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Thread: The Opiod Crisis

  1. #26
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    The opioid manufacturer Insys Therapeutics agreed to pay $225 million to settle federal criminal and civil charges that it illegally marketed a highly addictive fentanyl painkiller to doctors, federal prosecutors said on Wednesday.

    As part of the deal, a subsidiary of Insys will plead guilty to five counts of mail fraud and the company will pay a $2 million fine and $28 million in forfeiture, according to a statement from the United States attorney’s office in Massachusetts. The company will also pay $195 million to settle allegations that it violated the federal False Claims Act, which involves defrauding the federal government through drug sales to health care programs like Medicare.

    A month ago, a federal jury in Boston found the company’s top executives, including the founder, John Kapoor, guilty of conspiring to fuel sales of the drug, Subsys, by bribing doctors and misleading insurance companies.

    Insys said in a statement that it believed the settlement was in the best interest of the company and its stakeholders.

    The prosecution of Insys and its executives provides the latest example of the federal government’s recent crackdown on drug makers and others as it seeks to hold them accountable for the nation’s opioid epidemic, which has led to more than 200,000 overdoses in the past two decades.

    Dozens of states are suing opioid manufacturers and distributors over their roles in the crisis, with some — including the state attorneys general of New York and Massachusetts — showing a willingness to go after individuals, like members of the Sackler family who own Purdue Pharma, the maker of OxyContin.

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    On Wednesday, prosecutors said Insys’ egregious behavior required action. “For years, Insys engaged in prolonged, illegal conduct that prioritized its profits over the health of thousands of patients who relied on it,” Andrew E. Lelling, the United States attorney for the District of Massachusetts, said in a statement. “Today, the company is being held responsible for that and for its role in fueling the opioid epidemic.”

    Prosecutors said that from August 2012 to June 2015, Insys used phony “speaker programs” to spread the word about its newly approved product, Subsys, which is a form of fentanyl that is sprayed under the tongue. The powerful painkiller was approved only for use in patients with cancer who were already using round-the-clock opioids, but the company quickly began marketing the product to a broader range of patients, prosecutors said, and used lavish dinners and other events to entice doctors to prescribe more of its product.

    The prosecutors cited one example of a physician assistant in New Hampshire who did not write any prescriptions for Subsys until after May 2013, when he joined the company’s speaker program. After joining the speaker program, he wrote 672 Subsys prescriptions and was paid $44,000 from Insys, which prosecutors said amounted to illegal kickbacks.

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    The company’s legal troubles have battered its financial outlook, and in May, Insys told investors that its legal costs might force it into bankruptcy. One year ago, Insys stock was trading at about $7; when the markets closed on Wednesday — before news of the settlement — shares were trading at 86 cents.

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    Now there is an Opioid Lawsuit in Nevada

    LAS VEGAS (KLAS) -- Nevada Attorney General Aaron Ford announced Monday the state has filed an expansive lawsuit against manufacturers and distributors of opioids.

    Local and state governments around the country, including in Nevada, are suing pharmaceutical companies as authorities try to get a handle on the opioid crisis.

    And as we learned, the Silver State is doubling down on its efforts.

    "Every single Nevadan has been affected by the opioid crisis in some way," Nevada Attorney General Aaron Ford said at a morning news conference.

    Flanked by law enforcement and local leaders, his message was very direct:

    "These companies lied to us and thousands of people have died because of their greed."

    His office has filed a 240-page lawsuit against more than 40 entities naming opioid manufacturers, marketers and pharmacies as defendants.

    "For years, these companies have used fake science, fake medical associations, fake publications, fake experts, fake medical conditions, and all to deceive our doctors into thinking that these drugs were safe," Ford said.

    READ: 8 News Now has done extensive coverage of the opioid crisis

    The result -- Ford and others allege -- people are dying or are in need of treatment leaving local jurisdictions, like Clark County, on the hook to deal with the problem. Commission Chair Marilyn Kirkpatrick says the county has spent $100 million in areas related to opioids in just the past two years.

    "Social services, a huge piece of it, whether it's children and Child Haven, because their parents have a substance abuse problem, whether it's in our jails..." Kirkpatrick said.

    "And we know that the answer to this problem is not arrest, the answer to this problem is counseling resources and medical benefits outside of opioids for us to be successful," said Sheriff Joe Lombardo.

    The litigation replaces a prior civil suit against Purdue Pharmaceuticals filed during former Attorney General Adam Laxalt's tenure. The state claims the defendants violated Nevada's Deceptive Trade Practices Act, False Claims Act, and Racketeering Act along with committing negligence, and creating a public nuisance.

    The lawsuit is in addition to nine others by local jurisdictions including Clark and Nye counties in the south, as well several cities across the state.

    Attorney Robert Eglet is handling those and will handle this one as well.

  4. #29
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    Lawyers suing over the toll of opioids asked a judge Friday to allow a structure for all 25,000 municipal and county governments in the U.S. to be paid — if a settlement can be reached with companies that make and distribute powerful prescription painkillers.

    Denver is one of the "proposed negotiating class representatives" listed in the filing, along with New York, Los Angeles, Chicago, San Francisco, Phoenix and several other cities and counties.

    The approach, if approved, would create dueling negotiating systems as state governments are also in collective settlement negotiations with the drug industry.

    The unified approach on behalf of municipalities would also help the manufacturers and distributors by defining a finalized group of entities benefiting from a settlement, said Joseph Rice, a South Carolina-based attorney representing local governments in the complaint.

    "If you're a corporation trying to address this problem, you need to get closure, you need to put it behind you," Rice said in an interview. "If you're going to put significant resources into the resolution, you've got to know it's behind you. The only way to do that is to get releases from everybody that's got a potential claim."

