As the opioid epidemic was raging in America, in May 2008 a representative of the nation’s largest manufacturer of opioid pain pills sent an email to a client at a wholesale drug distributor in Ohio.
Victor Borelli, a national account manager for Mallinckrodt, told Steve Cochrane, the vice-president of sales for KeySource Medical, to check his inventories and “[i]f you are low, order more. If you are okay, order a little more, Capesce?”
Then Borelli joked, “destroy this email. . .Is that really possible? Oh Well. . .”
Previously, Borelli used the phrase “ship, ship, ship” to describe his job. Those email excerpts are quoted in a 144-page plaintiffs’ filing along with thousands of pages of documents unsealed by a judge’s order Friday in a landmark case in Cleveland against many of the largest companies in the drug industry.
A Drug Enforcement Administration database released earlier in the week revealed that the companies had inundated the nation with 76 billion oxycodone and hydrocodone pills from 2006 to 2012.
Nearly 2,000 cities, counties and towns are alleging that the companies knowingly flooded their communities with opioids, fuelling an epidemic that has killed more than 200,000 since 1996.
The filing by plaintiffs depict some drug company employees as driven by profits and undeterred by the knowledge that their products were wreaking havoc across the country. The defendants’ response to the motion is due on 31 July.
In January 2009, Borelli told Cochrane in another email that 1,200 bottles of oxycodone 30mg tablets had been shipped.
“Keep ‘em comin’!” Cochrane responded. “Flyin’ out of there. It’s like people are addicted to these things or something. Oh, wait, people are. . .”
Borelli responded: “Just like Doritos keep eating. We’ll make more.”
Borelli and Cochrane did not return calls for comment on Friday night.
In a statement Friday night, a spokesman for Mallinckrodt sought to distance the company from Borelli’s email: “This is an outrageously callous email from an individual who has not been employed by the company for many years. It is antithetical to everything that Mallinckrodt stands for and has done to combat opioid abuse and misuse.”
The Controlled Substances Act requires drug companies to control against diversion, and to design and operate systems to identify “suspicious orders,” defined as “orders of unusual size, orders deviating substantially from a normal pattern, and orders of unusual frequency.”
The companies are supposed to report such orders to America’s Drug Enforcement Administration (DEA) and refrain from shipping them unless they can determine the drugs are unlikely to be diverted to the black market. The plaintiffs, in the filing, allege that the companies ignored red flags and failed at every level.
At Cardinal Health, one of the nation’s largest drug distributors, then-CEO Kerry Clark in January 2008 wrote in an email to Cardinal senior officials that the company’s “results-oriented culture” was perhaps “leading to ill-advised or shortsighted decisions,” the filing contends.
In the previous 18 months, Cardinal had been hit with nearly $1 billion in “fines, settlements, and lost business as a result of multiple regulatory actions,” the filing alleges, including the suspension of licenses at some of its distribution centres for failing to maintain effective controls against opioid diversion.
Cardinal Health did not immediately return a request for comment on Friday night.
On Aug. 31, 2011, McKesson Corp.’s then-director of regulatory affairs, David B. Gustin, told his colleagues he was concerned about the “number of accounts we have that have large gaps between the amount of Oxy or Hydro they are allowed to buy (their threshold) and the amount they really need,” according to the filing, which cites Gustin’s statements.
“This increases the ‘opportunity’ for diversion by exposing more product for introduction into the pipeline than may be being used for legitimate purposes.”
According to the filing, he had earlier noted to his colleagues that they “need to get out visiting more customers and away from our laptops or the company is going to end up paying the price... big time.”
Another McKesson regulatory affairs director responded: “I am overwhelmed. I feel that I am going down a river without a paddle and fighting the rapids. Sooner or later, hopefully later I feel we will be burned by a customer that did not get enough due diligence,” according to the filing.
McKesson is the largest drug distributor in the United States. It distributed 14.1 billion oxycodone and hydrocodone pills from 2006 to 2012, about 18% of the market, according to the DEA database.
McKesson said that the DEA was responsible for setting the annual production quota of pills.
“For decades, McKesson has consistently reported opioid transactions to the DEA,” McKesson spokeswoman Kristin Chasen said in a statement. “We have also invested heavily in further strengthening our anti-diversion program.”
