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

|

Moore had become familiar with the signs of an overdose sincehis nephew, for whom he’s a father figure, filled his firstlegal prescriptions in 2006 for Percocet, anopioid painkiller made by Endo Pharmaceuticals Inc. By2010, his nephew, who asked not to be named, was obtaining genericfentanyl on the street. Another synthetic analog to the opiumpoppy, fentanyl—the drug that killed Prince—is as much as 100 timesstronger than morphine. The night of the overdose, Moore’s nephewhad been wearing a fentanyl patch on his arm and sucking onanother. “An ordinary horse would have been dead,” Moore recalls inhis Mississippi drawl.

|

Related: CDC: Opioids are a last resort

|

Rather than waiting for an ambulance, Moore dragged his nephewto his car and raced toward the hospital. As doctors revived theunconscious man, the stares of the staff and other patients weremade worse for Moore by recognition. Once his home state’shighest-profile public official, now he was just one more Americanconfronting the opioid epidemic.

|

Moore, who’s 65, served as Mississippi’s attorney general from1988 to 2004. In 1994, using an untested and widely derided legalstrategy, he became the first state AG to sue tobacco companies forlying about nicotine addiction and hold them accountable for sicksmokers’ health-care costs. A Democrat, he marshaled AGs fromaround the country along with private plaintiffs’ lawyers who stoodto reap massive fees. He went on to negotiate the largest corporatelegal settlement in U.S. history: a 50-state, $246 billionagreement that funds smoking cessation and prevention programs tothis day. He even scored a Hollywood credit, playing himselfin The Insider, the 1999thriller about a tobacco industry whistleblower, starring Al Pacinoand Russell Crowe.

|

After his 16 years as AG, Moore left public service for aprivate-sector salary, opening a practice in the Jackson suburb ofFlowood. The Mike Moore LawFirm specializes in complex disputes between states andcompanies. This spring he finished helping oversee negotiationsbetween BP Plc and the federal government, five states,and 475 municipalities, which resulted in a $20 billion settlementfor damages from the Deepwater Horizon oil spill.

|

Continued on next page>>>

|

|

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

|

|

“It’s clear they’re not going to be part of the solution unlesswe drag them to the table”

On June 20, 1997, a coalition of state AGs stood behind a podiumin the grand ballroom of the ANA Hotel in Washington to announcethe culmination of a four-year effort. They’d filed so manyindividual, expensive lawsuits that tobacco companies were corneredinto negotiating a collective settlement instead of fighting eachone separately. The agreement punished the industry for pastmisconduct, created a fund to pay for tobacco-related medicalcosts, and banned using Joe Camel in advertisements. “We wantedthis industry to have to change the way they do business—and wehave done that,” a youthful Moore said to the roomful ofjournalists and cameras.

|

Twenty years later, in mid-July 2017, he was back at the samehotel, now a Fairmont. In a third-floor meeting room, he and morethan a dozen private attorneys sat around a rectangular conferencetable discussing strategies for the legal battle they’d helpedignite with companies that make, distribute, and sell opioids.

|

Aided by the lawyers in the room (and others, includinghigh-profile and high-profiting alumni of the tobacco wars, such asJoe Rice and Steve Berman), 10 states and dozens of cities andcounties have sued companies including Purdue Pharma, Endo,and Johnson & Johnson’s Janssen Pharmaceuticals—beginningin 2014 but mostly in the past few months. (Forty state AGs havelaunched preliminary investigations as a way to gauge the viabilityof litigation.) The suits allege that the companies triggered theopioid epidemic by minimizing the addiction and overdose risk ofpainkillers such as OxyContin, Percocet, and Duragesic. Opioidsdon’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, aquarter of which was paid by taxpayers through increased publiccosts for health care, criminal justice, and treatment. Theindustry, the suits contend, should bear the financial burden ofthis wreckage.

|

Paul Hanly Jr., a Manhattan attorney who’s filed on behalf ofalmost a dozen cities and counties, opened the discussion at theFairmont with lessons from previous suits. P. Rodney Jackson, alawyer from West Virginia, got heads nodding with hisrecommendation that suits targeting manufacturers should be amendedto add distributors who sell pills to pharmacies. A retired agentfrom the Drug Enforcement Administration, one of severalconsultants, laid out the fines that distributors and pharmacieshave already paid after failing to follow federal requirements toreport suspiciously large pill orders.

|

Continued on next page>>>

|

|

Officially, Moore’s name is listed only on cases filed byMississippi, which was the first state to sue, and Ohio. But thisbelies his outsize role in convening the like-minded whileenvisioning the long-term, big-picture strategy. “We’re trying tobuild coalitions, because it won’t get done with me and our littleteam,” he says, referring to a core group of longtime friends thatincludes former Arizona Attorney General Grant Woods, the firstRepublican AG to join the anti-tobacco crusade, and Chip Robertson,a former chief justice of the Supreme Court of Missouri who helpedhis state sue tobacco companies.

