The Lawyer Who Beat Big Tobacco Takes On the Opioid Industry

Mike Moore made cigarette companies pay for the high cost of treating smokers. Here he comes again.

https://www.bloomberg.com/news/features/2017-10-05/the-lawyer-who-beat-big-tobacco-takes-on-the-opioid-industry

Seven years ago, Mike Moore stepped from the 2 a.m. darkness into the light of a small home off Lakeland Drive in Jackson, Miss., to find his nephew close to death. The 250-pound 30-year-old was slumped on the living room couch, his face pale, breath shallow, and chest wet with vomit. It was his fiancée who’d called Moore, waking him in a panic. Now they were both screaming in the man’s ears, dousing him with ice cubes and water, and pinching him as his respiratory system began to collapse.

Moore had become familiar with the signs of an overdose since his nephew, for whom he’s a father figure, filled his first legal prescriptions in 2006 for Percocet, an opioid painkiller made by Endo Pharmaceuticals Inc. By 2010, his nephew, who asked not to be named, was obtaining generic fentanyl on the street. Another synthetic analog to the opium poppy, fentanyl—the drug that killed Prince—is as much as 100 times stronger than morphine. The night of the overdose, Moore’s nephew had been wearing a fentanyl patch on his arm and sucking on another. “An ordinary horse would have been dead,” Moore recalls in his Mississippi drawl.

Rather than waiting for an ambulance, Moore dragged his nephew to his car and raced toward the hospital. As doctors revived the unconscious man, the stares of the staff and other patients were made worse for Moore by recognition. Once his home state’s highest-profile public official, now he was just one more American confronting the opioid epidemic.

Moore, who’s 65, served as Mississippi’s attorney general from 1988 to 2004. In 1994, using an untested and widely derided legal strategy, he became the first state AG to sue tobacco companies for lying about nicotine addiction and hold them accountable for sick smokers’ health-care costs. A Democrat, he marshaled AGs from around the country along with private plaintiffs’ lawyers who stood to reap massive fees. He went on to negotiate the largest corporate legal settlement in U.S. history: a 50-state, $246 billion agreement that funds smoking cessation and prevention programs to this day. He even scored a Hollywood credit, playing himself in The Insider, the 1999 thriller about a tobacco industry whistleblower, starring Al Pacino and Russell Crowe.

After his 16 years as AG, Moore left public service for a private-sector salary, opening a practice in the Jackson suburb of Flowood. The Mike Moore Law Firm specializes in complex disputes between states and companies. This spring he finished helping oversee negotiations between BP Plc and the federal government, five states, and 475 municipalities, which resulted in a $20 billion settlement for damages from the Deepwater Horizon oil spill.

Moore now lives near Orlando, with his wife, four rescue dogs, and Jade, a capuchin monkey. He’s remained immersed in anti-tobacco efforts, chairing such nonprofits as the Partnership for a Healthy Mississippi and the Truth Initiative. But as he’s watched the tobacco victory pay off in declining smoking rates, he’s also seen easy access to powerful pain medication spark a new deadly crisis. He’s convinced this is the moment to work the same mechanisms on the drug companies that forced the tobacco industry to heel—and he’s committed himself to making that happen.

On June 20, 1997, a coalition of state AGs stood behind a podium in the grand ballroom of the ANA Hotel in Washington to announce the culmination of a four-year effort. They’d filed so many individual, expensive lawsuits that tobacco companies were cornered into negotiating a collective settlement instead of fighting each one separately. The agreement punished the industry for past misconduct, created a fund to pay for tobacco-related medical costs, and banned using Joe Camel in advertisements. “We wanted this industry to have to change the way they do business—and we have done that,” a youthful Moore said to the roomful of journalists and cameras.

Twenty years later, in mid-July 2017, he was back at the same hotel, now a Fairmont. In a third-floor meeting room, he and more than a dozen private attorneys sat around a rectangular conference table discussing strategies for the legal battle they’d helped ignite with companies that make, distribute, and sell opioids.

Aided by the lawyers in the room (and others, including high-profile and high-profiting alumni of the tobacco wars, such as Joe Rice and Steve Berman), 10 states and dozens of cities and counties have sued companies including Purdue Pharma, Endo, and Johnson & Johnson’s Janssen Pharmaceuticals—beginning in 2014 but mostly in the past few months. (Forty state AGs have launched preliminary investigations as a way to gauge the viability of litigation.) The suits allege that the companies triggered the opioid epidemic by minimizing the addiction and overdose risk of painkillers such as OxyContin, Percocet, and Duragesic. Opioids don’t just cause problems when they’re misused, the suits argue: They do so when used as directed, too.

