PHILADELPHIA (Legal Newsline) - Amerisource Bergen asked a federal judge to dismiss a Justice Department lawsuit accusing it of filling hundreds of thousands of suspicious opioid orders, saying the government is seeking billions of dollars in fines for violating “hopelessly vague” rules it refuses to identify with any specificity.
Justice sued the wholesale drug distributor in December, accusing it of failing to report suspicious orders to the Drug Enforcement Agency or block them from being filled as required under the Controlled Substances Act. The government sued after Amerisource Bergen and other major distributors negotiated a $26 billion settlement of opioid claims brought by states and thousands of municipalities.
In a filing with U.S,. District Judge Gerald Pappert in Pennsylvania, Amerisource said the case is “profoundly flawed,” accusing the government of trying to “pile on” with its own multibillion-dollar demands based on unconstitutionally vague allegations. The government’s core theory was rejected by a federal judge in West Virginia last July, Amerisource said, who refused to accept a plaintiff expert’s opinion that once a distributor detects a single suspicious order the company must cut off that customer from any further orders.
“Just as there is no way for distributors to determine in advance whether the DEA would consider an order to be suspicious,” Amerisource said in its March 30 motion to dismiss, it “can only guess about which orders the government now claims in hindsight were suspicious, and why.”
The government accuses Amerisource of shipping hundreds of thousands of illegal opioid orders without further explanation. It identifies five suspicious pharmacies it says Amerisource shouldn’t have shipped opioids to, but the company, in a news release after the lawsuit was filed, said it reported four of the five to the DEA and terminated sales to all but one the DEA investigated the pharmacy and declined to cancel its registration.
The Controlled Substances Act doesn’t mention “red flags,” but a DEA regulation requires distributors to “design and operate a system” to uncover “suspicious orders of controlled substances,” which it defines as orders of “unusual size,” “deviating substantially from a normal pattern,” or “unusual frequency.” Other government entities, including the Office of Inspector General and the General Accountability Office, have repeatedly criticized DEA for failing to give distributors more specific definitions of what constitutes a suspicious order.
Nevertheless, Amerisource said it continuously improved its suspicious order system in the 2000s, including hiring outside consultants to develop a two-stage process using computer algorithms to identify orders that deviated from customer peer groups and human reviewers to determine if they were truly suspicious.
“During these years, the DEA audited defendants’ distribution centers dozens of times and never made any adverse findings regarding defendants’ suspicious order monitoring and reporting systems,” the company said. “Moreover, the DEA renewed the registration for each of defendants’ dozens of distribution centers every year during this period—a process which obligated the DEA to consider annually whether each facility was maintaining effective controls against diversion.”
The U.S. Supreme Court has held that the void-for-vagueness defense applies to civil and criminal cases, the company said. The government’s allegations also violate a federal rule requiring the government to identify the specific statutory provisions a company violated, Amerisource said.
“Is an order `suspicious’ because it is one pill larger than a pharmacy’s average order? Because it is twice as large as a pharmacy’s average order? How about three times?” the company said. “These and myriad other questions are left unresolved by the language of the statute.”
In its lawsuit, the government doesn’t say what makes an order “statistically unusual,” only saying there were “at least hundreds of thousands” of them.
“If the DEA believes a distributor has not maintained “effective controls,” the company said, “the remedy is an enforcement action to revoke the distributor’s license.”