|

|

“If you ask Big Pharma right now, Mike Moore is thedevil”

Just as he did during the tobacco-litigation era, Moore has beentraversing the country to recruit people to his cause. His trip toWashington was one of more than 50 he estimates he’s taken in thepast six months to meet with hundreds of private attorneys, about30 AGs, and professionals in law enforcement and public health. Analumnus of Ole Miss, where he wore his hair long and jammed on asynthesizer in a rock band, Moore’s expertise is in glad-handingand dealmaking. “My talents are not writing briefs, they are notresearching the law,” he says. “I know people. I know how to dealwith people. I treat people fairly.”

|

Moore and his allies hope to corral at least 25 states to exertenough pressure, collect enough evidence, and drive potentialdamages so high that it will be cheaper for opioid manufacturers toback down. They’re confident that the epic scale of the crisisravaging the country has gotten too big to dodge. What was onceconsidered a problem only among the Appalachian poor now touchesevery demographic. The most recent data, from 2015, show the opioiddeath toll exceeded 33,000 that year.

|

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

While the governmentlawsuits filed so far target combinations of drug companies, theyconsistently single out Purdue. With its aggressive marketing ofOxyContin—the Kleenex or Google of opioids—Purdue established themarket as we know it and invented many of the practices thegovernment suits now seek to frame as unlawful.

Tenacious promotion is woven into Purdue’s DNA. In 1952 threebrothers, Arthur, Mortimer, and Raymond Sackler, all psychiatrists,bought a little-known laxative maker in New York. From it theybuilt the modern Purdue, still a family-owned company. During thoseearly years, Arthur Sackler pioneered now-common pharmaceuticalmarketing techniques—for example, sending “detailers,” orspecialized salesmen, to pay calls directly on physicians.

|

Continued on next page >>>

|

As recently as a quarter-century ago, few doctors prescribed theopium-derived drugs (and synthetic versions of them) for chronicpain related to backaches, headaches, or arthritis. This class ofmedications was distributed primarily to postoperative patients andthose dying of cancer. That wasn’t much of a market, though. In thelate 1980s a handful of researchers and pain doctors began to arguethat pain was vastly undertreated, and one company more than anyother—Purdue—grabbed the opportunity. Almost single-handedly, itturned what had been a niche product into one of the mostprescribed classes of drugs.

|

Outspoken experts such as Dr. Russell Portenoy, a New York-basedpain specialist, argued in journal articles and Purdue-paid talksto doctors that opioids weren’t inherently addictive and couldsafely be prescribed over extended periods. In 1995 the AmericanPain Society, a Purdue-funded group over which Portenoy laterpresided, urged physicians to monitor pain as a “fifth vital sign,”along with blood pressure, body temperature, pulse, andrespiration. In 1996, Purdue unveiled OxyContin, which pairedoxycodone, an opium derivative, with Continus, a time-releaseformula. Approving the pill, the U.S. Food and Drug Administrationaccepted Purdue’s contention that because the drug entered thebloodstream gradually, it wouldn’t cause the surging highs andsubsequent lows that kindle addiction.

|

Pseudoaddiction and other sales strategies

Purdue put its full energy into selling OxyContin, according toa U.S. Government Accountability Office report in 2003. The companydoubled the number of detailers devoted to the drug, from 318 in1996 to 767 in 2002. Total annual cash bonuses tied to sales soaredfrom $1 million to $40 million. Purdue directed its reps to call onprimary care physicians, despite their scant training in thetreatment of serious pain. In videos and publications, it relied ona dubious statistic—that only 1 percent of patients treated withnarcotics would become addicted—even though the figure came notfrom a peer-reviewed scientific study, but from a one-paragraph1980 letter to the editor in the New England Journal ofMedicine. The company gave away OxyContin-branded fishing hats,plush toys, and golf balls. Detailers handed out big-band music CDstitled Swing in the Right Direction with OxyContin, and 34,000coupons for a free one-time prescription.

|

Purdue also embraced a questionable condition called“pseudoaddiction,” which holds that behaviors normally associatedwith addiction—requesting drugs by name, displaying a demanding ormanipulative manner, or seeking out more than one doctor to obtainopioids—might be signals that a patient needs more pain medication,not less. The concept was promoted in a 2007 publicationcalled Responsible OpioidPrescribing, distributed by the Federation of State MedicalBoards and co-sponsored by Purdue. It had been coined almost twodecades earlier by a pain doctor named J. David Haddox. He became aPurdue employee in 1999 and remains vice president for healthpolicy. Purdue declined to make him available for comment, butcompany spokesman Robert Josephson contends that the FDA takes theconcept seriously. OxyContin’s FDA-approved label says“preoccupation … with achieving adequate pain relief can beappropriate behavior in a patient with poor pain control.”

