In Re Lupron Marketing and Sales Practices Litigation

245 F. Supp. 2d 280, 2003 U.S. Dist. LEXIS 3184, 2003 WL 165778
CourtDistrict Court, D. Massachusetts
DecidedFebruary 19, 2003
DocketMDL 1430, 01-CV-10861-RGS
StatusPublished
Cited by28 cases

This text of 245 F. Supp. 2d 280 (In Re Lupron Marketing and Sales Practices Litigation) is published on Counsel Stack Legal Research, covering District Court, D. Massachusetts primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
In Re Lupron Marketing and Sales Practices Litigation, 245 F. Supp. 2d 280, 2003 U.S. Dist. LEXIS 3184, 2003 WL 165778 (D. Mass. 2003).

Opinion

MEMORANDUM AND ORDER ON DEFENDANT TAKEDA’S MOTION TO DISMISS FOR WANT OF PERSONAL JURISDICTION

STEARNS, District Judge.

A consortium of patients and health care plans maintains that defendants Abbott Laboratories (“Abbott”), Takeda Chemical Industries, Ltd. (“Takeda”) and TAP Pharmaceutical Products, Inc. (“TAP”) (an Illinois corporation owned by Abbott and Takeda) conspired to artificially inflate the price for the cancer drug Lupron®. 1 The plaintiffs’ consolidated class action is grounded on the civil provisions of the Racketeer Influenced and Corrupt Organizations Act (“RICO”), 18 U.S.C. § 1962. 2 It seeks to recover the alleged overcharges for Lupron® and to impose a treble measure of punitive damages. Defendants deny the conspiracy allegations, question the legal theories on which the RICO claims are based, and, in the case of Take-da, challenge the existence of jurisdiction in the courts of the United States. Consistent with the rule that a trial court should determine whether Article III jurisdiction exists before proceeding to the merits of a claim, the court will in this decision address Takeda’s jurisdictional arguments. See Steel Co. v. Citizens for a Better Environment, 523 U.S. 83, 95-103, 118 S.Ct. 1003, 140 L.Ed.2d 210 (1998).

BACKGROUND

Abbott is a major manufacturer and distributor of prescription drugs. With headquarters in Abbott Park, Illinois, Abbott employs some 60,000 people. It reported sales of $13.7 billion during its fiscal year 2000. Takeda, based in Osaka, Japan, is Japan’s largest pharmaceutical company. Takeda reported worldwide sales in 1999 of $8.7 billion. Takeda manufactures Lu-pron® in Japan for export to the United States. TAP is an Illinois-based corporation jointly owned by Takeda America Holdings (“TAH”) 3 and Abbott. Lupron® is distributed in the United States by TAP *284 though a subsidiary, TAP Pharmaceuticals, Inc. Plaintiffs concede that TAP is a “separate and distinct” entity in the sense that it “maintains its own employees and operations and conducts its affairs separately from Abbott and Takeda.” Corrected Consolidated Amended Class Action Complaint (“Amended Class Action Complaint”) ¶ 61. TAP’s corporate headquarters are in Waukegan, Illinois.

Lupron® (leuprolide acetate), which acts to suppress the human hormone testosterone, is used primarily in the treatment of male prostrate cancer. It is also effective in treating endometriosis, central precocious puberty, and uterine fibroid preoperative anemia. Lupron® is administered by intramuscular injection, typically in the arm or buttocks, in daily or monthly doses. Consequently, most Lupron® is sold to doctors who administer their patients’ injections.

On October 13, 2001, the U.S. Attorney for the District of Massachusetts announced that TAP had agreed to pay $875 million to settle criminal charges and civil claims arising from the fraudulent marketing of Lupron®. 4 The primary victim identified in the criminal information filed against TAP was the U.S. Department of Health and Human Services (“HHS”) Medicare program. Medicare was created in 1965 by Congress as an extension of the Social Security Act. Medicare reimburses the costs of a number of medical services, including the costs of certain prescription drugs, for enrolled recipients. Beneficiaries are not, as a rule, reimbursed for the costs of self-administered drugs. However, Medicare Part B pays providers 80% of the allowable cost of an injectable drug like Lupron®. 5

“Allowable cost” was defined by HHS regulations until 1998 as the lesser of either a drug’s estimated acquisition cost or its national average wholesale price (“AWP”). 6 42 C.F.R. § 405.517. Medicare administrators historically relied on the AWP provided by TAP to the Red Book, an industry compilation of wholesale drug prices, in setting the reimbursement rate for Lupron®. 7 The Red Book AWP for Lupron® in 1992 was $418.75— $437.50; in 1993 $437.50; in 1994 $463.75; in 1995 $477.50; in 1996 $496.25-$515.63; in 1997 $515.63; in 1998 $540.63; in 1999 $594.65; in 2000 $623.70; and in 2001$623.79. 8 In pleading guilty to violating the Prescription Drug Marketing Act, 21 U.S.C. §§ 331(t) and 333(b), TAP admitted to encouraging doctors to bill Medi *285 care at the Red Book AWP for free samples of Lupron® as part of a scheme to promote “brand loyalty” by permitting doctors to pad their incomes by pocketing the AWP reimbursement. 9 “TAP knew that [it] could ‘raise’ the average wholesale price of Lupron at any time by simply forwarding to the Redbook a new and higher average wholesale price. This allowed TAP, in effect, to control the maximum Medicare reimbursement paid to a doctor for [prescribing] Lupron.” Government’s Sentencing Memorandum, at 12. The Memorandum further acknowledged that the proposed settlement did not include restitution for private insurers and co-paying patients who had also been victimized by the scheme, but noted that “some patients and health insurers have commenced litigation against TAP to recover overpayments caused by the criminal conduct and thus have a forum in which to demonstrate and obtain any appropriate damages.” Id. at 4.

Plaintiffs are among the health care providers and individual consumers who purchased (or reimbursed the purchase) of Lupron® at the inflated AWP. Nine of the cases transferred to this court by the MDLP for pretrial proceedings were filed as putative class actions in federal courts in Illinois, Massachusetts, Alabama, and Minnesota. For convenience, each will be referred to by the name of the lead plaintiff. 10 The direct action filed in Massachusetts by the Blue Cross and Blue Shield Plans will be referred to as the Blues Complaint. 11

THE AMENDED CLASS ACTION COMPLAINT

The essential facts set out in the Amended Class Action Complaint are as follows. 12 According to plaintiffs, the AWPs for Lupron® reported by the defendants to the publishers of the Red Book bore no resemblance to the actual prices charged by TAP to doctors, nor did they *286

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Bluebook (online)
245 F. Supp. 2d 280, 2003 U.S. Dist. LEXIS 3184, 2003 WL 165778, Counsel Stack Legal Research, https://law.counselstack.com/opinion/in-re-lupron-marketing-and-sales-practices-litigation-mad-2003.