The Department of Justice (DOJ) is suing pharmaceutical giant AmerisourceBergen and accused it of fueling the opioid crisis by allegedly failing to report suspicious orders of drugs for years.
In a civil complaint, federal prosecutors wrote (pdf) Thursday that AmerisourceBergen violated federal laws that require opioid manufacturers to alert the Drug Enforcement Administration (DEA) to any suspicious orders. Pharmaceutical companies, under the law, are also required to block shipments of orders that are deemed suspicious.
It said that AmerisourceBergen and two of its subsidiaries since 2014 had systematically refused or negligently failed to flag suspicious orders by pharmacy customers when it had reason to know that opioids were being diverted to illegal channels.
The suit also said the Conshohocken, Pennsylvania-based company, with $238.6 billion of revenue in its latest fiscal year, even intentionally altered how one of its units monitored orders, dramatically reducing the number that underwent internal scrutiny. The lawsuit seeks penalties that could reach billions of dollars, and an injunction against future violations of the federal Controlled Substances Act.
“The Department of Justice is committed to holding accountable those who fueled the opioid crisis by flouting the law,” said Associate Attorney General Vanita Gupta in a statement. “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 release, DEA Administrator Anne Milgram hailed the lawsuit. “The company’s repeated and systemic failure to fulfill this simple obligation helped ignite an opioid epidemic that has resulted in hundreds of thousands of deaths over the past decade,” she said Thursday.
Between 1999 and 2020, some 564,000 people died from an opioid-involved overdose, says the U.S. Centers for Disease Control and Prevention. About 80,000 people died from opioid overdoses last year, the agency said.
Last week, the federal health agency said that new data shows U.S. life-expectancy dropped in the past year to the lowest levels in 25 years. Officials, in part, blamed the decline on the opioid epidemic.
The Justice Department said AmerisourceBergen for years understaffed and unfunded programs designed to ensure compliance with the Controlled Substances Act. In 2014, for example, it budgeted just $4 million for its internal compliance department, a sum dwarfed by its spending on taxicabs and office supplies, the government alleged.
The complaint also alleged AmerisourceBergen even kept shipping drugs to two pharmacies in West Virginia and Florida after being told by an auditor that the drugs were likely being sold in parking lots for cash.
Company Denies Claims
AmerisourceBergen on Thursday denied wrongdoing after the complaint was filed. It faulted the DOJ lawsuit for focusing on five, “cherry picked” pharmacies out of thousands.
“In fact, AmerisourceBergen terminated relationships with four of them before DEA ever took any enforcement action while two of the five pharmacies maintain their DEA controlled substance registration to this day,” the company said in a statement to news outlets.
“Even in these five hand selected examples presented by the DOJ, AmerisourceBergen verified DEA registration and State Board of Pharmacy licenses before filling any orders, conducted extensive due diligence into these customers, reported every sale of every controlled substances to the DEA, and reported suspicious orders of controlled substances to the DEA for every one of these pharmacies—hundreds of suspicious orders in total,” the firm also said.
“With the vast quantity of information that AmerisourceBergen shared directly with the DEA with regards to these five pharmacies, the DEA still did not feel the need to take swift action itself,” the statement added.
The lawsuit followed AmerisourceBergen’s agreement in 2021 to pay up to $6.4 billion to resolve thousands of lawsuits accusing it and other drug distributors of ignoring red flags that prescription painkillers were being used improperly.
That settlement was part of a broader, $26 billion settlement resolving more than 3,000 lawsuits by state and local governments against the company, distributor Cardinal Health Inc., distributor McKesson Corp., and drugmaker Johnson & Johnson.
In the only case to go to a verdict, a West Virginia judge ruled in July that AmerisourceBergen, Cardinal Health, and McKesson were not responsible for fueling an opioid epidemic in part of that state.
Federal prosecutors filed the lawsuit in the U.S. District Court for the Eastern District of Pennsylvania this week.