ST. PAUL, Minn.--(BUSINESS WIRE)-- St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today issued the following statement regarding a settlement agreement reached with the U.S. Department of Justice (DOJ) regarding a previously disclosed 2005 investigation in Boston related to an industry-wide review of post-market studies and registries:
We are pleased to have reached a settlement agreement with the DOJ that fully resolves the post-market study matter in Boston. The company maintains that its post-market studies and registries are legitimate clinical studies designed to gather important scientific data and St. Jude Medical does not admit liability or wrongdoing by entering into this agreement. The company entered into a settlement agreement to avoid the potential costs and risks associated with litigation. This settlement brings the previously reported post-market study investigation to a close.
As part of this settlement, the company will make a payment of $16 million to the DOJ. St. Jude Medical affirms that the resolution of this matter has no material impact on the company’s financial position or operations.
About St. Jude Medical
St. Jude Medical develops medical technology and services that focus on putting more control into the hands of those who treat cardiac, neurological and chronic pain patients worldwide. The company is dedicated to advancing the practice of medicine by reducing risk wherever possible and contributing to successful outcomes for every patient. St. Jude Medical is headquartered in St. Paul, Minn. and has four major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. For more information, please visit sjm.com.
Forward-Looking Statements
This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. Such forward-looking statements include the expectations, plans and prospects for the Company, including potential clinical successes, anticipated regulatory approvals and future product launches, and projected revenues, margins, earnings and market shares. The statements made by the Company are based upon management’s current expectations and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include market conditions and other factors beyond the Company’s control and the risk factors and other cautionary statements described in the Company’s filings with the SEC, including those described in the Risk Factors and Cautionary Statements sections of the Company’s Quarterly Report on Form 10-Q for the fiscal quarter ended October 2, 2010. The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.
CONTACT:
St. Jude Medical, Inc.
Media contact:
Amy Jo Meyer, 651-756-3029
[email protected]
or
Investor contact:
J.C. Weigelt, 651-756-4347
[email protected]
KEYWORDS: United States North America Minnesota
INDUSTRY KEYWORDS: Health Biotechnology Clinical Trials Public Policy/Government Healthcare Reform Medical Devices Professional Services Legal
MEDIA:
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