FAITH S. HOCHBERG, District Judge.
This matter comes before the Court upon Class Plaintiffs' Motion for Discovery Pursuant to the Crime-Fraud Exception to Attorney-Client Privilege. Plaintiffs seek in camera review of documents deemed privileged by Defendants Pfizer, Inc. and Warner-Lambert Company LLC (collectively, "Pfizer") in order to determine whether the crime-fraud exception applies. The Court has considered the written submissions of the parties and held oral argument on the motion on May 5, 2010.
Plaintiffs in the instant action directly purchased Neurontin, a brand-name version of the drug compound gabapentin anhydrous from Defendants. In their Amended Complaint, Plaintiffs allege that Pfizer engaged in an overarching anti-competitive scheme to acquire and maintain monopoly power in the market for gabapentin products in violation of Section 2 of the Sherman Act, 15 U.S.C. § 2.
Plaintiffs claim that these actions were designed to, and did, in fact, delay the entry of generic gabapentin into the market until late 2004. Plaintiffs allege that but for Pfizer's anti-competitive scheme, generic manufacturers would have entered the market at lower prices as early as 2000. As a result of this delayed entry, Plaintiffs contend that they and other direct purchasers of Neurontin were foreclosed from the opportunity of purchasing lower-priced generic versions of the drug for years, and were accordingly compelled to pay non-competitive prices for gabapentin.
The attorney-client privilege is the oldest confidential communications privilege known to the common law. United States v. Zolin, 491 U.S. 554, 562, 109 S.Ct. 2619, 105 L.Ed.2d 469 (1989). The purpose of the privilege is to:
Upjohn Co. v. United States, 449 U.S. 383, 389, 101 S.Ct. 677, 66 L.Ed.2d 584 (1981).
Typically, application of the crime-fraud exception begins with "presentation of the factual basis for a good faith belief that the exception would apply," followed by "in camera evaluation of the material by the court," and provision of an opportunity to be heard to the party opposed to disclosure. Prudential Ins. Co. of Am. v. Massaro, 47 Fed.Appx. 618 (3d Cir.2002) (citing Haines v. Liggett Group, Inc., 975 F.2d 81, 96-97 (3d Cir.1992)).
"[T]he decision to engage in in camera review implicates a much more lenient standard of proof than the determination to apply the crime/fraud exception...." Haines, 975 F.2d at 96 (internal quotations omitted). In order for a court to engage in in camera review, the party seeking must show "a factual basis adequate to support a good faith belief by a reasonable person that in camera review of the materials may reveal evidence to establish the claim that the crime-fraud exception applies." Id.
Once the documents are before the court for in camera review, the party invoking the crime-fraud exception must make "a prima facie showing that (1) the client was committing or intending to commit a fraud or crime and (2) the attorney-client communications were in furtherance of that alleged crime or fraud." In re Grand Jury Subpoena, 223 F.3d 213, 217 (3d Cir.2000).
Class Plaintiffs seek in camera review of documents related to (1) the filing of the '479 Patent litigation as part of a profit-protection scheme that included Defendants' off-label marketing of Neurontin and (2) potential fraud or misrepresentation to then Magistrate Judge Chesler and Judge Lifland
Class Plaintiffs point to two potential bases upon which this Court might find a "fraud or crime" in order to properly invoke the crime-fraud exception after in camera review: (1) Defendants' illegal off-label promotion of Neurontin and the filing of the '479 patent litigation as part of a scheme to create and protect the profits generated by Neurontin and (2) a fraud on the court with regard to statements about Defendants' off-label promotion.
Pfizer, as set forth in its own guilty plea, engaged in the illegal off-label promotion of Neurontin between 1995 and 1996. A Massachusetts court recently found, based on lengthy civil trial proceedings, that those illegal activities continued in some cases until December 2004.
As set forth in greater detail below, Class Plaintiffs argue that the filing and prosecution of several lawsuits designed to protect Pfizer's interest in the '479 Patent—the filing of which triggered an automatic stay of the FDA approval process for all generic products for 30 months— were part of a plan by the company to protect the large profit base generated by Neurontin's off-label sales.
On May 13, 2004, a criminal information was filed in Massachusetts, charging Warner-Lambert with distribution of an unapproved new drug in violation of 21 U.S.C. §§ 331(d), 333(a)(2) and 355(a) and with distribution of a misbranded drug in violation of 21 U.S.C. §§ 331(a), 333(a)(2) and 352(f)(1). See United States v. Warner-Lambert Co., Crim. No. 04-10150 "Information," (D.Mass. 2004). The Information charged that though Neurontin was approved for use only in epilepsy patients, between April 1995 and August 1996, Warner-Lambert promoted it for a variety of unapproved or "off label" uses, including post-herpetic neuralgia, painful diabetic neuralgia, anxiety disorder, social phobias, bipolar disorder, alcohol withdrawal syndrome, amyotrophic lateral sclerosis ("ALS"), spinal cord injury, essential tremor, restless leg syndrome, reflex sympathetic dystrophy and migraine headaches.
On June 7, 2004, Pfizer pled guilty to all counts in the Information pursuant to a plea agreement with the Government. As part of that agreement, Pfizer "expressly and unequivocally admit[ted] that it committed the crimes charged in the Information" and agreed "that the facts set forth in the Information are true."