The opioid epidemic cost the U.S. economy $78.5 billion in 2013, according to the U.S. Centers for Disease Control and Prevention, a quarter of which was paid by taxpayers through increased public costs for health care, criminal justice, and treatment. The industry, the suits contend, should bear the financial burden of this wreckage.

Paul Hanly Jr., a Manhattan attorney who’s filed on behalf of almost a dozen cities and counties, opened the discussion at the Fairmont with lessons from previous suits. P. Rodney Jackson, a lawyer from West Virginia, got heads nodding with his recommendation that suits targeting manufacturers should be amended to add distributors who sell pills to pharmacies. A retired agent from the Drug Enforcement Administration, one of several consultants, laid out the fines that distributors and pharmacies have already paid after failing to follow federal requirements to report suspiciously large pill orders.

Officially, Moore’s name is listed only on cases filed by Mississippi, which was the first state to sue, and Ohio. But this belies his outsize role in convening the like-minded while envisioning the long-term, big-picture strategy. “We’re trying to build coalitions, because it won’t get done with me and our little team,” he says, referring to a core group of longtime friends that includes former Arizona Attorney General Grant Woods, the first Republican AG to join the anti-tobacco crusade, and Chip Robertson, a former chief justice of the Supreme Court of Missouri who helped his state sue tobacco companies.

Just as he did during the tobacco-litigation era, Moore has been traversing the country to recruit people to his cause. His trip to Washington was one of more than 50 he estimates he’s taken in the past six months to meet with hundreds of private attorneys, about 30 AGs, and professionals in law enforcement and public health. An alumnus of Ole Miss, where he wore his hair long and jammed on a synthesizer in a rock band, Moore’s expertise is in glad-handing and dealmaking. “My talents are not writing briefs, they are not researching the law,” he says. “I know people. I know how to deal with people. I treat people fairly.”

Moore and his allies hope to corral at least 25 states to exert enough pressure, collect enough evidence, and drive potential damages so high that it will be cheaper for opioid manufacturers to back down. They’re confident that the epic scale of the crisis ravaging the country has gotten too big to dodge. What was once considered a problem only among the Appalachian poor now touches every demographic. The most recent data, from 2015, show the opioid death toll exceeded 33,000 that year.

The goal, according to Moore, isn’t to simply win a pile of money to be allocated haphazardly into government coffers. One of his regrets from the cigarette windfall is that some of the money didn’t go where intended. This time, he wants a comprehensive, company-funded national program that would make treatment more widely available—currently just 1 in 10 addicts has access—as well as expand prevention education and force a change in doctors’ prescribing habits. Despite having fallen since its 2010 peak, the number of opioid prescriptions in 2015 was three times what it was in 1999, the CDC says.

“Litigation is a blunt instrument; it’s not a surgical tool,” Moore says. “But it provokes interest quicker than anything I’ve ever seen.”

While the government lawsuits filed so far target combinations of drug companies, they consistently single out Purdue. With its aggressive marketing of OxyContin—the Kleenex or Google of opioids—Purdue established the market as we know it and invented many of the practices the government suits now seek to frame as unlawful.

Tenacious promotion is woven into Purdue’s DNA. In 1952 three brothers, Arthur, Mortimer, and Raymond Sackler, all psychiatrists, bought a little-known laxative maker in New York. From it they built the modern Purdue, still a family-owned company. During those early years, Arthur Sackler pioneered now-common pharmaceutical marketing techniques—for example, sending “detailers,” or specialized salesmen, to pay calls directly on physicians.

As recently as a quarter-century ago, few doctors prescribed the opium-derived drugs (and synthetic versions of them) for chronic pain related to backaches, headaches, or arthritis. This class of medications was distributed primarily to postoperative patients and those dying of cancer. That wasn’t much of a market, though. In the late 1980s a handful of researchers and pain doctors began to argue that pain was vastly undertreated, and one company more than any other—Purdue—grabbed the opportunity. Almost single-handedly, it turned what had been a niche product into one of the most prescribed classes of drugs.

