Johnson & Johnson opioid ruling explained – the key points

By Chris McGreal in Washington

Mon 26 Aug 2019 21.08 EDT

An Oklahoma judge has ordered Johnson & Johnson to pay $572m for its role in driving Oklahoma’s opioid epidemic. The landmark ruling will have wide-ranging consequences for the other opioid makers, distributors and pharmacy chains facing thousands of lawsuits across the country.

Judge Thad Balkman determined that Johnson & Johnson ran a “false and dangerous” sales campaign that led to addiction and death in the state, as well as helping to fuel the worst drug epidemic in US history. These are the key points from his damning 42-page decision.

“The Defendants, acting in concert with others, embarked on a major campaign in which they used branded and unbranded marketing to disseminate the messages that pain was under-treated and ‘there was a low risk of abuse and a low danger’ of prescribing opioids”.

This is the core of the judge’s finding. By “branded” he means efforts by Johnson & Johnson’s sales reps to sell its own drugs, often by persuading doctors to prescribe them with claims that they carried little risk of addiction and were effective for long term treatment of chronic pain. The judge said these claims were “unsupported by any high quality evidence”. Alongside this was the hugely successful “unbranded” campaign in concert with other drug makers to influence medical practice and government regulators to escalate opioid prescribing, and therefore sales, in general.

“A key element in Defendants’ opioid marketing strategy to overcome barriers to liberal opioid prescribing was its promotion of the concept that chronic pain was under-treated (creating a problem) and increased opioid prescribing was the solution.”

The judge said this contributed to an oversupply of opioids because of increased prescribing, which caused addiction and deaths.

“False, misleading, and dangerous marketing campaigns have caused exponentially increasing rates of addiction, overdose deaths.”

The judge found that Johnson & Johnson took distorted or discredited claims of a very low addiction rate from opioid painkillers and presented them to doctors as proof of the drugs’ safety.

“In 2001, Defendants were advised by Defendants’ own hired scientific advisory board that many of the primary marketing messages Defendants used to promote opioids in general, and Duragesic [the company’s high-strength drug] specifically, were misleading and should not be disseminated.”

The court found that Johnson & Johnson was repeatedly warned that its sales materials for its high-strength drug Duragesic were misleading at best. The warnings came not only from its own advisory board but the Food and Drug Administration (FDA). The company adapted some of the materials but maintained the central thrust of its sales pitch: that its opioids were effective, safe and could be widely prescribed without significant risk of addiction.

“Defendants made substantial payments of money to a variety of different pain advocacy groups and organizations that influences prescribing physicians and other health care professionals.”

Johnson & Johnson, with other drug makers, funded professional organizations such as the American Pain Society to reassure doctors that opioids were safe and effective. These organizations played a leading role in the promotion of “pain as the fifth vital sign” which led to regulations that caused hospitals and clinics to emphasize pain treatment and resulted in the use of opioids as the default medication.

“Defendants additionally executed their strategy of targeting high-opioid-prescribing physicians in Oklahoma, including doctors who ultimately faced disciplinary proceedings or criminal prosecution.”

Johnson & Johnson representatives focussed their sales efforts on doctors already prescribing opioids, particularly OxyContin manufactured by rival Purdue Pharma.

“Defendants did not train their sales representatives regarding red flags that could indicate a ‘pill mill’, including, for example, pain clinics with patients lined up out the door or patients passed out in the waiting room.”

Although Johnson & Johnson representatives were trained to pressure doctors to increase opioid prescribing by allaying their concerns about addiction, the company’s sales force was not trained to spot doctors or clinics where unusually large numbers of opioids were prescribed.


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