Not disputedThe devastation of prescription opioids has been deadly and overly expensive.
disputed: Who should pay the bill?
A little over a year ago, opioid prosecutions against manufacturers and distributors of painkillers proliferated so rapidly that a judicial jury brought together all federal cases under the responsibility of. one judge. One January morning, Judge Dan Aaron Polster, from the North District of Ohio, made an opening statement in front of the lawyers of nearly 200 municipal governments gathered in his courtroom in Cleveland. He wanted the national opioid crisis to be resolved within a year by proclaiming: "We do not need briefs or trials."
This year is up.
Far from being settled, the litigation escalated to 1,548 cases in federal courts, 77 tribes, hospitals, provident funds, children with neonatal abstinence syndrome and others, totaling millions. of people. With a pay potential of several tens of billions of dollars, it has become one of the most complicated and gigantic legal battles in American history.
Negotiations to conclude talks resulted in failures, the judge began a parallel procedure involving, yes, briefs, focused on, yes, a trial. He will preside over three consolidated lawsuits in Ohio under what is called a "witness," or test. Defendants include Purdue Pharma, Mallinckrodt PLC, CVS RX Services Inc. and Cardinal Health, Inc. The jury's verdict could determine whether the parties will seriously negotiate or continue to fight.
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The date of the trial has already been postponed twice. It is now scheduled for October 21st.
"I knew it would be complex and challenging," Judge Polster said in an interview, "but that turned out to be so much more than I had envisioned."
To help you understand the complexity, here are some important developments and their meanings:
Amazing evidence of D.E.A. records
Manufacturers, distributors and pharmacies are expected to track and report prescription opioids to the Drug Enforcement Administration and trigger alarms when orders seem suspicious.
After considerable judicial skirmishes, the D.E.A. has complied with the orders of Judge Polster and provided more than 400 million lines of data. This is a detailed history, from 2006 to 2014, showing the number of opioids manufactured by each manufacturer, trucked by each distributor and sold in pharmacies across the country.
The plaintiffs have long said that companies have deliberately turned their eyes away from unlikely quantities. But the lawyers did not have the hard numbers on hand to back up their claims.
Now they do it.
For the moment, the judge will not disclose the data to the public. But an excerpt from a congressional report gives an idea of the detailed information contained in the data: for ten months in 2007, a distributor, McKesson, had shipped three million prescription opioids in a single pharmacy in a town of 400 inhabitants in West Virginia.
The data proved to be a modest help for some of the defendant companies, too: because the DEA reports show that some drugs have not been sold in large quantities in some communities, the companies that manufacture them and distribute them have been discontinued in a few cases. In the lawsuit in Cuyahoga County, Ohio, for example, Kroger, which owns grocery stores that include pharmacies, was abandoned because it was found to have no location in the area. .
Going to trial is a victory for the plaintiffs
In a 39-page decision last month, Judge Polster ended the drug industry's efforts to overturn Ohio's lawsuit. Instead, he gave the lawyers the green light to test just about all the legal theories raised by the plaintiffs.
They understand: that companies have conspired; fraud committed; were careless; violated public nuisance laws – the latter being a relatively new and innovative way for communities to address health crises.
Of course, legal theory is one thing. Then comes the difficult part: the plaintiffs will have to prove their allegations before a jury.
Companies Require Personal Medical Records
As a general rule, patients who sue for medical malpractice or product liability must submit their own medical records as evidence. They renounce the right to conventional privacy.
Here, the vast majority of applicants are government entities and not individuals. They seek reimbursement for the cumulative costs of drug addiction and collateral damage. The accused want them to provide clear evidence of how these costs are calculated, including the chain of events – for example, from the development of a drug to its issuance, through a prescription filled in pharmacy, to finish by hospital bills or others.
This means that the pharmaceutical industry requests patient records and for each prescription, the complainants are considered "suspect" in medical terms.
But they give ground.
Complainants have now returned millions of coded insurance claims related to opioids. The fight focused on the scope and quantity of patients' medical records.
Meanwhile, plaintiffs pursue their own lawsuit in paper
At the same time, applicants are seeking internal documents from the pharmaceutical industry relating to development strategies, marketing and sales.
They are also looking for documents showing companies' efforts to prevent the misappropriation of their drugs. Years ago, some companies settled cases promising to take such measures. The plaintiffs want to know if they have actually done it.
Defense lawyers say that they have already handed about 67 million documents.
Pharmacies could be held responsible for black market fentanyl
An operated knee patient goes home with opioids. Her teenage son finds the pills in the bathroom medicine cabinet and engages in a jagged street that results in a heroin addiction.
Should companies that have manufactured, distributed and sold prescription pain medications be held accountable?
What if the son sold them to a friend who had taken illegal drugs and overdosed? Are the pharmaceutical companies responsible then?
Multiply these examples by several years and generations of similar scenarios. Now calculate the accumulated losses on municipal budgets for emergency responders; hospitals; incarceration; drug courts; rehab; mental health services; protection of childhood.
The question of whether companies should have forecast the growth of a second illicit market – including pills, heroin and fentanyl – is one of the thorny issues.
At the present time, Judge Polster, who ruled only on the affairs of Ohio, said yes.
But to make things even more complicated: if more belloteurs go to trial, the answers to these questions and to many others may differ depending on the jurisdiction.
Why pharmaceutical companies could have the upper hand
Lawyers on both sides agree: This litigation raises a host of new legal issues.
If the plaintiffs eventually triumph, the courts of appeal, increasingly populated by conservative judges, will probably not be able to confirm all of Polster J.'s rulings on these unresolved legal issues, much less an enormous emotional judgment. of the jury. Complexity favors defense.
And in the negotiations for a settlement, the long game is the best friend of the defense: she can afford to lie down. As a rule, the longer it lasts, the more the final tab is pressed.
But do not count the plaintiffs
According to Andrew S. Pollis, a litigation expert who teaches at Case Western Reserve Law School in Ohio, plaintiffs also have benefits.
"The unusual level of Polster J.'s commitment to a settlement" is powerful, he said. The judge continues to press for a relatively quick resolution, with funds directed to help remedy the crisis and put in place preventive measures.
The most important trial of the judge, which is likely to lead the accused to the negotiating table, is the most important that can bring the accused to the negotiating table. A lawsuit could not only release more money than a settlement would, but the documents of companies currently under seal would be made public blatantly, telling more fully the relationship of the accused with the crisis.
And at this point, Mr. Pollis added: Do not neglect the power of exploitation of the perception and pressure of the public, which weighs on the defense – "especially since the plaintiffs are, in fact, all of us ".
But wait! There is more!
The defendants want a comprehensive settlement – a comprehensive agreement that will compensate them for any further prosecution. Multiparty litigation, with all federal cases, is well positioned to achieve this goal.
But to achieve this, Judge Polster needs the cooperation of state courts. About 332 other cases have been filed in state courts. The coordination of data sharing between state cases and federal cases is an achievement in itself. Indeed, with Purdue documents from the federal litigation, Massachusetts has made progress on its own record; Despite Purdue's objections, the Massachusetts judge made public much more than Judge Polster.
So there is a baroque dance going on between Judge Polster and the states. It can not be perceived as a big foot. State judges must be considered independent. And yet, Judge Polster needs the cooperation of the states to reach this global settlement.
In a recent interview, Justice Polster repeatedly pointed out, "I do not control state court judges or attorneys general, but I appreciate their participation. They are indispensable. "
The eyes will be on the first trial in another state, which must begin before Judge Polster: the state of Oklahoma c. Purdue Pharma, currently set for May 28th.