Historians push to create public archive of documents from massive opioid litigation

In settling lawsuits against them, companies often insist that all of the documents and depositions gathered as part of the cases be locked away or destroyed. To head that off — and to ensure a full accounting of the origins of the prescription opioid crisis — a group of historians is asking that any settlement in the massive opioid litigation require all collected documents be preserved and made public.

In a court brief Thursday, the experts called for “full and permanent access to the records” for scholars, policymakers, journalists, and the public, and for the defendants to cover the costs of creating an archive.

“The concealment of information about the abuse potential and distribution patterns of opioid painkillers allowed the epidemic of opioid abuse to take root in the first place and to grow to its current dimensions,” the brief says. “Since secrecy fueled the crisis, no just and genuinely remedial settlement can be reached unless it honors the public’s right to know and secures the conditions for its effective exercise into the future.”

The historians are modeling their entreaty after the 1998 tobacco settlement, which led to the public release of millions of pages of industry documents and included funding for the preservation of and access to the records. The records are maintained by the University of California, San Francisco’s Industry Documents Library and are available online.

Read more: Purdue Pharma touts data that downplay its role in the opioid epidemic, new analysis shows

“Settlements typically are used by companies to hold on to their documents and avoid their release,” said Antoine Lentacker, a historian of medicine at the University of California, Riverside, who helped organize the brief. Tobacco is an exception to that, he said, and he and his colleagues are hoping the opioid documents will be as well.

Signatories on the brief include 35 health and medical historians and the Organization of American Historians.

The brief was sent to the federal court in Cleveland overseeing some 2,000 bundled lawsuits against opioid manufacturers, distributors, and pharmacies from local and tribal governments. Almost every state has also filed cases against industry players. The allegations center on companies misleading prescribers and the public about the safety and effectiveness of prescription painkillers and failing to intervene to stop unsafe prescribing patterns, all while they reaped billions of dollars and thousands of people died from overdoses.

Read more: OxyContin maker Purdue Pharma agrees to tentative settlement in opioid lawsuits

The filing was submitted as lawyers announced they were nearing a global settlement deal with Purdue Pharma, the maker of OxyContin and one of the defendants, though some states remained opposed to the proposal.

Through court orders, some information gathered as part of the litigation has been unsealed, notably a federal database tracking opioid sales. Lawsuits brought by attorneys general in state courts in places like Oklahoma, New York, and Massachusetts have also provided glimpses at how companies such as Johnson & Johnson and Purdue marketed their drugs.

But reams of internal company communications, reports, and other documents remain hidden from public view. The scholars behind the brief fear that the defendants will fight to keep the documents withheld as part of any settlement, so they wanted to put the issue on the radar of Judge Dan Polster, who is overseeing the bundled cases, together called a multidistrict litigation, or MDL.

Read more: Watch: In never-before-seen video, Purdue’s Richard Sackler defends OxyContin marketing

“Let’s have the judge encourage the parties that part of the settlement needs to be full disclosure,” said Jennifer Oliva, an associate professor at Seton Hall University School of Law, who helped the historians with the brief.

(Technically, the experts on Thursday filed a motion asking the judge for permission to file the brief, which he can accept or deny. The brief, however, was attached to their motion.)

The brief argues that the documents should be available through one website and that the cost of processing them should be covered by the defendants as part of a settlement. Accompanying the brief is an estimate from staff at the UCSF Industry Documents Library that building a public archive for the opioid documents would cost about $30 million — $5 million for initial expenses and $25 million for an endowment.

In addition to the tobacco documents, the library has gathered records from the drug, chemical, food, and fossil fuel industries, and it hopes to obtain the opioid documents. The tobacco documents have been used in more than 1,000 publications, according to library staff.

“You see what a company says publicly, but when you get their internal documents, you see what they say privately is completely different,” said Rachel Taketa, an archivist at the library. “Making these documents public and exposing what some of these big industries do to impact public health goes a long way to helping the public health side, and the people who are trying to counter some of the industry influence.”

The historians’ brief is similar in some ways to one filed in May by public health experts outlining how money from a settlement could be allocated to help address the addiction epidemic. They called for a nonprofit that would be funded by the settlement “to coordinate and implement a range of activities to reduce the public health impact of the opioid crisis.” Some experts and advocates have cautioned that much of the funding from the tobacco settlement was routed to general state budgets and not directed to prevention and cessation efforts, and argue that the opioid settlement should avoid that.

Action in the yearslong legal effort is coming to a head. Purdue and Teva settled cases brought by Oklahoma, while a judge in that state ordered Johnson & Johnson to pay $572 million in a case that went to trial. Meanwhile, suits from two counties from the MDL are scheduled for trial next month as test cases. Settlement talks with some of the companies have been accelerating, though disagreements between states and local governments over how money will be meted out have complicated the discussions.

The historians’ brief references a case brought by STAT in Kentucky to release internal Purdue records about its drug OxyContin. The records were gathered as part of a lawsuit by the state alleging that Purdue marketed OxyContin illegally. The case was settled in 2015, and as part of the deal, the records were either destroyed or sealed. Purdue fought efforts to unseal the records, but STAT last month prevailed after a three-and-a-half year legal battle, and the records will be made public soon.