NORMAN , Okla. (Legal Newsline) – On his third day of testimony, an opioids researcher was cross-examined by attorneys for Johnson & Johnson as the company defends itself from allegations that it is to blame for the nation's addiction crisis.
“This was a man-made epidemic,” said Dr. Andrew Kolodny, co-director of Opioid Policy Research for the Brandeis University Heller School for Social Policy and Management in Massachusetts. “We need to counter information as hard as Johnson & Johnson did disseminating misinformation.”
On Thursday, after two days of testifying without facing questions from J&J, Kolodny called the company “the kingpin” in creating the opioid crisis in Oklahoma and elsewhere.
During cross-examination, Michael Yoder, the attorney for Johnson & Johnson with the Newport Beach, Calif. law firm of O’Melveny, took issue with Kolodny’s depiction of Johnson & Johnson as a drug epidemic kingpin. Yoder said J&J’s supplying of materials for use in opioid drugs was highly regulated by government and conducted in a lawful manner.
Yoder asked Judge Thad Balkman for the right to question Kolodny about his knowledge of government regulations controlling opioid drugs.
“He (Kolodny) suggested some sort of impropriety (kingpin remark),” Yoder said.
Balkman declined allowing the introduction of what he indicated would be a new impromptu line of questioning.
Yoder called Kolodny’s closing testimony for Beckworth “quite a speech.”
“How long did you work on it with your lawyers?” Yoder asked.
“Not a lot, I didn’t work on it with lawyers,” Kolodny said.
“You agree that Oxycontin is made by Purdue?”
“Yes,” Kolodny said.
The trial in the Cleveland County District Court is being streamed live courtesy of Courtroom View Network.
Kolodny, considered a leading advocate for reform of opioid prescriptions, spent a third day answering questions from attorneys hired by the State of Oklahoma. Lawyers defending Johnson & Johnson took over cross-examination of Kolodny in the afternoon session.
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.
Kolodny told Brad Beckworth, the state’s attorney, that 500,000 people had lost their lives from opioid overdose. He described a drug company environment in which aggressive sales techniques combined with new marketed opioid drugs and the influence-peddling of front-organizations posing as health advocacy groups rocketed the drug abuse.
One such group was the American Pain Foundation, purportedly an advocacy group to represent pain patients but which Kolodny said was funded by Janssen and which folded operation in 2012 after criticism about its ties to the drug industry. Another group mentioned was the U.S. Pain Foundation.
“Are Johnson & Johnson connected to front groups?” Beckworth asked.
“Yes,” Kolodny responded. “They (J&J) have been a major player like Purdue. I had believed Purdue had been responsible for the lion’s share (misinformation influence). But I think Johnson & Johnson could be even worse.”
Kolodny compared deceptions by the drug industry similar to that of big tobacco companies denying that they manipulated addictive nicotine levels in cigarettes and targeted adolescents as smokers.
Beckworth exhibited a chart that showed states heavily impacted by opioid drug addiction and death (appearing colored in red) early in the epidemic (2000) including Oregon, Florida, New York, Louisiana, Montana. By 2009 virtually the entire country, including Oklahoma, appeared in the red.
Before 1996, estimates said there was one person dead (from overdose) per 100,000 people. By 2009 the figure was 14 deaths per 100,000.
Kolodny said the publishing of articles in medical journals funded and ghost-written by Janssen officials was designed to grow the sales of opioids.
“Was Janssen operating blindly?” Beckworth asked.
“They had a data-driven approach to make the chronic pain market grow,” Kolodny said.
An exhibited company document advised, “Determine which education has the greatest return on investment,” and another stated, “Physicians respond differently (to information).”
“Was Janssen doing this to educate?” Beckworth asked.
“No, to increase profits,” Kolodny said.
Kolodny said one in 15 people who took non-medication prescription opioids would likely take heroin later.
Yoder said a petition from a group Kolodny helped to found called Physicians for Responsible Opioid Prescribing (PROP) had petitioned the Food and Drug Administration (FDA) for changes in marketing opioids.
“It (petition) said long term use (opioids) may be neither safe nor effective, was that the position of PROP?” Yoder asked.
“Correct,” said Kolodny, adding it wasn’t just the position of PROP members, but other scientists as well.
One of the suggested changes in the petition was to strike out the term “moderate pain" for recommended use of the drugs. The petition also asked for limits to the number of days a prescribed drug should be used and for maximum daily dose levels in non-cancer patients.
The FDA, responding to the petition in a letter in September 2013, said that when used properly a drug could alleviate pain and suffering.
Kolodny said he agreed as long as a patient was appropriately selected, or a patient was at the end of life.
“It says pain is a serious growing problem and is inadequately treated, see that?” Yoder asked.
“I see,” Kolodny said.
One estimation reported 50 million adults in the U.S. suffering from chronic pain.
“You would agree it’s a serious issue (pain)?” Yoder asked.
“I would agree,” Kolodny answered.
The FDA response letter stated that the agency, “knows no basis to differentiate between treatment of chronic pain in cancer or in the absence of cancer.”
Kolodny said it would be wrong for a pain advocacy organization to advance a position based on the fact it would be bad financially for the manufacturer of an opioid drug.