NORMAN, Okla. (Legal Newsline) - Attorneys defending Johnson & Johnson made a case on Wednesday that drug abusers and irresponsible doctors share responsibility for an opioid overdose epidemic, while a top state health official repeated her opinion that overzealous J&J officials and sales reps were to blame.
A list of reimbursement claims for the year 2007 from the Oklahoma Health Care Authority was exhibited that showed 8,837 claims in a six-month period made for the drug OxyContin, and 57 claims for Duragesic.
“Is 57 too many?” asked Steve Brody the attorney for J&J.
“Do I think we had an over-supply (of opioid drugs), yes,” said Terri L. White, commissioner of the Oklahoma Dept. of Mental Health and Substance Abuse Services.
“Is 8,837 OxyContin (prescriptions) too many?” Brody asked.
“It seems like a high number,” White said. “I’m saying that 8,837 is an over-supply that far exceeds 1996 levels.”
The trial in the Cleveland County District Court is being streamed live courtesy of Courtroom View Network.
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.
Earlier in the week, Jessica Hawkins, prevention services senior director for the Oklahoma Mental Health Dept. unveiled an abatement plan that would take 30 years to implement at a cost of $17.5 billion. The plan would include university drug screening, adult treatment services, prenatal screening, K-12 school education, addiction helpline, drug disposal, support services and expansion of family courts among others.
State officials want Johnson & Johnson and Janssen to pay the cost and not taxpayers, contending it was the company that caused the opioid crisis.
White appeared for a second day of questioning by J&J attorneys about the abatement plan.
As he had done the day before, Brody continued to press White for an answer on how low opioid prescription use has to go for the epidemic to be abated.
“How many (prescriptions) is too many?” he asked.
“I don’t have an exact number,” White responded. “We have too many.”
Brody exhibited an email from state narcotics officials to the Attorney General's Office warning in 2008 that some patients were seeing 10 or more doctors, in some cases as many as 66, to get medications for an addiction.
“This is an indication of over-supply,” White said.
Brody countered this was before a prescription monitoring program (PMP) became a state requirement.
Another advisory document stated that 87,000 Oklahomans routinely obtained controlled (prescribed) drugs from the medical community and then sold the drugs or used them for purposes other than intended.
Brody exhibited reports issued by narcotics authorities about doctors irresponsibly proscribing opioids. One dated from 2010 involved a complaint from a woman whose son died from an overdose.
“Did the state inform Janssen about these complaints?” Brody asked.
“I don’t know,” White said.
In another case an investigator for the state obtained medical records from a physician suspected of over-prescribing opioids.
“Did the board (Drug Utilization Review Board) advise Janssen?” Brody asked.
“I don’t know,” White said.
The DUR report on the case found that the doctor was over-prescribing up to 500 (opioid) tablets every four weeks with no discussion of the hazards.
“I find it appalling,” the narcotics investigator concluded in the written report, “that a 22-year-old went from 15 tabs of Lortab to 480 (meds) in four months with no reason.”
Brody asked White if in forming her opinions about the cause of the drug crisis, she looked into misconduct by physicians and suspensions of licenses along with penalties. White answered she was aware some physicians were being pursued by the Attorney General’s Office and narcotics officials.
In yet another case, a doctor was investigated by an undercover agent who made an appointment and brought no medical records with him. A cursory examination was given and later the disguised agent was prescribed opioids on multiple occasions with no records or exam.
“Did they notify Janssen?” Brody asked.
“I do not know if they (state officials) chose to let Janssen know about the undercover operation,” White said.
One doctor not only over-prescribed drugs but also prescribed them for his own use.
White said her office was not notified about such unprofessional conduct at the time and did not know the doctor in question had been targeted by Janssen sales reps as a prime candidate to push more opioids.
“He (doctor) was an important target,” she said.
White said she was very upset that Janssen reps had tried to convince doctors that opioids were safe including prescriptions for pregnant mothers. In earlier testimony she had cited neonatal abstinence syndrome, withdrawal symptoms inherited by a child from a drug-using mother, as a major component of the crisis.
“I believe that Johnson & Johnson and Janssen created the belief and the perception among Oklahomans and Oklahoma physicians that conditions like this (pregnancy) were an under-treated and untreated pain, and we've heard testimony on the effect that has had on pregnant women," White said.
Brody asked for specifics.
“Sitting here you can’t point to anything can you?” he asked.
“I can’t at this minute,” White said.
Brody exhibited a chart that reported 231 claims for prescriptions of Nucynta in 2014. He again asked White if this was a high number.
"I take it from your testimony this is not about Janssen drugs is it?" he asked.
"It's absolutely about Janssen drugs," White said. "If I haven't been clear let me be clear."
White added that Janssen had been involved in the production of drugs including hydrocodone, oxycodone, morphine and Nucynta.
"Absolutely there was an over-supply," she said.
Reggie Whitten, the state-hired attorney, asked White if in hiring sales reps, Janssen would expect sales of opioid drugs to go up.
"Yes," White said. "I think they (J&J) are trying to minimize what they've done."
White said an un-branded campaign is promoting a type of drug without mentioning a brand name to prepare the way for later sales when a particular name brand is released on the market.
"They hope it will raise product sales," she said.
Whitten exhibited a chart that showed the doctor Brody had mentioned who got in trouble for over-proscribing opioid drugs had been visited 80 times by (J&J) sales reps between 2009 and 2014.