DOJ Files Nationwide Lawsuit Against AmerisourceBergen and Subsidiaries for Controlled Substances Act Violations

On Friday, the United States filed a complaint against AmerisourceBergen Corporation as well as two of its subsidiaries for perpetuating the opioid epidemic. It alleges that the company and its subsidiaries did not do their due diligence to track and report suspicious orders to the Drug Enforcement Agency (DEA). 

Specifically the complaint states that the company as well as a subsidiary, AmerisourceBergen Drug Corporation (ABDC), and Integrated Commercialization Solutions, LLC (ICS) used overly specific instruments to detect suspicious opioid orders, did not do their due diligence in vetting pharmacy clients, and even when they found suspicious activity, they continued fulfilling those orders in the name of profit.

Passed in 1970, the Controlled Substance Act established a closed system for regulating and monitoring controlled substances, including opioids, under which it is unlawful to distribute or dispense any controlled substance, except in a manner authorized by law. Specifically, every entity in the distribution process must register with the DEA and comply with the requisite regulations. 

In particular, the complaint cites the federal regulation that “[registrants] shall design and operate a system to disclose to the registrant suspicious orders of controlled substances.  The registrant shall inform [DEA] of suspicious orders when discovered by the registrant.  Suspicious orders include orders of unusual size, orders deviating substantially from a normal pattern, and orders of unusual frequency.”

The federal government alleges AmerisourceBergen, ABDC, and ICS did not do so. The complaint details how the two successive organizations within ABC that were tasked with finding suspicious orders and customers were underfunded, and their mechanisms only found the most suspicious of suspicious orders. 

When suspicious orders and clients were found, they were often cleared for delivery anyway. The filing lists numerous cases in which pharmacies that were later shut down and prosecuted for fueling the opioid epidemic received order after order from the defendants. In one of these cases, the complaint lists executive emails celebrating continued sales to one such pharmacy, with adulations like “SELL….SELL….SELL!!!!!”

Furthermore, the defendants are alleged to have known how insensitive their suspicious order catching algorithm was in 2014. To remedy this issue, they hired a consulting firm to improve it. However, the new system was even less sensitive and would only catch a suspicious order if it was extremely larger than typical and came at an usual frequency. 

According to the complaint, in 2007, AmerisourceBergen sought to implement a Know Your Customer program in which potential clients had to fill out a form describing their operations. However, the forms were never fully enforced, and pharmacies could even become ABC customers while leaving key sections blank or vaguely answered. 

For all these alleged violations, the United States government seeks the maximum allowable civil penalty and an injunction against this continued alleged behavior. The case is set in the Eastern District of Pennsylvania.