Synthes Settles with New Jersey Attorney General and Agrees to Reimburse Investigation Costs of US$ 236,000
West Chester (PA), USA, May 5, 2009
Synthes, Inc. ("Synthes", SWX:SYST.VX) announced today that it has entered into an Assurance of Voluntary Compliance Agreement ("AVC") with the State of New Jersey and its Division of Consumer Affairs. The AVC reinforces Synthes' compliance policies regarding the collection and dissemination of information about relevant financial relationships of its clinical investigators.
The AVC represents a settlement of an inquiry initiated in 2008 by the New Jersey Attorney General. The inquiry focused on Synthes' disclosure of the financial interests of certain investigators involved in the clinical trials for the artificial spinal discs, ProDisc-L and ProDisc-C (collectively "ProDisc"), which were approved by the U.S. Food and Drug Administration ("FDA") in August 2006 and December 2007, respectively.
Patient safety and the effectiveness of the ProDisc products were not issues in the inquiry. The FDA was advised of the results of the New Jersey inquiry and has not changed its conclusions that the ProDisc clinical studies are scientifically valid and that the ProDisc products are safe and effective.
Collaborations between physicians and the medical device industry have been important in the development of new and innovative clinical solutions. The FDA expressly permits clinical investigators to have financial interests in a product or company. The FDA requires, however, that clinical investigators disclose their relevant financial relationships to the company sponsoring a study and that the company report these financial disclosures to the FDA. It is important to note that FDA-approved clinical trials are specifically designed to eliminate or minimize the potential for investigator bias.
In the interest of a speedy resolution to the inquiry, Synthes voluntarily entered into the AVC without any admission of wrongdoing and has agreed to reimburse the State of New Jersey for the cost of the investigation in the amount of US$ 236,000. No fines or penalties were paid by Synthes.
Synthes strives to meet the highest legal and ethical standards and maintains a comprehensive compliance program that is regularly reviewed and updated. In particular, Synthes seeks to promote unbiased clinical trials and full disclosure of clinical investigators' relevant financial relationships.
Synthes: A leading medical device company
Synthes is a leading global medical device company. We develop, produce and market instruments, implants and biomaterials for the surgical fixation, correction and regeneration of the human skeleton and its soft tissues.
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Gilgian Eisner, Investor Relations, Synthes, Inc.
Phone +41 32 720 47 45
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