State Sues J&J Subsidiary Alleging Improper Opioid Marketing, Distribution

Attorney General says Janssen targeted elderly, downplayed dangers, put people at risk. Company says it acted appropriately and responsibly

Credit: Office of Attorney General/Tim Larsen
State Attorney General Gurbir Grewal
For six years, New Jersey-based Janssen Pharmaceuticals Inc. lobbied doctors and patients — particularly seniors — to choose its opioid-based medications based on claims that the drugs were safer than other brands, appropriate for treating a wide range of chronic pain, and free of the risks associated with over-the-counter options.

But a lawsuit filed Tuesday by the state Attorney General alleges that Janssen, a subsidiary of Johnson & Johnson, deceived prescribers and the public about the nature of these drugs, downplayed the dangers involved, and put communities at risk by exacerbating the Garden State’s growing opioid epidemic.

The suit also claims the company deliberately sought to expand the opioid market by targeting elderly individuals, without proper concern for their safety, in an effort to increase its bottom line.

In civil charges submitted to Superior Court in Mercer County, the suit claims Janssen violated the state’s Consumer Fraud Act, the False Claims Act, and the common-law prohibition against creating a public nuisance with misleading marketing of the drugs Nucynta and Nucynta ER. While the statute of limitations has expired on criminal charges, officials said they continue to explore how to hold this company, and others, accountable.

‘…ill-gotten gains’

New Jersey is seeking unspecified penalties and damages and has called for the company to “disgorge its ill-gotten gains,” or profits from the drugs, which were sold between 2009 and 2015, when Janssen sold the rights to another pharmaceutical company for $1.05 billion. The state has spent more than $13 million on claims for these medications alone since then, for public employees and Medicaid patients, officials said.

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“Janssen helped fuel a public health crisis unlike any other our state has faced,” Attorney General Gurbir S. Grewal said, noting that New Jersey is on track to lose some 3,000 residents to drug-related deaths this year.

“It is particularly disturbing that so much of this misconduct took place in our own backyard,” Grewal continued, in a state considered the home of the pharmaceutical industry and the source of so many life-saving medical treatments.

“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,” he said.

Even international drug giant Johnson & Johnson, one of the first names in New Jersey pharmaceuticals, is not beyond reproach, Grewal noted. The 132-year-old company, based in New Brunswick, was ranked 37th on the Forbes 500 list of the nation’s largest companies this year and employs more than 130,000 people worldwide; Janssen, based in Raritan, has 35,000 workers in sites around the globe.

‘Baseless and unsubstantiated’

In a response to the civil suit, Janssen said its practices were appropriate and dismissed the state’s charges. It also claimed its medications have some of the lowest rates of abuse for these types of drugs.

“Our actions in the marketing and promotion of these medicines were appropriate and responsible. The labels for our prescription opioid pain medicines provide information about their risks and benefits, and the allegations made against our company are baseless and unsubstantiated,” the company said. “Opioid abuse and addiction are serious public health issues. We are committed to being part of the ongoing dialogue and to doing our part to find ways to address this crisis.”

While opioid prescriptions are now declining, more than 2,000 New Jersey residents died of drug-related deaths in 2016, according to state data, including some 1,400 that involved opioids. Grewal said, based on population, that death rate is 20 percent higher than the national average and it has increased more than 300 percent since 1999. Tens of thousands of other New Jerseyans seek treatment annually, and scores more don’t get the help they need.

High cost of opioid epidemic

The cost of the opioid epidemic is significant in many ways, said Grewal, who has worked with others in the administration of Gov. Phil Murphy to find new ways to address the crisis, including expanding a partnership between addiction providers and law enforcement to help nonviolent drug offenders connect with treatment. In addition to the deaths, there is the toll of lost work hours and missed productivity among those who became addicted, and the price of the claims themselves.

New Jersey spent $183 million on all opioid-related health and workers’ compensation claims for public workers since 2010, and more than $106 million for opioid prescriptions for Medicaid members in the state’s largest managed care plan; more than $13 million of this was for Nucynta products, according to the lawsuit.

State officials have already filed or joined multi-state lawsuits against a number of opioid-making pharmaceutical companies — including Purdue Pharma, which makes OxyContin, a popular opioid that has triggered a backlash nationwide — but this is the first time they have targeted a New Jersey-based drug maker.

While Nucynta isn’t used as widely as some other brands, Grewal said the state should not ignore the damage done by Janssen in pushing these pills. Janssen “took a page right out of the Purdue playbook,” he said.

Heavily redacted

The 97-page lawsuit — based on internal company documents and an ongoing investigation — details the state’s allegations, but reveals little about Janssen’s specific efforts, given the heavy redaction demanded by the company. Heavy black lines appear over sections of the document that explain what kind of money, staff and other resources Janssen committed to marketing these drugs, the company’s goals in this promotion, and its awareness of the dangers involved.

The state is requesting the court lift these restrictions and is asking Janssen not to oppose this release. “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,” Grewal said.

According to the lawsuit, Janssen relied heavily on limited pre-clinical data on the drugs to improperly claim they behaved differently from other opioids, a fact that was not proven in the research. But promotional materials relied on these initial findings to claim Nucynta was safer, milder and less addictive than similar products, and, as such, less likely to be diverted for illegal use.

“There were no valid clinical studies to prove their claims,” said Paul R. Rodriguez, the acting director of the Division of Consumer Affairs, which is part of the Attorney General’s Office. The company also promoted debunked theories, like “pseudo-addiction,” in an effort to increase prescribing, he said.

Nucynta and Nucynta ER

Sales staff from Janssen told doctors Nucynta (approved in 2008) and Nucynta ER, or extended-release (which followed in 2011), were more appropriate for patients with long-term pain than other opioids, the lawsuit states. Nucynta could serve as a safe next step from over-the-counter medicines, the sales staff said, and the company exaggerated the dangers involved with painkillers like aspirin or ibuprofen, which are not strictly controlled like opioids, the suit maintains.

Janssen also funded studies to emphasize the drug’s safety and promotional speeches by healthcare professionals, and paid doctors in New Jersey and elsewhere to encourage prescription of Nucynta; a West Orange physician collected $16,000 over two years, the suit alleges. Sales staffers were paid bonuses of up to $20,000 a quarter for their role in expanding its use.

State says Janssen used "unbranded" websites like PrescribeResponsibly
It also relied on “unbranded” websites and other outreach in which the drugs, and opioid use in general, were promoted through apparently unrelated organizations, according to the filing. One site, — which is still active — targets doctors, including those treating older adults, while the “Let’s Talk Pain” coalition and its website sought to diminish concerns about opioids among the public.

Grewal and Rodriguez lamented how the company specifically targeted elderly residents, a group that is particularly vulnerable to the side effects of opioids — and potentially fatal related risks, like falls — and less likely to understand the dangers involved, according to the lawsuit. “Janssen’s decision to target elderly and opioid-naive patients reflects a business strategy that placed too little value on the wellbeing and safety of consumers,” the claim states.