PHILADELPHIA, June 17 (UPI) -- A medical device-maker and four executives were indicted Wednesday on charges of conducting unauthorized clinical trials, the U.S. Justice Department said.
The indictment, returned in Philadelphia, charges Norian Corp. with 52 felony counts, including making false statement during a Food and Drug Administration inspection, and shipping adulterated and misbranded Norian XR -- a bone cement used in fractures -- across state lines with intent to defraud.
The parent company, Synthes, is charged with 44 misdemeanor counts of interstate shipping adulterated and misbranded Norian XR. The four executives -- Michael Huggins, Thomas Higgins, Richard Bohner and John Walsh -- each is charged with one misdemeanor count of interstate shipping adulterated and misbranded Norian XR.
The indictment claimed that between May 2002 to fall 2004 Norian conspired with others,including Synthes and the four named executives, to conduct unauthorized clinical trials of Synthes's medical devices, Norian XR and Norian SRS,2 (another bone cement) in surgeries to treat vertebral compression fractures of the spine. The surgeries allegedly were performed despite a warning on the FDA-cleared label against such use because of serious medical concerns about the safety of the cements when used in the spine.
Even after three operating room deaths, Norian and Synthes did not recall Norian XR, the indictment said. Instead, the company and executives lied to the FDA during an official inspection in May and June 2004.
"We have an FDA approval process to be certain that medicines and medical devices that are used in the United States have gone through appropriate testing to determine that the products are safe and effective," U.S. Attorney Michael Levy said. "The defendants charged today bypassed the process, with the knowledge that the product that they were marketing posed potentially significant risks."