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), 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!
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.
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The FDA's new enforcement plan makes one thing clear: Developing a successful CAPA program has never been more important. But creating an FDA-proof CAPA isn’t easy. If only you could pick the brain of someone who is coping successfully with CAPA — the best and the brightest, an industry leader who has devised programs, procedures and solutions that have put companies out in front with the FDA. Well, you can. Register today.Read More
The FDA’s cadre of freshly trained inspectors — many of whom come directly from industry — and increased focus on specialized inspections are making it harder than ever to predict the outcome of your next FDA inspection. Unless, of course, you have Surviving an FDA Inspection at your fingertips. If you could spend less than $400 to get your drug manufacturing facility fully prepared to face a tough inspection by the FDA, would you even hesitate? ... Of course not!