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Saturday, August 24, 2019

In high-profile opioid trial, Johnson & Johnson reminds that its addiction warnings were approved by the FDA

Lawsuits

By John Sammon | Jun 5, 2019


Cleveland County Courthouse

NORMAN, Okla. (Legal Newsline) – Defense attorneys for Johnson & Johnson took over the questioning of Kimberly Deem-Eshleman, southeast regional business director for Janssen Pharmaceuticals and the marketer of its opioid drug Nucynta, attempting to establish that drugs had plenty of warnings about possible addiction.

“It’s very important - the black box warning (on the drug package),” Deem-Eshleman said. “It’s the FDA’s (Food and Drug Administration’s) way of telling the clinician that there are key risks that prescribers need to be aware of.” 

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

The suit launched by Oklahoma Attorney General Mike Hunter is one of more than a thousand around the country that alleges that J&J and Janssen (and other opioid makers and distributors) carried out a fraudulent advertising campaign to over-supply opiates around the country for profit, leading to an epidemic Hunter called the worst in the state's history. J&J's opioid products are Duragesic, which dispenses opioids by the use of a timed-release patch, and a pill called Nucynta.

It's 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. An Oklahoma law professor recently told Legal Newsline that use of the public nuisance claim is improper and that Hunter's case is really a products liability case.

Two other co-defendant pharmaceutical companies, Purdue and Teva Pharmaceutical based in Israel, 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 representing the State 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.

Deem-Eshleman was questioned by attorneys for the State of Oklahoma for three days earlier this week who attempted to portray Johnson & Johnson as a company more interested in profiting off the drug industry with new brands of opioids than it was with an overdose epidemic it helped to create.

During Tuesday’s session, Larry Ottaway - the attorney for Johnson & Johnson with the firm of Foliart, Huff, Ottaway & Bottom of Oklahoma City - exhibited warning labels on the drug products that urged caution and monitoring of patients during use.

“Duragesic should only be used in patients who are opioid tolerant,” a warning label read. “The drug can be abused, the risk should be considered.”

The warning label pinpointed potential problems for users with family histories of abuse, mental illness, drug and alcohol problems and other conditions.

“Patients should be accessed and carefully monitored,” the Duragesic label advised. "The drug can lead to overdose and death."

The label for Nucynta carried similar warnings.

Duragesic uses a substance called “fentanyl,” 100 times more potent than morphine and 50 times more potent than heroin according to Medical News Today. The warning label described it as an opioid of the morphine type and that such drugs are sought by drug abusers.

“The FDA approved the labels and the (drug) instructions on every prescription,” Deem-Eshleman said.

Nucynta’s label said the drug was to be used for relief of moderate to severe and acute pain.

Deem-Eshleman added that warning labels would be used to inform doctors, prescribers, consumers and end-users.

“Every time there is a change to a (warning) label a letter goes to the doctor telling them about the change,” she noted.

Deem-Eshleman said possible changes reported could include how to deal with damaged or cut (drug) patches, chemical interactions with other drugs or alcohol and other issues. She added the audience for such messaging includes in addition to prescribers, insurance companies and payers of drugs.

Sales reps are used to present to the clients the risks and the benefits of the drugs, she added.

“Now they (reps) use I-pads and technology,” Deem Eshleman said. “We have dose guides and doctors can refer to them when making a decision to proscribe a medication.”

The reps also leave behind reminders of the sales calls leaving with the doctor a pen or magnet with the name Duragesic on them, also an FDA label and proscribing information.

“Vendors create these materials,” Deem-Eshleman said.

The pain-relieving benefits touted in the drug literature included “efficiency, duration, safety, flexibility, history, confidence.”

In 2004 the FDA sent Janssen a warning letter accusing the company of making misleading statements about Duragesic, by saying the drug had a “low abuse potential.”

Janssen officials sent a response saying they “respectfully disagreed” with the FDA assertions. Deem-Eshleman said the company made an action plan in response to the FDA letter.

“We discontinued use of the promotional materials and sent a 'dear doctor' letter to doctors,” she said. “This is an update to labels about changes in promotional activities, an alert.” 

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Organizations in this Story

Johnson & Johnson Nix, Patterson & Roach Oklahoma Attorney General's Office Purdue Pharma L.P

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