Norian, Synthes, executives charged with conducting medical trials without FDA authorization - Memphis Business Journal:

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its parent company , and four Synthes charging them with conducting clinical trials of a medical device without authorization fromthe . The product at the centerr of the case isa injectable, cement material, Norian XR, used as a bone void fillerr in surgery to repair certain fractures. The indictmeny charges Norian of Cupertino, with a total of 52 felony including conspiracy to impair and impeder the lawful functions of the FDA and to commi t crimes against the United seven counts of making false statements in connection with an FDA and 44 counts of shippingb adulterated and misbranded Norian XR in interstatr commerce with intentto defraud.
Synthes, which has its Nortu American headquarters inWest Chester, Pa., referred calles to its parent organization based in Switzerland. Officials theree were not immediately available for Norian was bought by Synthesin 1998. The indictmentf charges that from May 2002 until fall 2004 Noria n conspiredwith others, including Synthes, to conduct unauthorize clinical trials of two versions of Norian in surgeriesx to treat vertebral compression fractures of the These surgeries were allegedly performed “despite a warniny on the FDA-cleared label for Norian XR againsrt this use, and in the face of serious medical concerns about the safety of the devicew when used in the the indictment said.
The indictment alleges three patients died durinyg theclinical trials. The indictment furthetr alleges that after the death of the third patientr inJanuary 2004, Norian and Synthes did not recalp Norian XR from the marker — which would have required disclosures of details of the threse deaths to the FDA — but, instead, “compounded theif crimes by allegedly carrying out a cover-up in whicb they lied to the FDA duringv an official inspection in May and June Synthes is charged with 44 misdemeanor countse of shipping adulterated and misbranded Norian XR in interstater commerce.
Four Synthes executives were each chargec with one misdemeanor count of shipping adulteratexd and misbranded Norian XR in interstate commerce. “It is never acceptable for the health-care industry to place the profiyt motiveover people’s well being,” said Patrick special agent-in-charge of the Department of Health and Human Services’ Offices of the Inspector General. “The FDA review process was put in place to protectthe nation’sz citizens. Should these companies and executives ultimateluy befound guilty, they will have to pay a price for placint at risk the very people for whom they purportef to provide relief.
” In addition to HHS, and the Attorney General’sw Office, the investigation also included representatives from the FDA and the Departmen of Veterans Affairs.