United States ex rel. Coyne v. Amgen, Inc.

• Decision Date: 17 January 2017
• Docket Number: CV 12–3881 (JMA)(AYS)
• Citation: 229 F.Supp.3d 159
• Parties: UNITED STATES of America, et al., EX REL. Daniel COYNE, M.D., Plaintiff, v. AMGEN, INC., Defendant.
• Court: U.S. District Court — Eastern District of New York

229 F.Supp.3d 159

UNITED STATES of America, et al., EX REL. Daniel COYNE, M.D., Plaintiff,

v.AMGEN, INC., Defendant.

CV 12–3881 (JMA)(AYS)

United States District Court, E.D. New York.

January 17, 2017

Eric Owen Corngold, Christopher Leonard McCall, Friedman Kaplan Seiler & Adelman, New York, NY, David S. Rosenbloom, McDermott Will & Emery LLP, Chicago, IL, for Defendant.

Lori Aileen Siler, The Restaino Law Firm, Denver, CO, Kenneth J. Brennan, Tor hoerman Law, Edwardsville, IL, for Relator.

REPORT AND RECOMMENDATION

SHIELDS, Magistrate Judge:

This case was commenced as a qui tam action pursuant to the Federal False Claims Act, 31 U.S.C. § 3729 (the "FCA"). Plaintiff Daniel Coyne, M.D. ("Coyne" or "Plaintiff") brought the action as relator, seeking to represent the interests of the United States of America (the "United States"), the District of Columbia, and twenty-nine States (collectively the "Governmental Entities"). The case was commenced on August 6, 2012. See Docket Entry herein ("DE") 1. The presently operative amended complaint (the "Amended Complaint") was filed on January 5, 2015. DE 25.

All of the Governmental Entities have declined to intervene but Plaintiff is continuing, as is his right, to litigate this matter. Presently before this Court, upon referral by the Honorable Joan M. Azrack for Report and Recommendation, is Defendant's motion pursuant to Rule 12 of the Federal Rules of Civil Procedure, to dismiss the amended complaint. See Docket Entries herein ("DE") 38 (motion to dismiss) and order dated October 17, 2016 (referring motion).

After initial briefing of the motion, the parties submitted letters regarding additional authority in support of their positions. DE 39, 40. This Court held oral argument on the motion on January 4, 2017. Counsel for the United States observed the argument, and shortly thereafter submitted a letter addressing certain points raised during the course thereof. DE 42. In a letter dated January 11, 2017, Defense counsel responded to that letter, as well as a question raised by this Court during oral argument, DE 43. Upon consideration of all of the submissions before his Court, including the oral argument and the post-argument submissions, this Court recommends, for the reasons set forth below, that the motion be granted.

BACKGROUND

I. Documents Considered on Motion to Dismiss

As required in the context of this motion, Plaintiff's factual allegations, though disputed by Defendants, are accepted as true. All reasonable inferences are drawn from those allegations, and are construed in favor of Plaintiff.

While facts to consider in the context of a Rule 12 motion to dismiss are generally limited to those set forth in the pleadings, a court may consider matters outside the pleadings when determining, for purposes of a Rule 12(b)(1) motion, whether subject matter jurisdiction exists. M.E.S., Inc. v. Snell , 712 F.3d 666, 671 (2d Cir. 2013) ; Romano v. Kazacos , 609 F.3d 512, 520 (2d Cir. 2010) ; Morrison v. Nat'l Australia Bank Ltd. , 547 F.3d 167, 170 (2d Cir. 2008) aff'd. 561 U.S. 247, 130 S.Ct. 2869, 177 L.Ed.2d 535 (2010). In the context of a Rule 12(b)(6) motion, a court may consider: (1) documents attached to the complaint as exhibits or incorporated by reference therein; (2) matters of which judicial notice may be taken; or (3) documents upon the terms and effect of which the complaint "relies heavily" and which are, thus, rendered "integral" to the complaint.

Chambers v. Time Warner, Inc. , 282 F.3d 147, 152–53 (2d Cir. 2002) ; see International Audiotext Network, Inc. v. American Tel. and Tel. Co. , 62 F.3d 69, 72 (2d Cir. 1995).

Pursuant to these standards, this Court has considered in addition to the pleadings, publicly available labelling and packaging information promulgated by the Federal Food and Drug Administration that apply to the drug at issue in this lawsuit. The parties are aware of such publicly available information. Moreover, they have referred to and relied upon it in their pleadings and motion papers.

II. Facts

A. The Parties

Plaintiff Coyne is a medical doctor specializing in the areas of renal disease

and nephrology. Coyne is board certified in both internal medicine and nephrology, and is a Professor of Medicine at Washington University School of Medicine. Defendant Amgen, Inc. ("Amgen") is a company engaged in the business of manufacturing and distributing biopharmaceuticals including, inter alia , a synthetically produced hormone marketed under the trade name "Epogen." At certain times prior to the complaint, Coyne served as a paid speaker for Amgen, assisting in its marketing of Epogen.

