Medtronic 2012 Annual Report Download - page 135

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Medtronic, Inc.
Notes to Consolidated Financial Statements (Continued)
118
As of April 27, 2012, the amount of disputed royalties and interest related to CRT-D products was $120
million. This amount has not been accrued pursuant to U.S. GAAP requirements because the loss is not
currently probable.
Other Matters
On September 25, 2007 and November 16, 2007, the Company received letters from the U.S. Securities
and Exchange Commission (SEC) and the U.S. Department of Justice (DOJ), 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 DOJ have made additional requests for information
from the Company. The Company is fully cooperating with these requests.
In late June 2008, the Company received a subpoena issued by the U.S. Attorney’s Office for the District
of Massachusetts pursuant to the Health Insurance Portability & Accountability Act of 1996 (HIPAA),
relating to the Company’s marketing of biliary stents. On February 9, 2012, the U.S. Attorney’s office for the
District of Massachusetts informed the Company that it had closed its inquiry into the Company’s marketing
of biliary stents.
On October 6, 2008, the Company received a subpoena from the U.S. Attorney’s Office for the District
of Massachusetts pursuant to HIPAA requesting production of documents relating to Medtronic’s INFUSE
bone graft product. On May 16, 2012, the U.S. Attorney’s Office for the District of Massachusetts notified
the Company that it had closed its investigation into the INFUSE bone graft product. The Company also
received subpoenas or document requests from certain state government bodies in connection with the
INFUSE bone graft product, including civil investigative demands from the Attorneys General in
Massachusetts, California, Oregon, and Illinois. The Company is fully cooperating with these requests.
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 Eastern 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. Allegations relating to post-market clinical studies in this matter were resolved as part of the
settlement agreement reached with the DOJ, on behalf of the U.S. Attorney’s Office for the District of
Minnesota, in November 2011.
On March 12, 2010, the Company received a civil investigative demand from the DOJ pursuant to the
federal False Claims Act seeking information regarding the Company’s knowledge about claims to Medicare
for the implantation of implantable cardioverter defibrillators (ICDs), including reimbursement advice
given by the Company, payments to persons or entities involved in decisions about implantation of ICDs,
and the national coverage determination relating to ICDs. The Company is fully cooperating with this
investigation.
On October 14, 2010, the Company received a subpoena issued by the U.S. Attorney’s Office for the
Western District of New York pursuant to HIPAA, relating to the Company’s sales, marketing, and
reimbursement support practices regarding certain neurostimulation devices. The Company is fully
cooperating with this investigation.
On November 9, 2010, the French Competition Authority commenced an investigation of the Company,
along with a number of other medical device companies, and the companies’ trade association, Syndicat
National de l’Industrie des Technologies Medicales (SNITEM), to determine whether such companies or
SNITEM engaged in any anticompetitive practices in responding to tenders to purchase certain medical
devices. The Company is fully cooperating with the investigation.
On August 24, 2011, the Company received a letter from the DOJ requesting information relating to
the Company’s practices regarding the replacement of insulin pumps for Medicare beneficiaries. The
Company is fully cooperating with this inquiry.