On November 3, 2010, Judge Patti B. Saris of the United States District Court for the District of Massachusetts issued Findings of Fact and Conclusions of Law in In re Neurontin Marketing and Sales Practices Litigation, No. 04 Civ. 10739(PBS) (D.Mass. Apr. 13, 2004). The opinion dealt specifically with a suit filed by Kaiser Foundation Health Plan and Kaiser Foundation Hospitals alleging that Pfizer violated the Racketeer Influenced and Corrupt Organizations Act and the California Unfair Competition Law. After a five week jury trial, a jury found that "Pfizer engaged in a RICO enterprise that committed mail and wire fraud by fraudulently marketing Neurontin for off-label conditions . . ." Kaiser Found. Health Plan, Inc. v. Pfizer, Inc., 748 F.Supp.2d 34, 38 (D.Mass.2010). The court found for Kaiser on its Unfair Competition claim as well. Id.
The Kaiser court found that Pfizer had engaged in fraudulent marketing activities—promoting Neurontin to treat bipolar disorder, neuropathic pain and migraines and generally to be taken in doses greater than 1800 mg/day—as recently as December 2004. Id. at 48. Pfizer was found to have "suppressed negative clinical trials and showcased positive ones," "sponsored continuing medical education programs and detailed doctors to promote
Despite later acknowledging its illegal conduct, Warner-Lambert repeatedly denied having engaged in off-label promotion to the court presiding over Warner-Lambert v. Purepac & Faulding, No. 98-2749(JCL), an action in which Warner-Lambert alleged infringement by generic pharmaceutical companies of the '479 Patent.
In a July 1, 1999 letter to then-Magistrate Judge Stanley R. Chesler addressing a variety of discovery disputes in that action, counsel for Warner-Lambert wrote that, "Warner-Lambert has never promoted or advertised Neurontin® for any other use other than epilepsy—and it will never do so unless that use becomes approved by the F.D.A."
That year, two of the generic defendants—Purepac and Apotex—moved for summary judgment. In opposing the motions, Warner-Lambert submitted two affidavits indicating that off-label sales were the product of the efficacy of Neurontin for other indications, without acknowledging that any off-label promotion had taken place.
During a December 27, 2000 hearing, Magistrate Judge Chesler asked Warner-Lambert's counsel to confirm that he has "just stated earlier that your view of the record indicates that there is no evidence or no suggestion that there was—or no issue that there was any improper promoting of Neurontin for off-label use with regard to the off label uses that are covered by the patent?"
It was only after Pfizer entered a guilty plea in Massachusetts that the company acknowledged to the court presiding over the related patent litigations that it engaged in unlawful off-label marketing.
To satisfy the "in furtherance of" element of the crime-fraud exception, "a logical link must exist between the privileged
Plaintiffs seek in camera review of a set of communications between Warner-Lambert and its counsel relating to Warner-Lambert's prosecution of actions against several generic drug manufacturers alleging infringement of its '479 patent. Specifically, Plaintiffs seek the communications between Warner-Lambert and its counsel concerning the basis for filing and prosecuting the '479 patent litigation. Plaintiffs argue that:
(Pltf. Feb. 19, 2010 Br. at 23)
This Court is deeply troubled by the illegal conduct to which Pfizer admitted in its guilty plea in Massachusetts, as well as by Judge Saris's conclusions about Pfizer's off-label marketing and promotional practices in Kaiser Foundation Health Plan, Inc. v. Pfizer, Inc. As this Court acknowledged in its June 9, 2011 Opinion & Order, this Court "fully expects" the issue of estoppel based on past admissions and judicial determinations with respect to off-label promotion "will be the subject of a summary judgment or in limine motion as this case proceeds." In re Neurontin Antitrust Litig., No. 02-1390(FSH), Opinion & Order at *17-18, 2011 WL 2357793 at *9 (D.N.J. June 9, 2011) (Dkt. No. 469).
As disturbing as Pfizer's conduct with respect to off-label promotion of Neurontin is, Class Plaintiffs have not set forth a reasonable basis upon which to conclude that in camera review would demonstrate that communications about the prosecution of the '479 Patent litigation were made with an intent to further unlawful promotion or profit-making schemes involving off-label marketing.
Class Plaintiffs' theory is, at its essence, that both the '479 Patent litigation and Pfizer's off-label marketing were designed to generate greater profits than those the company would legally have gained from Neurontin, and therefore the privileged communications regarding the latter would reasonably reveal acts in furtherance of a crime or fraud involving the former. This theory suffers from two flaws at this juncture. First, Class Plaintiffs' have not presented any basis beyond their own allegations upon which this Court could conclude that Pfizer's willingness to engage in misconduct with regard to off-label promotion necessarily means that Pfizer filed the '479
Class Plaintiffs also seek in camera review of documents regarding Pfizer's off-label marketing and subsequent representations to the Court on that subject. They argue that the communications embodied in these documents were made in furtherance of the scheme to hide illegal off-label promotion.
As set forth above, Pfizer made several representations to the court presiding over Neurontin related patent litigation that it was not involved in illegal off-label promotion. Those statements are directly contrary to Pfizer's admission in its 2004 guilty plea and with the court's conclusions in Kaiser Found. Health Plan, Inc. v. Pfizer, Inc. If the statements made to the court were untrue, Class Plaintiffs are entitled to probe what the speakers knew and what Pfizer knew about those speakers' statements. A reasonable person might well conclude that the statements were made as part of a scheme to hide Pfizer's misconduct.
For the reasons set forth above,
The Clerk of the Court is directed to terminate the motion: Dkt. No. 288.