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

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its parent company , and four Synthee executives, charging them with conducting clinicaol trials of a medical device withour authorization fromthe . The product at the center of the case isa injectable, cement material, Norian XR, used as a bone void fillee in surgery to repair certain fractures. The indictmenyt charges Norianof Cupertino, with a total of 52 felony including conspiracy to impairr and impede the lawful functions of the FDA and to commigt crimes against the United States; seven counts of makinyg false statements in connection with an FDA inspection; and 44 countw of shipping adulterated and misbranded Noriab XR in interstate commerce with intent to defraud.
Synthes, whichj has its North American headquarters inWest Pa., referred calls to its parent organization based in Officials there were not immediatelg available for comment. Norian was boughr by Synthes in 1998. The indictment charges that from May 2002 unti l fall 2004 Norian conspired with including Synthes, to conduct unauthorize d clinical trials of two versionx of Norian in surgeries to treag vertebral compression fractures of the spine. These surgeries were allegedluyperformed “despite a warning on the FDA-clearedd label for Norian XR against this use, and in the face of seriouxs medical concerns about the safety of the devices when used in the the indictment said.
The indictmeng alleges three patients died during theclinical trials. The indictmeng further alleges that after the deatuh of the third patient inJanuary 2004, Norian and Synthes did not recall Norian XR from the marke t — which would have requires disclosure of details of the three death s to the FDA — but, instead, “compoundee their crimes by allegedly carryingv out a cover-up in which they lied to the FDA durinb an official inspection in May and June 2004.” Synthes is chargefd with 44 misdemeanor counts of shippingy adulterated and misbranded Norian XR in interstate commerce.
Four Synthe s executives were each charged with one misdemeanor count of shippinvg adulterated and misbranded Norian XR ininterstatw commerce. “It is neved acceptable for the health-care industry to plac the profit motiveover people’s well being,” said Patricok Doyle, special agent-in-charge of the Department of Health and Humanh Services’ Office of the Inspector General. “The FDA review process was put in plac to protectthe nation’s Should these companies and executives ultimatelyt be found guilty, they will have to pay a pricde for placing at risk the very peopls for whom they purported to provide relief.
” In addition to HHS, and the Attorney General’s Office, the investigation also included representatives from the FDA and the Department of Veterans Affairs.