© Reuters. FILE PHOTO: Cataldo Ambulance medicscare for a man. who was found unresponsive after overdosing
By Benjamin Lesser, Dan Levine, Lisa Girion and Jaimi Dowdell
WELCH, West Virginia (Reuters) – The opioid epidemic that has so far killed half a million Americans is routinely blamed on greedy drug makers, feckless doctors and lax regulators. But theres another group that has contributed to the depth and duration of the catastrophe: judges.
Judges like Booker T. Stephens.
Until his retirement in May, Stephens sat on the West Virginia Circuit Court in Welch, deep in Appalachian coal country, where addiction took early root among miners who were prescribed the blockbuster opioid OxyContin for the pain their jobs inflicted. And it was in his court where the first lawsuit filed by a state against OxyContins maker, Purdue Pharma LP, landed in 2001.
West Virginia accused Purdue of duping doctors into widely prescribing the drug by minimizing its risks, convincing them it was less addictive than other opioids because just one dose delivered steady relief for 12 hours. In the pretrial “discovery” phase of the case, Purdue sent thousands of pages of internal memos, notes from sales calls on doctors, marketing plans and other records to the states lawyers who had requested them.
That evidence was clearly compelling: In a 2004 ruling, Judge Stephens rejected Purdues motion that he dismiss the case and sided with the states assertion that the material could convince a jury that Purdues sales pitch was full of dangerous lies.
But Stephens sealed the evidence on which he relied in that ruling. And when Purdue and the state reached a settlement that year, before the case went to trial, the evidence remained hidden, out of sight to regulators, doctors and patients. Over the next few years, as OxyContin sales and opioid-related deaths climbed, more than a dozen other judges overseeing similar lawsuits against Purdue took the same tack, keeping the companys records secret.
It would be 12 years – and 245,000 overdose deaths – before evidence Stephens and other judges kept hidden was made public, and then only after it was leaked to a newspaper https://www.latimes.com/projects/oxycontin-part1. What it showed was revelatory: OxyContin, the first billion-dollar-a-year narcotic, was not the reliable 12-hour painkiller Purdue long claimed it was. Its effects often wore off much sooner, exposing patients to a relapse of pain, withdrawal, or both – suffering relieved only by the next pill. When doctors raised concerns, the documents showed, Purdue sales reps counseled them to put patients on bigger, more dangerous doses.
The eventual release of the evidence reinforced the widely held view that OxyContin was a catalyst for the epidemic, which by then had expanded beyond prescription opioids to include illicit drugs such as heroin. The material also informed hundreds of new lawsuits seeking to force accountability on the entire opioid industry for its role in the addiction crisis.
But for untold numbers of opioid users who had overdosed, it was too late. “Heartbreaking and sickening” is how Congresswoman Katherine Clark, a Massachusetts Democrat who has been involved in investigating the causes of the opioid epidemic, described the early decisions to seal the Purdue evidence. In an interview, Clark said she believes that had the secrets come out earlier, doctors would have written fewer OxyContin prescriptions and fewer insurers would have covered the drug. “We dont know how many lives we could have saved,” she said.
Stephens told Reuters he doesnt second-guess his decision. “It happened, and thats all that I can say about it,” he said. “It speaks for itself.”
CONTINUING THE TRADITION
Today, 15 years after Stephens protected Purdues secrets, Federal Judge Dan Polster is providing the same cover for multiple opioid makers, distributors and retailers. He is presiding over a mass of litigation that seeks to hold the entire industry responsible for the epidemic. Life-saving information contained in those cases, too, may remain under seal, as Polster has stuck to a strict secrecy playbook.
Polster declined to comment for this article.
The trail of hidden evidence running through the opioid crisis is emblematic of a pervasive and deadly secrecy that shrouds product-liability cases in U.S. courts, enabled by judges who routinely allow the makers of those products to keep information pertinent to public health and safety under wraps. And since nearly all such cases are resolved before trial, the evidence often remains secret indefinitely, robbing consumers of the chance to make informed choices and regulators of opportunities to improve safety.
In an unprecedented analysis, Reuters found that over the past 20 years, judges sealed evidence relevant to public health and safety in about half of the 115 biggest defective-product cases consolidated before federal judges in so-called multidistrict litigation, or MDLs. Those cases comprised nearly 250,000 individual death and injury lawsuits, involving dozens of products used by millions of consumers: drugs, cars, medical devices and other products. And the numbers dont convey the full extent of information locked away because they dont include thousands of product-liability cases heard in state courts.
The impact is broad. Although secrecy makes complete analysis impossible, Reuters found that hundreds of thousands of people were killed or seriously injured by allegedly defective products after judges in just a handful of cases allowed litigants to file under seal, beyond public view, evidence that could have alerted consumers and regulators to potential danger.
