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Tuesday, October 22, 2019

Mathematician says Janssen’s market share of opioids low while state says figuring is skewed

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By John Sammon | Jul 17, 2019


Cleveland County Courthouse

NORMAN, Okla. (Legal Newsline) – A statistical mathematician testifying as an expert witness for Johnson & Johnson last week said the market share of opioids sold by the company’s drug subsidiary Janssen Pharmaceuticals was low, while state-hired attorneys contended his figuring was off.

"Any way you look at it, drug sales go up,” said Brad Beckworth the state-hired attorney. “Deaths (opioid overdose) went up 15 times.”

“It (sales) does go up to the 2010 era,” agreed Dr. Laurentius Marais, vice president and pain consultant for William E. Welker Assoc. in Jackson, Wyoming.

However, Marias insisted that Janssen’s share of the opioid sales pie was minimal.

The trial in the Cleveland County District Court was streamed live courtesy of Courtroom View Network. Closing arguments were heard Monday.

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.

Marais told Steve Brody, the attorney for Johnson & Johnson, his firm does statistical analysis for real-world problem solving.

“Did you analyze Janssen’s market share (opioids) for Oklahoma?” Brody asked.

“Yes,” Marais said.

“What data did you use?”

“I used pharmacy claims data from Sooner Care (State Medicaid) also Blue Cross and Blue Shield,” Marais explained.

Charts exhibited showed that according to the analysis Janssen had a .82 percent market share in prescription claims between 1996 and 2017, and 1.09 percent for prescriptions of fentanyl (timed-release) patches of the kind used in Duragesic. Blue Cross Blue Shield showed a .20 percent share and .38 percent in fentanyl patches, while a care provider called Health Choice had rates of .36 and .81 percent.

“The .82 percent means that for every 100 prescriptions; fewer than one are for Janssen opioids,” Marias said.

Market said the share for all other opioids from 1996 to 2017 amounted to an estimated 99.18 percent.

Marais took issue with a chart state attorneys have repeatedly used during the trial showing that overdose death rates in Oklahoma mirrored a similar increase in sales of opioids during the time period from 1994 to 2018.

He said because the author of the chart had used different scales to depict the rates of deaths compared to the number of sales, a misleading reading of the chart had been achieved.

“It makes it look like a coincidence (deaths and sales increase at the same rate),” Marais said.

Marais indicated that when the proper methodology was used, the correct scaling, the chart would appear different. The rate of deaths would be flatter.

“We don’t see it (overdose deaths) going up with the sales line on the chart?” Brody asked.

“That’s correct,” Marais said.

However, Brad Beckworth the state attorney, said Marais in his figuring did not look at the marketing of all opioids. Prior testimony concerned the “unbranded” marketing of drugs in which state attorneys said drug companies like Janssen had promoted opioids without referring to a specific brand hoping to generate sales in preparation for the release of a specific product like Nucynta.  

Marais stood by his figures.

“I have confidence in the accuracy of my marketing share calculations,” he said.

“You were looking at specific branded drugs, you didn’t look at opioids as a class of drugs, true?” Beckworth asked.

“I was asked to calculate Janssen’s share of the market,” Marais said.

Marais said it was the state attorney’s contentions that were wrong.

“That’s not how calculations work,” Marias said.

“Your calculations,” Beckworth said.

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