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United States ex rel. Solis v. Millennium Pharmaceuticals Inc.

United States District Court, E.D. California

March 26, 2015

UNITED STATES OF AMERICA, ex rel. FRANK SOLIS, Plaintiffs,
v.
MILLENNIUM PHARMACEUTICALS, INC., SCHERING-PLOUGH CORP., and MERCK & CO., Defendants

Decided March 25, 2015.

Page 1209

[Copyrighted Material Omitted]

Page 1210

For Frank Solis, Plaintiff: C. Brooks Cutter, John R Parker, Jr, LEAD ATTORNEYS, Kershaw Cutter & Ratinoff, LLP, Sacramento, CA.

For USA, Intervenor Plaintiff: Catherine J. Swann, LEAD ATTORNEY, United States Attorney's Office, Sacramento, CA; Jay D. Majors, LEAD ATTORNEY, Department of Justice, Washington, DC.

For State of California, Intervenor Plaintiff: Brian Vincent Frankel, LEAD ATTORNEY, California Department of Justice, San Diego, CA.

For State of Texas, Intervenor Plaintiff: Donald Cameron Duncan III, PHV, LEAD ATTORNEY, PRO HAC VICE, Texas Office of the Attorney General, Austin, TX.

For Millennium Pharmaceuticals, Inc., Defendant: Kimberly Ann Dunne, LEAD ATTORNEY, Sidley Austin LLP, Los Angeles, CA; Sean Ashley Commons, LEAD ATTORNEY, Sidley Austin, LLP, Los Angeles, CA; McGregor Scott, Orrick, Herrington & Sutcliffe LLP, Sacramento, CA; Paul Kalb, PHV, PRO HAC VICE, Sidley Austin LLP, Washington, DC.

For Schering-Plough Corp., Defendant: Rocky Chiu-feng Tsai, LEAD ATTORNEY, Ropes & Gray LLP, San Francisco, CA; Douglas Hallward-Driemeier, PHV, PRO HAC VICE, Ropes & Gray LLP, Washington, DC; John P. Bueker, PHV, PRO HAC VICE, Ropes & Gray LLP, Boston, MA; Laura G. Hoey, PHV, PRO HAC VICE, Ropes & Gray LLP, Chicago, IL.

For Merck & Co., Defendant: John P. Bueker, PHV, LEAD ATTORNEY, Ropes & Gray LLP, Boston, MA.

For Pharmaceutical Research & Manufacturers of America, Amicus: David J. Weiner, LEAD ATTORNEY, Arnold & Porter LLP, Washington, DC.

MEMORANDUM AND ORDER

Page 1211

MORRISON C. ENGLAND, JR., CHIEF UNITED STATES DISTRICT JUDGE.

This lawsuit was originally filed under seal on November 4, 2009, pursuant to the qui tam provisions of the Federal False Claims Act, 31 U.S.C. § 3729, et seq. (" FCA" ), against Defendants, who are pharmaceutical companies, include Millennium Pharmaceuticals, Inc., Schering-Plough Corp., and Merck and Co. (" Defendants" unless otherwise indicated). The so-called " Relator" Plaintiff, Frank Solis, a former sales employee who at various points worked for all three Defendants (" Relator" or " Plaintiff" ) claims that the companies fraudulently marketed and/or promoted the use of two drugs, Integrilin and Avelox, for so called " off label" uses not approved by the Food and Drug Administration.[1] In so doing, according to Relator, Defendants " caused" physicians to improperly prescribe the drugs and, consequently, to submit false claims to Medicare, Medicaid and TRICARE (United States Military Healthcare) for federal reimbursement, which the government allegedly paid without knowing the claims were ineligible. Following a three-year investigation, the United States and all twenty-four states named in the initial complaint chose not to intervene, and Relator's Complaint was subsequently unsealed on December 20, 2012.

In response to Motions to Dismiss previously filed on behalf of each of the Defendants, Relator filed a First Amended Complaint (" FAC" ) on June 27, 2013. The viability of Plaintiff's FAC was then also attacked through three separate motions. Defendants Schering-Plough Corp. (" Schering-Plough" ) and Merck & Co. (" Merck" ) filed a joint Motion to Dismiss for lack of subject matter jurisdiction under Federal Rule of Civil Procedure 12(b)(1)[2] on grounds that Relator's complaint was barred by the FCA's so called " public disclosure" bar. Defendant Millenium Pharmaceuticals, Inc. (" Millenium" ) subsequently joined in that motion. Additionally, two other motions, one filed jointly by Schering-Plough and Merck and the other by Millenium, argued that the various causes of action pled in the FAC are substantively deficient in contravention of Rule 12(b)(6). By Memorandum and Order filed March 26, 2014, this Court granted

Page 1212

Defendants' Rule 12(b)(1) motion on grounds that Relator's " combination use" allegations were precluded under the FCA's s-called " public disclosure" bar precluding suits whose allegations have already been disclosed. Because Relator's FAC contained other allegations beyond combination use, however, including assertions pertaining to a completely different drug, Avelox, as well as allegations of fraud, improper billing, and impermissible kickbacks, the Court permitted Relator to file a Second Amended Complaint (" SAC" ) omitting the combination use allegations.[3]

Relator's SAC was filed on April 5, 2014, and that amended pleading is the subject of yet another motion, this time offered by Defendant Millenium alone, that challenges the court's jurisdiction under Rule 12(b)(1) as to any claims asserted against Millenium. As set forth below, that Motion is GRANTED. Because the Court concludes that it has no jurisdiction over Relator's claims against Millenium in this matter, Millenium's concurrently filed Motions to Dismiss under Rule 12(b)(6), and to strike under Rule 12(c), are DENIED as moot.[4]

BACKGROUND

Integrilin is a drug that helps reduce blood clots and thereby helps to prevent heart attacks and death in patients suffering from acute coronary syndrome (" ACS" ). ACS is an umbrella term covering a variety of diseases related to clotting in the coronary arteries that supply blood to the heart muscle, including unstable angina (" UA" ), mild heart attacks known as non-ST--segment elevation myocardial infarctions (" NSTEMI" ), and more severe heart attacks called ST-segment elevation myocardial infarctions (" STEMI" ). Avelox, on the other hand, is an antibiotic approved by the Food and Drug Administration (" FDA" ) for treating adult patients with infections caused by a few susceptible strains of microorganisms.[5]

With respect to Integrilin, FDA approval was first obtained in May 1998 by a company named COR Therapeutics, Inc. (" COR" ), which thereafter promoted the drug along with Defendant Schering-Plough. In February of 2002, Defendant Millennium acquired COR and thereby obtained the right to co-promote Integrilin. In September of 2005, Defendant Millennium transferred its right to market Integrilin within the United States to Defendant Schering-Plough, thereby relinquishing any responsibility for the drug after a period of less than four years. Schering-Plough later merged with Merck in November of 2009 to form a new company, also known as Merck.

The allegations incorporated within Relator's initial complaint ...


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