In re Epogen & Aranesp off-Label Marketing & Sales

• Decision Date: 17 December 2008
• Docket Number: MDL No. 08-1934 PSG (AGRx).
• Court: U.S. District Court — Central District of California
• Parties: In re: EPOGEN & ARANESP OFFLABEL MARKETING & SALES PRACTICES LITIGATION.

590 F.Supp.2d 1282

In re: EPOGEN & ARANESP OFFLABEL MARKETING & SALES PRACTICES LITIGATION.

MDL No. 08-1934 PSG (AGRx).

United States District Court, C.D. California.

December 17, 2008.

COPYRIGHT MATERIAL OMITTED

PHILIP S. GUTIERREZ, District Judge.

Before the Court are Defendants' separate motions to dismiss the Complaint. The Court heard oral argument on the matter on November 3, 2008. For the reasons set forth below, the Court DIMISSES the complaint with leave to amend.

I. Background

A. The Parties

Plaintiff Sheet Metal Workers National Health Fund ("SMW") is a welfare plan that provides post-retirement health benefits to approximately 17,000 retired members of the Sheet Metal Workers International Association. Plaintiff United Food & Commercial Workers Central Pennsylvania & Regional Health & Welfare Fund ("UFCW") is a not-for-profit trust established and maintained to provide health care benefits to participant-workers who are employed under various collective bargaining agreements, as well as to their dependents. Plaintiff Painters District Counsel No. 30 Health & Welfare Fund is a not-for-profit trust established and maintained to provide health care benefits to participant-workers and their dependents. Plaintiffs Ironworkers Local Union No. 68 and Participating Employers Health and Welfare Funds, Ironworkers Local Union No. 399 and Participating Employers Health and Welfare Funds, and Ironworkers District Council of Philadelphia and Vicinity Benefit and Pension Plan are health and welfare funds. Plaintiff Linda A. Watters, Commissioner, Offices of Financial and Insurance Services for the State of Michigan, has sued in her capacity as liquidator of Michigan Health Maintenance Organization Plans, Inc., formerly known as Omnicare Health Plan, Inc. ("Omnicare"). Omnicare was a private third-party payor who assumed the risk of payment for medical and prescription costs on behalf of the participants in its plan. Collectively, the foregoing parties are referred to as "Plaintiffs." Plaintiffs seek to represent a proposed class ("the Class") consisting of all persons and entities that paid any portion of the purchase price of Epogen and Aranesp when the drugs were prescribed for purposes not specified on their FDA-approved labels between May 21, 2002 and March 9, 2007 ("the Class Period").

Defendants are Amgen, Inc. ("Amgen"), one of the largest pharmaceutical companies in the United States; DaVita, Inc. ("DaVita"), a provider of dialysis services for patients suffering from chronic kidney failure, or end stage renal disease; and Fresenius Medical Care Holdings, Inc. ("Fresenius"), a wholly owned subsidiary of Fresenius Medical Care AG & Co., which operates dialysis services in the United States (collectively, "Defendants").

B. Factual Background

This action arises out of Defendants' allegedly unlawful promotion of two drugs: epoetin alfa, which Amgen markets in the United States as Epogen, and darbepoetin alfa, which Amgen markets in the United States as Aranesp (jointly referred to as "EPO"). Consolidated Class Action Complaint ("Compl.") ¶ 3. Both of these drugs are known as erythropepoiesis-stimulating agents, or ESAs, because they stimulate the production of red blood cells. Compl. ¶ 4.

The Food and Drug Administration ("FDA") approved Epogen in 1989 for the treatment of anemia in chronic renal failure patients (whether or not they are on dialysis), HIV-infected patients, cancer patients on chemotherapy, and for surgery patients to reduce allogeneic blood transfusion. Compl. ¶¶ 40, 42. Epogen's 2005 FDA-approved package insert regarding dosage and administration for patients with chronic renal failure states that "EPOGEN® may be given either as an IV or SC injection. In patients on hemodialysis, the IV route is recommended."¹ Compl. ¶ 47. The insert further states that "the dose should be adjusted for each patient to achieve and maintain a target hemoglobin not to exceed 12 g/dL." Id. In 2001, the FDA approved a similar drug, Aranesp, for the treatment of anemia associated with chronic renal failure. Compl. ¶ 48. In July 2002, the FDA approved Aranesp for the treatment of chemotherapy-induced anemia. Compl. ¶ 48.

From 2002 to at least 2007, Amgen issued a number of press releases touting the positive results of clinical studies on the off-label use of Aranesp. Compl. ¶¶ 54-56, 59-60, 62-63, 65-70. Many of these press releases did not reveal that the studies were not conducted by independent researchers and instead were funded by Amgen. Compl. ¶¶ 56, 59, 60, 62. According to the Complaint, Amgen also promoted off-label uses of EPO to physicians and the public by funding third-party organizations that provided educational materials, Continuing Medical Education ("CME") programs, and physician brochures highlighting the off-label uses of EPO. Compl. ¶¶ 71-87. While engaging in this promotion, Amgen allegedly concealed or minimized the results of studies that showed risks associated with off-label uses of EPO, such as higher incidence of heart attacks, strokes, tumor growth, and death. Compl. ¶¶ 88-90, 92-93. Plaintiffs refer to this allegedly fraudulent scheme as the "Off-Label Marketing Enterprise" ("OLME").

