First Major Opioid Trial Begins In Oklahoma

Oklahoma initially sued three large opioid manufacturers and their affiliated companies, but two of the groups have entered into settlement agreements and been dropped from the lawsuit.

By Randy Ellis

Barring another last-minute settlement, the eyes of the national news media will focus on the county courthouse here Tuesday for the start of a trial where Johnson and Johnson and a group of affiliated opioid manufacturers are accused of creating a multibillion-dollar public nuisance that has led to thousands of deaths and addictions.

"We've had almost 3,000 overdose deaths in the last three years in Oklahoma," Attorney General Mike Hunter said when he filed the state's lawsuit in 2017. "We need to hold these people accountable. Manufacturers have in a consistent and ... coldblooded fashion marketed these drugs in a way that has misrepresented their tendency to be addictive and the extent to which they can be deadly."

Oklahoma initially sued three large opioid manufacturers and their affiliated companies, but two of the groups have entered into settlement agreements and been dropped from the lawsuit.

OxyContin manufacturer Purdue Pharma LP entered into a $270 million settlement with the state in March that calls for the bulk of that money, nearly $200 million, to go to the Oklahoma State University Center for Wellness and Recovery in Tulsa to establish a national center on addiction modeled after the University of Texas MD Anderson Cancer Center in Houston.

A second settlement agreement with Teva Pharmaceuticals USA Inc. and its affiliates was announced Sunday. Still being finalized, that agreement calls for those companies to pay $85 million in cash to the state, with the money to be used to help abate the opioid crisis, Hunter said.

Still remaining as defendants in the lawsuit are a group of affiliates headed by Johnson & Johnson and Janssen Pharmaceuticals Inc., which manufacture Nucynta opioid pills and Duragesic, a fentanyl patch.

Attorneys for the state say they expect it will take between $12.7 billion and $17.5 billion over a 20- to 30-year period to abate Oklahoma's opioid problem. They want Cleveland County District Judge Thad Balkman to order the drug companies named in the lawsuit to pay for the abatement.

Opioid manufacturers acknowledge the state and nation have an opioid abuse and addiction problem, but contend they have complied with U.S. Food and Drug Administration labeling regulations.

They argue that the state is unfairly attempting to hold them financially responsible for doctors who over-prescribe, street drugs trafficked by international drug cartels and the state's failure to enforce its own drug laws.

They also contend the public nuisance law they are accused of violating requires the state to prove that they engaged in some unlawful act or omission. They claim the state won't be able to prove that.

More than 140 journalists have requested courtroom credentials, including representatives of the Washington Post, Wall Street Journal, New York Times, The Guardian-London, Bloomberg, CBS-60 Minutes, ARTE-Europe, CNN, NBC News-New York, Fox News Channel, NPR, The Oklahoman, Norman Transcript and all major local television outlets.

Not since the 2004 state trial of Oklahoma City bombing conspirator Terry Nichols has an Oklahoma trial drawn this much media attention.

Not since 46 states sued the nation's four largest tobacco companies in the 1990s has a public health crisis prompted such high-stakes litigation on a national scale. The tobacco litigation ended in a $206 billion settlement.

The national Centers for Disease Control and Prevention reports opioids were involved in more than 47,000 overdose deaths in 2017, alone. That year, 388 of the opioid-related deaths were in Oklahoma. In 2015, more than 326 million opioid pills were dispensed to Oklahoma residents, enough for every adult to have 110 pills, the state's attorneys say.

The president of the United States has declared opioid abuse to be an epidemic.

Hundreds of cities, counties, states and American Indian tribes have responded to the crisis by filing lawsuits against opioid manufacturers and others in the distribution chain. More than 1,700 of those lawsuits have been consolidated in a major federal court action pending in Ohio. Attorneys refer to those lawsuits as multi-district litigation, or MDL.

Some entities, however, have pushed to have their cases tried in state court. The state of Oklahoma is the first of those entities to get its case to trial.

So the nation will be watching -- not only to see whether Oklahoma Attorney General Hunter can win a multibillion-dollar judgment against opioid manufacturers, but also to see whether the state's attorneys have uncovered evidence that drug companies engaged in fraudulent marketing practices and other abuses in an effort to bolster sales.

Joe Rice, co-lead counsel in the National Prescription Opiate Litigation, said since this is the first case to go to trial, this is the first time the public will get to see much of the evidence that attorneys across the country have gathered that will show how opioid manufacturers marketed their products.

Pharmaceutical companies have been forced to turn over tens of millions of pages of documents to opposing attorneys, but up to this point most of those documents have been kept from public view by protective orders designed to protect company trade secrets and other confidential corporate information.

That is expected to change dramatically during the trial.

"It will be the first time that there will be a trial where a lot of the evidence that has been put under a confidentiality agreement or documents that haven't been released to the public will be available," Rice said. "I think the transparency that it offers is very valuable to addressing this whole health epidemic problem that we have not only with opioids, but how the health industry works."

Rice said he thinks the public will view opioid manufacturers differently once they see the evidence.

"You have to face the fiddler," he said.

Just because Oklahoma is the first state to get its case to trial doesn't necessarily mean that Oklahoma will get its money first if a huge judgment is awarded, Rice said, adding that is not something that he worries about.

"Whatever Oklahoma does to beat the epidemic is of benefit to everybody," he said. "Many of these cases are about the same thing. Stop the marketing and the improper use of these drugs. ... Help us get people the help they need."

The Oklahoma opioid case is considered so critical by the pharmaceutical companies and the state's attorney general that 116 attorneys made appearances in the case. While many of those attorneys represented companies that have now settled, dozens remain.

Judge Balkman has agreed to allow cameras in the courtroom, so the public should get a more complete view of proceedings than is often the case. The trial was initially expected to last two to three months, but should be shortened some by the settlements.

Oklahoma's lawsuit accuses opioid manufacturers of causing the crisis by orchestrating misleading marketing campaigns that understated the addictive properties of the powerful painkillers while overstating their therapeutic benefits.

Attorneys for the state say opioid pain medications have been around for decades but initially didn't create much of a problem because doctors were aware of their addictive and deadly properties and generally restricted their use to end of life care, cancer treatment and short-term pain management following surgeries.

They claim that changed in the 1990s when opioid manufacturers began promoting the use of opioids for chronic, non-cancer pain in an effort to boost profits. They allege an "arms race" developed with drug companies using "massive sales forces, speaker programs, continuing medical education, branded marketing and unbranded marketing."

"Defendants 'targeted' Oklahoma prescribers and hammered them with these messages from all angles," state attorneys allege.

They also claim the drug companies targeted consumers directly and that Johnson & Johnson, in particular, targeted "children, the elderly and veterans."

Attorneys for Johnson & Johnson and subsidiary Janssen Pharmaceuticals said in a joint trial brief that Janssen marketed two Schedule II opioid pain medications in Oklahoma during the period involved in this case: a fentanyl-based skin patch called Duragesic and a tapentadol-based tablet called Nucynta.

"These Janssen medications bear no responsibility of any kind for Oklahoma's opioid abuse crisis," the companies claimed. "None occupied more than a minuscule share of opioid pain medication prescriptions written by Oklahoma doctors."

"Some of the state's claims with regard to unbranded materials are simply made up," they said. "For example, Janssen never promoted opioid use by children."

The trial is scheduled to begin 9 a.m. Tuesday with attorneys presenting their opening statements.

(c)2019 The Oklahoman