Attorney General Gurbir S. Grewal announced today that the State has submitted for filing a five-count lawsuit against Janssen Pharmaceuticals Inc., a subsidiary of Johnson & Johnson, for deceiving consumers about the dangers of two of the company’s opioid products with high potential for abuse – Nucynta and Nucynta ER. Today’s lawsuit is the third case brought by the Attorney General’s Office against an opioid manufacturer, and the first such case brought by the Office against a pharmaceutical company based in New Jersey.
The State’s 97-page complaint is based in part on internal company documents obtained by the Attorney General’s Office during a lengthy investigation into Janssen’s marketing practices. A redacted complaint has been filed with the court.
The State has submitted for filing a motion seeking to make publicly available the full, unredacted complaint. Janssen will decide whether to consent to that request or try to prevent the release by claiming the unredacted complaint contains confidential information.
Today, Attorney General Grewal called on Janssen to allow the public to read the full, unredacted complaint.
“Janssen helped fuel a public health crisis unlike any other our state has faced,” Attorney General Grewal said. “The public has a right to know about Janssen’s efforts to mislead healthcare providers and patients, and we will fight any effort to keep today’s filing hidden from view. Janssen’s conduct was illegal, and details about it should not be kept confidential.”
“It is particularly disturbing that so much of this misconduct took place in our own backyard,” said Attorney General Grewal. “New Jersey’s pharmaceutical industry is the envy of the world, with a long history of developing vital, life-saving drugs. But we cannot turn a blind eye when a New Jersey company violates the law and threatens the lives of our residents. We intend to hold Janssen accountable for its deception, and to make the company pay for the public health crisis it helped to create.”
Submitted for filing today in Superior Court in Mercer County, the State’s lawsuit charges violations of the New Jersey Consumer Fraud Act, the New Jersey False Claims Act, and the common-law prohibition against creation of a public nuisance.
The complaint seeks a judgment requiring that Janssen pay civil penalties, disgorge its ill-gotten gains, and pay damages for false claims submitted to the State.
In addition, the suit seeks an order requiring that Janssen halt all unlawful practices under the Consumer Fraud Act, correct its misrepresentations, and “abate the public nuisance that its deceptive marketing has been a substantial factor in creating.”
Among other allegations, the State’s complaint highlights the following harmful conduct by Janssen:
Two types of deception. There were principally two levels of deception at work in Janssen’s marketing campaign for its opioid products Nucynta and Nucynta ER: (1) minimizing the risks of opioids generally, and (2) attempting to differentiate its own opioid products from competitors’ products by deceptively promoting Nucynta and Nucynta ER as safer, milder, and less addictive than other prescription opioids.
Unbranded marketing campaign. Using literature and web content that was designed to appear independent but was, in reality, a front for the company, Janssen oversaw an extensive unbranded marketing campaign designed to embed its deceptions about the viability of long-term opioid use in the minds of doctors and patients. Among other examples, this unbranded marketing campaign included (1) a website called PrescribeResponsibly.com, (2) the “Let’s Talk Pain” Coalition and (3) a brochure entitled “Finding Relief.” The “Finding Relief” brochure – subtitled “Pain Management for Older Adults” – included a list headlined “Opioid Myths” that purported to debunk several fallacies about opioids. It included the assertion: ”Many studies show that opioids are rarely addictive when used properly for the management of chronic pain.”
Targeting elderly and non-opioid users. Janssen specifically targeted the elderly and “opioid-naïve” patients to expand its market share. The details in the complaint have been redacted because Janssen has designated them confidential. Attorney General Grewal has called upon the company to allow this information to be seen by the public.
Promotion of bogus clinical theory (“pseudoaddiction”). Through its unbranded marketing campaign, Janssen promoted the misleading and dangerous concept of “pseudoaddiction” -- the debunked theory that a patient’s signs of opioid addiction are actually symptoms of having been under-treated for pain, and that the problem can be solved by simply increasing the patient’s opioid dosage.
