
Company Website:
http://www.invacare.com
ELYRIA, Ohio -- (Business Wire)
Late this afternoon, Invacare Corporation (NYSE: IVC) learned that the
United States District Court for the Northern District of Ohio, has
approved the terms of the previously announced consent decree of
injunction with the United States Food and Drug Administration (FDA).
The consent decree relates to previously announced inspectional
observations at the Company's corporate facility and its Taylor Street
wheelchair manufacturing facility, both located in Elyria, Ohio.
As the Company announced yesterday, the decree limits production and
design activities at the two Elyria facilities until they are certified
to be in compliance with FDA regulations by an independent third-party
expert and subsequently approved by the FDA. With certain documentation
requirements, the Company may continue manufacturing at Taylor Street in
cases of existing orders, medical necessity and repair and replacement
of products currently in use. All other Invacare facilities remain in
full operation.
A copy of the consent decree, which is now in effect, has been disclosed
by Invacare in a filing with the Securities and Exchange Commission
(“SEC”).
Invacare Corporation (NYSE:IVC), headquartered in Elyria, Ohio, is the
global leader in the manufacture and distribution of innovative home and
long-term care medical products that promote recovery and active
lifestyles. The Company has 6,200 associates and markets its products in
approximately 80 countries around the world. For more information about
the Company and its products, visit Invacare's website at www.invacare.com.
Forward-Looking Statements
This press release contains forward-looking statements within the
meaning of the “Safe Harbor” provisions of the Private Securities
Litigation Reform Act of 1995. Terms such as “will,” “should,” “could,”
“plan,” “intend,” “expect,” “continue,” “believe” and “anticipate,” as
well as similar comments, are forward-looking in nature that are subject
to inherent uncertainties that are difficult to predict. Actual results
and events may differ significantly from those expressed or anticipated
as a result of risks and uncertainties which include, but are not
limited to, the following: compliance costs, limitations on the design,
production and/or distribution of the Company's products, inability to
bid on orwin certain contracts, or other adverse effects of the
FDA consent decree of injunction; unforeseen circumstances that might
delay or adversely impact the results of the third party expert
certification audits or FDA inspections of the Company's quality systems
at the impacted Elyria facilities; the failure or refusal of customers
or healthcare professionals to sign necessary certification forms
required by the exceptions to the consent decree; adverse changes in
government and other third-party payor reimbursement levels and
practices both in the U.S. and in other countries (such as, for example,
more extensive pre-payment reviews and post-payment audits by payors, or
the Medicare national competitive bidding program covering nine
metropolitan statistical areas that started in 2011 and an additional 91
metropolitan statistical areas beginning in July 2013), impacts of the
U.S. Affordable Care Act that was enacted in 2010 (such as, for example,
the expected annual impact on the Company of the excise tax beginning in
2013 on certain medical devices and the Company's ability to
successfully offset such impact); legal actions, regulatory proceedings
or the Company's failure to comply with regulatory requirements or
receive regulatory clearance or approval for the Company's products or
operations in the United States or abroad; product liability claims;
exchange rate or tax rate fluctuations; inability to design,
manufacture, distribute and achieve market acceptance of new products
with greater functionality or lower costs, (particularly given the
impact of the FDA consent decree); consolidation of health care
providers; lower cost imports; uncollectible accounts receivable;
difficulties in implementing/upgrading Enterprise Resource Planning
systems; risks inherent in managing and operating businesses in many
different foreign jurisdictions; ineffective cost reduction and
restructuring efforts; potential product recalls; possible adverse
effects of being leveraged, including interest rate or event of default
risks (particularly as might result from the impact of the FDA consent
decree); heightened vulnerability to a hostile takeover attempt arising
from depressed market prices for Company shares; provisions of Ohio law
or in the Company's debt agreements, shareholder rights plan or charter
documents that may prevent or delay a change in control, as well as the
risks described from time to time in Invacare's reports as filed with
the Securities and Exchange Commission. Except to the extent required by
law, we do not undertake and specifically decline any obligation to
review or update any forward-looking statements or to publicly announce
the results of any revisions to any of such statements to reflect future
events or developments or otherwise.
Contacts:
Invacare Corporation
Lara Mahoney, 440-329-6393
Source: Invacare Corporation