FDAnews Device Daily Bulletin

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.
The GMP Letter