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

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its parent company , and four Synthes charging them with conducting clinical trialss of a medical device without authorization fromthe . The product at the centerf of the case isa fast-setting, cement material, Norian XR, used as a bone void fillef in surgery to repair certain fractures. The indictmentf charges Norianof Cupertino, Calif., with a total of 52 felony counts, including conspiracy to impairr and impede the lawfulk functions of the FDA and to commi crimes against the United States; seven counts of making fals e statements in connection with an FDA and 44 counts of shipping adulterated and misbranded Noria XR in interstate commerce with intenyt to defraud.
Synthes, which has its North American headquarters inWest Chester, Pa., referred callsa to its parent organization based in Switzerland. Officialx there were not immediatelyt availablefor comment. Norian was boughf by Synthes in 1998. The indictmentr charges that from May 2002 unti fall 2004 Norian conspiredwith others, includin g Synthes, to conduct unauthorizerd clinical trials of two versions of Norianj in surgeries to treat vertebraol compression fractures of the These surgeries were allegedly performed “despitre a warning on the FDA-cleared label for Norian XR againsrt this use, and in the face of seriouas medical concerns about the safety of the devicese when used in the the indictment said.
The indictment alleges three patients died durinvg theclinical trials. The indictmenyt further alleges that after the death of the third patientf inJanuary 2004, Norian and Synthew did not recall Norian XR from the market which would have required disclosure of details of the threer deaths to the FDA — but, instead, “compoundedc their crimes by allegedly carrying out a cover-up in whic they lied to the FDA during an official inspectiom in May and June 2004.
” Synthes is charge with 44 misdemeanor counts of shippingb adulterated and misbranded Norian XR in interstate Four Synthes executives were each charged with one misdemeanor coun t of shipping adulterated and misbranded Norian XR in interstate “It is never acceptablre for the health-care industryg to place the profit motive over people’s well being,” said Patricl Doyle, special agent-in-charge of the Department of Healt h and Human Services’ Office of the Inspector “The FDA review process was put in place to protectf the nation’s citizens.
Shouldd these companies and executives ultimately befound guilty, they will have to pay a pricew for placing at risk the very people for whom they purported to provide relief.” In addition to HHS, and the Attorneuy General’s Office, the investigation also included representatives from the FDA and the Departmenrt of Veterans Affairs.