The records revealed
A cache of previously undisclosed internal drug company documents and other records are being released as the result of the largest civil action in U.S. history. About two dozen drug companies are being sued in federal court by nearly 2,000 cities, towns and counties, alleging they conspired to flood the nation with opioids. Below are portions of some of the documents in the case, entered by the plaintiffs as exhibits and selected by The Post.
The companies deny the allegations in the lawsuit and have blamed the epidemic on overprescribing by doctors and pharmacies and on customers who abused the drugs. They say they were working to supply the needs of patients with prescriptions who were desperate for pain relief.
[Newly unsealed exhibits reveal inner workings of the drug industry ]
Key documents
New document
“I see our friends are at it again.”
Jack Crowley, then the executive director of compliance at Purdue Pharma, emailed a Cardinal Health executive in December 2007 following a DEA enforcement action at a Cardinal drug distribution center. “I wish there was something I could do to help in this situation - we are all in the same boat.”
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“What, if any, legal options do we have ... ”
In September 2007, the senior director of regulatory affairs and health-care policy for the drug industry’s trade group, the Healthcare Distribution Management Association, drafted an email to members requesting a meeting to discuss the DEA’s enforcement efforts and related issues. “What, if any, legal options do we have to address all of the above?” she asked.
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A “Crisis Playbook” for the drug industry
The industry alliance hired a crisis communications company to create a “Crisis Playbook” that drafted possible responses to DEA enforcement actions and other crises. The 2013 playbook said, for example, that if the DEA suspended a drug company’s license, the industry trade group could “push its message of misdirected DEA enforcement with national media” and to “inform relevant members of Congress about the action to head off greater criticism.”
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Lawmakers and drug industry lobbyists worked together on bill that weakened one of DEA’s enforcement tools
In a June 2013 email, a lobbyist for the Healthcare Distribution Management Association wrote that then-Rep. Tom Marino (R-Pa.) had sent her draft language for legislation that would eventually weaken one of the DEA’s biggest enforcement tools.The lobbyist noted that “Rep. Marino’s office is very open to feedback and additional ideas.”
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“Three areas of attack”
After a meeting at the Healthcare Distribution Management Association’s headquarters in December 2013, a senior vice president at a drug distribution company, H.D. Smith, emailed his bosses. He wrote that there were “three areas of attack” in response to DEA enforcement efforts: create an alliance of drug companies; lobby federal government officials and “prepare for blowback” when the Marino bill is introduced; and prepare “canned” responses to news stories about pill mills and other topics.
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Purdue executive says company helped shape the Marino bill
Burt Rosen, vice president of government affairs for Purdue Pharma, emailed other Purdue executives the night the Marino bill passed the House in April 2016, saying “Purdue was very active in influencing the ultimate definition of an ‘imminent danger to the public health or safety.’”
“Just like Doritos keep eating, we’ll make more.”
In an email exchange from January 2009, Victor Borelli, a national account manager for the manufacturer Mallinckrodt, told Steve Cochrane, a vice president for KeySource Medical, that 1,200 bottles of oxycodone 30 mg 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.”
“I think we’re responsible for something. I don’t know what.”
In a July 2018 deposition, Nathan J. Hartle, McKesson’s vice president of regulatory affairs and compliance, was asked whether McKesson accepts partial responsibility for the societal costs of prescription drug abuse in the United States.
“I think we’re responsible for something. I don’t know what -- how you define all societal costs and -- I still believe it depends on different circumstances.”
“Tell them anything they want to hear”
In May 2008, a customer service representative for Mallinckrodt raised questions internally about orders from a new customer, Sunrise Wholesale of Florida.
“Were you expecting Sunrise to place such a large order??” the customer service employee asked in an email to Victor Borelli, a national account manager with Mallinckrodt. “And do they really want 2520 bottles of OXYCODONE HCL 30MG TABS USP, 100 count each ??”
This email was forwarded to one of Malinkrodt’s top compliance officers with the note: “FYI — the customer service reps all state that Victor will tell them anything they want to hear just so he can get the sale.........”
″ ‘A lot’ is a relative term”
In a November 2018 deposition, Victor Borelli, a national account manager at Mallinckrodt, was asked about large orders placed by the company’s clients.
“You knew how much Oxy 15 and 30 your clients were buying … and you knew they were buying a lot, correct?” he was asked.
“ ‘A lot’ is a relative term,” Borelli responded. “A lot to what? For history or the United States needs?”
Obligation to the laws, not to the public
In an August 2018 deposition, Jennifer Norris, a vice president and general counsel at Cardinal Health, was asked if Cardinal had an obligation to the general public given the opioid epidemic.
“Cardinal Health does not have an obligation to the general public. Cardinal Health has an obligation to perform its duties in accordance with the law, the statute, regulations, and guidance,” Norris said.
Suspicious-order monitoring system needed upgrades
Karen Harper, Mallinckrodt’s senior manager of controlled substance compliance, said in a January 2019 deposition she believed that the company’s suspicious-order monitoring program needed to be upgraded in 2008.
She also said she offered to resign after the company paid $35 million as part of a settlement with the Drug Enforcement Administration over allegations that Mallinckrodt had a deficient suspicious-order monitoring program between 2008 and 2011.
“I offered to quit,” Harper said. “... It happened on my watch.”
“This might raise a red flag in the suspicious order monitoring reports.”
A customer representative at Mallinckrodt’s parent company at the time, Covidien, raised concerns about an uptick in orders but was dismissed by a Mallinckrodt executive.
