved to compel from defendant Allergan production of documents that Allergan shared with two independent consultants, Robert Pollock of Lachman Consultant Services, Inc. and Timothy Hanford of ADC Strategies LLC.
On December 19, 2018, I heard extensive oral argument on plaintiffs' motion. For the reasons stated below, the motion is granted.
I. FACTUAL BACKGROUND
Allergan has submitted declarations from Damon Burrows, its Vice President and Associate General Counsel during the relevant period; Robert Lively, Allergan's Vice President of Global Government Affairs; and Christina Markus, a partner at King & Spalding, a law firm Allergan retained to provide legal advice concerning, among other things, regulatory issues. These declarations describe the roles that Mr. Pollock and Mr. Hanford played in responding to the draft guidance of the Food and Drug Administration (FDA), which contained recommendations to applicants seeking approval for generic versions of Restasis ®, Allergan's branded version of cyclosporine ophthalmic emulsion. Allergan's responses to this draft guidance-which included filing comments and citizen petitions-are central to the plaintiffs' allegations in this litigation. See In re Restasis (Cyclosporine Ophthalmic Emulsion) Antitrust Litig. ,
A. Robert Pollock of Lachman Consultant Services, Inc.
Mr. Pollock is the former Acting Deputy Director of the FDA's Office of Generic Drugs. In July 2013, Allergan retained Mr. Pollock as a consultant based on the recommendation of Mr. Burrows, who believed Mr. Pollock would help "ensure that Allergan's in-house and outside attorneys provided informed and effective legal advice regarding the FDA draft guidance and related documents." Mr. Burrows and Ms. Markus "consider[ed] Mr. Pollock to have uniquely specialized knowledge and experience on FDA regulatory issues," especially FDA draft guidance. Mr. Burrows believed that Mr. Pollock's knowledge "was different from what Allergan's employees and attorneys could have themselves provided."
As an example of when Mr. Pollock's "specialized input" shaped her legal advice, Ms. Markus cites an email in which she shared with Allergan's legal team and Mr. Pollock a draft of Allergan's comment on the FDA's draft guidance. She sent the email to "obtain[ ] Mr. Pollock's strategic advice" about the document so that she "could provide effective legal advice to Allergan and its in-house counsel."
According to Mr. Burrows and Ms. Markus, Mr. Pollock worked closely with Allergan's attorneys to determine its strategy regarding the FDA. They treated Mr. Pollock as they did any other Allergan employee; he was "an integral member" of their team. Mr. Burrows and Ms. Markus believed that confidential communications shared with Mr. Pollock would remain confidential, and Allergan's consulting agreement with Lachman Consultant Services *210required that the firm not disclose Allergan's confidential information.
B. Timothy Hanford of ADC Strategies LLC
After Allergan retained Mr. Hanford in August 2015, Mr. Lively recommended that Allergan's legal team work with him to respond to the FDA's draft guidance. Mr. Hanford had previously served as counsel to the U.S. House of Representatives' Ways and Means Committee and, according to Mr. Lively, had "many years of experience and deep knowledge about members of Congress and congressional and federal agency practices." Mr. Lively "consider[ed] Mr. Hanford to have uniquely specialized knowledge and experiences with government affairs involving health care." Although Mr. Hanford is a lawyer, he did not provide Allergan with legal advice. However, Mr. Lively considered Mr. Hanford "keenly aware of the type of information lawyers need to provide effective legal advice to a corporate client."
Mr. Lively, who is not a lawyer, forwarded emails containing privileged information from Allergan's attorneys to Mr. Hanford. Plaintiffs have highlighted two such emails, redacted versions of which were provided to the court. The first contains legal advice from Robert Bailey, Allergan's General Counsel, about an executive order relevant to the company's communications with the FDA regarding cyclosporine ophthalmic emulsion. The second contains legal advice from three lawyers, including Mr. Bailey, concerning Allergan's August 2017 citizen petition. According to Mr. Lively, he forwarded these emails to Mr. Hanford so that Mr. Hanford could provide "strategic advice" to Mr. Lively and Allergan's counsel. Mr. Lively also sought Mr. Hanford's "reaction and input" regarding Mr. Bailey's advice to inform Mr. Lively's discussions with Mr. Bailey.
Ms. Markus and Mr. Lively explained that they worked with Mr. Hanford as they did with any other Allergan employee; he was an "important" or "integral" member of the team tasked with responding to the FDA and to Congress regarding Restasis ®. They considered communications shared with Mr. Hanford confidential. The consulting agreement between Allergan and ADC Strategies required that ADC Strategies keep information it received from Allergan confidential.
