Wednesday, November 27, 2019

Federal prosecutors launch criminal investigation against manufacturers and distributors of opioid painkillers

"Federal prosecutors have opened a criminal investigation into whether pharmaceutical companies intentionally allowed opioid painkillers to flood communities, employing laws normally used to go after drug dealers, according to people familiar with the matter," Corinne Ramey reports for The Wall Street Journal. "Prosecutors are examining whether the companies violated the federal Controlled Substances Act, a statute that federal prosecutors have begun using against opioid makers and distributors this year." Under that law, companies must monitor commonly abused drugs and report suspicious orders.

The U.S. attorney for the Eastern District of New York has sent grand-jury subpoenas to at least six companies: drugmakers Teva Pharmaceutical Industries Ltd., Mallinckrodt PLC, Johnson & Johnson and Amneal Pharmaceuticals Inc.; and distributors AmerisourceBergen Corp. and McKesson Corp. All the companies have denied responsibility and said they followed all laws concerning manufacture and distribution of prescription opioids, Ramey reports.

But according to recently released Drug Enforcement Administration databases, billions of pills were distributed across the country between 2006 and 2012, with disproportionate numbers sent to rural areas struggling with opioid addiction. More than 2,600 communities, counties, and Native American tribes have alleged in federal lawsuits that the companies didn't report suspicious orders, in order to maximize profits. Most of the suits were consolidated into a few large cases, and most companies have settled out of court.

If the probe results in charges, the case could become the biggest criminal prosecution to date of drug companies for the opioid epidemic. "Executives and companies can face civil charges under the Controlled Substances Act for not reporting signs, like suspicious orders, that could indicate drugs are being used for nonmedical purposes," Ramey reports. "Criminal charges require prosecutors to prove an effort to willfully and intentionally avoid such requirements, legal experts said."

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