Until Friday, the documents had been sealed under a protective order issued by U.S. District Judge Dan Polster. The order was lifted a year after The Washington Post and HD Media, which publishes the Charleston Gazette-Mail in West Virginia, filed a lawsuit for access to the documents and a DEA database tracking opioid sales, known as the Automation of Reports and Consolidated Orders System, or ARCOS.
The drug companies and the DEA strenuously opposed the release of the data and the documents, and Polster agreed with them. But a three-judge panel of the US Court of Appeals for the 6th Circuit in Ohio ordered that some of the information should be released with reasonable redactions and the database should be made public.
By consolidating cases from around the nation, the Cleveland case, for the first time, provides specific information about how and in what quantity the drugs flowed around the country, from manufacturers and distributors to pharmacies. The case also brings to light internal documents and deliberations by the companies as they sought to promote their products and contend with enforcement efforts by the DEA.
The local and state government plaintiffs in the case argue that the actions of some of America’s biggest and best-known companies – including Mallinckrodt, Cardinal Health, McKesson, Walgreens, CVS, Walmart and Purdue Pharma – amounted to a civil racketeering enterprise that had a devastating effect on the plaintiffs’ communities.
The case is a civil action under the Racketeer Influenced and Corrupt Organisations (RICO) Act, making use of a law originally developed to attack organised crime.
In statements on Tuesday in response to the release of the DEA database, the drug companies issued broad defences of their actions during the opioid epidemic. They have said previously that they were trying to sell legal painkillers to legitimate pain patients who had prescriptions.
They have blamed the epidemic on overprescribing by physicians and also on corrupt doctors and pharmacists who worked in “pill mills” that handed out drugs with few questions asked. The companies also said they should not be held responsible for the actions of people who abused the drugs.
The companies said that they were diligent about reporting their sales to the DEA and that the agency should have worked with them to do more to fight the epidemic, a point former DEA agents dispute. The companies also note that the DEA set the quotas for opioid production.
“We report those suspicious orders to state boards of pharmacy and to the DEA but we do not know what those government entities do with those reports, if anything,” Cardinal Health said in a statement.
The companies issued statements rejecting the plaintiffs’ allegations.
McKesson said in its statement: “The allegations made by the plaintiffs are just that – allegations. They are unproven, untrue and greatly oversimplify the evolution of this health crisis as well as the roles and responsibilities of the many players in the pharmaceutical supply chain.”
Mallinckrodt said the company “has for years been at the forefront of preventing prescription drug diversion and abuse, and has invested millions of dollars in a multipronged program to address opioid abuse.”
One of the biggest points of contention in the lawsuit is whether the nation’s largest drug companies did enough to identify suspicious orders of opioids. What exactly constitutes a suspicious order is at the heart of the case.
The DEA has long said there should be no confusion because the agency has given frequent guidance and briefings to the industry, and repeatedly defined what constitutes a suspicious order.
The plaintiffs argue that the companies failed to “design serious suspicious order monitoring systems that would identify suspicious orders to the DEA” and shipped the drugs anyway.
“Their failure to identify suspicious orders was their business model: they turned a blind eye and called themselves mere ‘deliverymen’ with no responsibility for what they delivered or to whom,” according to the plaintiffs’ filing.
Between 1996 and 2018, the plaintiffs alleged in the filing, drug companies shipped hundreds of millions of opioid pills into Summit and Cuyahoga counties in Ohio, filling orders that were suspicious and “should never have been shipped”.
“They made no effort actually to identify suspicious orders, failed to flag orders that, under any reasonable algorithm, represented between one-quarter and 90% of their business, and kept the flow of drugs coming into Summit and Cuyahoga Counties,” the plaintiffs’ lawyers wrote.
In 2007, the DEA told Mallinckrodt that the numeric formula it used to monitor suspicious orders was insufficient, the filing contended. It alleges the company’s suspicious order monitoring program from 2008 through 2009 consisted of solely verifying that the customer had a valid DEA registration and that the order was accurately logged into the DEA’s tracking database.
