Off-Label Drugs Will Be Next Enforcement Focus, Law Prof Predicts

Corporate Compliance

Off-Label Drugs Will Be Next Enforcement Focus, Law Prof Predicts

Posted Aug 27, 2008, 09:39 am CST
By Martha Neil

Every year, when Dallas attorney Steve Kardell kicks off the corporate compliance and governance class he teaches at Southern Methodist University's Dedman School of Law, he starts by predicting the subject of the next wave of company scandals.

Last year, he pointed to subprime lending. The year before, it was stock options in Silicon Valley. And this year, he is targeting pharmaceutical companies' promotion of off-label uses for the drugs they manufacture and market, reports the Dallas Morning News.

He also says companies are looking lower in the food chain when facing potential sanctions for alleged Sarbanes-Oxley Act violations, so middle managers should watch their backs.

"Corporations in real trouble will try to absolve themselves by offering up the guilty parties. It's almost like an Aztec sacrifice to appease the gods," he tells the newspaper. "They'll take a midlevel exec's heart out and roll it down the temple steps to prove they have diligence and zero tolerance."

The 60-year-old Kardell, a partner of Clouse Dunn Khoshbin, often represents executives in wrongful termination cases.

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