|

The tactics worked. OxyContin sales rose from $45 million in1996 to more than $1.5 billion in 2002. But the drug’s huge successas a treatment for long-term chronic pain—and much of the marketingthat drove it—had no basis in meaningful science, according toAndrew Kolodny, a physician and co-director of opioid policyresearch at the Heller School for Social Policy and Management atBrandeis University. There was no controlled, double-blindresearch—and there’s none still—that supports the notion thatopioids are effective for treating chronic pain over a period ofmany months, let alone years. “For the vast majority of patients,the known, serious, and too-often-fatal risks far outweigh theunproven and transient benefits,” the CDC said in 2016.

States have tried to legally challenge opioid marketingpractices, aiming mostly at Purdue, since at least 2001. But theseearlier attempts produced only modest, piecemealsettlements—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 suitsinstigated in 2003 against Purdue by people who claimed they orloved ones got hooked on prescription opioids despite obtainingthem legally and taking them as directed. In conducting hisinvestigation, Moore visited pain clinics and interviewed users,doctors, and people who’d advertised and marketed the company’sdrugs. The effort ended in 2007 when claimants, represented bylawyers including Hanly, the Manhattan attorney, settled for $75million. Purdue admitted no wrongdoing, and the court agreed tokeep the corporate documents gathered in discovery confidential.The case may not have done much to waylay Purdue, but it did giveMoore early insight into how opioid litigation could work andhelped him establish connections with attorneys who are now amongthe most active filers.

|

Continued on next page >>>

|

In a federal criminal prosecution, also resolved in 2007, Purdueand three of its top executives pleaded guilty to “misbranding”OxyContin and collectively agreed to pay some $630 million in civiland criminal penalties. The company specifically acknowledged thatit trained its sales representatives to mislead physicians aboutopioid risks. Purdue emphasized that its plea covered misconductonly from 1995 through 2001. “We accept responsibility for thosepast misstatements and regret that they were made,” the companysaid.

|

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

|

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

Portenoy, thePurdue-affiliated pain doctor, recanted publicly in 2011, concedingthat research he relied on to push his and Purdue’s pro-opioidcampaign didn’t prove anything about the treatment of chronic pain.(He wrote in an email that no one “anticipated the widespreadoverdosing and medication misuse we see today.”) He and otherindustry-funded physicians, described as “key opinion leaders,” arenamed as defendants in a handful of the current governmentlawsuits.

Ohio is representative of how lethal andcostly the opioid epidemic has become and how thegovernment lawsuits work. In 2012 prescriptions reached a peak, 793million opioid doses, according to state statistics—enough tomedicate every resident with 68 pills apiece. Half of the state’sfoster-care population is made up of children with opioid-addictedparents, and the rate of babies born addicted to opioids grewalmost eightfold from 2006 to 2015. In 2014, Ohio Attorney GeneralMike DeWine, a Republican, began considering litigation. With hisown office lacking manpower and expertise, he invited pitches froma half-dozen teams of outside lawyers. Moore’s group won theassignment.

|

Filed in May in state court, Ohio’s suit accuses drugmakers of“borrowing a page from Big Tobacco’s playbook” by concealingaddiction risks. According to the state, Purdue, TevaPharmaceutical Industries, Janssen, Endo,and Allergan invested millions to change attitudes aboutopioid prescribing. Janssen distributed a patient education guidecalling opioid addiction a “myth,” for example, while Endoadvertised that an abuse-deterrent reformulation of one of its mostpopular opioids, Opana ER, made it crush-resistant, despite its ownstudies disproving that claim. From 2001 through 2015, Purduehosted the website inthefaceofpain.com, whichpromoted “the notion that if a patient’s doctor does not prescribewhat, in the patient’s view, is a sufficient dosage of opioids, heor she should find another doctor who will.”

|

Ohio accuses the companies of creating a public nuisance,violating state laws against unfair sales practices, and committingMedicaid fraud by spurring unnecessary prescriptions that the statereimbursed. The conduct dates to at least 1996 and continuesthrough the present, says Jonathan Blanton, who heads the AG’sconsumer protection unit. The companies, DeWine says, have reapedunjust profits while devastating communities and fueling a heroinresurgence. “It’s clear they’re not going to be part of thesolution unless we drag them to the table.”

|

Like most of the current lawsuits, Ohio’s complaint isn’tspecific about how much money it aims to recoup. But Ronny Gal, ananalyst at Sanford C. Bernstein & Co., views thelitigation as a material threat to companies, with potentialaggregate damages “in the many billions.”