Outspoken experts such as Dr. Russell Portenoy, a New York-based pain specialist, argued in journal articles and Purdue-paid talks to doctors that opioids weren’t inherently addictive and could safely be prescribed over extended periods. In 1995 the American Pain Society, a Purdue-funded group over which Portenoy later presided, urged physicians to monitor pain as a “fifth vital sign,” along with blood pressure, body temperature, pulse, and respiration. In 1996, Purdue unveiled OxyContin, which paired oxycodone, an opium derivative, with Continus, a time-release formula. Approving the pill, the U.S. Food and Drug Administration accepted Purdue’s contention that because the drug entered the bloodstream gradually, it wouldn’t cause the surging highs and subsequent lows that kindle addiction.

Purdue put its full energy into selling OxyContin, according to a U.S. Government Accountability Office report in 2003. The company doubled the number of detailers devoted to the drug, from 318 in 1996 to 767 in 2002. Total annual cash bonuses tied to sales soared from $1 million to $40 million. Purdue directed its reps to call on primary care physicians, despite their scant training in the treatment of serious pain. In videos and publications, it relied on a dubious statistic—that only 1 percent of patients treated with narcotics would become addicted—even though the figure came not from a peer-reviewed scientific study, but from a one-paragraph 1980 letter to the editor in the New England Journal of Medicine. The company gave away OxyContin-branded fishing hats, plush toys, and golf balls. Detailers handed out big-band music CDs titled Swing in the Right Direction with OxyContin, and 34,000 coupons for a free one-time prescription.

Purdue also embraced a questionable condition called “pseudoaddiction,” which holds that behaviors normally associated with addiction—requesting drugs by name, displaying a demanding or manipulative manner, or seeking out more than one doctor to obtain opioids—might be signals that a patient needs more pain medication, not less. The concept was promoted in a 2007 publication called Responsible Opioid Prescribing, distributed by the Federation of State Medical Boards and co-sponsored by Purdue. It had been coined almost two decades earlier by a pain doctor named J. David Haddox. He became a Purdue employee in 1999 and remains vice president for health policy. Purdue declined to make him available for comment, but company spokesman Robert Josephson contends that the FDA takes the concept seriously. OxyContin’s FDA-approved label says “preoccupation … with achieving adequate pain relief can be appropriate behavior in a patient with poor pain control.”

The tactics worked. OxyContin sales rose from $45 million in 1996 to more than $1.5 billion in 2002. But the drug’s huge success as a treatment for long-term chronic pain—and much of the marketing that drove it—had no basis in meaningful science, according to Andrew Kolodny, a physician and co-director of opioid policy research at the Heller School for Social Policy and Management at Brandeis University. There was no controlled, double-blind research—and there’s none still—that supports the notion that opioids are effective for treating chronic pain over a period of many months, let alone years. “For the vast majority of patients, the known, serious, and too-often-fatal risks far outweigh the unproven and transient benefits,” the CDC said in 2016.

States have tried to legally challenge opioid marketing practices, aiming mostly at Purdue, since at least 2001. But these earlier attempts produced only modest, piecemeal settlements—including $10 million for West Virginia in 2004, and $19.5 million for 26 states and Washington, D.C., in 2007.

In private practice, Moore was involved in a cluster of suits instigated in 2003 against Purdue by people who claimed they or loved ones got hooked on prescription opioids despite obtaining them legally and taking them as directed. In conducting his investigation, Moore visited pain clinics and interviewed users, doctors, and people who’d advertised and marketed the company’s drugs. The effort ended in 2007 when claimants, represented by lawyers including Hanly, the Manhattan attorney, settled for $75 million. Purdue admitted no wrongdoing, and the court agreed to keep the corporate documents gathered in discovery confidential. The case may not have done much to waylay Purdue, but it did give Moore early insight into how opioid litigation could work and helped him establish connections with attorneys who are now among the most active filers.

In a federal criminal prosecution, also resolved in 2007, Purdue and three of its top executives pleaded guilty to “misbranding” OxyContin and collectively agreed to pay some $630 million in civil and criminal penalties. The company specifically acknowledged that it trained its sales representatives to mislead physicians about opioid risks. Purdue emphasized that its plea covered misconduct only from 1995 through 2001. “We accept responsibility for those past misstatements and regret that they were made,” the company said.

More than a dozen years of scattershot litigation “accomplished absolutely zero” in terms of preventing or stemming the crisis, says Woods, the former Arizona AG and Moore ally. “Some lawyers made money. States put some money in coffers. But the problem is greater today than it’s ever been.” The difference this time, Woods and his colleagues say, is that such a large group will pool their resources and evidence.

