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FDAnews Device Daily Bulletin
July 13, 2012 | Vol. 9 No. 137
Synthes Sentences Could Serve as Warning: Lawyer
Last year’s court ruling that sent four former Synthes executives to prison for clinical trial deaths represents an expansion of case law and a warning to other devicemakers, a legal expert says. The case involved Synthes’ Norian subsidiary, which marketed a calcium phosphate bone cement to treat vertebral compression fractures (VCFs) despite a known serious risk of hypotension. Knowledge of the risk required the company to include language in its labeling saying the cement was not for use on VCFs.
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