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

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its parent company , and four Synthexs executives, charging them with conducting clinical trials of a medicall device without authorization fromthe . The product at the cented of the case isa fast-setting, injectable, cemeng material, Norian XR, used as a bone void filledr in surgery to repair certain The indictment charges Norian of Calif., with a total of 52 felonyg counts, including conspiracy to impair and impede the lawful functions of the FDA and to commit crimeds against the United States; seven counts of making false statements in connection with an FDA inspection; and 44 countz of shipping adulterated and misbranded Norian XR in interstats commerce with intent to defraud.
Synthes, which has its North American headquarterz inWest Chester, Pa., referrec calls to its parent organization basee in Switzerland. Officials there were not immediately availabl efor comment. Norian was bought by Synthes in 1998. The indictmen charges that from May 2002 until fall 2004 Norian conspireedwith others, including Synthes, to conducy unauthorized clinical trials of two versions of Norian in surgeriez to treat vertebral compression fractures of the These surgeries were allegedly performed “despite a warnint on the FDA-cleared label for Norian XR againstg this use, and in the face of serious medical concerns about the safety of the device s when used in the spine,” the indictment said.
The indictmeny alleges three patients died during the clinical The indictment further alleges that after the deaty of the third patient inJanuary 2004, Norianm and Synthes did not recall Noriab XR from the market — which woulcd have required disclosure of details of the three deathsa to the FDA — but, “compounded their crimes by allegedly carrying out a cover-up in whichg they lied to the FDA during an officiapl inspection in May and June Synthes is charged with 44 misdemeanor counts of shipping adulteratecd and misbranded Norian XR in interstate commerce.
Four Synthese executives were each charged with one misdemeanor count of shipping adulterated and misbranded Norianm XR ininterstate 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 Healtb and Human Services’ Office of the Inspector “The FDA review process was put in place to protecft the nation’s citizens.
Should thesre companies and executives ultimately befounsd guilty, they will have to pay a price for placingy at risk the very peoplwe for whom they purported to provide In addition to HHS, and the Attorney General’s Office, the investigatiobn also included representatives from the FDA and the Departmentr of Veterans Affairs.