B. Epogen

Epogen

, Amgen's name for "epoetin alpha," is a drug that promotes red blood cell production. Epogen raises the level of hemoglobin, a protein in red blood cells that carries oxygen throughout the body. Hemoglobin is measured as "grams per deciliter" ("g/dl"). The normal range of hemoglobin levels for males is between 13 and 18 g/dl. For females, the normal range is between 12 and 16 g/dl. Broadly speaking, a low level of hemoglobin is referred to as anemia. Epogen's ability to increase hemoglobin levels has led to its use in the treatment of anemia. In particular, Epogen has been used in patients with chronic kidney disease ("CKD") undergoing kidney dialysis, nearly all of whom suffer from some level of anemia. Epogen is typically prescribed for such patients to raise hemoglobin levels and thereby avoid, or at least defer, the need for blood transfusion.

C. FDA-Approved Packaging for Epogen

The Court details below certain information contained in the packaging of Epogen

that has been approved by the Federal Food and Drug Administration (the "FDA" or the "Agency"). Because of the nature of Plaintiff's claims, the Court highlights language used with respect to "target" levels of Epogen, and statements as to Epogen's effect on "quality of life," and certain domains related thereto. It is the alleged marketing of Epogen to patients with hemoglobin levels of 11 g/dl (with the intent of increasing that level to 12 or above to improve their "quality of life") that forms the factual basis of Plaintiff's FCA claim. DE 25 ¶ 29.

The FDA first approved the use of Epogen

for treatment of anemia in CKD patients in 1989. DE 25 ¶ 34. The 1989 approved packaging included information as to target hemoglobin levels, setting the target range at 10–11 g/dl. Statements regarding improved quality of life do not appear in the 1989 packaging. In 1994, the FDA approved new Epogen packaging, setting the target hemoglobin range at 10–12 g/dl. Statements as to improvements in quality of life first appeared as part of the FDA-approved Epogen packaging in 1994. See Exh. 1 to Memorandum of Law in Support of Motion to Dismiss (1994 FDA approved Epogen label) DE 38–2 at 5. Unlike the target level statements, which appear in the "Indications and Usage" section, language as to quality of life, appears in the "Clinical Experience" section of the packaging. In the latter section, the packaging states that once target hematocrit levels were achieved, "statistically significant improvements were demonstrated for most quality of life parameters measured, including energy and activity level, functional ability, sleep and eating behavior, health status, satisfaction with health, sex life, well-being, psychological effect, life satisfaction and happiness." Exh. 1; DE 38–2 at 6. The statement as to improved quality of life does not distinguish between improvements made at specific points within the 10–12 g/dl target hemoglobin range, nor does it state specifically that those achieving a level of between 11 and 12 g/dl experienced increases in quality of life that differed from those who achieved hemoglobin

levels of 10–11 g/dl. Instead, the packaging states only that once target levels were achieved, patients experienced improved quality of life as described therein.

In 2007, consistent with the FDA's evolving approach to statements as to patient-reported outcome claims, the label for Epogen

began to refer to specific domains within the broader "quality of life" category.¹ Thus, in 2007, the Clinical Experience section of the Epogen label refers to the specific findings of a study conducted of 118 anemic dialysis patients who entered the study with average hemoglobin levels of approximately 7 g/dl. Those levels were increased by administration of Epogen to an average of approximately 11 g/dl. Instead of referring to the broad category of quality of life improvement, the 2007 label states that study participants treated with Epogen"experienced improvements in exercise tolerance and patient reported physical functioning."²

Beginning in 2008, the FDA-approved Epogen

label differed markedly from prior labeling in that it began to include a "black box" warning with respect to Epogen use by patients with renal failure.³ That warning is not directed to quality of life indicators. Instead, it addresses cardiovascular issues, and states that "patients experienced greater risks for death and serious cardiovascular events" when using drugs in the Epogen class to "target higher versus lower hemoglobin levels." While this label thus recognized cardiovascular dangers associated with the targeting of higher hemoglobin levels, it made, as noted, no changes to prior quality of life language. Importantly, the new language made no change to the indications and usage section of the label, which continued to refer to use of Epogen to reach a target hemoglobin range of 10–12 g/dl.

In June of 2011, the FDA issued a "Drug Safety Communication" referring to the Epogen

dosing regimen (the "2011 Statement").⁴ That statement informs healthcare providers of modified recommendations for more conservative dosing of products such as Epogen. In conjunction with the 2011 Statement, the FDA-approved Epogen packaging underwent a substantial change. Like the 2008 label, the 2011 packaging contains a black box warning. The 2011 label, however, states...