Legal Newsline

Friday, December 13, 2019

Oklahoma making its case in big opioid trial with director of Kentucky pain clinic

By John Sammon | Jun 7, 2019

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NORMAN, Okla. (Legal Newsline) – The director of a Kentucky pain clinic on Thursday told attorneys for the State of Oklahoma that pharmaceutical companies like Janssen, the drug division of Johnson & Johnson, organized a campaign of misinformation to sell opioids and make money.

“The pharmaceutical companies have influence,” said Dr. Danesh Mazloomdoost, director of the Wellward Regenerative Medicine clinic in Lexington. “They talk about things like how to identify risky patients, but not alternatives (to opioids).”

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

The State of Oklahoma, through private lawyers hired by Attorney General Mike Hunter on a contingency fee, sued Johnson & Johnson and Janssen claiming that the company’s aggressive marketing of opioid drugs as pain killers fueled an overdose epidemic Hunter called the worst in the state’s history.

Attorneys defending Johnson & Johnson contend the company was responding to a need for sufferers of chronic pain and that warnings about potential addiction were clearly provided with the products.

Thousands of cases are still pending around the country and the precedent-setting Oklahoma case is being closely 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 and Teva Pharmaceutical, recently 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 OxyContin and agreed to pay $600 million, at the time one of the largest pharmaceutical settlements in U.S. history.

The trial is expected to take at least a month.

J&J's opioid products are Nucynta and Duragesic, which dispenses opioids by the use of a timed-release patch.

Trey Duck with the Austin, Texas-based law firm of Nix Patterson, attorneys hired by the state, asked Mazloomdoost if he ever heard J&J officials discuss alternatives to using opioid drugs, for example, using better nutrition to help alleviate pain instead of pills.

“No sir,”  Mazloomdoost answered.

“Were they (drug companies) divorced from opioids?”

“No sir.”

Duck exhibited a CME (Continuing Medical Education) brochure advertising a multi-media presentation for doctors on the subject of appropriate opioid therapy, funded by a grant from Janssen and featuring a photo of a lion.

Mazloomdoost called it ironic for the advertising of Nucynta to use a logo with a lion.

“Their marketing is like the roar of a lion,” he said.

Mazloomdoost indicated the brochure amounted to a form of influence-peddling for doctors.

 “It sets up a pedestal that tells them (doctors) they will be esteemed if they learn this," he said.

Mazloomdoost said there are alternatives to manage pain other than using addictive opioids.

“They (pharmaceutical companies) are saying the patients are victims of their own condition,” he said. “They’re saying it’s something that can be fixed with a single pill.”

Mazloomdoost called the drug industry’s characterization that pain was under-treated and its aggressive sales efforts “nefarious.”

He faulted treating doctors to lunches and dinners by drug company sales reps as a way of influencing sales and profits.

“Have you written prescriptions of opioid drugs that you wouldn’t today?” Duck asked.

“Yes sir,” Mazloomdoost said.   

“Do we need to re-educate physicians about the proper use of opioids?” Duck asked.

“Absolutely,” Mazloomdoost said.

Mazloomdoost said alternatives to the use of opioids to alleviate pain can include physical therapy and life-style changes.

“If you’re 40 pounds overweight and your knees hurt, what happens if you lose the wright, your knees hurt less,” he said. 

Mazloomdoost said the use of opiate drugs can discourage the body’s attempts to heal.   

He was asked if the promotional effort of companies like Janssen showed bias toward the use of opioids.

“It absolutely does,” Mazloomdoost said. “It’s real hard to un-learn this, to change course is a lot more difficult. We need to turn this ship around.”

Under cross examination Michael Yoder the attorney for Johnson & Johnson with the law firm of O’ Melveny & Myers in Los Angeles asked Mazloomdoost if he understood not all drug companies were alike.

Mazloomdoost responded that Johnson & Johnson was processing (drug) ingredients for many drug companies.

“Would you agree science changes over time?” Yoder asked.

“Yes,” Mazloomdoost said.

“Pain management science has changed?”

Mazloomdoost said some of the science presented was not legitimate science.

Yoder asked if any of the wording on the CME brochure exhibited for the court had been written by officials of Janssen.

“No, but it was sponsored by Janssen,” Mazloomdoost said.

Yoder asked if there was any evidence officials of Janssen had dictated the written content of such brochures.

“I can’t answer that,” Mazloomdoost said.  

“Do you believe it is the responsibility of the pharmaceutical companies to insure what is taught in medical school is sufficient?” Yoder asked.

“No sir, that’s why I think things like this (brochure) are irresponsible.”

“Have you performed any studies (opioids)?” Yoder asked.

“My focus is on clinical application,” Mazloomdoost answered.

Yoder asked if there was a Risk Evaluation and Mitigation Strategy, a drug safety program called REMS, in place for the drug Duragesic in 2009.

“I don’t know,” Mazloomdoost said.

Mazloomdoost said he had heard a sales rep for Janssen make a false statement about the benefits of using opioids (Nucynta) at a Janssen-sponsored dinner event, stating that its long-term impacts were appropriate for dealing with pain.

“Did you register a complaint?” Yoder asked.

“I didn’t know it was an option,” Mazloomdoost responded.

Yoder said such drugs had been approved by the Food & Drug Administration (FDA) and asked Mazloomdoost if he knew the details of the approval.

“That’s outside my expertise,” Mazloomdoost said.

“You knew that (opioid) drugs are addictive?”

“Yes sir.”

“You know they have to have a warning?”

“Yes sir.”

  

   

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