Medtronic 2010 Annual Report Download - page 103

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On February 22, 2010, the Company received a civil investigative
demand from the United States Attorney’s Office for the District
of Massachusetts pursuant to the federal False Claims Act seeking
documents relating to the CoreValve clinical trial and Medtronic’s
interactions with hospitals, other medical institutions, and
physicians. The Company is fully cooperating with this investigation.
On September 16, 2009, the Company received a subpoena
from the Office of Inspector General for the Department of Health
and Human Services in the District of California requesting
production of documents relating to the Company’s cardiac
rhythm medical devices, including revenue, sales, marketing and
promotional documents, documents relating to reimbursement
communications to customers pertaining to the devices,
documents relating to scientific studies and registries pertaining
to the devices and documents relating to payments or items of
value provided to customers. The Company is fully cooperating
with this inquiry.
On June 16, 2009, the Company received an administrative
subpoena from the New Jersey Attorney General, Division of
Consumer Affairs, requesting production of documents relating to
the Company’s clinical studies, its financial arrangements with
certain physicians and healthcare providers and clinical research
done by certain physicians and healthcare providers. The
Company is fully cooperating with this inquiry.
On May 21, 2009, the Company received a subpoena from the
United States Attorney’s Office for the District of Massachusetts
pursuant to the Health Insurance Portability & Accountability Act
of 1996 (HIPAA) seeking documents related to a study published
in the British volume of the Journal of Bone & Joint Surgery, and
contracts, research grants, speaking and education programs and
payments for certain named physicians. The Company is fully
cooperating with this inquiry.
On April 13, 2009, the Company received an administrative
healthcare subpoena from the United States Attorney’s Office for
the Northern District of Indiana requesting documents relating to
the Company’s relationship with customers, as well as documents
relating to certain employees. The Company is fully cooperating
with this inquiry.
On February 9, 2009, the Company received letter notice that
the United States Department of Justice in the Southern District
of Texas is investigating marketing practices, reimbursement
advice of the Company and appropriateness of therapy delivery
relating to the Company’s cardiac surgical ablation devices. On
July 2, 2009, the United States District Court for the Southern
District of Texas ordered the unsealing of a qui tam complaint
related to the same matter that was filed against Medtronic on
November 17, 2008. On August 21, 2009, the Department of
Justice decided not to intervene at that time but reserved the
right to intervene in the future. The qui tam complaint was served
on October 1, 2009. On December 16, 2009, Medtronic filed a
motion to dismiss the complaint.
On December 18, 2008, the Company received a civil
investigative demand from the Massachusetts Attorney General’s
Office, requesting production of documents related to Medtronic’s
INFUSE Bone Graft product. The Company is fully cooperating
with this investigation.
On October 6, 2008, the Company received a subpoena from
the United States Attorney’s Office for the District of Massachusetts
pursuant to HIPAA requesting production of documents relating
to Medtronic’s INFUSE Bone Graft product. The Company is fully
cooperating with this inquiry.
In late June 2008, the Company received a subpoena issued by
the United States Attorney’s Office for the District of Massachusetts
pursuant to HIPAA, relating to the Company’s marketing of biliary
stents. The Company is fully cooperating with this inquiry. On
February 19, 2010, a complaint captioned United States of America
ex rel Tricia Nowak and Enda Dodd v. Medtronic, filed in the
United States District Court for the District of Massachusetts and
relating to similar issues was unsealed. On April 23, 2010, Medtronic
filed a motion to dismiss the complaint.
On or about October 31, 2007, the Company received a letter
from the United States Attorney’s Office for the Eastern District of
Pennsylvania requesting documents relating to the Company’s
relationship with one of its customers and any payments or things
of value provided by the Company to physicians, physician
groups, hospitals, medical practices or other entities relating to
the purchase of the Company’s cardiac resynchronization therapy
devices and cardiac stents. The Company is fully cooperating with
this inquiry.
On September 25, 2007 and November 16, 2007, the Company
received letters from the U.S. Securities and Exchange Commission
(SEC) and U.S. Department of Justice, respectively, requesting
information relating to any potential violations of the U.S. Foreign
Corrupt Practices Act in connection with the sale of medical
devices in several non-U.S. countries. A number of competitors
have publicly disclosed receiving similar letters. Subsequently, the
SEC and Department of Justice have made additional requests for
information from the Company. The Company is fully cooperating
with the requests.
Medtronic, Inc.