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Tuesday, October 22, 2019

Researcher touts safety of J&J's opioids at Oklahoma trial

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By John Sammon | Jul 10, 2019

Cleveland County Courthouse

NORMAN, Okla. (Legal Newsline) – A drug researcher on Tuesday told defense attorneys that opioid drugs sold by Janssen Pharmaceuticals are safe for pain relief, and later under questioning by state-hired attorneys declined to describe Oklahoma's situation as an epidemic.

“What does it (study information) tell you about the transdermal patch (Duragesic)?” asked Michael Yoder, the attorney for Johnson & Johnson.

“It works,” answered Dr. Richard De La Garza, professor and director of the research dept. of psychology for the University of Texas M.D. Anderson Cancer Center in Houston.

De La Garza was called as a witness for the defense.

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

Oklahoma Attorney General Mike Hunter is suing Johnson & Johnson and its prescription-drug wing Janssen alleging that the companies 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.

State attorneys said Johnson & Johnson and Janssen should pay $17.5 billion earmarked in a proposed state abatement plan and not taxpayers because the companies caused the epidemic.

During testimony De La Garza said rates of addiction among patients with no prior history of drug abuse who receive opioid treatment are very low.

In one study among 11,882 patients, he said only four cases of addiction resulted while in another study (Cochrane Library Study of 2018), the rate was .27 percent from among approximately 4,800 patients.

“The rates of addiction are quite low,” De La Garza said.

De La Garza also disputed the earlier testimony of Dr. Andrew Kolodny, a major expert witness for the state. Kolodny, a psychiatrist, has played a central role in the State of Oklahoma’s case by linking narcotics marketing to opioid addiction and overdose deaths. He maintained that one in four people (25 percent) using long-term prescription opioids had developed an opioid use disorder (OUD). 

J&J claims Kolodny is a de facto member of Oklahoma's legal team.

"Dr. Kolodny said his views are widely accepted in the scientific community, do you agree?” Yoder asked.

“I certainly do not,” De La Garza responded.

Called a “neuropharmacologist,” De La Garza said his lab studies a variety of drugs from methamphetamine to cocaine, heroin and ecstasy, also opioids. Rodents are used as test animals to see the impacts of narcotics on the brain.

“People who use cocaine will use other drugs,” De La Garza said. “They co-use other drugs including opioids.”

Drugs impact receptors in the front cortex of the brain and release a substance called dopamine, a chemical that stimulates pleasure-seeking behavior.

Duragesic, which uses a fentanyl patch for a timed release, De La Garza said, was preferred over some other orally taken medications.

“It provided better pain relief with less constipation,” he said.

He agreed studies had also shown a low rate of tolerance, or needing more of a prescribed drug over time to get the same benefits.

Yoder exhibited a slide that stated “long-term opioid treatment (for pain) is effective and well-tolerated for moderate to severe chronic pain.”

Yoder asked De La Garza about a letter from the Food and Drug Administration (FDA) in 2004 warning Janssen about marketing statements it was making for its drug products.

“Does this give you concern about (scientific) studies?” Yoder asked.

De La Garza said it did not.

“That (FDA) letter came from their director of marketing,” he said. “It was about verbiage, not the safety and efficacy of the compound.”  

Reggie Whitten, the attorney for the State, asked De La Garza if he ever treated anyone with chronic pain. De La Garza agreed he had not.

“You never conducted your own research on long-term opioid use for pain?” Whitten asked.

“No,” De La Garza said.

Whitten said De La Garza’s opinions were shaped from reading literature.

“No,” De La Garza responded. “From research in the field.”

“You held yourself as an expert on addiction?”


“You don’t believe people with opioid addiction suffer?”

“I would not use that term,” De La Garza said. 

“How can you be an expert if you don’t know that people suffer?”

Defense attorneys objected. The objection was sustained.

“Were articles given to you (to prepare for testifying) by Johnson & Johnson attorneys?” Whitten asked.

“Most were given,” De La Garza agreed.

“You don’t have a clue how Johnson & Johnson sales reps use these articles when they’re out marketing (opioids) to doctors?” Whitten asked.

“I don’t know anything about marketing, I can’t comment,” De La Garza said.

“You don’t think Oklahoma has an opioid crisis or an epidemic,” Whitten said.

“I would not use epidemic,” De La Garza said.

“Do we have an opioid crisis?”

“I’m not sure it’s a specific crisis,” De La Garza said. “It is a public health problem that needs to be addressed. I would not use the word epidemic.”

"Did you know that the Centers for Disease Control (CDC) were first to use epidemic?” Whitten asked.

Whitten exhibited the CDC statement using the word "epidemic."

“That was in 2011 - that is out of date,” De La Garza said.

De La Garza said the problem has lessened the past few years.

Whitten said De La Garza had just used the word "suffering" in making his comments.

“I did?” De La Garza asked.


“Good,” De La Garza said. “You have an influence.”

Whitten exhibited a list of medical influence organizations (nonprofits) that Janssen was associated with. The list included the College on Problems of Drug Dependence, of which he said De La Garza had been president.

De La Garza agreed he had been the organization’s president.

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Organizations in this Story

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

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