FDAnews
www.fdanews.com/articles/131132-norian-settles-charges-stemming-from-unapproved-clinical-trials

Norian Settles Charges Stemming From Unapproved Clinical Trials

October 15, 2010
Synthes and its subsidiary Norian will pay more than $23 million to resolve felony and misdeameanor charges relating to unapproved clinical trials of bone-cement products that resulted in three deaths. As part of the settlement with the Justice Department, Norian will pay about $23.5 million to resolve one felony count of conspiracy to impair and impede the FDA and 110 misdemeanor counts of shipping adulterated and misbranded Norian XR. Synthes, which has agreed to divest its Norian assets, will pay $808,000 to settle a misdemeanor charge of shipping adulterated and misbranded Norian XR in interstate commerce, the company said.
Clinical Trials Advisor