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Monday, July 22, 2019

With just one defendant left, Oklahoma struggles to blame J&J for opioid crisis

Opioids

By Daniel Fisher | May 28, 2019


NORMAN, Okla. (Legal Newsline) – Lawyers for the State of Oklahoma opened a closely watched trial seeking to hold Johnson & Johnson responsible for $17.5 billion in damages over the opioid crisis with a simple refrain: “something happened.”

That statement, repeated several different ways throughout the state’s opening arguments, was designed to convince the judge hearing this case that Oklahoma can prove causation, a necessary element in any tort lawsuit. Unfortunately for the state, its best evidence points squarely at Purdue Pharma, the Oxycontin manufacturer that already settled for $270 million in March.

Displaying a chart showing how overdose deaths in the state neatly tracked sales of prescription opioids, attorney Brad Beckworth said that Oklahoma had a minimal problem until 1996.


Beckworth and Ottoway

“There was a nothing, and then there was a something,” said Beckworth, one of a team of private lawyers hired by Oklahoma Attorney General Mike Hunter that have already been awarded $60 million in fees for negotiating the Purdue settlement. “That something was a crisis caused by an oversupply.”

Purdue launched Oxycontin in 1996 and pills based on oxycodone and hydrocodone rapidly became market leaders in Oklahoma and elsewhere. Johnson & Johnson’s Janssen unit sold only two opioids in Oklahoma: Duragesic, a fentanyl patch introduced in 1991; and Nucynta, an opioid painkiller launched in late 2009. Together, the two drugs accounted for a “miniscule” share of the opioid market in Oklahoma, J&J says, and the state’s own records show Duragesic and Nucynta represented just 0.87% of prescriptions paid for by Oklahoma Medicaid between 1996 and 2017.

The market-share numbers demonstrate the challenge Oklahoma faces in convincing Cleveland County Judge Thad Balkman that J&J is the cause of the state’s problems associated with widespread opioid abuse. Oklahoma’s lawsuit accuses J&J of creating a “public nuisance” by using misleading and illegal marketing to convince doctors to prescribe opioids in excess quantities. But to prevail, it must overcome J&J’s arguments that there are substantial intervening causes between its actions and the effects of opioid addiction, including federal regulators who controlled the amount of opioids produced, state officials who put them on formularies and paid for them, and licensed physicians and pharmacists who had an independent duty to make sure the drugs were properly dispensed.

The state’s opening argument was crafted to get around these issues. In addition to “something happened,” Beckworth repeatedly said “if you oversupply, people will die.” Combined, the two suggest that J&J knew what would happen if too many opioids got into the wrong hands and ramped up its marketing in 1996 to make it happen anyway. The opioid crisis was the predictable result of J&J’s unreasonable behavior, Beckworth told Judge Balkman.

“Why is Johnson & Johnson a cause?” he said. “It’s simple. They ignored what they knew.”

Oklahoma is also counting on joint and several liability, a principle of tort law under which one defendant can be required to pay all the damages associated with a single injury caused by multiple actors. The Oklahoma legislature got rid of joint and several liability for most civil cases in 2011 but kept it for the state. Oklahoma argues J&J’s small market share doesn’t absolve it of responsibility to pay for the “very big mess” the opioid manufacturers collectively caused in the state. In its defense, J&J says the state can’t press joint and several liability when damages stem from multiple causes, including the state’s own role in promoting the use of opioids.

Oklahoma also dismisses arguments by J&J that a century of precedent holds that public nuisance law applies only to claims stemming from damage to property. With opioids, the state claims J&J misled prescribing physicians with improper marketing practices, creating a nuisance that will require $17 billion to clean up. That number, redacted as recently as J&J’s trial brief submitted late last week, includes more than $1 billion to pay for quarterly monitoring of every Medicaid recipient in the state for drug and alcohol abuse for the next 30 years, syringe exchange programs and yoga therapy, among many other things.

The opioid crisis “occurred on property,” Beckworth said. “It occurred in doctor’s offices, in pharmacies.” 

The lead attorney for J&J, Larry Ottoway, slowly and methodically attempted to dismantle the state’s arguments, using his own refrain borrowed from John Adams: “Facts are stubborn things.” He started by citing statements from the Food and Drug Administration and Centers for Disease Control as recently as this year that opioids are necessary for the treatment of chronic pain, undercutting the state’s claim that J&J improperly promoted them for that use, as opposed to treating the pain associated with terminal illness. The labeling also warns physicians and pharmacists that opioids are addictive and can kill, he said.

“The people prescribing Schedule II opioids know this,” he said. “They have to know it to get a DEA license to prescribe it.”

Even the chart Beckworth relied upon in his opening, Ottoway said, came from a 2011 CDC publication that concluded states are responsible for monitoring and preventing inappropriate prescribing. He placed some of the “unbranded marketing” statements Oklahoma claims propelled the opioid crisis on the chart to show they came in 2009, more than a decade after the state says J&J began to cause the problem. Oklahoma says it was misleading for J&J to say opioids are “rarely addictive” in those materials, but the FDA used identical language at the same time.

“Not only does the release of the material not fit the state’s theory, the actual material doesn’t fit the state’s theory,” Ottoway said.

The trial gives both sides to air long-redacted materials including internal documents from J&J and state records pinpointing sales of opioids. In 2013, for example, Oklahoma paid for more than 400,000 prescriptions of oxycodone and hydrocodone, compared with less than 400 for Duralgesic and Norcynta.

Oklahoma presented embarrassing call notes from marketing representatives, in which they boasted to superiors that they had convinced doctors to switch from oxycodone to fentanyl patches or delivered a sales pitch describing the supposedly less addictive qualities of Janssen’s products. While damning, J&J is sure to contrast them with the remarkably low percentage of opioid sales it actually achieved in the state.

Ottoway, meanwhile, presented evidence that officials with the Oklahoma Health Care Authority’s Drug Utilization Board, a multiagency group, repeatedly discussed the problem of drug diversion and illegal sales during the time period the state says J&J was causing the opioid crisis. The state kept Oxycontin as a Schedule I drug, making it easier to prescribe than J&J’s products, which were rated Schedule II meaning they could only be prescribed if Schedule I drugs failed or the patient was allergic to them.

“Janssen’s conduct was not a nuisance,” Ottoway said. “They provided medically necessary treatment for terrible, terrible problems.”

One minor skirmish flared when Ottoway discussed Dr. Russell Portenoy, a onetime cheerleader for opioid treatment who quietly signed on as a plaintiff expert last year in exchange for being dismissed from the litigation. A special master in the federal opioid multidistrict litigation in Ohio in April recommended sanctions against the plaintiffs for failing to disclose the agreement to defendant companies, even though they shared it with the lawyers for Oklahoma. But U.S. District Judge Dan Aaron Polster overruled his special master, saying it would be excessive to bar Portenoy from testifying.

The state’s lawyers objected to Ottoway suggesting Portenoy had struck some sort of agreement with Oklahoma, but Ottoway said the doctor’s consulting agreement states plaintiff lawyers would make their best efforts to prevent him from being a defendant in the Oklahoma case. The exchange suggests J&J will try to undermine Portenoy’s testimony that it engaged in a conspiracy to promote the improper use of opioids by saying he is contradicting his earlier views because he is being paid.

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