CLEVELAND (Legal Newsline) - The federal judge overseeing hundreds of lawsuits against opioid manufacturers and distributors has ordered a series of bellwether trials starting in 2019 to test disputed legal theories and facts before live juries, all but admitting defeat in his initial goal of crafting a global settlement and solution to the opioid crisis this year.

In a second order, U.S. District Judge Dan Aaron Polster in Cleveland ordered the Drug Enforcement Administration to turn over detailed information about the quantities of pills defendant companies produced and shipped, citing the DEA’s “failures” to control the epidemic. 

The information from the agency’s Automated Records and Consolidated Orders System, or ARCOS, will help plaintiffs – most of them represented by private lawyers operating under contingency fees -- identify additional companies to sue, as well as helping them understand how the drugs were distributed. Releasing the information to the plaintiff lawyers will represent a “step toward defeating the disease,” the judge wrote.

A DEA spokeswoman declined to comment on whether the agency plans to appeal.

The pair of orders issued April 11 signal Judge Polster’s acknowledgement that he can’t force an early settlement of the sprawling opioid litigation, but that he retains great faith in litigation as a way to bring the opioid crisis under control. 

Cities as large as Philadelphia and Chicago, as well as hundreds of small towns and cities, are seeking compensation from the opioid industry for costs associated with addiction and illegal drug use, as well as changes in how drugs are distributed. Polster oversees perhaps the largest chunk of cases, hundreds of federal lawsuits consolidated in a single court for the collection of evidence and other pretrial activities. 

But he has no jurisdiction over hundreds more lawsuits filed in state courts around the country, as well as parallel investigations and potential litigation by state attorneys general and the federal government.

In his trial order, the judge said the parties have “made good progress” in settlement discussions - “The parties have indicated, however, they believe settlement will be made more likely if, in addition to the `settlement track,’” the court “also creates a `litigation track.’” 

The judge set lawsuits by the city of Cleveland and Summit and Cuyahoga counties for trial on March 18, 2019. He ordered the parties and special masters to meet by Aug. 17 of this year to schedule additional case tracks for lawsuits by other cities and counties as well as hospital districts and health plans and Indian tribes.

Judges overseeing multidistrict litigation often use bellwether trials to help establish the boundaries of liability as well as to give juries a view of the evidence and determine damages. Plaintiffs and defendants then use that information to negotiate settlements based on what would likely happen in court if they took each case to trial. The opioid litigation is dominated by experienced MDL plaintiff attorneys, most of whom took an active role in lawsuits over Volkswagen cars, pharmaceuticals and the landmark tobacco lawsuits of the 1990s.

The opioid litigation may be particularly challenging to settle, however, because of the broad range and size of defendants, from manufacturers and distributors like Purdue Pharma and Cardinal Health and big retail pharmacy chains like Walgreens down to small-town pharmacies and prescribing physicians. 

While Judge Polster has made it clear he considers big companies to be the primary targets of the litigation – “we won’t bring individual pharmacies into the settlement discussion,” he said in a Feb. 26 hearing – a crucial defense theory is that manufacturers and distributors can’t be held liable for misuse of drugs that were prescribed by licensed physicians or dispensed by crooked “pill mill” pharmacies.

Most of the lawsuits claim the drugs represent a public nuisance, and historically that has meant plaintiffs must show the defendants had control over the product when it caused the nuisance. Another complication is that most of overdose deaths are caused by illegal drugs like fentanyl, meaning plaintiffs must prove victims were launched on the path to addiction by legally prescribed opioids or pills that were illegally diverted with the drug companies’ knowledge.

In his 22-page order requiring the DEA to hand over information from the ARCOS database, Polster rejected the DEA’s argument it needed to keep details about the identities of individual companies and the numbers of pills they handled confidential, both to protect ongoing federal investigations and proprietary business information. The DEA will only have to turn over records for six bellwether states including Ohio, West Virginia, Michigan and Florida from 2006 to 2014, the judge ruled, eliminating any risk to ongoing investigations of criminal activity within the statute of limitations.

“There is overwhelming need for the plaintiffs in this case to learn the truth surrounding marketing and distribution of opioids,” the judge wrote, “including what the manufacturers, distributors, retailers and the DEA knew and when they knew it; what, if anything, was kept, intentionally or unintentionally, away from the DEA and the public by the defendants; and what, if anything, the DEA kept, intentionally or unintentionally, away from the States, counties and cities that have filed the MDL lawsuits.”

In an initial hearing in January, Polster said a federal court is “probably the least likely branch of government to try and tackle this, but candidly, the other branches of government, federal and state, have punted.” He followed up on that with even more direct criticism of the federal government on Wednesday, saying “the objective of the DEA is protection of the public,” but the agency “failed to consider important aspects of many factors underlying the opioid epidemic.” 

Handing the ARCOS information, which includes the exact number of pills from each manufacturer that wound up in each pharmacy nationwide, “will only serve to strengthen these objectives by revealing the ways the system failed, so that deficiencies may be fixed.”

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