For example, beginning in the early 1980s, judge after judge kept under seal evidence that the trigger on Remington Arms Cos Remington 700 hunting rifle was prone to misfiring. In 2014, after decades of secrecy, a judge presiding over a class-action lawsuit in Missouri refused to seal the trove of documents, which showed that the company had been aware of the defective trigger since the late 1940s. By then, nearly 200 people had died from accidental shootings blamed on the problem. The company then recalled the defective rifles.
Thousands more people died in rollover accidents involving General Motors Co (NYSE:) cars and trucks while judges agreed to hide records showing the company knew that reinforcing vehicle roofs would save lives. After a decade of lawsuits in which those records were kept secret, a Los Angeles judge released the information in 2004 at the request of plaintiffs who wanted to share it with regulators. In 2009, the federal government upgraded a decades-old standard on roof strength.
Remington declined to comment. In a statement emailed to Reuters, GM said: “Advances in auto safety effectively addressed this concern many years ago … Also, its fair for individuals or companies to be able to request that certain sensitive or personal information be safeguarded.”
THE LAW AND THE REALITY
In fact, court records are presumed to be public as a matter of law. They can only be sealed for valid concerns about privacy, including personal medical records, and to protect company trade secrets.
In most states and nearly all the 13 federal appellate circuits, judges are legally obliged to weigh any litigants request that information be sealed against the broader public interest in making it public. They also must explain in the court record any decision in favor of secrecy. Judges incur no penalty for failing to do these things.
In practice, secrecy has become so ingrained in the system that judges rarely question it. In 85 percent of the cases where Reuters found health and safety information under seal, judges provided no explanation for allowing the secrecy.
Judge Stephens was bound by West Virginia law to weigh secrecy against transparency and provide in the court record his reasoning. Like many judges in his position, he did neither. “This case was sealed because both sides agreed and asked me to seal it,” he told Reuters.
That reasoning explains why secrecy has become the norm: It makes things easier for everyone involved. Corporate lawyers want to protect their clients reputations. Plaintiffs lawyers want to avoid miring their clients cases in lengthy courtroom wrangling over requests that filings be sealed or redacted. And judges want to keep the business of justice moving.
Secrecy is amplified by the growing practice of consolidating similar lawsuits under a single judge. MDLs, which now cover as much as 40 percent of all lawsuits filed in federal courts, are meant to promote efficient resolutions. Each decision the judge makes applies to all of the consolidated lawsuits. Thus, with one sealing order, a judge can impose secrecy in thousands of cases.
That is now happening in federal district court in Ohio, where Judge Polster is managing nearly 2,000 lawsuits filed against the opioid industry. Cities and counties across the country claim that companies up and down the supply chain – drug makers like Johnson & Johnsons Janssen Pharmaceuticals subsidiary and Teva Pharmaceutical Industries (NYSE:) Ltd, as well as Purdue, distributors like McKesson Corp (NYSE:), and retailers like Walgreen Co (NASDAQ:) – contributed to the public-health disaster by using misleading marketing and other ruses to boost sales at the expense of public safety.
So far, Polster has imposed a draconian secrecy on the proceedings. The judge, a former federal prosecutor confirmed to the bench in 1998, has given the litigants broad discretion to determine what records remain secret. As a result, entire lawsuits have been filed under seal in his court, including supporting evidence drawn from millions of records that detail the industrys conduct over two decades.
All the companies have denied the allegations. Teva and McKesson declined to comment for this article. Walgreens did not respond to a request for comment. Janssen said its marketing of opioids was “appropriate and responsible.”
Privately held Purdue, controlled by the Sackler family, said that OxyContin “has been deemed safe and effective for 12-hour dosing,” that it has always given the U.S. Food and Drug Administration (FDA) all information the agency requires, that protective orders are routine, and that any suggestion the company used court-ordered secrecy to withhold relevant safety information about OxyContin is misleading and inflammatory. Purdue said it has spent more than $1.5 billion on efforts to solve the opioid crisis. "These efforts, not the disclosure of Purdues internal documents, will help solve the complex opioid abuse crisis," it said.
A few states, including Texas and Florida, have adopted “sunshine” rules and laws that limit the sealing of health and safety records. At the federal level, corporate lobbying has stymied sunshine legislation for decades.
Opponents of sunshine laws often cite a 1991 Harvard Law Review article in which New York University law professor Arthur Miller wrote that no hard evidence showed that court secrecy caused any harm to public health or safety. “Research or statistical data is completely nonexistent,” Miller wrote.
