Lawyer: Synthes Case Highlights Considerations in RCO Pleas

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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!

How can you minimize the risk of being investigated for an off-label promotion violation and ensure your promotional program is in compliance? That’s simple with FDAnews’ webinar, Device Off-Label Promotion Understanding What the FDA Is Looking For.

Medical device manufacturers walk a fine line between providing up-to-date, relevant and accurate medical information to their clients and being subject to violating FDA regulations against off-label promotion. Especially since the FDA agrees that firms should respond to unsolicited requests for information about FDA-regulated medical products and may even include information about unapproved or uncleared indications or conditions of use.

Remain up to speed with the knowledge you need by registering for this Thursday webinar today!

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