Most of the current lawsuits target multiple companies based on the allegation that while Purdue pioneered misleading marketing tactics, its competitors subsequently replicated them as sales of OxyContin exploded. The complaints charge that Purdue and its rivals never stopped their alleged campaign of misinformation carried out by means of industry-funded experts and pamphlets, online publications, and medical educational programs. (Josephson declined to comment on any of Purdue’s marketing tactics, citing the pending litigation.)

Portenoy, the Purdue-affiliated pain doctor, recanted publicly in 2011, conceding that research he relied on to push his and Purdue’s pro-opioid campaign didn’t prove anything about the treatment of chronic pain. (He wrote in an email that no one “anticipated the widespread overdosing and medication misuse we see today.”) He and other industry-funded physicians, described as “key opinion leaders,” are named as defendants in a handful of the current government lawsuits.

Ohio is representative of how lethal and costly the opioid epidemic has become and how the government lawsuits work. In 2012 prescriptions reached a peak, 793 million opioid doses, according to state statistics—enough to medicate every resident with 68 pills apiece. Half of the state’s foster-care population is made up of children with opioid-addicted parents, and the rate of babies born addicted to opioids grew almost eightfold from 2006 to 2015. In 2014, Ohio Attorney General Mike DeWine, a Republican, began considering litigation. With his own office lacking manpower and expertise, he invited pitches from a half-dozen teams of outside lawyers. Moore’s group won the assignment.

Filed in May in state court, Ohio’s suit accuses drugmakers of “borrowing a page from Big Tobacco’s playbook” by concealing addiction risks. According to the state, Purdue, Teva Pharmaceutical Industries, Janssen, Endo, and Allergan invested millions to change attitudes about opioid prescribing. Janssen distributed a patient education guide calling opioid addiction a “myth,” for example, while Endo advertised that an abuse-deterrent reformulation of one of its most popular opioids, Opana ER, made it crush-resistant, despite its own studies disproving that claim. From 2001 through 2015, Purdue hosted the website inthefaceofpain.com, which promoted “the notion that if a patient’s doctor does not prescribe what, in the patient’s view, is a sufficient dosage of opioids, he or she should find another doctor who will.”

Ohio accuses the companies of creating a public nuisance, violating state laws against unfair sales practices, and committing Medicaid fraud by spurring unnecessary prescriptions that the state reimbursed. The conduct dates to at least 1996 and continues through the present, says Jonathan Blanton, who heads the AG’s consumer protection unit. The companies, DeWine says, have reaped unjust profits while devastating communities and fueling a heroin resurgence. “It’s clear they’re not going to be part of the solution unless we drag them to the table.”

Like most of the current lawsuits, Ohio’s complaint isn’t specific about how much money it aims to recoup. But Ronny Gal, an analyst at Sanford C. Bernstein & Co., views the litigation as a material threat to companies, with potential aggregate damages “in the many billions.”

While the evidence marshaled by Ohio and other plaintiff governments is compellingly grim, whistleblowers and smoking-gun documents would help turn these suits into tobacco-scale winners. Moore predicts that insiders willing to testify are bound to materialize as plaintiffs’ lawyers continue to investigate. Jeffrey Wigand, a star whistleblower (and subject of The Insider), didn’t emerge until a year after Moore filed suit on behalf of Mississippi in 1994.

Denying any wrongdoing, all of the companies say they want to help resolve the crisis, but not through litigation, which they call wasteful and unfair. “We firmly believe the allegations in these lawsuits are both legally and factually unfounded,” Janssen spokesman William Foster says in a representative statement. “Janssen has acted responsibly and in the best interests of patients and physicians with regard to these medicines.” The only company willing to discuss the litigation on the record—as opposed to issuing a boilerplate statement—is Purdue. It declined to make any executives available for interviews or allow a reporter to visit its headquarters in Stamford, Conn., but it dispatched Josephson and an outside lawyer to discuss the cases. Purdue has the most to lose: More than half of its revenue comes from opioids, Josephson says. It doesn’t release financial information, but Sanford C. Bernstein & Co. estimates that OxyContin alone generated sales of $1.3 billion in 2016. (Opioid sales overall totaled $8.6 billion last year, up from $1.1 billion in 1992, according to Quintiles IMS Holdings Inc.) Of drugs made by the other four most commonly named defendants in the government suits, the next biggest was Johnson & Johnson’s Duragesic (fentanyl), with sales of $288 million. J&J derives 0.4 percent of its revenue from opioids and could stop making them tomorrow with barely any impact on its bottom line.

