A pharmaceutical company’s push to boost profits help push the state into an opioid crisis, according to a five-count lawsuit filed by N.J. Attorney General Christopher Porrino.
Purdue Pharma L.P. manipulated the public and the medical community to see pain as something that was undertreated and the opioids were the first-line solution for patients with chronic conditions such as back pain, migraines and arthritis, the 100-page complaint charges.
“When we point the finger of blame for the deadly epidemic that has killed thousands in New Jersey, Purdue is in the bull’s eye of the target,” Porrino said. “Today, my office took the first step toward holding them legally and financially responsible for their deception.”
Purdue allegedly used deceptive tactics to market blockbuster opioids, particularly OxyContin, as safe, effective, long-term treatments for chronic pain. The elderly and “opioid-naïve” were vulnerable new markets, the suit claims.
“In a campaign of almost inconceivable callousness and irresponsibility, we allege that Purdue has spent hundreds of millions of marketing dollars to downplay the addiction risk associated with taking opioids for chronic pain, all the while exaggerating the benefits of using these dangerous drugs,” Porrino said. “We allege that this fraudulent conduct has not only given false hope to many pain patients, it has led to addiction, overdose, and death. It also has cost the State hundreds of millions on opioid prescriptions and the broader health and social effects of overprescribing. Many of these prescriptions never should have been written.”
Purdue denounced the claims in a statement forwarded to BreakingAC in response to a request for comment,
“We vigorously deny these allegations and look forward to the opportunity to present our defense,” it said.
The company also said it is “deeply troubled by the opioid crisis and we are dedicated to being part of the solution. As a company grounded in science, we must balance patient access to FDA-approved medicines, while working collaboratively to solve this public health challenge. Although our products account for approximately 2 percent of the total opioid prescriptions, as a company, we’ve distributed the CDC Guideline for Prescribing Opioids for Chronic Pain, developed three of the first four FDA-approved opioid medications with abuse-deterrent properties and partner with law enforcement to ensure access to naloxone.”
The lawsuit also alleges Purdue failed to disclose that it had no studies to support the efficacy or safety of opioid medications for treatment periods longer than 12 weeks.
Each Purdue sales representative was required to visit seven to eight doctors per day, five days a week to promote these opioids, a state investigation found.
The highest volume prescribers were given the title of “Super Core Prescribers,” and received special attention from Purdue. Sales representatives were compensated based on reaching their “Rx quota” for each drug.
The quotas for OxyContin alone were in the range of 500 to 700 prescriptions per month for each sales representative – amounting to quotas of 6,000 to 8,400 prescriptions.
“The sheer number of marketing visits made by Purdue sales representatives to New Jersey prescribers is staggering – and based on the number of prescriptions, the scheme clearly was a smashing success for the company,” Porrino said.
Since the market debut of OxyContin in 1996, Purdue has generated overall sales estimated at more than $35 billion. The company’s current annual revenues are estimated at about $3 billion, mostly from the sale of OxyContin.
The state’s largest Medicaid managed-care organization has paid $109 million for opioids through the Medicaid program since 2008. Another $6 million was paid under its Workers’ Compensation Program since 2008, and about $136 million under its State Employee and Retiree Health Plan since 2012. Meanwhile, New Jersey consumers – including individuals, employers and private insurers – easily have paid hundreds of millions for opioid prescriptions.
That doesn’t include the millions state and private consumers have paid to treat addiction, overdose and other injuries associated with opioid overprescribing and misuse.
The complaint seeks monetary damages for false claims, maximum statutory penalties under the Consumer Fraud Act and the False Claims Act, disgorgement of ill-gotten gains and other relief as contribution for the expensive solutions — including addiction treatment and prescriber education.
“Prescribing opioids for routine chronic pain is dangerous and, in many cases, inappropriate,” Porrino said. “However, in New Jersey and across the nation it became mainstream medical practice and the treatment of first resort. How did that happen? It happened because certain companies within the pharmaceutical industry saw a chance to grow their profits by peddling extraordinarily potent, highly-addictive opioid drugs for routine pain. We allege that Purdue Pharma was chief among these opportunistic and predatory companies.”
According to the State’s complaint, Purdue’s campaign to change the health care landscape with regard to opioids began in the late 1990s.
Before that, opioids were used on a much more limited basis – to treat acute trauma-related pain, post-surgical pain or for palliative care – because the drugs were considered too addictive and debilitating for long-term use, the lawsuit claims.
