Lawyer: Synthes Case Highlights Considerations in RCO Pleas

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) RCO holds that corporate executives can be held accountable for criminal activity they could have prevented. The four were eventually sentenced, to a range of five- to nine-month prison terms.

But based on his reading of the case, Patrick O’Brien, a partner at Holland & Knight, said the executives did not believe the company’s promotion of bone cement to treat VCFs amounted to a clinical trial. Synthes referred to its sales of the cement for that purpose as “test marketing” and relied on peer-to-peer discussions to spread the word about the off-label use — activities the company believed were acceptable, he said.

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.

How can you minimize the risk of being investigated for an off-label promotion violation and ensure your promotional program is in compliance?

Manufacturers could see a stronger crackdown on off-label promotion according to a March 2012 Office of Inspector General (OIG) report directing HHS to focus on the practice. OIG flagged that issue among others as “weaknesses” with the FDA in its annual report on the top management and performance challenges facing HHS.

Last week, FDAnews presented Device Off-Label Promotion: Understanding What the FDA Is Looking For. What? You missed it? Not a problem. Through our encore presentation, learn types of off-label communications that may not be considered violative, and actions that your staff must avoid in such situations. Don’t miss it again. Sign up today!