Searching over 5,500,000 cases.

Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.

United States ex rel. Brown v. Pfizer, Inc.

United States District Court, E.D. Pennsylvania

June 22, 2017



          R. BARCLAY SURRICK, J.

         Presently before the Court is Defendant's Motion to Certify Questions for Interlocutory Review And For Stay. (ECF No. 126.) For the following reasons, Defendant's Motion will be granted.

         I. BACKGROUND

         Eleven years ago, Relators filed this lawsuit against Defendant Pfizer under the False Claims Act (“FCA”) based on allegations that Defendant submitted misleading information to the Food and Drug Administration (“FDA”), and concealed critical information in order to gain approval of its antifungal drug, Vfend. A full review of the facts in this matter appears in our previous Memoranda addressing Defendant's First and Second Motions to Dismiss, dated February 29, 2016 and April 12, 2017, respectively. (ECF Nos. 94, 122.)

         A. Procedural History

         On December 29, 2005, Relators filed a qui tam Complaint on behalf of the United States under seal, pursuant to the FCA, 31 U.S.C. § 3729 et seq. (ECF No. 1.) Nearly four years later, on December 1, 2009, Relators filed an Amended Complaint. (ECF No. 19.) The case remained under seal for six years while the United States decided whether to intervene. Ultimately, the United States declined to intervene, and on November 28, 2011, the Amended Complaint was unsealed. (ECF No. 32.) Defendant filed a motion to dismiss Relators' Amended Complaint, which we granted in part and denied in part. Relators then filed a Second Amended Complaint. (SAC, ECF No. 98.) Defendant filed a motion to dismiss Relators' SAC, which we denied. Defendant now seeks interlocutory review of our April 12, 2017 Memorandum and Order.

         B. Relevant Facts

         Defendant seeks certification of the April 12th Order, which denied Defendant's Second Motion to Dismiss Relators' SAC. Relators' SAC alleges that Defendant knowingly caused to be presented false or fraudulent claims for payments, and knowingly entered into conspiracies with paid “speakers, ” medical marketing firms, “experts, ” and other third parties for the purpose of defrauding the United States Government. (SAC ¶¶ 204-20.) Defendant made several arguments in its Second Motion to Dismiss. Three of these arguments are relevant for the purposes of addressing the instant Motion. They are: (1) that the Court lacked subject matter jurisdiction over portions of Relators' SAC; (2) that Defendant's off-label use of Vfend on neutropenic patients and for empiric therapy is covered by Medicare; and (3) that Relators have failed to satisfy the materiality requirement of the FCA because the Government continued to pay for Vfend despite Relators' allegations in 2005. In the Memorandum and Order of April 12th, after a full analysis, we concluded that: (1) Relators were permitted to file an amended complaint in order to cure a first-to-file defect; (2) 42 U.S.C. § 1395x(t)(2)(A) applied to Vfend, an antifungal drug; and (3) the Government's continued payments of Vfend were insufficient to establish that Relators' claims failed for lack of materiality.

         Defendant's instant Motion requests that this Court certify three questions for interlocutory review:

1. Is it possible for allegations to satisfy the FCA's demanding materiality requirement when the government learned about the allegations more than a decade ago, conducted a multi-year investigation, and continues to pay the relevant claims?
2. If a relator “brings a related action” in violation of the FCA's first-to-file rule, can the relator cure this defect merely by filing an amended complaint after the earlier-filed lawsuit is no longer “pending?”
3. Does 42 U.S.C. § 1395x(t)(2)(B) apply to Vfend even though it is not “used in any anticancer chemotherapeutic regimen?”


         Generally, an order denying a motion to dismiss is not immediately appealable because it is not a final judgment. See In re Chocolate Confectionary Antitrust Litig., 607 F.Supp.2d 701, 704 (M.D. Pa. 2009) (“Denials of motions to dismiss are not final orders, and a losing party may not ordinarily pursue an immediate appeal from them.”). However, district courts may certify a non-final order for interlocutory appeal under 28 U.S.C. § 1292(b). Id. To certify a non-final order for interlocutory appeal, “[t]he order must (1) involve a ‘controlling question of law, ' (2) offer ‘substantial ground for difference of opinion' as to its correctness, and (3) if appealed immediately, ‘materially advance the ultimate termination of the litigation.'” Katz v. Carte Blanche Corp., 496 F.2d 747, 754 (3d Cir. 1974) (quoting 28 U.S.C. ยง ...

Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.