In an interview, Miller said Reuters analysis of court data helps fill that void and suggests that judges are not fulfilling their responsibility to guard the public interest. “Certainly, anything relating to public health or things tied to social policy, you would want to have an explanation as to why something is sealed,” he said.
In the years following the Purdue case, Judge Stephens watched the wreckage of opioid addiction flow through McDowell County Circuit Court: burglaries, robberies, assaults. Thursdays in the hilltop courthouse in Welch were usually spent dealing with parents accused of child abuse and neglect.
On one rainy Thursday last February, a clerk led a steady stream of mothers and fathers into Stephenss chambers, where he decided whether their children could remain with them. “In almost every case, the parents are addicted,” Stephens said later. “We have parents who are now choosing drugs over their own children.”
When the states suit against Purdue came before him in 2001, the cumulative U.S. death toll from opioids since 1999 was 16,000, according to the National Institute on Drug Abuse. Stephens, who served for more than three decades on the McDowell County court before his May retirement, still counts it as his most high-profile case.
During the discovery process, each side was obliged to send information requested by the other – including the Purdue documents describing the companys development and marketing of OxyContin. That exchange is where secrecy gets its start in lawsuits.
For decades, the rules of civil litigation required that evidence collected during discovery be logged with the court, open to public scrutiny. Secrecy was the exception.
In the 1980s and 1990s, rule changes moved discovery out of the courthouse and thus out of public view. Instead, the material was to be swapped privately between the lawyers involved. Companies eager to keep their records confidential had pushed for the change, but it also served the interests of judges and court clerks inundated with increasingly complex product-liability cases and huge caches of documents accompanying them.
In the early 2000s, under the new discovery rules, Purdues lawyers sent the companys documents directly to lawyers working for West Virginia, outside the court record and thus inaccessible to the public. This exchange occurred, as it almost always does, under the judges protective order that the material remain confidential.
Lawyers for Purdue filed a pretrial motion asking Judge Stephens to dismiss the case. West Virginia, to support its argument that the case should go to trial, submitted as evidence some of the documents Purdue had handed over in discovery.
Such evidence entered into the court record to support a pretrial motion is generally the only way, short of a trial, that discovery material is made public – though that evidence often represents only a tiny fraction of whats produced in discovery. Here, too, secrecy prevailed. Lawyers for Purdue and the state agreed between themselves that the state would file its motion and supporting evidence under seal. Stephens did not evaluate the material to determine whether secrecy was warranted, as required by state law, and he provided no rationale.
“Thats bananas,” said Jennifer Oliva, a professor at West Virginia University College of Law. “Hes not allowed to do that without providing reasons.”
Judge Stephens was no rogue outlier. At least 16 other judges allowed internal documents produced by Purdue in lawsuits filed between 2001 and 2007 to be sealed without explanation. Court records make clear that evidence under seal pertained to Purdues marketing.
More broadly, in at least 31 of the 115 large federal product-liability cases Reuters reviewed, judges sealed entire arguments that dealt directly with the strength of the evidence. Court rules frown on such broad sealing practices because truly confidential information rarely spans an entire legal brief. In most of those cases, nothing in the court record indicates that the judge conducted any analysis of whether secrecy was merited.
Almost immediately after Stephenss 2004 ruling that the evidence against Purdue was sufficient for the case to proceed to trial, Purdue settled with West Virginia for $10 million. Stephens left his sealing order intact. The evidence was locked away in a vault in McDowell County Courthouse. By the end of that year, opioid deaths neared 65,000.
Stephens told Reuters that he was simply honoring the litigants wishes. “Obviously when you settle a case of this magnitude and of this nature, Purdue Pharma would not want to let the world know they had engaged in deceptive marketing practices,” he said.
Frances Hughes, West Virginias chief deputy attorney general at the time, said the state agreed to Purdues sealing requests to get the evidence it needed and avoid a potentially lengthy court fight. “We were doing something that is very much routine and necessary when you are involved in litigation with a major corporation,” she said.
Many plaintiffs lawyers privy to evidence that could affect public health and safety told Reuters they had often employed a similar calculus. Bound by ethics rules to put their clients interests first, they want access to records that can help their cases. Demanding transparency can cause protracted delays.
Judges, while charged with guarding the public interest, also have large caseloads. At the federal level, their efficiency in handling those caseloads is measured by the Administrative Office of the U.S. Courts, the federal judiciarys management agency, but judges arent formally penalized for letting cases drag on.
Many judges want to avoid getting bogged down in confidentiality battles, said Jeremy Fogel, who as a judge until last year managed the Federal Judicial Center in Washington, D.C., an agency that helps educate judges.