A key defense that Purdue and the other opioid makers have to deploy involves causation. The companies contend that between the time a manufacturer sells pills to a wholesaler and when those pills cause social harm, several other actors—pharmacies, prescribing doctors (some negligent or even criminal), drug abusers, and pill traffickers—break the chain of causation. Suits filed by municipalities against firearm manufacturers in the late 1990s failed, in part, because some judges ruled that gunmakers shouldn’t be held liable for the misuse of their otherwise lawful products. For a pistol to be misused, another actor—a criminal, a suicide, or a curious child—has to intervene and pull the trigger. Similarly, when opioids are misused, blame should rest elsewhere, says Mark Cheffo, one of Purdue’s outside lawyers.

Purdue and its rivals also argue that the evidence, even if incriminating, is too old. In the opioid cases, many of the allegations are based on events—such as the publication of suspect medical literature—that took place 10 years or more in the past, beyond some states’ statutes of limitations on proving fraud. Josephson says the company hasn’t received an FDA warning letter about its marketing since 2003—“14 years!” he adds for emphasis. He also complains that the suits fail to give Purdue credit for switching in 2010 to a new “abuse-deterrent” version of OxyContin that’s more difficult for addicts to crush, break, or dissolve. On its website, the company calls itself “the new Purdue Pharma,” which “has learned from the past and is focused on the future.” It says it’s investing in research and development for non-opioid pain medication, has widely disseminated the CDC guidelines for prescribing among doctors and pharmacists, and joined with the National Sheriffs’ Association in an $850,000 program to provide naloxone kits and training for police officers.

Another defense is that the states and localities should really be suing the makers of generic painkillers. Of the roughly 234 million annual opioid prescriptions, only 4 million, or 1.7 percent, are for Purdue drugs. “We don’t see how you solve this problem when you don’t have the biggest players involved,” Josephson says.

While generic medicines cause harm, they generally aren’t promoted, Moore says. Going after the branded manufacturers makes sense because they created the environment in which generics later thrived. Even so, he adds, “When this is all said and done, all the companies will be sued one way or the other.”

Moore’s nephew first became acquainted with opioids at 26, after he woke up from a four-day medically induced coma following an altercation with his then-girlfriend that ended with him being shot in the chest with his own .45. Neither party filed charges, and his recollection of the night is so hazy he doesn’t know who pulled the trigger. The gunshot caused extensive damage to his subclavian artery and surrounding nerves that would require almost 30 operations.

Doctors administered intravenous morphine while he was in intensive care; once at home, he received prescriptions for various combinations of Percocet, Norco, Dilaudid, fentanyl, and Demerol. About a year and a half later, while working full time as a manager at a Nissan auto plant in Jackson, he began finishing a month’s worth of medication after only three weeks, then two weeks, as his tolerance increased. Soon he was turning to the black market for Lortabs, hydrocodone, and fentanyl patches. At one point, during an appointment to which Moore accompanied him, a doctor assured him that he suffered from pseudoaddiction—and needed not fewer opioids, but more.

After seven years, two stints in detox, and dozens of trips to the hospital following overdoses or suffering from debilitating withdrawals, he says it was his move to Mississippi’s Gulf Coast to be closer to family that enabled him to gain some control over his addiction. He’s now 37. Despite his history, he still has a prescription for the opioid Opana IR, which he’s convinced he can use sparingly because his fear of going through withdrawal again is greater than his desire for the drug.

Moore acknowledges that weak regulation, lax prescribing practices, and abuse play a role in his nephew’s and the nation’s addiction problem. “But a huge part of it is because of the externalities of greedy companies. It wasn’t enough to make this much money,” he says, holding his hands a foot apart. “They wanted to make this much money,” he says, widening his arms as far they’ll go.

“If you ask Big Pharma right now, Mike Moore is the devil,” says Robertson, the former chief justice of Missouri. “But they haven’t talked to him. And when they sit down, he’s going to walk in and say, ‘We’ve got a business problem. Let’s figure out a business solution.’ ”

Moore is confident that the opioid industry will be driven to negotiate for the same reasons tobacco companies were: to end the demonization and obtain financial predictability. “The vilification of this industry has not even begun yet,” he says. “In other words: This litigation will vilify them. It won’t make the companies look like they’re legitimate businesspeople. It’ll make them look like they took advantage and made billions of dollars on lots of people who died from their products. And they can claim misuse and abuse all they want to—it’s too many.”

Filed under: General Problems