Faced with a medical and popular understanding of opioids that constrained its market, the complaint alleges that Purdue aggressively set out to change the image of opioids by encouraging prescribers to believe the drugs would permanently reduce pain in chronic pain patients and improve their function, with little or no addiction risk.
Helping push opioids into the mainstream was Dr. Russell Portenoy, a pain management specialist who received “substantial” funding from Purdue to conduct research, and was paid to serve as a Purdue consultant, the suit says.
Portenoy led a successful campaign in the national medical community to make pain “the fifth vital sign” — to be checked in every health care encounter – putting it on par with measuring blood pressure, heart rate, body temperature and breathing.
Purdue’s early marketing of OxyContin led to criminal fraud charges against the company and its executives, charges that Purdue paid more than $600 million to settle with the U.S. Department of Justice in 2007. But Purdue built upon those foundational deceptions, and continued deceptive and unconscionable marketing from 2007 through the present.
Among other actions in the 2007-2017 timeframe, the complaint charges that Purdue:
- Blanketed the State with sales representatives trained to emphasize the benefits of opioids, minimize their risks, deflect questions about addiction risks, and encourage doctors to consult unbranded websites and materials that did the same.
- Funded and created “unbranded” educational materials and websites that never identified Purdue or its products by name because they were deceptively designed to look like the work of unaffiliated patient advocacy groups. These unbranded materials magnified and supported Purdue’s deceptive marketing scheme.
- Promoted the unsubstantiated concept of “pseudoaddiction” to assure doctors that patients showing signs of addiction were actually suffering from undertreated pain and needed more medication.
- Promoted its 2010 “abuse-deterrent” reformulation of OxyContin by distributing and recommending materials that misleadingly described the signs of abuse as the stigmata of injecting or snorting opioids—skin popping, track marks, and perforated nasal septa – when, in fact, oral use (swallowing a pill) is the most common method of abuse and was not minimized by the 2010 “abuse-deterrent” reformulation.
- Refused to acknowledge that OxyContin ER does not provide 12 hours of constant pain relief, despite widely reported end-of-dose failure. Instead, Purdue recommended that doctors prescribe patients with end-of-dose supplemental opioids for short-term relief and higher doses of OxyContin ER, putting patients in a perpetual cycle of craving their medication and at greater risk for addiction.
- Ignored a growing body of research showing that long-term use of opioids was neither safe nor effective.
- The company also trained its sales representatives to persuade doctors to prescribe OxyContin and Purdue’s other opioids for the elderly and for “opioid naïve” patients (patients who had not previously taken opioids).
“Purdue’s decisions to target the elderly and opioid-naïve patients reflect, yet again, a business strategy that placed little, if any, value on the well-being and safety of consumers,” the suit states. “ Elderly patients taking opioids are at greater risk for fracture and hospitalization, and they have increased vulnerability to adverse drug effects such as respiratory depression.”
A Purdue sales representative interviewed by the State recalled intense pressure from Purdue to persuade doctors to convert patients from over-the-counter medications – such as Advil or Tylenol – to a “low dose” of OxyContin. Purdue knew, however, that chronic pain patients don’t stay on a “low dose” of OxyContin – as their bodies develop a tolerance to the drug, the dosage will likely be increased. In fact, Purdue’s marketing scheme included a focus on “titrating up” – the technical word for increasing a patient’s opioid dosage.
“This conduct was incredibly exploitative and put people in danger. As we allege in our complaint, Purdue targeted New Jersey seniors and the opioid-naïve for a reason – they were a growth sector,” Porrino said.
In 2016, one in three Medicare Part D enrollees received at least one opioid prescription, according to the complaint.
The State’s lawsuit notes that recent findings by both the federal Food and Drug Administration (FDA) and the national Centers for Disease Control (CDC) directly debunk Purdue’s claims about the efficacy and limited risks associated with opioids.
The CDC has confirmed there are no controlled studies about the use of opioids beyond 12 weeks, and the federal Agency for Healthcare Research and Quality has made plain “there is no evidence that opioids improve patients’ pain and function long-term.”
In addition to Connecticut-based Purdue Pharma, L.P., the State’s lawsuit names two other Purdue entities as defendants – Purdue Pharma Inc. and the Purdue Frederick Company. The State’s complaint includes three counts alleging violations of New Jersey’s Consumer Fraud Act and one count alleging violations of the New Jersey False Claims Act. It also charges a fifth count of Creating a Public Nuisance.