NORMAN, Okla. (Legal Newsline) - Tensions ran high in court Thursday as the Oklahoma opioid trial continued, with defense attorney Larry Ottoway objecting throughout the day to opposing counsel's line of questioning directed at defense witness, business director for Janssen Pharmaceuticals Kimberly Deem-Eshleman.
Ottoway challenged whether the state's attorney, Brad Beckworth, was posing questions of the witness or making speeches.
At the outset, Cleveland County District Judge Thad Balkman, presiding over what is expected to be a two-month long bench trial, called the state and Johnson & Johnson and Janssen Pharmaceuticals to approach the bench, reviewing several items placed into evidence Wednesday as the state accuses the companies of being lead contributors of the opioid crisis within Oklahoma.
Ottoway was particularly peeved at Beckworth's examination of Deem-Eshleman involving her knowledge of documents from the company's affiliates, saying the state barraged her even when she stated she was unaware of them.
Revisiting a question asked in January (in deposition) and briefly again on Wednesday, Beckworth asked Deem-Eshleman if anyone knows exact risk statistics of opioid addiction, to which she replied, “not that I am aware of.”’
“So you can’t say it is one percent, two percent, three percent, four percent of risk taking opioids, when there is no data,” Beckworth said. “It would have been wrong for you to say you knew when you don’t know?”
Deem-Eshleman said that based on the data available at the time, it was thought throughout the market that the risk of addiction to opioids was low.
“There was data, they were looking for more data,” Deem-Eshleman said, adding that individual risk of addiction is unknown. “The data at the time is what the community was saying.”
Beckworth proceeded with a long showcase of documents, including an ‘execution tip’ in a document produced by Janssen for NeoPathways training. The document reads: “avoid the addiction ditch. Use [Dr. Russell] Portenoy’s study to create dialogue about Opiophobia as a barrier. Many HCPs [healthcare professionals] will find the 2.6 percent incidence of addiction to be extremely low. It's not about the percentage, but about the barrier contributing to the under treatment of pain.”
Beckworth’s questioning on Thursday revolved around several documents that stated that much of the risk data used by J&J has been discredited by the Food and Drug Administration.
Among those documents Beckworth introduced was an FDA letter which stated that referenced studies by Drug Abuse Warning Network, Milligan, Simpson and Allan were inadequate to support J&J claims made about the extent of opioid addiction.
“The FDA did send us this letter and we did not necessarily agree with them, we didn’t believe they were accurate,” Deem-Eshleman said.
In another, the FDA Advisory Committee said information on the overall extent of opioid abuse is impossible to provide since there are many sources of opioid abuse data, but all differ in how they collect, analyze and present it.
“Even the DAWN database, which is generally accepted by many in the field, has limitations,” the FDA said in a media response document to J&J.
J&J consultants, Key Opinion Leader’s and one of its own employees also discredited risk data used by the defendants, according to documents produced by Beckworth.
“We never use the DAWN data…fentanyl is a highly addictive opioid; there should be no data presented to suggest otherwise,” said Bruce Moskovitz, therapeutic areas head of Ortho-McNeil Janssen Scientific Affairs in an email from 2009.
“I have grave concerns about the acceptability of the DAWN data, based on absolutely negative response at the Scientific Ad Board,” said Christine DeVries in a Duragesic team meeting email sent to other J&J employees in 2001. “If there had been any shades of gray, I wouldn’t be so concerned. While these are pain specialists, their opinions will carry weight and could compromise any message we send.”
Deem-Eshleman said she did not know if DAWN data has been updated since 2001.
“We give them training on the drug itself, pharmacology and the disease itself - pain management,” Deem-Eshleman said. “We didn’t have drugs that treat addiction, they have addiction potential.”
Beckworth said that because there is not enough sufficient data to provide the community on the risk of opioid prescriptions, they should not be marketed with a risk percentage.