BRUNSWICK, GA (Legal Newsline) - Former U.S. Drug Enforcement Administration (DEA) investigator James Rafalski told a courtroom in Georgia that the in-house anti-drug diversion programs of opioid distributors were “fatally flawed” in that they failed to report suspicious orders.
“It was my expectation to see a file (information on suspicious orders),” Rafalski said of the defendant Cardinal Health on Thursday. “That was not the case. It was difficult to find any information.”
Rafalski said suspicious order documents were incomplete in some cases with only a curse notation that an increase in drug dispensing was due to “business growth.”
“There was not a comprehensive reason (for increased dispensing),” Rafalski said, adding that requests to release more drugs from distributors were made almost “automatically,” and that threshold amounts of pills were increased.
The trial in the Glynn County Georgia Superior Court is being streamed live courtesy of Courtroom View Network.
Cardinal Health, McKesson and JM Smith Corp., distributors of prescription opioid drugs, stand accused of flooding Georgia with addictive pills causing an epidemic. The case is unusual because it was not filed by a state or local government, but by 21 individual plaintiffs. These include adults and their children who claim they lost loved ones or suffered physical and mental damage because of prescribed opioids.
The trial is being closely watched for the precedent its outcome could set.
Defense attorneys, as they have in past trials, contend the epidemic was caused by societal problems and illegal street drug use including heroin and fentanyl, and that the companies simply going about the legal business of supplying pain pills to doctors are being scapegoated.
When a legally prescribed opioid drug gets into the wrong hands, someone for whom it was not intended, it is called “diversion.”
Rafalski was a DEA special investigator from 2002 until 2017.
He told a jury that after analyzing DEA information and “due diligence” files from the companies, they had failed to report suspicious orders (unusually large or more frequent). He agreed that McKesson had not tried to block an order from being shipped since 2008.
“Is your purpose to see if the companies comply with federal law?” a state attorney asked.
“Yes,” Rafalski agreed.
“Do you have to look at Georgia law?”
“I do not,” Rafalski said.
“Does Georgia law require a Georgia (drug distributor) licensee to comply with federal law?”
“Yes.”
“The distributor is supposed to design a system (in-house) that tells the distributor an order is suspicious?”
“That’s correct,” Rafalski said. “The maintenance of an efficient system controls the way to monitor sales. It’s pretty simple, orders of unusual size. The (DEA) focus has always been to prevent diversion.”
“Who knows best?” the state attorney asked of suspicious orders, “the DEA or the distributor?”
“The distributor,” Rafalski answered.
“Who has the most (suspicious order) information first?”
“The distributor.”
“Who does the drug order come from?”
“The pharmacy.”
“Who does it (order) go to?”
“The distributor.”
Rafalski said DEA investigators peruse Automation of Reports and Consolidated Orders Systems (ARCOS) data on the transactions of distributors.
“It (ARCOS) collects millions of (drug) orders,” Rafalski explained. “It’s a data base to do queries and it’s a post shipment report (made after a drug has been shipped).”
“Is it fair to say the distributor has (suspicious order) information the DEA doesn’t have?” Rafalski was asked.
“Yes,” he said.
Rafalski said the anti-diversion programs of Cardinal Health and McKesson had not prevented diversion.
Defense attorney Andrew Stanner of the Covington law firm said there are numerous circumstances where an order could appear to be suspicious and not be. Also, that no specific guidelines were given from the DEA how to operate an in-house checking system.
“The DEA says that each distributor has to figure it out (how to operate an anti-diversion program)?” Stanner asked.
“That’s correct,” Rafalski agreed.
“You are aware there are all sorts of circumstances where an order could be suspicious but not be diverted?”
“Yes.”
“Over time how many orders were actually diverted, orders where it was reported they should not be shipped, more or less than five percent?”
Rafalski said he did not know.
Stanner contended and Rafalski agreed that he had not done a specific study of pharmacies in Georgia that were filling the drug orders. These include the Darien Pharmacy in the town of that name and the Altama Pharmacy in Brunswick. Both have been accused of dispensing too many pills. According to the Brunswick News, the Altama Discount Pharmacy upped its prescription of opioids (oxycodone) by three times from 2008 to 2010.
In 2019, a pharmacist at the Darien facility pleaded guilty to lying about filling prescriptions to high-volume-opioid doctors.
Rafalski said his assignment for the trial was to review the distribution of Cardinal Health and McKesson on a national basis and not specific to local pharmacies.
“You don’t consider Cardinal Health and McKesson to be drug dealers?” Stanner asked.
“I do not,” Rafalski said.