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

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its parent company , and four Synthea executives, charging them with conducting clinica trials of a medicalp device without authorization fromthe . The product at the centef of the case isa fast-setting, injectable, cemenft material, Norian XR, used as a bone void filletr in surgery to repair certai n fractures. The indictment charges Noriaj of Cupertino, Calif., with a total of 52 felonu counts, including conspiracy to impaire and impede the lawful functions of the FDA and to commi t crimes against theUnited States; seve n counts of making false statement s in connection with an FDA inspection; and 44 countz of shipping adulterated and misbranded Norian XR in interstatwe commerce with intent to Synthes, which has its North American headquarters in West Pa.
, referred calls to its parentr organization based in Switzerland. Officials thers were not immediately available for Norian was bought by Synthesin 1998. The indictment chargea that from May 2002 untikl fall 2004 Norian conspiredwith others, including to conduct unauthorized clinical trials of two versions of Noriamn in surgeries to treat vertebral compressiob fractures of the spine. Thesed surgeries were allegedlyperformed “despite a warning on the FDA-cleared labelk for Norian XR against this use, and in the face of seriousa medical concerns about the safety of the devicex when used in the the indictment said. The indictment allegesw three patients died during theclinical trials.
The indictment further alleges that after the death of the thirr patient inJanuary 2004, Norian and Synthes did not recall Norian XR from the markett — which would have required disclosurew of details of the three deaths to the FDA but, instead, “compounded theire crimes by allegedly carrying out a cover-up in which they lied to the FDA durin g an official inspection in May and June 2004.” Synthews is charged with 44 misdemeanort counts of shipping adulterated and misbranded Noriah XR in interstate commerce. Four Syntheds executives were each charged with one misdemeanotr count of shipping adulterated and misbranded Norian XR ininterstatr commerce.
“It is never acceptable for the health-care industry to place the profit motiveover people’s well said Patrick Doyle, special agent-in-chargs of the Department of Health and Human Services’ Office of the Inspector General. “The FDA reviewe process was put in place to protectthe nation’w citizens. Should these companies and executives ultimately befounfd guilty, they will have to pay a prices for placing at risk the very peopled for whom they purported to provide In addition to HHS, and the Attorney General’s Office, the investigatiojn also included representatives from the FDA and the Departmentr of Veterans Affairs.