Litigation

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.

You can find our recent statement on the Oklahoma Court ruling by clicking here.

Our Position

We firmly believe that the claims against us hold no merit.

We are parents, grandparents, children, and siblings, and we care deeply about the people that we serve and products that we make. We know that opioid abuse is a serious public health issue, and we remain committed to being a part of meaningful community-level solutions. We also know that we responsibly provided needed treatment options to physicians for their patients suffering from serious, long-term pain. Our Schedule II medicines had low rates of abuse, and we have appropriately and responsibly worked with regulators to prevent diversion and abuse of our opioid medicines (review the information here).

Since launch, our prescription opioid medicines – DURAGESIC® (fentanyl transdermal system), CII, NUCYNTA® and NUCYNTA® ER (tapentadol) tablets, CII – represented less than one percent of total opioid prescriptions in the United States. Additionally, we stopped promoting DURAGESIC® (fentanyl transdermal system), CII in April 2008 and sold our rights to NUCYNTA® and NUCYNTA® ER (tapentadol) tablets, CII in April 2015.1

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 – everything you’d expect a responsible company to do.

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 recognize the opioid crisis is a tremendously complex public health issue and we have deep sympathy for everyone affected. Janssen did not cause the opioid crisis. We responsibly provided needed treatment options to physicians for their patients suffering from serious, long-term pain. Since launch, our medicines, DURAGESIC®, NUCYNTA® and NUCYNTA® ER, have accounted for less than one percent of total opioid prescriptions in the United States.

The opioid crisis is a complex public health issue that demands a public health response, and we continue to collaborate to help patients, families and communities in need.

INSIDE THE COURTROOM

The first state trial related to these claims began on May 28, 2019 in the State District Court of Cleveland County, Oklahoma. A judgment was rendered on August 26, 2019. See our press release on this decision here.

The first trial scheduled in the federal multi-district litigation (MDL) pending before U.S. District Judge Dan Polster in the United States District Court for the Northern District of Ohio is scheduled to commence in October 2019.

The court has ordered all parties to attend confidential mediation sessions. We are not permitted to share the substance of those discussions.

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.

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.

References

  1. 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
  2. Manufacturers Notice of Registration – 2015. Diversion Control Division. https://www.deadiversion.usdoj.gov/fed_regs/manufact/reg/2015/fr0930_2.htm
  3. Smart Moves, Smart Choices: Learn About Teen Prescription (Rx) Drug Abuse http://smartmovessmartchoices.org/

Disclaimer:

*Johnson & Johnson and its subsidiary Janssen Pharmaceuticals, Inc. are publicly presenting on this website documents provided that have been disclosed as part of ongoing discovery in this litigation. Documents shared here are not confidential or have been released by the court as part of ongoing litigation. This website will be periodically updated.

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