CHARLESTON — A special master in a landmark national opioid trial has ordered the release of previously secret reports that detail “suspicious” orders of powerful painkillers placed by pharmacies and purchased from giant drug suppliers.
Special Master David Cohen also directed that two additional years of federal opioid sales data be unsealed. The Drug Enforcement Administration records track prescription opioid shipments to every pharmacy in America.
What’s more, Cohen, who’s assisting with more than 2,000 opioid lawsuits filed against drug distributors and manufacturers in Cleveland federal court, unsealed transcripts of hundreds of depositions, including testimony from drug company executives and DEA agents.
The unsealing of the records follows a yearlong legal battle by the Charleston Gazette-Mail, The Herald-Dispatch and The Washington Post to make the information public. The nation’s largest drug distributors and manufacturers fought for months to keep the pharmacy order reports and data under wraps. The reports and data single out pharmacies that ordered unusually large numbers of prescription opioid pain pills.
“The court’s decision to finally open secret records and court filings to the public is long overdue,” said Suzanne Weise, a Morgantown lawyer who’s representing HD Media, which owns the Gazette-Mail and Herald-Dispatch. “Citizens are entitled to know the basic facts about the flood of prescription opioids into communities across West Virginia and the nation.”
The “suspicious order reports” are expected to number in the hundreds of thousands. The DEA database includes millions of entries about sales of the painkillers hydrocodone, oxycodone and other federally controlled drugs.
The companies wanted a judge to block the release of the reports even though the DEA, which collects them, no longer opposed making them public.
Under federal law, prescription drug distributors are required to report suspicious spikes in orders for opioids to the DEA. They’re also supposed to block the orders, something they routinely neglected to do, according to a congressional report released last year.
In court filings, the companies’ lawyers characterized the reports as “confidential business data” that contained “trade secrets.” They argued the distributors submitted the reports to the DEA under the assumption they would be kept confidential.
They also asserted the public release of the reports would violate the privacy rights of pharmacies — and their customers. And that rogue pharmacies could use past reports to “game the system” and avoid being flagged for suspicious orders in the future.
In his order this week, Cohen disagreed.
“Indeed, the evidence has been that the manufacturers, distributors and pharmacies all have fairly detailed competitive knowledge regarding whom each of them sells opioids to and buys opioids from,” Cohen wrote. “In any event, the public interest in knowing who was receiving opioids and their interactions with (the companies) outweighs the (companies’) interests in protecting the alleged trade secret.”
Cohen added that “some details” in the suspicious order reports could remain under seal, provided the companies could cite “specific information” that “provides a clear indication” to rogue pharmacies about how they could thwart scrutiny and divert drugs to the black market.
In late July, the newspapers asked U.S. District Judge Dan Polster to void part of a secrecy agreement between the distributors and the more than 2,000 cities and counties suing them as part of a landmark national case being heard in Cleveland. The local governments and drug companies signed a deal to keep the suspicious order reports confidential in May 2018.
Following a sharp rise in overdose deaths in the mid-2000s, the DEA told distributors they had to design systems to identify prescription painkiller orders of “unusual size and frequency, and deviating substantially from normal patterns.” The companies were directed to report those suspicious orders to DEA field offices.
But the distributors had a “series of breakdowns,” failing to follow the law, according to the congressional report. Some companies reported excessive orders after shipping the drugs to pharmacies. Others only notified the DEA when they ended sales contracts with suspect pharmacies.
According to the House Energy and Commerce Committee investigation:
- Between 2006 and 2012, drug wholesale giant McKesson shipped 163 million opioid painkillers to West Virginia, but submitted no suspicious order reports to the DEA about pharmacies in the state. During the next five years, McKesson turned in more than 10,000 such reports on state drugstores.
- Until 2012, Cardinal Health submitted just one suspicious order report in West Virginia, even though it sold 174 million doses of the painkillers hydrocodone and oxycodone in the preceding six years, the congressional investigation found. The next six years, the company reported more than 2,000 suspicious orders from West Virginia pharmacies.
- Another distributor, AmerisourceBergen, submitted reports that ranged from a high of 792 in 2013 to a low of three orders in 2016. The wholesaler reported more than 100 suspicious orders from a pharmacy in Beckley over five months in 2013 and 2014, yet AmerisourceBergen continued to sell prescription pain pills to that pharmacy for nearly a year.
Before 2007, the company mailed copies of suspicious order reports to the DEA monthly, but didn’t block any of those same orders.
In interviews with congressional staff, an executive with regional distributor Miami-Luken acknowledged that the company made only “rudimentary efforts” to block and report suspicious orders from its customers in West Virginia. Miami-Luken flagged suspect orders based on “one’s feeling,” the executive said.
The companies also were required to report suspicious orders to the West Virginia Board of Pharmacy. In late 2016, the board released 7,000 of the reports in response to a request from the Gazette-Mail. The agency’s then-executive director said the board shelved the reports and didn’t investigate any of the pharmacies that ordered excessive numbers of pain pills.
West Virginia has the highest drug overdose death rate in the nation. Local governments allege that distributors fueled the opioid epidemic by shipping massive quantities of prescription painkillers.
Last year, the newspapers first went to court to unseal a DEA database that details prescription opioid shipments to every state, county and city in the nation. Lawyers, including those in West Virginia, had been given access to the data as part of their lawsuits against opioid manufacturers and distributors. The DEA and drug companies vigorously fought against the news organizations to shield the painkiller sales numbers from the public.
Polster initially sided with the distributors, but the newspapers appealed and won in the 6th U.S. Court of Appeals in Cincinnati.
After the appellate court decision, Polster directed the release of the DEA data from 2006 to 2012, but postponed a decision on whether to make public more current data from 2013 to 2014. The judge also didn’t release the suspicious order reports at the time.
In August, the appeals court denied a request by the drug companies that wanted a second hearing to argue why the two additional years of prescription opioid data and suspicious order reports should be kept secret.
The 2006-12 data show that drug companies saturated the nation with 76 billion hydrocodone and oxycodone pain pills while overdose deaths surged, according to a Washington Post analysis. States like West Virginia and Kentucky, which had the highest number of pills per resident per year, also had the highest overdose rates. The drug companies have contended the DEA should have stopped the flood of opioid painkillers, and they only filled orders from licensed pharmacies.
Last month, the distributors agreed to pay $260 million to settle lawsuits with two Ohio counties. The settlement, which came the day the lawsuits were scheduled to go to trial, is expected to provide a framework for future deals with the other counties and cities suing the companies.
“The court’s decision to open court and DEA records to sunlight comes very late in the day,” said Pat McGinley, who also argued the case for HD Media. “But it sends a powerful message that issues of grave national importance should never be litigated in secrecy.”
Reach Eric Eyre at firstname.lastname@example.org or at 304-348-4869, or @ericeyre on Twitter.