US Department of Justice
16 April 2009
Smith & Nephew plc (NYSE: SNN; LSE: SN), the global medical technology business, announces that it has received a subpoena from the US Department of Justice in Massachusetts in connection with its ultrasound stimulation product known as EXOGEN*. EXOGEN is FDA approved for specific fresh fractures and long bone non-unions. The Department of Justice has asked for documents relating to EXOGEN and other matters from 1995 onwards. Smith & Nephew first started to market EXOGEN in 1998. It is believed that similar enquiries have been directed to a number of Smith & Nephew's US competitors. Smith & Nephew is co-operating fully with this request.
In addition, a qui tam complaint, filed four years ago in March 2005, was recently unsealed in federal court in Boston against the primary US manufacturers of bone growth stimulation products, including Smith & Nephew. The complaint makes allegations concerning the industry's sales and marketing of these products. Smith & Nephew will respond to this action.
Smith & Nephew is committed to compliance with law and ethical business standards and a robust programme to ensure compliance.
Enquiries
Investors/Analysts |
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Liz Hewitt |
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+44 (0) 20 7401 7646 |
Smith & Nephew |
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Group Director Corporate Affairs |
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Media |
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Jon Coles |
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+44 (0) 20 7404 5959 |
Brunswick - London |
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Cindy Leggett-Flynn |
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+1 (212) 333 3810 |
Brunswick - New York |
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About Us
Smith & Nephew is a global medical technology business, specialising in Orthopaedics, including Reconstruction, Trauma and Clinical Therapies; Endoscopy and Advanced Wound Management. Smith & Nephew is a global leader in arthroscopy and advanced wound management and is one of the leading global orthopaedics companies.
Smith & Nephew is dedicated to helping improve people's lives. The Company prides itself on the strength of its relationships with its surgeons and professional healthcare customers, with whom its name is synonymous with high standards of performance, innovation and trust. The Company operates in 32 countries around the world. Annual sales in 2008 were nearly $3.8 billion.
Forward-Looking Statements
This press release contains certain 'forward-looking statements' within the meaning of the US Private Securities Litigation Reform Act of 1995. In particular, statements regarding expected revenue growth and trading margins discussed under 'Outlook' are forward-looking statements as are discussions of our product pipeline. These statements, as well as the phrases 'aim', 'plan', 'intend', 'anticipate', 'well-placed', 'believe', 'estimate', 'expect', 'target', 'consider' and similar expressions, are generally intended to identify forward-looking statements. Such forward-looking statements involve known and unknown risks, uncertainties and other important factors (including, but not limited to, the outcome of litigation, claims and regulatory approvals) that could cause the actual results, performance or achievements of Smith & Nephew, or industry results, to differ materially from any future results, performance or achievements expressed or implied by such forward-looking statements. Please refer to the documents that Smith & Nephew has filed with the US Securities and Exchange Commission under the US Securities Exchange Act of 1934, as amended, including Smith & Nephew's most recent annual report on Form 20F, for a discussion of certain of these factors.
All forward-looking statements in this press release are based on information available to Smith & Nephew as of the date hereof. All written or oral forward-looking statements attributable to Smith & Nephew or any person acting on behalf of Smith & Nephew are expressly qualified in their entirety by the foregoing. Smith & Nephew does not undertake any obligation to update or revise any forward-looking statement contained herein to reflect any change in Smith & Nephew's expectation with regard thereto or any change in events, conditions or circumstances on which any such statement is based.
* Trademark of Smith & Nephew. Certain marks registered US Patent and Trademark Office.