We recognize the opioid crisis is a tremendously complex public health issue and we have deep sympathy for everyone affected. We hope the information on this site helps you better understand the importance of the safe use of these prescription medicines, our commitment to the health and well-being of patients everywhere, and why we believe lawsuits are not the way to develop an effective response to this complex public health challenge.
We firmly believe that the claims against us hold no merit.
The plaintiffs’ allegations in these cases generally consist of vague claims with little connection to us or our medicines. Our FDA-approved prescribing information, however, has always provided clear information about the risks and benefits of our medicines, allowing prescribers to make informed decisions about whether to prescribe them to appropriate patients. Likewise, our promotion of those medicines complied with applicable laws and regulations.
Johnson & Johnson has appropriately and responsibly worked with regulators to meet all laws and regulations. We will continue to defend ourselves against these allegations.
Plaintiffs are distorting the role our former affiliates played in the development of opioid pain medicines.
Our former affiliates, Tasmanian Alkaloids and Noramco, produced medical-grade ingredients for prescription opioid medicines. These companies sold these ingredients to third-party pharmaceutical manufacturers, which in turn used them to manufacture prescription opioid medicines. The ingredients were sold only to U.S. Drug Enforcement Administration (DEA)-licensed and approved manufacturers in amounts authorized in quotas established each year by the DEA.2
Importantly, as suppliers, these former affiliates played no role in the manufacturing, sale or marketing of the finished products of other DEA-regulated manufacturers.
At every stage of the supply chain, these companies were governed by and complied with international and federal regulations and quotas. These included importation and manufacturing quotas established by the DEA and FDA.
STATEMENT ON LAWSUITS FROM JANSSEN PHARMACEUTICALS, INC.
We deeply sympathize with those affected by the tragic impact of opioid abuse and addiction, and believe the opioid crisis is a public health issue that requires a public health response. We recently finalized our nationwide settlement with a majority of U.S. states and territories, which will directly support state and local efforts to make meaningful progress in addressing the opioid crisis.
Janssen worked with regulators to provide appropriate information about the risks and benefits of these important prescription pain medications. Additionally, DURAGESIC®, NUCYNTA® and NUCYNTA® ER accounted for less than one percent of total opioid prescriptions in the United States since launch. The Company no longer sells prescription opioid medications in the U.S.
Inside the courtroom
The third state trial related to these claims began on April 4, 2022, in the Circuit Court of Kanawha County, West Virginia. On April 18, 2022, the Company announced a settlement agreement with the State and its participating subdivisions, removing the Company from the ongoing trial. This settlement is not an admission of liability or wrongdoing, and the Company will continue to defend against any litigation that the final agreement does not resolve.
The first state trial related to these claims began on May 28, 2019, in the State District Court of Cleveland County, Oklahoma. An initial judgment was rendered on August 26, 2019. See our press release on the original decision here. On appeal, in November 2021, the Oklahoma State Supreme Court ruled in favor of Johnson & Johnson and its U.S.-based Janssen Pharmaceutical Companies in overturning the trial court’s previous judgment. See our statement on the ruling here. The Court issued its final mandate on December 8, 2021.
The second state trial related to these claims began on April 19, 2021, in the Orange County Superior Court of the State of California. Defendants in this bench trial included Johnson & Johnson, Teva Pharmaceutical Industries Ltd., Endo Health Solutions Inc., and Allergan PLC. In December 2021, the Court issued a final ruling in favor of the defendants, including J&J, finding that Plaintiffs “failed to prove an actionable public nuisance” for which defendants are liable, and found no evidence that statements made by defendants were false or misleading.
Johnson & Johnson and its U.S.-based Janssen Pharmaceutical Companies confirmed in February 2022 that there is a sufficient level of participation to move forward with the nationwide settlement agreement to resolve opioid-related claims and litigation by states, cities, counties, and other subdivisions in the United States. As previously announced, the Company will contribute up to $5 billion to the nationwide settlement, which is designed to directly support state and local efforts to make meaningful progress in addressing the opioid crisis in the United States. The Company reached separate settlement agreements consistent with the framework of the nationwide agreement with the State of New York in June 2021, Texas in October 2021, and Nevada and New Mexico in January 2022, as well as the federally recognized Tribes in February 2022.
Ahead of a trial that was set to begin in October, 2019, we announced a settlement agreement with two Ohio counties, which resolved all of the counties’ claims with no admission of liability and removing Johnson & Johnson and Janssen from the federal trial.
Addressing Important Questions
1. What are our products at issue in this litigation?
Plaintiffs’ claims against us focus on two Schedule II prescription opioid medicines: DURAGESIC®, a fentanyl transdermal patch, and NUCYNTA® and NUCYNTA® ER, tapentadol tablets. The Company no longer sells prescription opioid medications in the United States as part of our ongoing efforts to focus on transformational innovation and serving unmet patient needs.
2. Plaintiffs allege that you marketed directly to consumers to boost sales – how is that any different from other manufacturers’ practices?
Plaintiffs’ allegations are inaccurate. Our marketing and promotion of these medicines was appropriate and responsible. Our aim in unbranded educational materials accessible to patients was to provide them with information about available options for their condition and to enable them to have informed conversations with their doctors about their treatment options. In addition, in collaboration with the National Association of School Nurses, we created and funded two anti-drug abuse programs – Start Smart and Smart Moves Smart Choices – to educate elementary, middle, and high school students, and their parents, about the dangers of prescription drug abuse.3
We have been transparent in how our educational initiatives were developed and funded. We disclosed financial contributions made to support educational initiatives. When opioid medicines were discussed in unbranded materials, they were presented as but one treatment option from which doctors could choose, depending on what the doctor determines is right for his or her particular patient.
- Janssen, Janssen Pharmaceuticals, Inc. Completes Divestiture of U.S. License Rights to NUCYNTA® (tapentadol), NUCYNTA® ER (tapentadol) extended-release tablets and NUCYNTA® (tapentadol) Oral Solution to Depomed, Inc. Johnson and Johnson. https://www.jnj.com/media-center/press-releases/janssen-pharmaceuticals-inc-completes-divestiture-of-us-license-rights-to-nucynta-tapentadol-nucynta-er-tapentadol-extended-release-tablets-and-nucynta-tapentadol-oral-solution-to-depomed-inc
- Manufacturers Notice of Registration – 2015. Diversion Control Division. https://www.deadiversion.usdoj.gov/fed_regs/manufact/reg/2015/fr0930_2.htm
- Smart Moves, Smart Choices: Learn About Teen Prescription (Rx) Drug Abuse http://smartmovessmartchoices.org/