Additionally, Amgen entered into drug supply contracts with Defendants DaVita and Fresenius that provided volume-based discounts and other incentives for increased use of EPO. Compl. ¶¶ 7, 125. The Complaint alleges that Defendants engaged in a scheme to boost profits by unlawfully promoting the intravenous administration of EPO to treat anemia in kidney dialysis patients, even though this route of administration had the effect of achieving a dangerously high hemoglobin level of 13g/dL or above. Compl. ¶¶ 7, 128. Plaintiffs refer to this scheme as the "Kidney Dialysis Enterprise" ("KDE").

On February 16, 2007, The Cancer Letter published an article about the results of an October 2006 study regarding Aranesp's effectiveness on patients with head and neck cancer which had been closed early due to increased mortality rates. Compl. ¶¶ 10, 104. On March 9, 2007, the Food and Drug Administration ("FDA") mandated a "black box" warning for the off-label use of EPO. Compl. ¶¶ 11, 109. The warning cautioned that use of ESAs to achieve a target hemoglobin of 12/dL or greater in cancer patients: (1) "shortened the time to tumor progression in patients with advanced head and neck cancer receiving radiation therapy;" (2) "shortened overall survival and increased deaths attributed to disease progression in patients with metastatic breast cancer receiving chemotherapy;" and (3) "increased the risk of death in patients with active malignant disease not under treatment with chemotherapy or radiation therapy." Compl. ¶ 109. The FDA alert also included the results of a December 2003 study which indicated that anemia patients with nonsmall cell lung cancer receiving EPO died in half the time of patients given placebos; as a result, the study was cut short. Compl. ¶ 110.

C. Procedural Background

Initially, Plaintiffs in this MDL proceeding brought separate cases in the Central District of California. At various times, several cases were transferred to other districts around the country. Upon UFCW's motion, the Judicial Panel for Multidistrict Litigation ordered all cases transferred to this Court on April 8, 2008. On July 2, 2008, Plaintiffs filed a Consolidated Class Action Complaint alleging that Defendants engaged in a fraudulent scheme that caused Plaintiffs and the Class to pay millions of dollars for EPO prescribed for ineffective and unsafe offlabel uses. Compl. ¶ 151. Presently before this Court are Amgen, DaVita, and Fresenius's separate motions to dismiss the Complaint. With leave of the Court, Plaintiffs filed a single brief in opposition to Defendants' motions.

II. Legal Standard

Rule 12(b)(6) of the Federal Rules of Civil Procedure provides a mechanism for a party to dismiss a claim if the claimant fails to state a claim upon which relief can be granted. In evaluating the sufficiency of a complaint under Rule 12(b)(6), courts must be mindful that the Federal Rules require only that the complaint contain "a short and plain statement of the claim showing that the pleader is entitled to relief." Fed.R.Civ.P. 8(a). Even though a complaint attacked by a Rule 12(b)(6) motion to dismiss does not need detailed factual allegations, "a plaintiffs obligation to provide the grounds of his entitle[ment] to relief requires more than labels and conclusions, and a formulaic recitation of the elements of a cause of action will not do." Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 127 S.Ct. 1955, 1965, 167 L.Ed.2d 929 (2007) (internal citations omitted). The complaint must allege facts sufficient to raise a right to relief above the speculative level. Id. (citing 5 C. Wright & A. Miller, Federal Practice and Procedure § 1216, pp. 235-236 (3d ed. 2004)). The Court must accept as true all factual allegations in the complaint and must draw all reasonable inferences from those allegations, construing the complaint in the light most favorable to the plaintiff. Guerrero v. Gates, 442 F.3d 697, 703 (9th Cir.2006); Balistreri v. Pacifica Police Dept., 901 F.2d 696, 699 (9th Cir.1988).

III. Requests for Judicial Notice

As a threshold matter, the Court considers DaVita's requests for judicial notice. On a motion to dismiss, the Court may take judicial notice of facts that are not "subject to reasonable dispute." Lee v. City of Los Angeles, 250 F.3d 668, 689 (9th Cir.2001). Under Fed.R.Evid. 201, a fact is not subject to reasonable dispute when it is "capable of accurate and ready determination by resort to sources whose accuracy cannot reasonably be questioned." The Court grants DaVita's request as to Exhibits 1-4, labels for Epogen that are publicly available on the FDA website, finding that the labels are documents not subject to reasonable dispute. See In re Amgen Inc. Secs. Litig., 544 F.Supp.2d 1009, 1023 (...