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New York files $2 billion lawsuit against J&J for downplaying risks of opioids in its marketing

pharmafile | September 18, 2020 | News story | Medical Communications new york state, opioid crisis 

New York State is suing Johnson & Johnson in a lawsuit seeking $2 billion in damages for the company’s role in the opioid crisis.

The lawsuit targets the opioid medication Duragesic, which is a patch that contains fentanyl which the FDA first approved in 1990. It claimed to relieve pain over the course of 72 hours without the need to keep taking maintenance doses. The label did warn about the high concentration of fentanyl and said Schedule 2 opioids have the highest potential for abuse and fatal overdoses.

Despite the drug’s own warnings, Janssen marketed the drug as having fewer addictive qualities than competitors, citing various different studies and data. One of their primary data sources was the Drug Abuse Warning Network (DAWN). DAWN monitored emergency room visits for overdoses and collected data on which drugs resulted in these overdoses, and Janssen used the low rate of Duragesic overdoses to show the drug was less addictive than others. 

However, the DAWN data did not prove the drug was more or less addictive but simply showed that it was abused less in certain regions. In September 2004, the FDA warned the company to stop using this data to make the claims about the drug’s fewer addictive qualities. 

Another Janssen drug that the lawsuit focuses on is the Schedule 2 opioid Nucynta, a tablet medication containing the synthetic opioid analgesic tapentadol. It was approved by the FDA in 2008 and released the same year. Janssen’s original label stated that it was designed for the relief of moderate to severe acute pain but there is potential for abuse and misuse. Janssen marketed the drug as containing non-opioid qualities creating a misconception that the drug was somehow less severe than other Schedule 2 opioids. Janssen continued the misleading practice of understating the risk of addiction. 

New York Governor Andrew Cuomo commented on the lawsuit, saying: “The opioid crisis has taken too many lives and New York State will continue to take action against those who helped fuel this public health catastrophe and bring a measure of justice to families who have lost loved ones. Misrepresentation of opioids to consumers for profit is inexcusable and we will use every tool necessary to help ensure those responsible are held fully accountable.”

Conor Kavanagh

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