II. ANALYSIS
The attorney-client privilege is meant "to encourage full and frank communication between attorneys and their clients and thereby promote broader public interests in the observance of law and administration of justice." Upjohn Co. v. United States ,
Nonetheless, because "the privilege stands in derogation of the public's 'right to every man's evidence,' and as 'an obstacle to the investigation of the truth,' " it must be " 'strictly confined within the narrowest possible limits consistent with the logic of its principle.' " In re Horowitz ,
The voluntary disclosure of privileged communications to a third party generally waives the attorney-client privilege. See Schaeffler v. United States ,
A. Whether Allergan's Consultants were Necessary for the Provision of Legal Advice
In United States v. Kovel ,
Courts must narrowly construe the exception to third-party waiver recognized in Kovel . See United States v. Mejia ,
Allergan has not shown that the information Mr. Pollock and Mr. Hanford provided to its in-house and outside counsel allowed the attorneys to " 'understand aspects of [Allergan's] own communications that could not otherwise be appreciated in the rendering of legal advice.' " Calvin Klein Trademark Tr. v. Wachner ,
*212At oral argument, defense counsel asserted that Allergan believed the FDA was engaging in "highly unusual" behavior concerning Restasis ®, and it required the expertise of Mr. Pollock and Mr. Hanford to guide it through this "extremely complex regulatory situation," involving both the FDA and Congress. But that these consultants offered Allergan assistance in navigating a difficult situation-as opposed to facilitating attorney-client communication-does not shield Allergan's discussions with them from disclosure under Kovel . See Ackert ,
Defendant relies heavily on In re Grand Jury , 265 F.Supp.2d at 321, which "arguably extended the privilege the furthest." Ravenell ,
In sum, Allergan has not shown that its attorneys' communications with Mr. Pollock and Mr. Hanford are protected by Kovel . Rather than serving to translate concepts that Allergan's lawyers were otherwise incapable of understanding, Mr. Pollock and Mr. Hanford spoke the same language as these lawyers. Indeed, Allergan has not offered any principled way to distinguish Mr. Pollock and Mr. Hanford from any other consultant retained by a company. It thus seeks a ruling that would lead the narrow exception set forth in Kovel to swallow the third-party waiver rule.
B. Whether Allergan's Consultants were Functionally Equivalent to Allergan Employees
Defendant contends that its communications with Mr. Pollock and Mr. Hanford are protected by the attorney-client privilege because these consultants were "functionally equivalent" to its own employees. The "functional equivalent" exception to privilege waiver originated in In re BieterCo.,
Although several district courts within this Circuit have recognized the functional equivalent exception, the Second Circuit has yet to address it. Some district courts here have questioned whether the Court would adopt the exception given that it "has recognized very limited exceptions to privilege waiver." Church & Dwight Co. ,
Courts in this Circuit have considered the following factors, among others, to determine functional equivalency: whether the consultant exercised independent decision-making on the company's behalf; possessed information held by no one else at the company; served as a company representative to third parties; maintained an office at the company or otherwise spent a substantial amount of time working for it; and sought legal advice from corporate counsel to guide his or her work for the company.
For example, under the unique circumstances in In re Copper Mkt. ,
By contrast, in Exp.-Imp. Bank , the court found that a corporation had waived its right to assert the attorney-client privilege over documents shared with a financial consultant hired to assist in restructuring *214its debt.
Similarly, in Church & Dwight Co. ,
Defendant asks me to follow the approach to functional equivalency in In re Flonase Antitrust Litig. ,
Here, defendant has not shown that Mr. Pollock and Mr. Hanford played such exceptional roles at Allergan that they should be treated as anything other than typical part-time consultants.
Defendant also has not demonstrated that either Mr. Pollock or Mr. Hanford exercised any independent decision-making for Allergan. According to defendant, both consultants "evaluate[d] legal developments and provide[d] information and advice" on issues involving the FDA. Thus, while they offered their input to those at Allergan who made decisions, they did not make decisions themselves. Nor did either consultant appear on Allergan's behalf or correspond with third parties as company representatives. The consultants also worked out of their own offices (not Allergan's), communicated via the email addresses provided by their consulting firms (not Allergan), and likely served as consultants for other companies while they were assisting Allergan. Moreover, Allergan has not shown that either Mr. Pollock or Mr. Hanford was so integrated into its corporate structure that he sought and received legal advice from Allergan's counsel, rather than solely providing his input to Allergan's counsel and staff.
In conclusion, defendant has not met its burden to demonstrate that Mr. Pollock and Mr. Hanford were functionally equivalent to its own employees. Their roles, while no doubt important, are a far cry from that of the consultants in In re Bieter ,
III. CONCLUSION
Plaintiffs' motion to compel is granted. Defendant shall produce the relevant documents within two weeks of the date of this decision.
SO ORDERED.
Plaintiffs also sought to compel the production of two categories of communications involving Allergan's citizen petitions. At a status conference on December 19, 2018, the parties agreed to continue to meet and confer regarding those issues and, if they do not reach a resolution, to provide the court with additional briefing. Therefore, this decision does not address that portion of plaintiffs' motion.
With respect to Mr. Hanford, it was not even an attorney who recommended that he assist Allergan's legal team on Restasis ®. Mr. Lively, who is not a lawyer, not only made the referral but also often served as the conduit of information between Mr. Hanford and Allergan's counsel-casting significant doubt on defendant's claim that its counsel required Mr. Hanford's input to impart effective legal advice. See In re Grand Jury Subpoenas Dated Mar. 24, 2003 ,
Courts often evaluate these factors in the context of a test set forth in Exp.-Imp. Bank : (1) "whether the consultant had primary responsibility for a key corporate job," (2) "whether there was a continuous and close working relationship between the consultant and the company's principals on matters critical to the company's position in litigation," and (3) "whether the consultant is likely to possess information possessed by no one else at the company."
With a handful of exceptions, Allergan's privilege log entries involving Mr. Pollock are from July and August 2013-a short stint that is consistent with the role of a consultant, not an employee. While Mr. Hanford's relationship with Allergan spanned several years, it is not clear how much of his work for the company involved Restasis ® as opposed to other drugs. This motion concerns only 92 emails sent over the course of two years, which is hardly indicative of a de facto employee (although Mr. Hanford may have participated in other non-privileged communications). I also note that Mr. Lively declared that he "often"-as opposed to always-worked with Mr. Hanford in the same manner in which he worked with other Allergan employees.
Reference
- Full Case Name
- IN RE RESTASIS (CYCLOSPORINE OPHTHALMIC EMULSION) ANTITRUST LITIGATION This Document Applies To: All Cases
- Cited By
- 9 cases
- Status
- Published