The lawsuit also blames Janssen’s deceptive marketing of Nucynta and Nucynta ER for “dramatically” increased health insurance costs absorbed by the State and, ultimately, New Jersey taxpayers through false claims for chronic opioid therapy.
The complaint notes that New Jersey bears the cost of prescription drug coverage for low-and-moderate-income residents through its Medicaid programs, for active and retired State employees through two different, private-company-administered Employee Health Plans, and for State employees injured on the job under Workers’ Compensation.
Between 2010 and 2017, the complaint notes, the State spent an estimated $12.5 million on more than 41,000 claims for Nucynta or Nucynta ER submitted to its two Employee Health Plans (part of $178 million spent by the State overall for opioid prescriptions submitted to the Employee Health Plans.) During roughly the same time period, the State paid out a total of more than $800,000 to cover Nucynta and Nucynta ER claims submitted to the State’s largest Medicaid MCO, and under Workers’ Compensation. Under the New Jersey False Claims Act, Janssen is liable for three times the State’s damages.
Specific examples described in the complaint include one New Jersey Employee Health Plan patient who received 125 prescriptions for Nucynta and Nucynta ER – totaling more than a 2,700-day supply (the equivalent of a 7.6-year supply, taken every day) – during about a year period. These prescriptions cost the State more than $48,000 for this patient alone, and were written by a healthcare provider who had received hundreds of visits from Janssen sales representatives.
In another case referenced in the complaint, a New Jersey Workers’ Compensation patient who was diagnosed with a neck sprain and hip bruise received a total of 57 prescriptions for Nucynta and Nucynta ER – totaling a 1,700-day supply. These prescriptions cost the State nearly $28,000 for this patient, and were written by a healthcare provider who was repeatedly visited by Janssen sales representatives.
The State’s lawsuit against Janssen notes that, historically, opioids were prescribed only for short-term acute pain, for cancer pain, or for end-of-life pain. Opioids were recognized to be “too addictive and debilitating” to be used long-term, the complaint states, and “for less severe chronic pain conditions, it was generally understood that the risks of using opioids dramatically exceeded the benefits.”
The suit alleges that, beginning in the 1990s -- and driven by the desire for expanded market share and profits – opioid manufacturers mounted a sweeping campaign to “enlarge what was an appropriately narrow opioid patient profile,” through a series of deceptive marketing and promotional campaigns that touted opioid pain medications in treatment contexts where it “had not been traditionally accepted.”
Janssen joined the wave of opioid manufacturers working to persuade healthcare providers and patients – including the elderly and opioid-naïve – that pain had been widely and improperly under-treated, and that opioid pain medications were the answer.
Ultimately, the complaint notes, Janssen and other opioid manufacturers -- and the front groups they funded – successfully changed the overall medical and public perception of opioids to something not solely for treatment of acute pain and end-of-life care, but also for long-term treatment of chronic pain conditions. Nucynta and Nucynta ER – like OxyContin and Fentanyl – are “Schedule II” controlled substances as defined by the federal Controlled Substances Act, which means they are deemed to have a “high potential for abuse, which may lead to severe psychological or physical dependence.”
Janssen launched Nucynta in late 2008 and Nucynta ER in 2011. As alleged in the complaint, Janssen sought “to capitalize on and perpetuate … deceptions about prescription opioids, including that the benefits of opioids for long-term use for moderate pain conditions significantly outweighed the risks.”
Janssen’s sale force blanketed its home state of New Jersey with in-person visits to healthcare providers. The number of visits to New Jersey healthcare providers is one of the pieces of information that Janssen claims is confidential. The State’s complaint alleges that Janssen’s sales visits included deceptions that are illegal under New Jersey law. The New Jersey Consumer Fraud Act authorizes a penalty of up to $10,000 for each violation.
Janssen sold its U.S. license rights for Nucynta and Nucynta ER to Depomed (a company now known as Assertio Therapeutics, Inc.) for a reported $1.05 billion in 2015.
In addition, the Attorney General has retained the law firm of Cohen Milstein Sellers & Toll, PLC in the Janssen matter.