DOJ Files Lawsuit Against One of Largest US Pharma Companies

The Justice Department building in Washington, on Dec. 9, 2019. Samuel Corum/Getty Images

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) on Dec. 29, 2022, 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 deemed suspicious.

The complaint states 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 states that the Conshohocken, Pennsylvania-based company, which earned $238.6 billion in 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,” Associate Attorney General Vanita Gupta said 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 on Dec. 29, 2022.

This file photo shows five-milligram pills of the opioid drug oxycodone on June 17, 2019. Keith Srakocic/AP Photo File

Between 1999 and 2020, about 564,000 people died from an opioid-involved overdose, according to the U.S. Centers for Disease Control and Prevention. About 80,000 people died from opioid overdoses in 2021, the agency stated.

In December 2022, the federal health agency stated that new data show that U.S. life expectancy dropped in 2021 to the lowest level in 25 years. Officials, in part, blamed the decline on the opioid epidemic.

The DOJ stated that 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 alleges that AmerisourceBergen 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 Dec. 29, 2022, 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.

“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 substance 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.

“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 lawsuit follows 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, distributor McKesson Corp., and drugmaker Johnson & Johnson.

In the only case to go to a verdict, a West Virginia judge ruled in July 2022 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 last week.

Reuters contributed to this report.