The indictment charges that from May 2002 until 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, in surgeries to treat vertebral compression fracturesof the spine ("VCFs"), a painful condition commonly suffered by elderly individuals. These surgeries were allegedly performed despite a warning on the FDA-cleared label for Norian XR against this use, and in the face of serious medical concerns about the safety of the devices when used in the spine. According to the indictment, before the marketing program began, pilot studies showed the company that the bone cement reacted chemically with human blood in a test tube to cause blood clots. The research also showed, in a pig, that such Norian-caused clots became lodged in the lungs. Notwithstanding this knowledge, the company allegedly proceeded to market the product for VCFs without putting it through FDA-required testing. The company, it is alleged, did not stop marketing the product until after a third patient had died on the operating table. The indictment further alleges that after the death of the third patient in January 2004, Norian and Synthes did not recall Norian XR from the market - which would have required them to disclose details of the three deaths to the FDA - but, instead, compounded their crimes by carrying out a coverup in which they lied to the FDA during an official inspection in May and June 2004.

Levy said, "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. The FDA requires its independent review of the tests to ensure that companies do not put their financial interests ahead of the health and safety of the American people. The defendants charged bypassed the process, with the knowledge that the product that they were marketing posed potentially significant risks. When predictable bad results occurred, they lied to the FDA investigators. They put their profits ahead of responsible business practices and the truth."


Hertz said, "This case is another example of the Department of Justice working together as a team to enforce the Food, Drug, and Cosmetic Act against companies and individuals that fail to market their products in compliance with that statute."

"The FDA's Office of Criminal Investigations aggressively pursues and supports the prosecution of those who endanger the public health by circumventing the safeguards the FDA has in place to ensure that clinical trials are adequately supervised and controlled and that the public receives medical devices that have been shown to be safe and effective," said Michael Chappell, acting associate commissioner for regulatory affairs. "We will continue to do all we can to protect the public against companies and their representatives who are not truthful, put patients's health at risk and undermine the regulatory process."

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