Amgen 2012 Annual Report Download - page 145

F-46
Westmoreland v. Amgen Inc., Integrated Nephrology Network, AmerisourceBergen Specialty Group, ASD Healthcare and
AmerisourceBergen Corporation. The relator, Kassie Westmoreland, also filed a second amended complaint with the Massachusetts
District Court on the same day. The complaints alleged violations of the federal Anti-Kickback Statute and violations of state false
claims act statutes with regard to Amgen's marketing of overfill in vials of Aranesp® and with regard to Amgen's relationship with
the Integrated Nephrology Network (INN), a group purchasing organization. The relator's seconded amended complaint also
alleged that Amgen retaliated against and wrongfully terminated Ms. Westmoreland.
On January 20, 2010, the states of Florida and Texas voluntarily dismissed their complaints against Amgen. On February
12, 2010, February 16, 2010 and February 18, 2010, respectively, the states of New Hampshire, Louisiana and Nevada voluntarily
dismissed their complaints against Amgen. On February 23, 2010, the state of Delaware voluntarily dismissed its complaint against
Amgen. Also, on February 23, 2010, the Massachusetts District Court granted Amgen's motion to stay and sever the relator's
employment claims.
On April 23, 2010, the Massachusetts District Court dismissed all of the claims of the relator, on behalf of the federal
government and the states of New Mexico and Georgia, and all of the claims of the remaining states, for failure to state valid legal
grounds upon which relief could be granted. On May 26, 2010, the Massachusetts District Court granted leave for the relator to
file a fourth amended complaint. On May 24, 2010, the states of New York, Massachusetts, Michigan, California, Illinois, and
Indiana filed notices of intent to appeal the Massachusetts District Court's judgment to the U.S. Court of Appeals for the First
Circuit (the First Circuit Court).
On September 20, 2010, the Massachusetts District Court entered a written ruling denying Amgen's motions to dismiss the
relator's fourth amended complaint. On April 11, 2011, the Massachusetts District Court heard summary judgment arguments on
the fourth amended complaint from Amgen, INN and the relator. On July 22, 2011, the First Circuit Court issued a written decision
reversing the Massachusetts District Court's dismissal of the claims of the states of California, Illinois, Indiana, Massachusetts,
New Mexico, and New York and affirming the dismissal of the claims of Georgia.
In March 2011, the U.S. Attorney's Office of the Western District of Washington informed Amgen that the subject matter of
its investigation would be transferred to the U.S. Attorney's Office of the Eastern District of New York.
In October 2011, Amgen announced it had reached an agreement in principle to settle allegations relating to its sales and
marketing practices arising out of the Federal Investigations, and on December 19, 2012, Amgen announced that it had finalized
a settlement agreement (the Settlement Agreement), with the U.S. government, 49 states and the District of Columbia. The
Settlement Agreement resolved the Federal Investigations, the related state Medicaid claims (except for those of the State of South
Carolina) and the claims of nine of the ten Original Qui Tam Actions. The Settlement Agreement also resolved the claims of one
of the other civil qui tam actions that had not been included in the agreement in principle but of which Amgen was made aware
during settlement discussions (see below). This additional qui tam action resolved by the Settlement Agreement (the Additional
Qui Tam) included allegations that Amgen's promotional, contracting, sales and marketing activities and arrangements relating to
ENBREL caused the submission of various false claims under the Federal Civil False Claims Act and various State False Claims
Acts. Under the Settlement Agreement, Amgen paid approximately $612 million to resolve its civil liability related to certain
promotional practices related to the drugs Aranesp®, EPOGEN®, NEUPOGEN®, Neulasta®, ENBREL and Sensipar® as alleged
in the unsealed qui tam complaints and $150 million to resolve its criminal liability relating to the marketing of Aranesp®, as well
as accrued interest.
As part of the Settlement Agreement, Amgen pled guilty to a single misdemeanor count of misbranding Aranesp® by
promoting it in a way that was different from the dosages in the label. The plea was entered on December 18, 2012 in the New
York Eastern District Court and was accepted by the court on December 19, 2012. In connection with entering into the Settlement
Agreement, Amgen also entered into a corporate integrity agreement with the Office of Inspector General of the U.S. Department
of Health and Human Services that requires Amgen to maintain its corporate compliance program and to undertake a set of defined
corporate integrity obligations for a period of five years. In February 2013, Amgen resolved the state Medicaid claims of the State
of South Carolina related to the Federal Investigations for an immaterial amount. Amgen has accrued an immaterial amount to
resolve the remaining Original Qui Tam Action, which remains pending in the New York Eastern District Court.
As part of the settlement described above, Amgen was made aware that it was a defendant in several other civil qui tam
actions (the Other Qui Tams) in addition to those included in the October 2011 agreement in principle. As stated above, the
Additional Qui Tam was resolved by the Settlement Agreement. Amgen has been dismissed from two of the Other Qui Tams: U.S.
ex rel. May v. Amgen, et al. and another matter that continues under seal against other defendants. Amgen has reached a separate