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Tuesday, October 22, 2019

Attorneys for J&J spar with opioids researcher over warning labels during Oklahoma trial


By John Sammon | Jun 17, 2019

Cleveland County Courthouse

NORMAN, Okla. (Legal Newsline) – Attorneys for Johnson & Johnson on Friday during questioning of a researcher called as a witness by the State attempted to establish that the company’s production of opioid drugs was a government-regulated process with detailed warnings of possible addiction provided.

A portion of a warning approved by the Food and Drug Administration (FDA) stated; “Opioids can be extremely dangerous, but studies have shown that taken as prescribed, rarely cause addiction.”

“Is that correct?” asked Michael Yoder the attorney for Johnson & Johnson.

“That’s what the document says,” answered Dr. Andrew Kolodny, co-director of Opioid Policy Research for the Brandeis University Heller School for Social Policy and Management in Massachusetts.

Kolodny claims opioid drug companies helped fund pain organizations and influenced leaders to form an "Opioid Mafia."  

The trial in the Cleveland Country District Court is being streamed live courtesy of Courtroom View Network.

Kolodny, considered a leading advocate for reform in the prescribing of opioid drugs, appeared for a second day of questioning by Johnson & Johnson attorneys after testifying for State-hired attorneys earlier this week.

Oklahoma Attorney General Mike Hunter alleges that J&J and its prescription drug subsidiary Janssen Pharmaceuticals carried out a fraudulent advertising campaign to over-supply opiates in Oklahoma for profits leading to an epidemic Hunter called the worst in the state's history. J&J's opioid brands are Duragesic, which dispenses opioids by the use of a timed-release patch, and a pill called Nucynta.

Thousands of cases are still pending around the country and the Oklahoma case is being followed nationwide. It's also the first opioid trial under the "public nuisance" legal theory, attempting to hold pharmaceutical companies, distributors and pharmacies liable for the nation's addiction crisis. Critics of the nuisance claim say the state’s case is in reality a products liability case.

Two other co-defendant pharmaceutical companies, Purdue Pharma of Connecticut and Teva Pharmaceutical based in Israel, earlier settled with Oklahoma, $270 million from Purdue and $85 million from Teva. That left J&J (and Janssen) as sole defendants in the case.

In the Purdue Pharma settlement, private attorneys took in $60 million, while about $200 million went to a research project at Oklahoma State University, which is Hunter's alma mater.

Purdue officials pleaded guilty in 2007 of misleading the public about the risk of addiction from their opioid pain killer OxyContin and agreed to pay $600 million, at the time one of the largest pharmaceutical settlements in U.S. history.

Yoder questioned Kolodny about his qualifications.

“You’re not a pain management doctor, correct?”

“That’s correct,” Kolodny said.

“Are you a pain treatment specialist?”


“Was it 10 years ago you last prescribed for pain?”


Kolodny agreed labels on opioid drugs warned about possible misuse. He said he did not like the designation “drug abuser.” Instead in many cases, he said these were people who were addicted and maintaining their supply of drugs.

A Nucynta label from 2008 warned, “abuse potential” and “life threatening,” while another label exhibited stated, “sought by abusers and subject to criminal diversion, concerns about abuse, addiction.”

A label for Duragesic warned “tolerance, physical and psychological dependence may develop upon repeated administration of opioids.”

“Do you agree that iatrogenic (treatment-caused) addiction is relatively rare?” Yoder asked.

“We know for a fact that iatrogenic addiction is not rare,” Kolodny said.

“Words are important,” Yoder said

“Yes,” Kolodny agreed.

Kolodny said the use of prescription drug monitoring programs (PDMP’s), databases run by states to monitor drug use, were one of the best tools to combat the drug epidemic.

“I believe a physician well-informed about the risks and who has an understanding of the patient should make the clinical decisions,” Kolodny said.

“The decision of (opioid) dosage is best made by the treating physician?” Yoder asked.

“Yes,” Kolodny said.

However, Kolodny expressed concern about long-term dosage that would go beyond 90 days and a daily maximum dose of 90 mme (morphine milligram equivalent).

“I can’t see outside of palliative (life-threatened) care that the benefits outweigh the risks,” he said.

An organization Kolodny helped to found called Physicians for Responsible Opioid Prescribing (PROP) in 2013 asked the FDA to strengthen the warnings on drug labels.

“The FDA declined,” Yoder said.

“Yes, but I believe they (FDA) will move in that direction,” Kolodny said.

Yoder asked Kolodny about prescription guidelines to physicians written by the Oklahoma Health Care Authority. Janssen was listed at the bottom of a document as a contributor to the project.

Kolodny told Yoder that “risk tools” listed in the guidelines fell short and would not be effective in predicting addiction.

“The risk tools don’t do what we wish,” he said.

Kolodny added that misinformation by the drug companies in the past had been widely disseminated.

“My view is that the opioid manufacturers have had a pervasive influence for a long time,” he said.

Johnson & Johnson’s product Nucynta was a trade (brand) name for the opioid substance tapentadol.

“It (Nucynta) allowed pain relief with a lower dose of opioid?” Yoder asked.

“That claim was made by Johnson & Johnson, but it was not widely accepted,” Kolodny said.

Yoder said the pill was hard to crush for the purposes of snorting the drug.

“It makes it harder to snort or inject,” Kolodny agreed.

Yoder asked Kolodny if the Duragesic patch (timed-release opioid) could be a benefit to a patient.

“I can think of where it might be helpful,” Kolodny said.

“To some patients, opioids are essential,” Yoder said.

“Sometimes opioids are essential medications,” Kolodny said.

Yoder exhibited a chart that showed unintentional deaths from opioid overdose peaking in the year 2009.

The Nucynta (pill) went on the market in 2009.

“Would you agree that Janssen in the sale and marketing of Nucynta and Nucynta-ER (extended release) did not cause a substantial increase in overdose deaths up through 2009?” Yoder asked.

“Yes,” Kolodny said.

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