WELCH, West Virginia — 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 there’s 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 OxyContin’s 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 state’s lawyers who had requested them.
That evidence was clearly compelling: In a 2004 ruling, Judge Stephens rejected Purdue’s motion that he dismiss the case and sided with the state’s assertion that the material could convince a jury that Purdue’s 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 company’s 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. 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 don’t know how many lives we could have saved,” she said.
Stephens told Reuters he doesn’t second-guess his decision. “It happened, and that’s all that I can say about it,” he said. “It speaks for itself.”
CONTINUING THE TRADITION
Today, 15 years after Stephens protected Purdue’s 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 don’t convey the full extent of information locked away because they don’t 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 Co’s 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 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, it’s 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 litigant’s 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 & Johnson’s Janssen Pharmaceuticals subsidiary and Teva Pharmaceutical Industries Ltd, as well as Purdue, distributors like McKesson Corp, and retailers like Walgreen Co – 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 industry’s 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 Purdue’s 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 Stephens’s 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 state’s 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 company’s 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, Purdue’s lawyers sent the company’s 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 judge’s 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.
“That’s bananas,” said Jennifer Oliva, a professor at West Virginia University College of Law. “He’s 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 Purdue’s 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 Stephens’s 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 Virginia’s chief deputy attorney general at the time, said the state agreed to Purdue’s 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 judiciary’s management agency, but judges aren’t 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.
“You’re overburdened. You’ve got limited bandwidth. You have lawyers fighting about everything. And so, when they finally agree on something, you’re 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 doesn’t come to light.”
LITTLE DATA, LITTLE SUNSHINE
In the years following Stephens’s 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 product’s 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 Purdue’s 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, Purdue’s 80-milligram Oxycontin pill, the largest-dose version, was the company’s 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 Purdue’s 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 company’s false claims about the drug’s 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.
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 maker’s 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 & Co’s 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 based on the documents, Lilly threatened to seek criminal sanctions against Egilman. In 2007, he agreed to pay 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 drug’s early days. While reviewing Purdue’s 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 Purdue’s sales practices.
Massachusetts Superior Court Judge Linda Giles took a dim view of his petition, asking Egilman’s lawyer during a 2012 hearing, “What’s his agenda?” and “You want me to believe he’s some noble citizen?”
Sensing the case wasn’t going his way, Egilman said, he agreed to withdraw his petition rather than risk establishing an unfavorable precedent with a ruling that evidence collected in a state investigation was confidential.
“I could have stopped this,” Egilman said in an interview. “I am morally and ethically responsible. I took an oath to protect my patients’ health, not corporate profits.”
Coakley and Giles declined to comment.
By the end of 2012, the opioid death toll stood at 223,000.
The evidence that OxyContin wasn’t the benign pain reliever its maker said it was remained locked away until 2016. That year, the Los Angeles Times published a report, based on copies of sealed records, detailing how Purdue sold OxyContin as a 12-hour drug, even though the company knew it often didn’t last that long.
The report cited the company documents that Stephens and other judges had long kept under seal, revealing that OxyContin wore off early in Purdue test patients and that physicians complained to sales reps about the problem. Gaps in a narcotic’s effect can cause bouts of pain, withdrawal and relief known to foster addiction.
The sealed records further showed that despite what Purdue knew, it hired hundreds of sales reps to push OxyContin as a 12-hour drug because insurers would balk at paying top dollar for a pain reliever that was little different from cheaper alternatives.
After the Los Angeles Times report, Judge Stephens began releasing the records he had sealed in 2004 to news organizations that requested them, including Reuters. “I felt that it would be helpful to others who are going to pursue this type of litigation,” he said.
He was right. Many lawsuits against Purdue have cited the newspaper report and the original records.
When the opioid epidemic landed on Judge Polster’s docket in federal district court in Cleveland in late 2017, it had claimed 350,000 lives.
“What’s happening in our country with the opioid crisis is present and ongoing,” Polster told a courtroom packed with lawyers for a Jan. 9, 2018, hearing. “Since we’re losing more than 50,000 of our citizens every year, about 150 Americans are going to die today, just today, while we’re meeting.”
The judge said then, as he has said many times since, that he wanted the suits settled quickly so that communities ravaged by addiction can receive money to combat the crisis. “I don’t think anyone in the country is interested in a whole lot of finger-pointing,” Polster told the standing-room-only crowd. “People aren’t interested in depositions, and discovery, and trials.”
The tobacco industry settlement of 20 years ago, however, shows that when evidence is aired, it can have a big public impact. Under their landmark agreement with 46 states in 1998, cigarette makers paid $246 billion and divulged more than 26 million pages of records showing how they had manipulated nicotine to foster addiction and funded research to sway policy. That information formed the basis of public-health initiatives and regulatory action in 160 countries. Since then, smoking rates in the U.S. have plunged to historic lows.