In an email to colleagues on July 15, 2011, the Covidien representative sent colleagues a document that she said “indicates an increase in ordering for several of our existing wholesaler/distributors.” She added: “This might raise a red flag in the suspicious order monitoring reports.”
One of the recipients of the email was the Mallinckrodt director of national accounts, Victor Borelli. He said that while shipments to two wholesalers, McKesson and Cardinal, had increased, another distributor’s orders had decreased.
“Let’s not let Suspicious order monitoring limit or restrict shipments because this is only a swapping of business between wholesalers,” Borelli wrote.
“Not sure where this Oxy business will be coming from . . .”
In October 2008, executives at the drug distributor Rochester Drug Co-Operative exchanged messages about a pharmacy in suburban New Jersey that was ordering a large amount of oxycodone. Old Bridge Drugs, a pharmacy in a town of 67,000 people in central New Jersey, was ordering 38,000 pills each month and wanted more, according to the emails.
A Rochester executive contacted the drug’s manufacturer to request bigger shipments to keep up with the pharmacy’s surging demand.
“I am not sure where this Oxy business will be coming from but I can find out if necessary,” the Rochester executive wrote to an account manager at the drug manufacturer, Covidien. “They have requested 380 bottles of 100 [pills] per month. I will be increasing my purchases a bit when including this new usage,” she wrote.
″[T]hey are rolling and I don’t want to lose the momentum . . . ”
In March 2010, a customer service manager for Covidien sent an email to Victor Borelli, director of national accounts for Mallinckrodt, flagging a peculiar order of hydromorphone tablets from a buyer in Cincinnati.
“Do you know why they have increased their volume so much in March?” the manager asked.
In the email exchange, Borelli responded that the company had expanded its sales reach: “ . . . [T]hey are rolling and I don’t want to lose the momentum with them.”
“It’s only 700+ bottles, but we have to give a reason for the increase.”
In a May 2010 email, a pharmaceutical product manager at Covidien Mallinckrodt reported an unusually large order of methadone tablets: “HD Smith placed an order for more than 3 times their normal 10mg methadone,” the manager wrote. “It’s only 700+ bottles, but we have to give a reason for the increase.”
In response, a director of national accounts at Covidien Mallinckrodt said the increase was because of “increased compliance.”
When another employee asked by email what “increased compliance” meant, the director said it refers to a price offer that is contingent on the number of pills a buyer purchases.
The director wrote that if the purchase amount is not as large as expected, Covidien Mallinckrodt might “encourage them” to meet the quoted amount. Otherwise, she said, the price and “VIP” status of the buyer might change.
Larger order, quick approval
Emails show that a Purdue Pharma executive approved orders from distributors that, in some cases, far exceeded the average recent orders for those distributors.
In an email on Oct. 27, 2009, the executive approved an order by Cardinal for 115,200 oxycodone 15 mg pills that was nearly twice as large as the company’s three-month average of 59,200 pills. The order came in at 4:15 p.m., according to the email.
The executive approved it at 4:16 p.m.
DEA describes Walgreens as: “Direct and significant contributors to the epidemic”
In a September 2012 letter to Walgreens, DEA administrator Michele Leonhart said the company’s pharmacies were “direct and significant contributors to the epidemic of prescription drug abuse and diversion in Florida, yet it largely ignored these indicators, at all levels of the corporate structure.”
She outlined incidents, including:
After a Walgreens pharmacist at a Fort Pierce store mistakenly dispensed extra oxycodone pills to a customer in September 2010, the pharmacist was told by the customer’s girlfriend that the customer “was an addict who sells his pills and views the extra oxycodone as a ‘pot of gold’ which he would not return.” Despite this incident, Walgreens filled several additional oxycodone prescriptions for this customer.
In November 2010, a pharmacist at the same location reported to police that she dispensed a prescription for 60 oxycodone 15 mg pills for a 24-year-old man who she then witnessed transfer the drugs to a woman in the store. The woman entered the pharmacy restroom, leaving behind evidence indicating she had smoked the oxycodones. Despite this incident, Walgreens continued to fill the same customer’s oxycodone prescriptions for the next several months, according to the DEA letter.
Actavis sent more oxy to Florida than it did to almost every other state combined
On Sept. 12, 2012, DEA officials met with executives from Actavis and warned them about the company’s dramatic increase in shipments of oxycodone in Florida, according to an internal DEA memo.
At the agency’s Northern Virginia headquarters, DEA officials presented charts generated from the agency’s ARCOS database showing that Actavis was sending more oxycodone to Florida than it was to almost every other state combined.
A DEA staff coordinator advised Actavis’s director of customer service to “get to know their customers” by sending someone from the company’s compliance team to visit pharmacies receiving Actavis products in south Florida “to witness the long lines at pain clinics, out of state license plates, questionable clients, security guard(s) in the parking lots, and signs stating cash payments only.”
Explore the documents
Examine more than 50 documents and more than 1,400 pages. This page will update as additional documents are released.
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Credits
Edited by David Fallis and Jeff Leen. Data reporting by Steven Rich, Aaron Williams and Andrew Ba Tran. Reporting by Scott Higham, Sari Horwitz, Jenn Abelson, Amy Brittain, Aaron C. Davis, Robert O'Harrow, Shawn Boburg and Jennifer Jenkins. Design and development by Madison Walls, Leslie Shapiro, Matt Callahan and Greg Manifold. Production by Nick Kirkpatrick. Copy editing by Annabeth Carlson and Nora Simon. Project management by Julie Vitkovskaya and Sarah Dunton.
Originally published July 23, 2019.
