UPDATE 1/5/18: New details on Purdue's conduct unsealed
City of Seattle, Ferguson jointly announce separate suits against OxyContin maker
SEATTLE — Attorney General Bob Ferguson today filed a lawsuit accusing OxyContin maker Purdue Pharma of fueling the opioid epidemic in Washington state, embarking on a massive deceptive marketing campaign and convincing doctors and the public that their drugs are effective for treating chronic pain and have a low risk of addiction, contrary to overwhelming evidence. This deceptive marketing resulted in the deaths of Washingtonians and devastation to Washington families.
The lawsuit contends Purdue conducted an uncontrolled experiment on the American public without any reliable clinical evidence that opioids are effective at treating chronic pain. To doctors and patients, Purdue consistently downplayed the risks of addiction from long-term use and deceptively represented opioids as safe for treating long-term chronic pain.
Purdue’s deception yielded the company billions of dollars in profit nationwide from its opioid drugs. Ferguson’s lawsuit seeks to force Purdue to forfeit the Washington portion of those profits.
The City of Seattle filed a separate lawsuit today against Purdue, in addition to Teva Pharmaceuticals, Janssen Pharmaceuticals, Endo Pharmaceuticals and Allergan. The city and Ferguson announced their lawsuits together.
Both suits, filed today in King County Superior Court contend that Purdue’s illegal conduct contributed to excessive prescriptions and addiction, causing many addicted patients to look for other ways — including illegal means — to get more pills or to get heroin. A 2014 study found that nearly 80 percent of heroin users reported using prescription opioids prior to heroin.
By filing the state’s lawsuit, Ferguson has ended his participation in a multistate coalition investigating opioid manufacturers nationwide. Several states that have filed similar lawsuits are using outside attorneys to handle their cases. Washington is only the second state to handle its case internally.
“Purdue Pharma ignored the devastating consequences of its opioids and profited from its massive deception,” Ferguson said. “It’s time they are held accountable and pay for the devastation they caused.”
“I stand together with Attorney General Ferguson in fighting for justice for patients who were prescribed opioids and became addicted, because they were not irresponsible; they were deceived,” Seattle City Attorney Pete Holmes said. “Addiction to opioids and heroin does not stop at Seattle’s city limits. This is the city’s problem, the state’s problem, and everyone’s problem.”
“Most of our health care professionals want to do the right thing for patients, but some corporations sought to boost their bottom line to peddle opioids on false promises, which, in great part, created this crisis. These corporations must be held accountable. I appreciate the Attorney General taking this important step today,” Gov. Jay Inslee said. “This will help with some recompense so we can implement our state’s opioid response plan and my executive order with the goals to prevent the next generation from becoming addicted, to prevent overdoses and to treat people who have opioid use disorder, a true medical condition with an effective medical treatment."
Purdue falsely claims that opioids improve long-term function, have a low addiction risk that can be managed or prevented and that increased doses of opioids do not pose significant additional risks to patients.
False claims of the safety, effectiveness of long-term use
Purdue aggressively marketed its opioids for chronic pain from conditions like headaches and low back pain, despite a lack of clinical evidence that they are effective and safe for long-term use. Despite Purdue’s efforts over more than two decades, the Centers for Disease Control & Prevention (CDC) noted in its 2016 guidelines that “there is no good evidence that opioids improve pain or function with long-term use.”
Other, safer options — like acetaminophen or non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen — are effective and carry fewer risks, the CDC added.
False claims of low addiction risk and “pseudoaddiction”
Among its marketing claims, Purdue distributed thousands of videos and pamphlets claiming that opioid addiction occurred in less than 1 percent of patients. The number was not based on a clinical study, but rather a 1980 letter to the editor in the New England Journal of Medicine. The actual addiction rate is as high as 26 percent, according to the CDC.
A study sponsored by Purdue asserted that “opioids were well tolerated with only rare incidence of addiction,” and the need for higher and higher doses as patients built up a tolerance to opioids “was not a clinically significant problem when managing patients with opioids long-term.”
When signs of addiction appeared in patients, Purdue persuaded doctors that what appeared to be addiction was actually under-treatment of their pain, and to respond by increasing opioid dosages.
In marketing materials, Purdue told doctors and policymakers that “pain-relief seeking behavior can often be mistaken for drug-seeking behavior.”
The concept, called “pseudoaddiction,” was coined by Dr. J. David Haddox, who later became a Purdue executive. His theory was based on the case of a single cancer patient. No study has validated the theory of “pseudoaddiction.”
