In Re Pfizer Inc. Shareholder Derivative Litigation

722 F. Supp. 2d 453, 2010 U.S. Dist. LEXIS 69593, 2010 WL 2747447
CourtDistrict Court, S.D. New York
DecidedJuly 13, 2010
DocketMaster File No.: 09 Civ. 7822 (JSR)
StatusPublished
Cited by31 cases

This text of 722 F. Supp. 2d 453 (In Re Pfizer Inc. Shareholder Derivative Litigation) is published on Counsel Stack Legal Research, covering District Court, S.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 Pfizer Inc. Shareholder Derivative Litigation, 722 F. Supp. 2d 453, 2010 U.S. Dist. LEXIS 69593, 2010 WL 2747447 (S.D.N.Y. 2010).

Opinion

OPINION AND ORDER

JED S. RAKOFF, District Judge.

On September 2, 2009, the United States Department of Justice announced that Pfizer, Inc. had agreed to pay $2.3 billion in fines and penalties arising from the illegal “off-label” marketing by Pfizer and one of its subsidiaries of various regulated drugs. Immediately thereafter, several derivative actions were commenced, mostly by institutional investors, seeking recovery on behalf of the company from various senior executives and present and former board members who were alleged to be responsible for the misconduct that resulted in these vary large fines and penalties. The cases were consolidated, and on November 18, 2009, the plaintiffs jointly filed a 93-page, five-count Consolidated, Amended, and Verified Shareholder Derivative Complaint (the “Complaint”). On December 16, 2009, the defendants moved to dismiss the Complaint in its entirety. Following extensive briefing and oral argument, the Court, by Order dated March 17, 2010, (a) granted the motion to dismiss Count I (which alleged that the present and former directors caused Pfizer to disseminate materially inaccurate and misleading proxy statements in violation of the federal securities laws); (b) granted the motion to dismiss Count II (which *455 alleged that all defendants violated their fiduciary duties under Delaware law by allowing Pfizer to disseminate these statements); (c) granted the motion to dismiss Count V (which alleged that the defendants were unjustly enriched at Pfizer’s expense); (d) granted the motion to dismiss all claims asserted against defendant Allen P. Waxman (on the unopposed representation that he had never been served); and (e) denied the motion in all other respects, thus leaving in place Count III (which alleged that the director defendants, in violation of their fiduciary duties under Delaware law, intentionally approved or deliberately disregarded Pfizer’s alleged promotion of off-label drugs and its payment of alleged illegal kickbacks to health care professionals) and Count IV (which alleged similar breaches of duty by the executive defendants). This Opinion and Order explains the reasons for these rulings and specifies that the dismissals are with prejudice except as to Mr. Wax-man.

The Complaint alleges, in pertinent part, the following: Pfizer’s core business rests on the marketing of its drugs, not just to consumers, but also, importantly, to physicians and other health care professionals. Compl. ¶¶ 54-56. The Federal Food, Drug, and Cosmetics Act, 21 U.S.C. § 301 et seq., prohibits pharmaceutical companies from marketing or promoting their drugs for “off label” uses or dosages — ie., uses or dosages that have not specifically been approved by the Food and Drug Administration. Compl. ¶¶ 59-60. Various federal laws also prohibit paying “kickbacks” (ie., concealed commercial bribes) to health care professionals to get them to prescribe or promote a company’s drugs. Id. ¶ 61.

Pfizer was acutely aware of the need to prevent such illegal practices on the part of itself and its subsidiaries because of prior settlements with the Government attributing just such misconduct to various Pfizer subsidiaries shortly prior to their acquisition by Pfizer. For example, in 2002, Pfizer subsidiary Warner-Lambert settled charges brought by the Government under the False Claims Act alleging that Warner-Lambert, prior to its acquisition by Pfizer, had given concealed kickbacks to a managed care organization in exchange for that organization’s agreement to give preferred status to Lipitor, an anti-cholesterol drug. Id. ¶ 89. Pursuant to this settlement, Pfizer paid $49 million in fines and entered into a five-year corporate integrity agreement (the “2002 CIA”) to guarantee that Pfizer and Warner-Lambert would not pay illegal kickbacks in the future. Id. ¶ 90. The 2002 CIA required, among other things, that Pfizer’s board would create and implement a compliance mechanism that would bring information about illegal marketing activities to the board’s attention. Id. ¶¶ 90, 110-113.

Similarly, in 2004, Pfizer entered into a settlement with the Government regarding Warner-Lambert’s illegal off-label marketing (prior to Warner-Lambert’s acquisition by Pfizer 1 ) of Neurontin, an anticonvulsant medication with dangerous side effects. Id. ¶¶ 92-93, 100. In connection with this settlement, Warner-Lambert pleaded guilty to criminal and civil charges that it fraudulently promoted Neurontin for unapproved uses. The Government’s sentencing memorandum noted that the marketing scheme, implemented *456 “with knowledge and approval of senior management,” included a variety of tactics to promote off-label use, ranging from direct solicitations by Warner-Lambert’s sales representatives to sponsoring promotional meetings and “independent” medical education events to encourage off-label prescriptions. Id. ¶ 99. To settle these charges, Pfizer paid a $240 million criminal fine and an additional $190 million penalty. Id. ¶ 100. Additionally, Pfizer entered into another, more extensive CIA (the “2004 CIA”) that required even more stringent steps to bring any such misconduct to the Board’s attention. Id. ¶¶ 101, 114-20.

Finally, in 2007, Pfizer paid another $34.6 million in criminal fines relating to the illegal off-label marketing by Pharmacia & Upjohn Company, Inc. (“Pharmacia”), another of Pfizer’s wholly-owned subsidiaries, of Genotropin, a human growth hormone with dangerous side effects that were promoted by Pharmacia (prior to its acquisition by Pfizer 2 ) for its alleged use as an anti-aging agent. To settle these charges, Pharmacia pleaded guilty to illegally promoting and selling Genotropin and to intentionally violating the federal anti-kickback statute. Id. ¶¶ 102-08.

In the face of all these prior violations by its subsequently-acquired subsidiaries, and despite its promises to take significant steps to monitor and prevent any further violations, Pfizer itself engaged in the same misconduct. Using sophisticated “prescription data mining” and “influence mapping” analyses, Pfizer targeted specific physicians for visits by Pfizer sales representatives to promote off-label uses of Pfizer drugs. Id. ¶ 77. Sales representatives were given financial incentives and assigned quotas to encourage such off-label promotion, and these representatives were urged to make false claims regarding the safety and efficacy of off-label uses of Pfizer drugs. Id. ¶¶ 77, 81. Pfizer also developed a “Scientific Ambassador Program” that used medical liaisons to promote off-label uses. Id. ¶ 79. Further, Pfizer commissioned articles published in medical journals that promoted certain off-label uses for “blockbuster” drugs based on skewed and inaccurate data, and then instructed its sales representatives and medical liaisons to use these studies to market the drugs to physicians. Id. ¶¶ 82-83.

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Bluebook (online)
722 F. Supp. 2d 453, 2010 U.S. Dist. LEXIS 69593, 2010 WL 2747447, Counsel Stack Legal Research, https://law.counselstack.com/opinion/in-re-pfizer-inc-shareholder-derivative-litigation-nysd-2010.