The U.S. Attorney’s Office for the Eastern District of Pennsylvania indicted medical device manufacturer Norian and four of its executives for the alleged improper testing, marketing and sale of two of its bone cement devices and for false statements made by company personnel during a regulatory inspection of the facility. According to the indictment, the company did not seek pre-approval or clearance from the FDA for a new indication its sales force was promoting as an off-label use. Three people died from surgeries in which the bone cement was used and the company failed to provide proper adverse event notification to the FDA or to recall the products, prompting the investigation and resultant indictment.

The indictment charges the company with conspiring to defraud the United States and its agencies by allegedly failing to comply with FDA requirements for the labeling, testing, and marketing of medical devices. The indictment further charges the company with multiple felony counts based on allegations of materially false and misleading statements made to the FDA, and charges the company and its parent corporation with multiple felony and misdemeanor counts for allegedly shipping adulterated and misbranded medical devices into interstate commerce. The four executives each are charged with one misdemeanor count for shipping misbranded products. The U.S. Attorney further supports the off-label use allegation with statements that the company promoted the devices to physicians but did not inform them that the product label included a warning that it was not to be used for the off-label use, and that pilot test information indicated that use of the product in spinal surgeries could cause dangerous blood clots.  

The U.S. Attorney further supports the off-label use allegation with statements that the company promoted the devices to physicians but did not inform them that the product label included a warning that it was not to be used for the off-label use, and that pilot test information indicated that use of the product in spinal surgeries could cause dangerous blood clots.