Item 8.01. Other Events.
On October 30, 2009, fourteen states and the District of Columbia filed a single
complaint (the "Multi-State Intervention Complaint") in the United States
District Court for the District of Massachusetts (the "Federal District Court")
naming Amgen Inc. as well as certain business units of AmerisourceBergen
Specialty Group and AmerisourceBergen Corporation (the "Company") as defendants.
The Multi-State Intervention Complaint was filed for the purpose of intervening
in a civil case pending against the same defendants in the Federal District
Court under a complaint that was filed pursuant to the qui tam provisions of
both the federal civil False Claims Act and various state civil False Claims
Acts (the "Original Qui Tam Complaint"). The qui tam provisions authorize a
private person, known as a "relator," to file civil actions under these federal
and state statutes on behalf of the federal and state governments. The relator
in the Original Qui Tam Complaint is a former Amgen employee. Prior to the
filing of the Multi-State Intervention Complaint, the Company had not, and has
not to date, received a subpoena from or other request for information from the
Office of the New York Attorney General (which is leading the intervention on
behalf of the state governments) or any other state attorney general office.
Both the Multi-State Intervention Complaint and the Original Qui Tam Complaint,
as amended on October 30, 2009, allege that from 2002 through 2009, Amgen
offered remuneration to medical providers in violation of federal and state
health laws to increase purchases and prescriptions of Amgen's anemia drug,
Aranesp. Specifically with regard to the Company's business units, the
complaints allege that ASD Specialty Healthcare, Inc., which is a distributor of
pharmaceuticals to physicians and physician practices ("ASD"), and International
Nephrology Network, which was a business name for one of the Company's
subsidiaries and a group purchasing organization for nephrologists and
nephrology practices ("INN"), conspired with Amgen to promote Aranesp in
violation of federal and state health laws. The complaints further allege that
the defendants caused medical providers to submit to state Medicaid programs
false medical certifications and false claims for payment for Aranesp. The
latter conduct, according to the complaints, violated state civil False Claims
Acts and constituted fraud and unjust enrichment. The Original Qui Tam
Complaint, as amended, also alleges that the defendants caused medical providers
to submit to other federal health programs, including Medicare, false medical
certifications and false claims for payment for Aranesp.
The Original Qui Tam Complaint was filed by the relator initially under seal, in
accordance with the confidentiality protections afforded by the qui tam
provisions. On January 21, 2009, the Company learned that the United States
Attorney's Office for the Eastern District of New York (the "Department of
Justice") was investigating allegations in a sealed civil complaint filed in the
Federal District Court under the qui tam provisions of the federal civil False
Claims Act. In February 2009, the Company received a redacted copy of the then
current version of the Original Qui Tam Complaint, pursuant to a court order.
However, the Company was never served with the Original Qui Tam Complaint. Based
upon the unsealed portions of the case available to the Company, it appears that
the relator initially filed the action on or about June 5, 2006 and a first
amendment thereto on or about July 2, 2007. On May 18, 2009, the Federal
District Court issued an order extending until September 1, 2009 the time for
the federal and state governments to decide whether to intervene in the civil
action. On September 1, 2009, fourteen states and the District of Columbia filed
notices of their intent to intervene. The Department of Justice filed a notice
that it was not intervening as of September 1, 2009, but stated that its
investigation is continuing.
Under the federal civil False Claims Act and the applicable state civil False
Claims Acts, the filing of the Original Qui Tam Complaint by the former Amgen
employee triggered obligations of the federal and state governments to
investigate the allegations and to determine whether or not to intervene in the
action. In connection with this investigative process, the Company received a
subpoena for records issued by the Department of Justice on June 22, 2009. The
allegations in the Multi-State Intervention Complaint and the Original Qui Tam
Complaint, as amended, are within the scope of the Department of Justice's
subpoena. The Company has been cooperating with the Department of Justice in the
inquiry and is producing records in response to the subpoena.
The Company intends to defend itself vigorously against the allegations
contained in the Multi-State Complaint and the Original Qui Tam Complaint, as
amended. The Company cannot predict the outcome of either the civil action or
the Department of Justice investigation. Violations of various federal and state
laws governing the marketing, sale and purchase of pharmaceutical products can
result in criminal, civil, and administrative liability for which there can be
significant financial damages, criminal and civil penalties, and possible
exclusion from participation in federal health programs.