In a civil complaint filed last week, the U.S. Department of Justice (DOJ) opened a nationwide lawsuit against AmerisourceBergen Corp. and two of its subsidiaries, which together form one of the largest pharmaceutical distributors, for violating federal law on the distribution of controlled substances.
Allegedly, the companies contributed to the prescription opioid epidemic through unlawful violations of the act to the tune of hundreds of thousands of times spanning years. As a result, the Justice Department sought civil penalties and injunctive relief amounting to up to $10,000 for each reporting violation before November 2015, up to $16,864 for each violation relating to a suspicious order for any unreported non-opioid controlled substances after October 2018, and more generally for reporting violations between November 2015 and October 2018, along with the heftier sum of up to $109,374 for each violation relating to a suspicious opioid order not reported after October 2018.
If found liable, AmerisourceBergen could face billions of dollars in penalties, even before any awards of injunctive relief that would bar the company from committing future violations.
“The Department of Justice is committed to holding accountable those who fueled the opioid crisis by flouting the law,” Associate Attorney General Vanita Gupta said. “Companies distributing opioids are required to report suspicious orders to federal law enforcement. Our complaint alleges that AmerisourceBergen — which sold billions of units of prescription opioids over the past decade — repeatedly failed to comply with that requirement.”
In a response statement, AmerisourceBergen claimed that the DOJ “cherry picked details” and countered that the department’s complaint was an attempt to shift blame from past administrations in general and the Drug Enforcement Agency (DEA) in particular related to industries they had been supposed to regulate. It added that a federal judge in West Virginia had separately found that the company had maintained diversion control systems in accordance with the law.
“The complaint filed by the Department of Justice attempts to shift the onus of interpreting and enforcing the law from the Department of Justice and Drug Enforcement Administration (DEA) to an industry they are tasked with regulating and policing,” AmerisourceBergen said. “The simple fact is DEA-controlled and operated systems like the ability to limit the amount of opioid medication available through manufacturing quotas; and maintenance of registration for pharmacies that dispense controlled substances like opioid medications were not used to stem the crisis of opioid misuse and abuse. Instead, former bureaucrats at the DEA simply tried to make private companies take on their responsibility of determining what pharmacies should be able to dispense opioid medication.”
This new complaint was filed in the U.S. District Court for the Eastern District of Pennsylvania and concerns issues spanning almost a decade, from 2014 to the present. The government maintained that AmerisourceBergen not only failed to report orders from pharmacies that were likely pushing diversion of prescription opioids but also filing to the contrary, in a push for profits over legal obligations and consumer well-being. It added that this came despite the company being aware of the “red flags” on the issue, pointing to five examples, which included several resulting deaths. Reliance on internal systems to monitor and identify suspicious orders was further deemed inadequate, supposedly flagging only a small fraction of suspicious orders.
“Companies like AmerisourceBergen that sell controlled substances across the country have a significant responsibility to ensure that their product is handled appropriately and that they comply with their federal legal obligations,” said U.S. Attorney Jacqueline C. Romero for the Eastern District of Pennsylvania. “The allegations against AmerisourceBergen are disturbing, especially for a company that is headquartered only a few miles from neighborhoods in Philadelphia devastated by the opioid epidemic.”
This case was filed after a multi-year investigation by the DEA, the Civil Division’s Consumer Protection Branch, and several U.S. Attorneys’ Offices.