Despite a lack of evidence of “pseudoaddiction,” Purdue pushed this theory to convince doctors to give more drugs to patients who displayed signs of addiction, such as asking for early refills on their prescriptions or “doctor shopping” for additional prescriptions.
False claims on risks of overdoses
Opioids are most dangerous when taken long-term and when taken in high doses. In 2013, the FDA noted that research shows that risk of misuse and abuse is great for extended release long acting opioids and observed that these drugs are often used chronically.
Accordingly, the CDC recommends that physicians carefully reassess increasing opioid doses beyond 50 morphine milligram equivalents (MMEs), and avoid exceeding 90 MMEs per day.
Overdose risk for opioids begins at very low doses and doubles when the daily dose is between 20 MMEs and 49 MMEs. By 100 MMEs, the risk of death increases by nine fold. Overall, 1 in every 550 patients started on opioid therapy died of opioid-related causes a median of 2.6 years after their first opioid prescription. That number increased to 1 in 32 for patients receiving 200 MMEs per day.
Purdue’s sales representatives were trained to reassure prescribers that there is “no ceiling” on the amount of OxyContin a patient could be prescribed.
Ignoring red flags
Purdue sales staff kept detailed records of prescriptions in Washington by prescriber, drug strength, quantity and other factors. Purdue then used that data to aggressively market its drugs to the highest prescribers in the state.
Washington state medical boards sanctioned some of these prescribers for failing to follow rules related to opioid prescriptions and putting patients at risk. The lawsuit alleges that, in several cases, Purdue salespeople ignored red flags and continued to target these providers with sales pitches.
Details of specific interactions between Washington state providers and Purdue representatives are redacted from the complaint because Purdue contends the information is competitively sensitive. Ferguson plans to file a motion to unseal this information to reveal to the public additional details about these interactions.
Violating previous court order
Purdue has faced court action before over its deceptive marketing of OxyContin.
A 2007 court order resulting from a consent judgment with Washington and 25 other states prohibited the company from making misleading statements regarding abuse, addiction or dependence in its marketing materials for OxyContin. Purdue also promised to create an Abuse and Diversion Detection Program to detect and take appropriate steps upon detecting “atypical” prescribing patterns — including reporting “pill mill” doctors to the authorities.
Despite the court order, Purdue has continued to engage in deceptive marketing and has remained silent about suspicious prescribers it should have reported.
Prescriptions and sales of opioids in Washington skyrocketed more than 500 percent between 1997 and 2011. In 2011, at the peak of overall sales in Washington, more than 112 million daily doses of all prescription opioids were dispensed in the state — enough for a 16-day supply for every woman, man and child in Washington. More than 18.2 million daily doses of oxycodone were distributed in Washington in 2015.
Geographic areas in Washington with higher rates of opioid prescriptions show a strong correlation with higher overdose rates.
For example, Cowlitz, Clallam, Mason and Snohomish counties had the highest opioid overdose death rates in the state, according to the state Department of Health. Those counties also had some of the highest opioid prescription rates in the state.
Between 2009 and 2014, Washington saw a 60 percent increase in opioid-related hospital stays, the fourth-highest increase in the nation, according to a June study by the Agency for Health Care Research and Quality.
In 2015, the number of overdose deaths in Washington exceeded the number of deaths from car accidents, or deaths from firearms — whether from suicide, homicide or accidental. The majority of drug overdose deaths in Washington between 2010 and 2015 — more than 6 out of 10 — involved an opioid.
Ferguson’s lawsuit seeks civil penalties and damages. Ferguson also asks the court to order Purdue to give up the profits it made in Washington as a result of its illegal conduct. Sales of Purdue opioids are worth billions every year nationwide, and Washington’s portion is expected to be in the millions.
The surrendered profits will be used to remediate the effects of Purdue’s misrepresentations of opioids, possibly funding treatment, education and more.
Assistant Attorneys General Tad Robinson O’Neill and Kate Barach are leading the case for Washington.
Earlier this year, the Attorney General’s Office hosted a summit on Washington’s opioid epidemic in partnership with the Washington State Patrol and the Washington Association of Prosecuting Attorneys.
The Office of the Attorney General is the chief legal office for the state of Washington with attorneys and staff in 27 divisions across the state providing legal services to roughly 200 state agencies, boards and commissions. Visit www.atg.wa.gov to learn more.
Brionna Aho, Interim Communications Director, (360) 753-2727; email@example.com