Protecting Against Individual Prosecutions: Execs Remain A Focus, But There Are Ways To Reduce Risks
As the US Justice Department continues its focus on individual liability in device industry enforcement, it’s more important than ever that manufacturers bring executives in early on problems to limit liability.
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Agency is considering whether a breach of duty to act or correct violations under the Food, Drug and Cosmetic Act must occur before criminal charges are brought, Chief Counsel Rebecca Wood says; clarity on FDA's view of 'vicarious criminal liability' would be welcome news to the pharma industry and suggests an early priority for the agency's new top lawyer.
After two warning letters, eight inspections, and quality systems concerns dating to 2009, the government has largely blocked Philips Healthcare from manufacturing automated external defibrillators and similar products made at two of the company's facilities until the concerns are resolved.
The updated US Attorney’s Manual instructs government lawyers to focus on individuals from the launch of civil or criminal investigations into a company, and not to consider individual’s ability to pay a judgment in deciding whether to pursue charges.