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Wednesday, August 21, 2019

State presses Janssen's business director over sales rep notes as OK opioid trial continues

Opioids

By John Sammon | Jun 3, 2019


Deem-Eshleman and Beckworth

NORMAN (Legal Newsline) – Attorneys representing the State of Oklahoma on Friday displayed slips from salesmen and women representing Johnson & Johnson’s drug subsidiary Janssen Pharmaceuticals in which again and again the reps touted the drug Duragesic as being “low abuse potential.”

“When you over-supply drugs bad things will happen,” said Brad Beckworth the attorney for the state. “You’ve been using (sales) strategies to remove fear in doctors.”

“No,” Kimberly Deem-Eshleman, southeast regional business director for Janssen Pharmaceuticals, disagreed.

Deem-Eshleman said in response several times to similar questions that the reps were “educating” not influencing doctors.

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 alleges that J&J and Janssen 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.

It's the first suit filed by a state under public nuisance legal theory, attempting to hold pharmaceutical companies liable for powerful pain killing drugs that plaintiff attorneys say have destroyed thousands of lives, many of them young users.

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.

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.

 Beckworth asked if sales reps were taught to do right.

“Yes,” Deem-Eshleman said.

Beckworth presented numerous slips from sales reps with notations from the reps summarizing the results of meetings with doctors attempting to interest them in using the company’s drug products. The sales pitches as back-up used the findings of studies from the early 2000s, some funded by J&J.

One sales meeting slip noted, “Had to hold him (doctor) down to show him the study.”

“We believed that was data the medical community wanted to see,” Deem-Eshleman explained.

“It was a drive to prescribe (sell),” Beckworth said.  

“We were trying to educate,” Deem-Eshleman said.

Another sales slip advised “Don’t go over (drug) abuse.”

“This (slip) says, reinforce the consistency Duragesic has compared to other orals (drugs), see that?” Beckworth asked.

“I see that,” Deem-Eshleman said.

On another sales slip dated in 2003 the rep noted a doctor had a patient who couldn’t tolerate Duragesic so, “I asked him to try it again.”

“You talked about younger patients you wanted younger patients?” Beckworth asked.

Deem-Eshleman only agreed the company was a for-profit company.

“The FDA (Food and Drug Administration) is not in the room with the sales rep (selling to doctors),” Beckworth said.

“We do send out materials to the FDA,” Deem Estleman said.

“But you don’t send a script (sales dialog)?”

“No,” Deem-Eshleman said.

Beckworth said the FDA had told J&J not to use the study materials (2003) they said contained information about opioid drugs that was flawed with misrepresentations not supported by evidence.

Deem-Eshleman responded that the studies were informational in nature and were valid peer-reviewed studies.

“We did not agree they were bad science,” she said.

A 2003 sales rep notation read that a doctor had used Duragesic on a patient and the patient had “freaked out.”

“He (doctor) thinks Duragesic is abusable, see that?” Beckworth asked.

“I do,” Deem-Eshleman said.

Another sales slip noted that drug publicity had gotten worse because of conservative talk show host Rush Limbaugh.

“Limbaugh had a problem with OxyContin,” Beckworth said.

“Yes,” Deem-Eshleman said.

Yet another slip noted that a drug user had passed out in a car after injecting Duragesic and was taken to an emergency room at a hospital. “Don’t bring it up unless he (doctor) does,” the notation advised.  

Beckworth asked Deem-Eshleman if a DEA (Drug Enforcement Administration) agent was on the J&J payroll to talk to doctors about the products.

“He (agent) was one of our speakers,” she agreed.

Deem-Eshleman described the speakers the company used to promote its products as “thought leaders.”

“You paid them,” Beckworth said.

“Yes,” Deem-Eshleman said.

“How many mothers who have had children die from opioid addiction have you ever talked to?” Beckworth asked.

“Objection!” defense attorneys called.

The objection was sustained.

On two occasions Beckworth and Deem-Eshleman sparred over defining the strength of the drugs.

“It’s an opioid,” Beckworth said.

“It’s a weak opioid,” Deem-Eshleman countered.

“It’s an opioid,” Beckworth repeated.

Beckworth noted that written comments on the results of sales rep meetings were later scaled back.

“Sales reps came to Oklahoma over 125,000 times (sales calls) and they didn’t have time to write the comments?” he asked.

“We changed the notes system to streamline it after 2008,” Deem-Eshleman explained.

Beckworth exhibited a chart that showed that between the years 1994 and 2016 death rates from opioid overdose went up 14 times over the first year.

Nucynta was prepped for launch on the market in 2008.

A company document was shown that advised pulling in nurses to have discussions with doctors about the new Nucynta product.

“Check if the customer totally agrees,” the written advice to reps stated. “Don’t move until you have it done.”

Deem-Eshleman explained the passage was part of an educational campaign prior to the launch of Nucynta.

“This was an unbranded campaign,” she said.

“This was emotional selling of opioids, right?” Beckworth asked.

“It was educating the market about the issues in the marketplace at that time,” Deem-Eshleman said.

Beckworth took issue with the word “hook” in the document.

“What is educational about the hook?” he asked.

Deem-Eshleman said the term was used simply to note agreement over presented sales information. However Beckworth compared it to catching a fish.

“You use a hook,” he said. “In an effective strategy you often use a hook, true?”

“I don’t know if I’d put it that way,” Deem-Eshleman said.  

“You knew in 2001 there was a problem brewing,” Beckworth said.

“That opioids were addictive, yes,” Deem-Eshleman said. “We saw increased utilization.”

“There was more abuse and deaths in 2004.”

“I would assume yes,” Deem-Eshleman said.

Beckworth said the company was placing a new opioid on the market when deaths were increasing.

“We launched Nucynta because we felt it was a great drug,” Deem-Eshleman said.

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