Synthes Statement Regarding Service of Subpoenas
West Chester, Pa., March 23, 2006Synthes, Inc. today announced that it has received a grand jury subpoena from the United States Department of Justice United States Attorney’s Office in Philadelphia. Under the subpoena, Synthes is ordered to deliver certain documents and information concerning Norian XR® and related products. Synthes will cooperate fully in responding to the subpoena.
The document requests set forth in the subpoena suggest, among other things, that the Department of Justice is investigating the promotion, sale, and reimbursement of Norian XR® for off-label uses, i.e., outside of the scope for which it was cleared by the U.S. Food and Drug Administration (FDA). At this point in the investigation, Synthes does not know when the investigation will conclude or whether a sanction will be imposed.
Norian XR® is an injectable, fast setting carbonated apatite cement that contains barium sulfate to enhance radiopacity and is used to fill defects in areas of compromised cancellous bone during restoration or augmentation of the skeleton. The FDA cleared Norian XR® on December 19, 2002 for use in certain bony voids or defects that are not intrinsic to the stability of the bony structure. Following an FDA inspection and a warning letter dated November 5, 2004, Synthes voluntarily stopped selling Norian XR® and has had no revenues related to the product since 2004.
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.
For further information please contact
Peter Fehlmann, Investor Relations, Synthes, Inc.
Phone: +41 32 720 48 10 , Fax: +41 32 720 48 11
e-mail: ir.info@synthes.com