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Callan G. Stein, a partner in the Health Sciences Department and the White Collar Litigation and Investigations Practice Group of Pepper Hamilton, was quoted in the August 2, 2019 Compliance Week article, "Chief Compliance Officer Liability and the Opioid Epidemic."
Hire qualified compliance personnel. “That proved to be a major issue in the Rochester case,” says Callan Stein, a partner in the Health Sciences department at Pepper Hamilton. According to the complaint against RDC, at one point, “the primary individual responsible for managing compliance also performed a number of other time-consuming tasks, such as managing RDC’s warehouse and tracking inventory.”
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Do not ignore red flags. The allegations against RDC and Miami-Luken parallel each other in many important respects, particularly “actual knowledge of potential issues or suspicious behavior, coupled with a failure to act,” says Stein. In both cases, the issue was not that the companies did not have a DEA compliance program, but rather that they knowingly and willful ignored red flags that were identified, he says.