From 2003 to 2011, Mallinckrodt shipped a total of 53 million orders, flagged 37,817 as suspicious but stopped only 33 orders, the plaintiffs’ filing states.
A Mallinckrodt employee said in a deposition that the DEA had described the company as the “kingpin within the drug cartel” in a meeting with the agency in July 2010, according to a footnote in the filing.
In 2011, the filing cites a Justice Department document in which the DEA alleged that Mallinckrodt “sold excessive amounts of the most highly abused forms of oxycodone, 30 mg and 15 mg tablets, placing them into a stream of commerce that would result in diversion.”
According to the DEA, the filing states, “even though Mallinckrodt knew of the pattern of excessive sales of its oxycodone feeding massive diversion, it continued to incentivize and supply these suspicious sales,” and never notified the DEA of the suspicious orders.
In a settlement with the DEA, Mallinckrodt agreed that from Jan. 1, 2008, through Jan. 1, 2012, “certain aspects of Mallinckrodt’s system to monitor and detect suspicious orders did not meet the standards” outlined in letters from the DEA deputy administrator for diversion control.
Mallinckrodt was the nation’s leading manufacturer of oxycodone and hydrocodone, with 28.8 billion pills from 2006 to 2012, 37.7% of the market, according to the DEA database. It has since created a subsidiary for its generic opioids called SpecGx.
In 2017 federal prosecutors said 500 million of the company’s 30 mg oxycodone pills wound up in Florida between 2008 and 2012 – 66% of all oxycodone sold in the state. Pills at that dosage are among the most widely abused.
Prosecutors said the company failed to report suspicious orders, and Mallinckrodt that year settled the case by paying a $35m fine.
“Mallinckrodt’s actions and omissions formed a link in the chain of supply that resulted in millions of oxycodone pills being sold on the street,” then-Attorney General Jeff Sessions said at the time.
Walgreens used a formula to identify thousands of pharmacy orders as suspicious but shipped them anyway, the filing alleges. The orders were reported to the DEA after they had been shipped, according to agency documents quoted in the filing.
“Suspicious orders are to be reported as discovered, not in a collection of monthly completed transactions,” the DEA wrote in an immediate suspension order issued against Walgreens in 2012. “Notwithstanding the ample guidance available, Walgreens has failed to maintain an adequate suspicious order reporting system and as a result, has ignored readily identifiable orders and ordering patterns that, based on the information available throughout the Walgreens Corporation, should have been obvious signs of diversion.”
In one case, Walgreens’s suspicious order report to the DEA was 1,712 pages long and contained six months’ worth of orders, including reports on 836 pharmacies in more than a dozen states and Puerto Rico, the filing alleges.
The filing also alleges that Walgreens stores could “place ad hoc ‘PDQ’ (”pretty darn quick”) orders to controlled substances outside of their normal order days and outside of the [suspicious order monitoring] analysis and limits.”
Peviously, Kristine Atwell, who managed distribution of controlled substances for the company’s warehouse in Jupiter, Florida, sent an email on Jan 10, 2011, to corporate headquarters urging that some of the stores be required to justify their large quantity of orders.
“I ran a query to see how many bottles we have sent to store #3836 and we have shipped them 3271 bottles between 12/1/10 and 1/10/11,” Atwell wrote. “I don’t know how they can even house this many bottle[s] to be honest. How do we go about checking the validity of these orders?”
A bottle sent by a wholesaler generally contains 100 pills.
Walgreens never checked, the DEA said. Between April 2010 and February 2012, the Jupiter distribution centre sent 13.7 million oxycodone doses to six Florida stores, records show, many times the norm, the DEA said.
Walgreens ranked second among distributors in the nation, with 13 billion pills and 16.5% of the market for oxycodone and hydrocodone from 2006 through 2012, the DEA database shows. It stopped distributing opioids to its stores in 2014, but continues to dispense controlled substances.
As part of a settlement with the DEA in June 2013, Walgreens said that its “suspicious order reporting for distribution to certain pharmacies did not meet the standards identified by DEA.” The company paid an $80 million fine to the government.
In a statement earlier in the week, Walgreens defended its operations, saying, “Walgreens has been an industry leader in combating this crisis in the communities where our pharmacists live and work.”
The Washington Post