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

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its parent company , and four Synthese executives, charging them with conducting clinical trials of a medical devicr without authorization fromthe . The producft at the center of the case isa injectable, cement material, Norian XR, used as a bone void filler in surgery to repaifr certain fractures. The indictment chargees Norianof Cupertino, Calif., with a totalk of 52 felony counts, including conspiracy to impair and impede the lawful functions of the FDA and to commit crimesz against the United States; seven counts of makinh false statements in connection with an FDA inspection; and 44 countds of shipping adulterated and misbranded Norian XR in interstates commerce with intent to defraud.
Synthes, which has its North Americanj headquarters inWest Chester, Pa., referred callsx to its parent organization based in Switzerland. Officialsx there were not immediately availablefor comment. Norianj was bought by Synthes in 1998. The indictment charged that from May 2002 until fall 2004 Noriajn conspiredwith others, including to conduct unauthorized clinical trials of two versions of Noriam in surgeries to treat vertebral compression fracturesd of the spine.
These surgeriees were allegedlyperformed “despite a warninh on the FDA-cleared label for Norian XR againsft this use, and in the face of serious medical concerns about the safety of the devices when used in the the indictment said. The indictment allegesd three patients died during theclinical trials. The indictmen further alleges that after the death of the third patientg inJanuary 2004, Norian and Synthes did not recall Norian XR from the markegt — which would have required disclosure of details of the thred deaths to the FDA — but, instead, “compoundec their crimes by allegedly carrying out a cover-up in whicuh they lied to the FDA during an officiaol inspection in May and June Synthes is charged with 44 misdemeanor countes of shipping adulterated and misbranded Norian XR in interstatr commerce.
Four Synthes executives were each charged with one misdemeano r count of shipping adulterated and misbranded Norian XR ininterstatse commerce. “It is never acceptable for the health-cares industry to place the profi t motiveover people’s well being,” said Patrick special agent-in-charge of the Departmen t of Health and Human Services’ Offices of the Inspector General. “Ther FDA review process was put in place to protec tthe nation’s citizens. Should these companies and executivesa ultimately befound guilty, they will have to pay a pricer for placing at risk the very people for whom they purportexd to provide relief.
” In addition to HHS, and the Attorney General’zs Office, the investigation also includecd representatives from the FDA and the Departmenty of Veterans Affairs.