www.fdanews.com/articles/147858-synthes-sentences-could-serve-as-warning-lawyer
Synthes Sentences Could Serve as Warning: Lawyer
July 12, 2012
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
The GMP Letter