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• Government Actions:

  State Complaint
  

  The following describes a pending government action that has been formally brought by a government agency but has not yet been resolved. We are providing a summary of the governments allegations, which have not yet been proven.

  TRENTON – Attorney General Gurbir S. Grewal announced October 13, 2018  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 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. Attorney General Grewal called on Janssen to allow the public to read the full, unredacted complaint.

  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.

   

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• Government Actions:

  Texas Attorney General Civil Medicaid Fraud Lawsuit
  

  The following describes a pending government action that has been formally brought by a government agency but has not yet been resolved. We are providing a summary of the governments allegations, which have not yet been proven.

  On September 4, 2019, Texas Attorney General Ken Paxton announced that his office filed a civil Medicaid fraud lawsuit against pharmaceutical manufacturer Johnson & Johnson, and its subsidiary Janssen Pharmaceuticals, Inc., for misrepresentations made to the Texas Medicaid program about their opioid drug, Duragesic.

  The State alleges the companies directed their sales representatives to deliver false and misleading messages about their fentanyl opioid drug to doctors in Texas, including Medicaid doctors. Sales representatives told doctors Duragesic had fewer side effects, worked better, and posed less risk of addiction than other opioids, despite FDA reprimands that the claims were false and misleading. As a result of these alleged misrepresentations, Johnson & Johnson obtained the benefit of taxpayer-funded Texas Medicaid reimbursement for Duragesic.

  The matter is pending.

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