At Norian Four Executives Charged in Connection With Unlawful Clinical Trials – 3 Patients Died on the Operating Table

At the same time period, Norian was involved in a patent lawsuit against Stryker, with either the very same or similar products used.  You can read  more here.  When you visit the page today, warnings are there indicating this product should not be used in the spine. 

It’s pretty scary when you have 3 patients die on the operating table too.  Make sure when approached or looking for clinical trials that they are in fact FDA approved to be safe.  BD 

The indictment charges Norian with a total of 52 felony counts: conspiracy to impair and impede the lawful functions of the FDA and to commit crimes against the United States; seven counts of making false statements in connection with an FDA inspection; and 44 counts of shipping adulterated and misbranded Norian XR in interstate commerce with intent to defraud. The parent company, Synthes, is charged with 44 misdemeanor counts of shipping adulterated and misbranded Norian XR in interstate commerce, and the four executives, Michael D. Huggins, Thomas B. Higgins, Richard E. Bohner and John J. Walsh, are each charged with one misdemeanor count of shipping adulterated and misbranded Norian XR in interstate commerce. As explained below, these crimes allegedly prevented the FDA from carrying out its role of supervising clinical trials of significant risk devices, and deprived patients of the safeguards provided by FDA oversight of clinical trials.

According to the indictment, Synthes, a Delaware corporation based in West Chester, Pa., is the United States branch of a large multinational medical device manufacturer which specializes in trauma products to treat damaged human bone. Norian, it is alleged, is a wholly owned subsidiary of Synthes, specializing in the manufacture of osteobiologic medical devices, with a principal place of business in West Chester, Pa.

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(2.), in surgeries to treat vertebral compression fractures of 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.

According to the indictment, the company conducted two XR "Test Market Kick-Off" surgeon meetings, and one surgeon forum, from August of 2003 through mid-January 2004, training approximately 52 spine surgeons how to use Norian XR to treat VCFs. It is charged that, after the third person died on the operating table during a surgery in which a Norian cement was used to treat VCFs, the company cancelled the future surgeon forums. The indictment alleges that the company considered, but rejected, the idea of recalling or removing XR from the market, either of which actions would have required them to notify the FDA.

International Medical Device Maker; Four Executives Charged in Connection With Unlawful Clinical Trials

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