ARLINGTON, Tenn.–(BUSINESS WIRE)–Wright Medical Group, Inc. (NASDAQ: WMGI), a global orthopaedic medical
device company and a leading provider of surgical solutions for the foot
and ankle market, today announced that its wholly-owned subsidiary,
Wright Medical Technology, Inc. (WMT), has reached agreements with the
United States Attorney’s Office for the District of New Jersey (USAO)
and the Office of the Inspector General, U.S. Department of Health and
Human Services (OIG) in connection with the previously disclosed May 5,
2011 letter from the USAO regarding the Company’s Deferred Prosecution
Agreement (DPA). The May 5 letter was described in the Company’s Current
Report on Form 8-K filed May 5, 2011.
“As a direct result of the federal monitorship, Wright has made
significant and wide-ranging changes in corporate culture and tone at
the top”
Under its agreement with the USAO, WMT has voluntarily agreed to extend
the term of its DPA for 12 months; the DPA will now expire on September
29, 2012. The USAO has agreed not to take any additional action
regarding any breach of the DPA referenced in the aforementioned May 5,
2011 letter from the USAO unless it finds, prior to September 29, 2012,
that WMT has committed a knowing, willful and uncured breach of a
material provision of the DPA by its conduct after September 15, 2011 or
by conduct before September 15, 2011 of which the independent monitor
was not aware on that date. WMT also agreed with the OIG to an amendment
to the Corporate Integrity Agreement (CIA) under which certain of WMT’s
substantive obligations under the CIA will now begin on September 29,
2012, when the amended DPA monitoring period expires. The term of the
CIA has not changed, and will expire as previously provided on September
29, 2015. In connection with such amendment, the OIG has informed WMT
that it has no present intention, based on the information now known to
it, to exercise its authority under Paragraph 51 of the DPA to exclude
Wright from participation in federal healthcare programs based on any
breach referenced in the May 5 letter unless the USAO were to take
further action related to an alleged breach of the DPA by WMT.
“Wright Medical and our Board of Directors have taken significant steps
to enhance the Company’s compliance,” said David D. Stevens, Chairman of
the Board and interim Chief Executive Officer. “We believe that
voluntarily extending the term of the DPA will provide the Company with
an opportunity to further demonstrate its commitment to the highest
standards of ethical conduct. We will continue to work closely with the
Monitor, the USAO, the OIG and other regulators to ensure that the
Company complies with all laws and regulations that govern our business
practices.”
“As a direct result of the federal monitorship, Wright has made
significant and wide-ranging changes in corporate culture and tone at
the top,” First Assistant U.S. Attorney J. Gilmore Childers said. “Our
Office is pleased with the extensive cooperation from the newly
appointed interim senior management team. Today’s extension will allow
Wright to make the transition from interim to permanent senior
management while still under the terms of the DPA and the surveillance
of the federal monitor.”
The DPA Addendum and the CIA Amendment are attached as Exhibits 10.1 and
10.2, respectively, to the Company’s Current Report on Form 8-K filed
simultaneously with this press release.
Cautionary Note Regarding Forward-Looking Statements
This press release contains “forward-looking statements” as defined
under U.S. federal securities laws, including statements regarding
potential actions by the USAO, independent monitor, OIG and other
agencies or their potential impact. These statements reflect
management’s current knowledge, assumptions, beliefs, estimates, and
expectations and express management’s current views of future
performance, results, and trends and may be identified by their use of
terms such as anticipate, believe, could, estimate, expect, intend, may,
plan, predict, project, will, and other similar terms. Forward-looking
statements are subject to a number of risks and uncertainties that could
cause our actual results to materially differ from those described in
the forward-looking statements. The reader should not place undue
reliance on forward-looking statements. Such statements are made as of
the date of this press release, and we undertake no obligation to update
such statements after this date. Risks and uncertainties that
could cause our actual results to materially differ from those described
in forward-looking statements include those discussed in our filings
with the Securities and Exchange Commission (including those described
in Item 1A of our Annual Report on Form 10-K for the year ended December
31, 2010, and our subsequently filed quarterly reports, under the
heading “Risk Factors” and elsewhere), future actions of the FDA or any
other regulatory body or government authority that could delay, limit or
suspend product development, manufacturing or sale or result in
seizures, injunctions, monetary sanctions or criminal or civil
liabilities, the impact of any such future actions of the FDA or any
other regulatory body or government authority on our settlement of the
federal investigation into our consulting arrangements with orthopaedic
surgeons relating to our hip and knee products in the United States, and
the impact of such settlement of the federal investigation into our
consulting arrangements with orthopaedic surgeons relating to our hip
and knee products in the United States, including our compliance with
the Deferred Prosecution Agreement through September 2012 and the
Corporate Integrity Agreement through September 2015. Our failure to
comply with the Deferred Prosecution Agreement or the Corporate
Integrity Agreement could expose us to significant liability including,
but not limited to, exclusion from federal healthcare program
participation, including Medicaid and Medicare, which would have a
material adverse effect on our financial condition, results of
operations and cash flows, potential prosecution, including under the
previously-filed criminal complaint, civil and criminal fines or
penalties, and additional litigation cost and expense. In addition, a
breach of the DPA or the CIA could result in an event of default under
the Senior Credit Facility, which in turn could result in an event of
default under the Indenture.
Additional risks and uncertainties that could cause our actual
results to materially differ from those described in forward-looking
statements include the possibility of litigation brought by
shareholders, including private securities litigation and shareholder
derivative suits, which if initiated, could divert management’s
attention, harm our business and/or reputation and result in significant
liabilities; demand for and market acceptance of our new and existing
products; future actions of governmental authorities and other third
parties; tax measures; business development and growth opportunities;
product quality or patient safety issues; products liability claims;
enforcement of our intellectual property rights; the geographic and
product mix impact on our sales; retention of sales representatives and
independent distributors; inventory reductions or fluctuations in buying
patterns by wholesalers or distributors; ability to realize the
anticipated benefits of restructuring initiatives; and impact of the
commercial and credit environment on us and our customers and suppliers.
Wright Medical Group, Inc. is a global orthopaedic medical device
company specializing in the design, manufacture and marketing of devices
and biologic products for the extremity, hip and knee repair and
reconstruction. Wright Medical is a leading provider of surgical
solutions for the foot and ankle market. Wright Medical has been in
business for more than 60 years and markets its products in over 60
countries worldwide. For more information about Wright Medical, visit
its website at www.wmt.com.