Four ex-officers of a Pa.-based manufacturer of a bone cement product were sentenced to prison for an unapproved trial that led to three deaths. Each pled guilty to a single misdemeanor count of shipping adulterated and misbranded Norian XR in interstate commerce. The sentences, imposed in Philadelphia federal court, ranged from five to nine months in custody plus fines.
The judge said that the officials wanted to beat their competitors to market without going through the lengthy process of getting the bone cement product approved by the U.S. Food and Drug Administration. So they plotted to train select surgeons in its off-label use and then have the doctors publish their findings. The officers "approved rogue clinical trials" which used bone-void fillers "to treat vertebral compression fractures of the spine in elderly patients." The cement, approved for use elsewhere in the body, was used in the spines of 200 patients with fractured vertebrae. The program continued even after a patient died in surgery in Texas in 2003 and another died in California. The patients suffered sharp drops in blood pressure after the bone cement compound was injected into their spines. Synthes only halted the training after a third death in 2004.
Synthes Inc. pled guilty, paid a $23.2 million fine and agreed to sell the unit. Pa.-based Kensey Nash Corp. bought the entire Norian product line for $22 million in cash. As part of a long-term supply agreement, Kensey Nash will manufacture the Norian products, and Synthes will exclusively distribute the products worldwide. Johnson & Johnson now owns Synthes.
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