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Tuesday, October 22, 2019

Okla. health official takes stand in opioid trial, says she doesn't remember the year J&J's unbranded marketing began


By John Sammon | Jun 26, 2019

Cleveland County Courthouse

NORMAN, Okla. (Legal Newsline) – Oklahoma's top health officer told a courtroom on Tuesday that Johnson & Johnson preyed on the state’s citizens to sell opioid prescription drugs for profit, while attorneys for the company challenged the timeline in her head.

Terri L. White, commissioner of the Oklahoma Dept. of Mental Health and Substance Abuse Services, had nothing complimentary to say of the company during her Tuesday testimony in the trial of Oklahoma's lawsuit against the company.

Under cross-examination, Steve Brody, the attorney for Johnson & Johnson appeared to continue the defense's contentions that the danger of abusing opioid drugs was well-known and warned about in product labeling and that the process of making the drugs available through prescriptions was regulated by government agencies. 

He asked White if prescription monitoring by the state through the Oklahoma State Bureau of Narcotics had taken place as far back as 1990 under a program called OSTAR, the nation's first electronic prescription tracking system (later called the Prescription Monitoring Program PMP).

“There was a PMP system since 1990, yes,” White said.

“The problem with diversion of schedule II drugs was a problem going back to 1990, correct?” Brody asked.

“That’s what this (document) says,” White responded.

Brody challenged White’s assertion that an unbranded campaign advertising Johnson & Johnson opioids took place in the late 1990s.

“You understand the unbranded marketing materials produced by Janssen were created at the end of the last decade (2009) at the time of the release of Nucynta (pill).”

“It was at the beginning of the opioid crisis - I do not remember the year,” White said.

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.

White and Jessica Hawkins, prevention services senior director for the Oklahoma Dept. of Mental Health, developed an abatement plan that will take an estimated 30 years to reduce the opioid crisis to pre-1996 levels at a cost of $17.5 billion.

Hawkins appeared on Monday to walk the court through the costs and services of each proposal including 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.

Under the plan Johnson & Johnson and Janssen would pay for the abatement improvements.

“Should the taxpayers pay?” asked Reggie Whitten, the state-hired attorney.

“Absolutely not,” White said. “The defendants (J&J) created the crisis.”

White, who leads a team of 1,800 employees at the Dept. of Mental Health with an overall budget of $600 million, said the plan would save the taxpayers money and cost less than incarcerating the drug-addicted.

“Johnson and Johnson decided to prey on a vulnerable population,” she said. “They (J&J) targeted high-risk users. They unleashed bombs in the center of our country (Oklahoma). The thing that I’m offended by the most, they (J&J) are saying that the addicted are bad people.”

White said 6,137 Oklahomans died because of overdose from opioid drugs representing 139,359 lost years of potential life.

White said she and staff realized the seriousness of the problem when the number of deaths from opioid overdose exceeded those from statewide car crashes.

“Car crashes for decades were the No. 1 killer,” she said. “We knew we had a crisis.”

Whitten exhibited a chart that showed visits by sales representatives from Janssen to doctors peaking at 20,933 visits in 2005 and 18,388 in 2012, up from 2,024 visits in 1998. He said the rise was parallel to the number of opioid deaths in the state.

“Deaths go up parallel to sales?” Whitten asked.

“Yes,” White said.

“Are they linked?”

“It is not a coincidence,” White responded. "These are causally linked.”

Whitten asked White for the root cause of the problem.

“Over-supply,” White said. “The rapid increase in opioid prescriptions.”

“Do you agree that false marketing caused it?” Whitten asked.

“Yes,” White answered. “I saw sales materials that said start with and stay with (opioids) and there was a low potential for abuse. It was false and misleading.”

“You heard testimony that Johnson & Johnson had zero responsibility,” Whitten said.

“It’s absolutely incorrect,” White said. “That has been one of the most difficult things to swallow.”

Brody, J&J's lawyer, exhibited a document from the early 2000s that identified current trends in the use of OxyContin in which it stated the under-treatment of pain was a serious problem in the U.S. and that opioids provide significant relief. Nevertheless, the advisory document concluded, in spite or regulatory controls diversion, illicit use continued to be a problem.

Brody asked White if she was suggesting that the Oklahoma Drug Utilization Review Board, an advisory board for Medicaid recipients, had been improperly influenced by a non-voting board member representing PhRMA, the Pharmaceutical Research and Manufacturers of America.

“I’m suggesting Johnson & Johnson in its participation on PhRMA attempted to influence state agencies,” White told Brody. “You (J&J) influenced through multiple ways saying we need to provide opioids, that opioids are low risk. You duped the people of Oklahoma and influenced Oklahoma’s over-supply problem.”

Brody exhibited a chart that showed the number of illegal methamphetamine labs discovered by officers of the Oklahoma Bureau of Narcotics and Dangerous Drugs Control also rose with 1,254 labs seized in 2002.  

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Johnson & Johnson Oklahoma Attorney General's Office Purdue Pharma L.P

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