Citing the tobacco archives, public interest lawyers recently filed a brief in Polster’s court asking that any resolution of the opioid litigation require the disclosure of all documents to promote research, changes in public policy, regulations and consumption.
In Polster’s court, as lawyers began fleshing out their cases against the opioid industry in amended complaints, they redacted details of the companies’ conduct. In almost every instance, Polster failed to provide on the record his reason for allowing the secrecy, though the U.S. Court of Appeals for the Sixth Circuit, which oversees his jurisdiction, has established precedent requiring that he do so.
A few courts, recognizing the breadth of the opioid crisis, have recently signaled a less tolerant stance on secrecy, putting them at odds with Polster.
Massachusetts Superior Court Judge Janet Sanders was presiding over a hearing in January on Purdue’s request to maintain hundreds of redactions in a lawsuit filed against it by the state. News organizations, including Reuters, had petitioned Sanders to lift the redactions.
Sanders reminded the lawyers that they were in the courthouse where records of child sexual abuse by Roman Catholic priests had been sealed – until the Boston Globe petitioned the court here for their release.
That case, she said, showed that even if the litigants on both sides want to keep evidence secret, the “court has to separately make a determination.”
Purdue’s lawyers argued that disclosure would stoke outrage and embarrass the company.
Noting the “tremendous” public interest in the information, Sanders said: “This material – some part of it or all of it – is going to come out one day. I’m not sure why it shouldn’t be sooner rather than later.”
Tony LaGreca, whose son fatally overdosed after becoming addicted to opioids prescribed for a football injury, was in the courtroom that day. “She was pretty awesome,” he said of Sanders. LaGreca said parents like him are eager for the world to see evidence placing some responsibility for addiction on the drug companies. “It should be all made public,” he said.
In an emergency motion filed in Polster’s Cleveland court, Purdue urged the judge to block Sanders from lifting the redactions. The Massachusetts lawsuit was full of details that could make the company look bad, a Purdue lawyer complained at a hearing, and the effort to get Judge Sanders in Boston to release them was an attempt to get around Polster’s secrecy order.
Polster sympathized. “I’m not very happy with the Massachusetts AG either,” he said. But he decided he didn’t have the power to overrule Sanders.
The next day, an unredacted version of the Massachusetts lawsuit was made public. The state used excerpts of emails between Purdue executives and board members and details from other records to bolster its main allegation: Purdue’s sales campaign was a “deadly and illegal scheme to deceive doctors and patients” that had contributed to at least 671 fatal overdoses in Massachusetts since 2009.
The unredacted material supported allegations that, after pledging reforms in the 2007 plea agreement with federal prosecutors, Purdue pressed doctors to prescribe OxyContin to the elderly and military veterans, groups vulnerable to addiction. The state also alleged that Purdue sought to boost prescriptions for bigger doses, even though a 2012 internal analysis acknowledged that the more potent pills “very likely” carried heightened “dose-related overdose risk.” The underlying analysis remains under seal.
Purdue denies the allegations.
The unredacted material shows why doctors continued to write historically high numbers of OxyContin prescriptions even as deaths mounted, said Harvard Medical School professor Jerry Avorn. “It helps patients and doctors understand why so much OxyContin is being used.”
Judge Sanders declined to comment on the case. In product-liability cases generally, “the public has very much right to know what’s going on,” she said. “Transparency gives assurance that what’s going on is fair … There’s no hanky-panky. There are no agreements between the parties that are contrary to the public interest.”
Polster has since ratcheted up the secrecy in his court. He signed a Feb. 11 order that allows litigants to designate any document as “highly confidential – attorneys’ eyes only information.” That bars disclosure to anyone – even the mayors and other state and local officials the lawyers represent – without signed permission from Polster or the litigant who produced it.
Last week, the Sixth U.S. Circuit Court of Appeals rebuked Polster for his secrecy orders, after the Washington Post and the Gazette-Mail of Charleston, West Virginia, appealed his sealing of government data on the flow of opioids around the country.
The three-judge panel unanimously agreed that Polster had not stated adequate reasons for allowing parties to file documents under seal, not just about the government data, but beyond. They ordered him to do so. Polster “is advised to bear in mind that the party seeking to file under seal must provide a ‘compelling reason’ to do so,” Judge Eric Clay wrote.
In the coming weeks, the plaintiffs will file their most extensive briefs yet about the opioid industry’s conduct. It will be up to Polster to decide what the public will be allowed to see.
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