Off-label use of a bone cement could send four Synthes executives to prison. After pleading guilty to a misdemeanor, the four men now await sentencing in Pennsylvania, and could become the first execs jailed under the Park Doctrine, a legal tenet that U.S. officials have been promising to use against managers of misbehaving drugmakers and device firms.
The four former Synthes executives pleaded guilty in 2009 in connection with a plan to market the product for off-label use in spinal surgery. Prosecutors had alleged that, as corporate officers, they bore the responsibility of preventing such violations, the Philadelphia Inquirer reports. Yesterday, lawyers for the four men said that prison wasn't warranted, because they were not intimately involved in the bone-cement tests, which left three patients dead. "The evidence of intent is insufficient," one of the lawyers said (as quoted by the Inquirer).
As the Inquirer notes, the idea of a "responsible corporate officer" came out of two Supreme Court cases that said executives could be found guilty for violations that occurred while they were in charge, even if they didn't intend to break the law. In the wake of a series of big off-label marketing settlements with drugmakers, FDA and Health and Human Services officials have been promising to use this idea--the Park Doctrine--to press for individual penalties in such cases.
In fact, the agency recently issued guidelines for enforcement actions brought against executives of FDA-regulated companies. Corporate fines and settlements haven't been enough of a deterrent to prevent misbehavior, officials have said. Eric Blumberg, FDA's litigation chief, said the agency is looking for Park Doctrine cases to help "change the corporate culture," particularly where it comes to off-label marketing.