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.
Synthes’ decision to market the product for VCF use despite the risks made the company responsible for three deaths that occurred, the government alleged. Former Norian executives Richard Bohner, Michael Huggins, John Walsh and Thomas Higgins each pleaded guilty to one count of introducing the misbranded bone void filler into interstate commerce under the responsible corporate officer (RCO) doctrine (United States v. Park), which holds corporate executives can be held accountable for criminal activity they could have prevented.
Last year, the device industry paid the Justice Department close to $1.8 million due to its stepped-up enforcement campaign to curb off-label marketing and violations of the False Claims Act. Whoops!
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