“Youre overburdened. Youve got limited bandwidth. You have lawyers fighting about everything. And so, when they finally agree on something, youre all too happy to accept that,” said Fogel, now head of the Berkeley Judicial Institute at the University of California.
As a result, he said, “information that could have really made a difference sometimes doesnt come to light.”
LITTLE DATA, LITTLE SUNSHINE
In the years following Stephenss ruling, Purdue benefited from the secrecy that had shrouded the West Virginia and similar cases.
The U.S. Department of Justice in 2007 brought criminal charges against Purdue, accusing it of lying in its marketing about how easy it was to abuse OxyContin by crushing the pills to get their full narcotic payload all at once.
In a filing in federal court in Abingdon, Virginia, Purdue reasserted its 12-hour claim: “When taken as directed, without tampering with the products controlled-release delivery system, OxyContin is indisputably safe and effective.”
Under a plea bargain, three Purdue executives admitted guilt but served no time. The company paid $600 million to resolve the case. The three executives later left the company.
Company records that dribbled out over the years generated newspaper and government reports about aggressive sales tactics. But evidence undermining Purdues claims about OxyContin remained locked away in courthouses across the country. And Purdue continued marketing its drug based on the contested 12-hour claim.
OxyContin sales surged, topping $2 billion in 2008. Opioid deaths climbed to 135,000 by the end of 2008. The next year, Purdues 80-milligram Oxycontin pill, the largest-dose version, was the companys biggest moneymaker. That year, drugs – fueled by the spike in opioid overdoses – surpassed car accidents as a cause of death in the United States.
By then, Mississippi lawyer Philip Thomas was trying to bring information about Purdues marketing of OxyContin to the attention of regulators. Thomas represented Patricia Gwen Kiser, a nurse who alleged in a lawsuit against Purdue that her doctor had prescribed OxyContin for her fibromyalgia and arthritis pain based on the companys false claims about the drugs safety.
Purdue turned over more than 250 boxes of records to Thomas, designating most of the evidence confidential. Thomas asked Purdue to share just 21 of the documents – emails, meeting minutes and the script Purdue asked sales reps to use when pitching OxyContin to doctors – with the FDA. Purdue declined.
Thomas then asked Judge Linda Anderson, the judge hearing the case in federal court in Mississippi, to allow him to share the records with the regulator. Purdue resisted, arguing that the records were confidential trade secrets. Anderson, in a 2010 order, agreed with Purdue.
Anderson did not respond to a request for comment. In its statement to Reuters, Purdue said it provided “all or most” of the documents to the agency, though they “do not contain the type of scientific information” the agency usually relies on.
Some regulators have made efforts to counter the potential harm of court secrecy. In 2016, the National Highway Traffic Safety Administration (NHTSA) issued guidance for judges on allowing exemptions in secrecy orders so that lawyers can share health and safety records with the agency. The Consumer Product Safety Commission followed suit.
The FDA has not. In a statement to Reuters, the agency said the current regulatory regime gives it “the tools to keep patients and consumers safe.”
The year after NHTSA issued its guidance, the agency opened an investigation into possible safety defects in Goodyear tires on thousands of motor homes. In its December 2017 announcement, the agency said the inquiry, which is continuing, was made possible, in part, only after an Arizona judge allowed the release of the tire makers records, including insurance claims and complaints data.
Goodyear declined to comment, as did NHTSA.
In the absence of such exceptions, lawyers or anyone else with knowledge of confidential evidence put themselves at risk if they share that information outside the confines of court.
David Egilman was an expert witness in a lawsuit alleging Eli Lilly (NYSE:) & Cos antipsychotic drug Zyprexa could cause excessive weight gain and diabetes. Egilman, a clinical professor of family medicine at Brown University, made Lilly records he had reviewed in the case available to the New York Times.
After the newspaper published articles https://www.nytimes.com/2006/12/17/business/17drug.html based on the documents, Lilly threatened to seek criminal sanctions against Egilman. In 2007, he agreed to pay https://www.nytimes.com/2007/09/08/business/08lilly.html the drug maker $100,000 to resolve the matter. About a year later, Lilly pleaded guilty and agreed to pay $1.4 billion to resolve charges it had illegally marketed Zyprexa.
Lilly declined to comment.
Egilman had that earlier experience in mind when he sought to shine a light on OxyContin, which he had prescribed to a few patients in the drugs early days. While reviewing Purdues records as an expert witness in a lawsuit against the company, Egilman became convinced that doctors were getting the wrong message about OxyContin.
This time, he went to court to try to force Massachusetts Attorney General Martha Coakley to release evidence her office had gathered during an investigation into Purdues sales practices.