In re Restasis (Cyclosporine Ophthalmic Emulsion) Antitrust Litig.

352 F. Supp. 3d 207
CourtDistrict Court, E.D. New York
DecidedJanuary 17, 2019
Docket18-MD-2819 (NG) (LB)
StatusPublished
Cited by9 cases

This text of 352 F. Supp. 3d 207 (In re Restasis (Cyclosporine Ophthalmic Emulsion) Antitrust Litig.) is published on Counsel Stack Legal Research, covering District Court, E.D. New York primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
In re Restasis (Cyclosporine Ophthalmic Emulsion) Antitrust Litig., 352 F. Supp. 3d 207 (E.D.N.Y. 2019).

Opinion

GERSHON, United States District Judge:

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.1 Plaintiffs *209contend that Allergan waived its right to assert the attorney-client privilege over the documents because it shared them with these third parties. Defendant relies on two exceptions to the third-party waiver rule to argue otherwise. First, it asks the court to find that the input offered by Mr. Pollock and Mr. Hanford was necessary for Allergan's attorneys to provide informed legal advice. Second, Allergan argues that Mr. Pollock and Mr. Hanford were functionally equivalent to its own employees.

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 Hanford played in responding to the draft guidance of the Food and Drug Administration (FDA), which contained recommendations to applicants seeking approval for generic versions of Restasis ®, Allergan's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 Allergan's responses to this draft guidance-which included filing comments and citizen petitions-are central to the plaintiffs' allegations in this litigation.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. , 333 F.Supp.3d 135 (E.D.N.Y. 2018).

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 , 449 U.S. 383, 389, 101 S.Ct. 677, 66 L.Ed.2d 584 (1981). "[T]he privilege exists to protect not only the giving of professional advice to those who can act on it but also the giving of information to the lawyer to enable him to give sound and informed advice." Id. at 390, 101 S.Ct. 677.

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Bluebook (online)
352 F. Supp. 3d 207, Counsel Stack Legal Research, https://law.counselstack.com/opinion/in-re-restasis-cyclosporine-ophthalmic-emulsion-antitrust-litig-nyed-2019.