How judges added to the grim toll of opioids – Reuters
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.
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 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.
Blame for the public-health disaster was now directed at the entire industry – drug makers, distributors and retailers. The allegations in the hundreds of cases consolidated in Polster’s court remained consistent: The companies hyped opioids for everyday pain relief, downplayed their addictiveness, and then blamed the people who used them for getting hooked.
“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 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.
Additional reporting by Charles Levinson, Andrea Januta, Erica Evans and Nathaniel Okun.
By Benjamin Lesser, Dan Levine, Lisa Girion and Jaimi Dowdell
Data: Benjamin Lesser, Jaimi Dowdell, Nathaniel Okun and Charlie Szymanski
Graphics: Feilding Cage
Photo editing: Steve McKinley
Design: Troy Dunkley and Charlie Szymanski
Edited by Janet Roberts and John Blanton