|

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

|

Continued on next page>>>

|

|

Denying any wrongdoing, all of the companies say they want tohelp resolve the crisis, but not through litigation, which theycall wasteful and unfair. “We firmly believe the allegations inthese lawsuits are both legally and factually unfounded,” Janssenspokesman William Foster says in a representative statement.“Janssen has acted responsibly and in the best interests ofpatients and physicians with regard to these medicines.” The onlycompany willing to discuss the litigation on the record—as opposedto issuing a boilerplate statement—is Purdue. It declined to makeany executives available for interviews or allow a reporter tovisit its headquarters in Stamford, Conn., but it dispatchedJosephson and an outside lawyer to discuss the cases. Purdue hasthe most to lose: More than half of its revenue comes from opioids,Josephson says. It doesn’t release financial information, butSanford C. Bernstein & Co. estimates that OxyContin alonegenerated sales of $1.3 billion in 2016. (Opioid sales overalltotaled $8.6 billion last year, up from $1.1 billion in 1992,according to Quintiles IMS Holdings Inc.) Of drugs made by theother 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 itsrevenue from opioids and could stop making them tomorrow withbarely any impact on its bottom line.

|

A key defense that Purdue and the other opioid makers have todeploy involves causation. The companies contend that between thetime a manufacturer sells pills to a wholesaler and when thosepills cause social harm, several other actors—pharmacies,prescribing doctors (some negligent or even criminal), drugabusers, and pill traffickers—break the chain of causation. Suitsfiled by municipalities against firearm manufacturers in the late1990s failed, in part, because some judges ruled that gunmakersshouldn’t be held liable for the misuse of their otherwise lawfulproducts. For a pistol to be misused, another actor—a criminal, asuicide, 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.

|

|

“When this is all said and done, all the companies will be suedone way or the other”

Purdue and its rivals also argue that the evidence, even ifincriminating, is too old. In the opioid cases, many of theallegations are based on events—such as the publication of suspectmedical 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 letterabout its marketing since 2003—“14 years!” he adds for emphasis. Healso complains that the suits fail to give Purdue credit forswitching in 2010 to a new “abuse-deterrent” version of OxyContinthat’s more difficult for addicts to crush, break, or dissolve. Onits website, the company calls itself “the new Purdue Pharma,”which “has learned from the past and is focused on the future.” Itsays it’s investing in research and development for non-opioid painmedication, has widely disseminated the CDC guidelines forprescribing among doctors and pharmacists, and joined with theNational Sheriffs’ Association in an $850,000 program toprovide naloxone kits and training for policeofficers.

|

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

|

While generic medicines cause harm, they generally aren’tpromoted, Moore says. Going after the branded manufacturers makessense because they created the environment in which generics laterthrived. Even so, he adds, “When this is all said and done, all thecompanies will be sued one way or the other.”

|

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

|

Doctors administered intravenous morphine while he was inintensive care; once at home, he received prescriptions for variouscombinations of Percocet, Norco, Dilaudid, fentanyl, and Demerol.About a year and a half later, while working full time as a managerat a Nissan auto plant in Jackson, he began finishing a month’sworth of medication after only three weeks, then two weeks, as histolerance increased. Soon he was turning to the black market forLortabs, hydrocodone, and fentanyl patches. At one point, during anappointment to which Moore accompanied him, a doctor assured himthat he suffered from pseudoaddiction—and needed not fewer opioids,but more.

|

After seven years, two stints in detox, and dozens of trips tothe hospital following overdoses or suffering from debilitatingwithdrawals, he says it was his move to Mississippi’s Gulf Coast tobe closer to family that enabled him to gain some control over hisaddiction. He’s now 37. Despite his history, he still has aprescription for the opioid Opana IR, which he’s convinced he canuse sparingly because his fear of going through withdrawal again isgreater than his desire for the drug.

|

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

|

“If you ask Big Pharma right now, Mike Moore is the devil,” saysRobertson, the former chief justice of Missouri. “But they haven’ttalked to him. And when they sit down, he’s going to walk in andsay, ‘We’ve got a business problem. Let’s figure out a businesssolution.’ ”

|

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

|

Copyright 2018 Bloomberg. All rightsreserved. This material may not be published, broadcast, rewritten,or redistributed.

Complete your profile to continue reading and get FREE access to BenefitsPRO, part of your ALM digital membership.

  • Critical BenefitsPRO information including cutting edge post-reform success strategies, access to educational webcasts and videos, resources from industry leaders, and informative Newsletters.
  • Exclusive discounts on ALM, BenefitsPRO magazine and BenefitsPRO.com events
  • Access to other award-winning ALM websites including ThinkAdvisor.com and Law.com
NOT FOR REPRINT

© 2024 ALM Global, LLC, All Rights Reserved. Request academic re-use from www.copyright.com. All other uses, submit a request to [email protected]. For more information visit Asset & Logo Licensing.