    The action would also help address a problem that is widespread and reaches across city and county lines, Rice said. Providing assistance from a settlement to one county doesn't help the people in a neighboring town, he said.

    "These pills have wheels, they move around," Rice said, citing the documented cases of pain pills obtained in Florida being taken to West Virginia.

    The motion filed Friday requests the creation of a negotiating class "for the specific purpose of creating a unified body to enter into further negotiations with defendants," according to the filing. "It is neither aimed at being the vehicle for litigation or settlement."

    The filing says that Denver "has taken an active role in the Opioid Litigation, helping initiate a litigation effort among approximately 20 cities and counties in Colorado that have likewise filed suit."

    Hundreds of local governments and other entities, such as hospitals, have accused pharmaceutical companies of downplaying the addictive nature of opioids and prescription painkillers largely blamed for one of the deadliest drug crises in U.S. history. Opioids include prescription and illicit drugs.

    The complaints are being overseen by Cleveland-based U.S. District Judge Dan Polster. He previously ruled that lawsuits filed by the Ohio counties of Cuyahoga, which includes Cleveland, and Summit County, which includes Akron, will be heard first this October.

    A trial on claims made by West Virginia's Huntington and Cabell counties will be next, followed by Cleveland and Akron's claims.

    The Centers for Disease Control and Prevention says opioids are the main driver of drug overdose deaths. Opioids were involved in 47,600 overdose deaths in the U.S. in 2017, according to the agency.

    Attorneys general fighting for compensation in separate legal actions are likely to have mixed reactions to the filing, said Paul Nolette, a Marquette University political scientist.

    A law firm suing several opioid manufacturers and distributors made its pitch today for Ward County to join in the legal action.
    A representative of one of the law firms bringing the lawsuit told county board members there are several area counties already signed on as plaintiffs.

    Curtis Olafson said the county and its people would collect much more by entering the litigation directly, rather than hoping for a piece of what the state might collect.
    He says the current lawsuit provides a separate fund to pay local governments such as cities and counties.

    (Curtis Olafson, Law Firm Representative) “Any attorney general can only recover damages incurred to the state which are mainly limited to Medicaid damages. You as a county and your fellow counties around the state collectively have far greater damages than the state of North Dakota.”

    County board members voted to seek an opinion from the county state’s attorney before deciding whether or not to join the legal proceedings.
    The representative making the pitch said its expected this settlement will be the largest in the history of the American legal system.
    Currently, the largest settlement in such a case was 206 billion dollars paid by tobacco manufacturers in 1998.

  5. #30
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    At the request of federal regulators, the maker of painkiller Opana ER is pulling the drug off the market because of abuse. After consulting with the U.S. Food and Drug Administration, on Thursday Endo International PLC said it will voluntarily stop selling the pills. They were approved for use in patients with severe, constant pain. When used as intended, the company says the extended-release opioid is safe and effective. Last month, the FDA said it had concluded the drug is too risky. It's the first drug that the FDA has sought to remove from the market due to abuse. Wochit

    Endo Pharmaceuticals observed the success of competitor Purdue Pharma and learned from it, says Tennessee AG.
    Endo figured its Opana Extended Release opioid could do even better than OxyContin, a lawsuit says.
    Opana ER is twice as potent as OxyContin, and Endo looked to expand its share of the market.
    Endo even targeted adolescents, meeting with pediatricians and adolescent specialists to pump sales.
    Endo Pharmaceuticals already had seen the success Purdue Pharma enjoyed after pushing its OxyContin to vulnerable groups of people.

    Endo’s Opana Extended Release, twice as potent as OxyContin, could do even better, pharmaceutical execs thought, by also targeting the already addicted and the elderly.

    Endo even decided to target adolescents, a group Purdue didn't dare to pursue.

    A lawsuit filed against Endo May 14 by the state makes those claims and more: Tennessee Attorney General Herbert H. Slatery III says that “Endo likely inflicted more harm on Tennessee” — which had the highest prescription rate of Opana Extended Release in the nation —“than any other state.”

    Those details became public this month after the Knoxville News Sentinel filed a court motion — and prevailed — to unseal the lawsuit.

    The state last year filed a similar lawsuit against Purdue, which outlined its aggressive sales tactics and deceptive marketing strategies.

    The lawsuit said that Purdue “laid the groundwork … and provided the marketing blueprint” for Endo, which “wanted its own OxyContin and sought to outdo Purdue in both drug potency and marketing.”

    The company lied about the drug’s safety and risk for abuse, turned a blind eye to obvious pill mills and overdose deaths, and targeted and rewarded high-prescribing doctors, the lawsuit said.

    And when it came to expanding the customer base, age was no issue.

    Opana, right, began to replace OxyContin as addicts' drug of choice about four years ago after a new process made OxyContin more difficult to crush and dissolve for intravenous use. (Photo: Rich Pedroncelli, AP)
    Hid risks to elderly
    Purdue’s sales reps were trained to visit providers who took care of the elderly and to push OxyContin while minimizing the risks — which included death.

    Endo went a step further, claiming Opana Extended Release was a panacea for osteoarthritis, which predominantly affects elderly patients, and that it had fewer drug interactions than competitors.

    Neither disclosed the increased risk of respiratory depression, death and other serious health issues.

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    Patients overdose from Opana, OxyContin and other opioids when the drugs depress their respiratory systems — in other words, they aren’t taking in enough oxygen. That’s an even bigger problem among the elderly, who often are more at risk for trouble breathing anyway.

    And both companies failed to tell providers that low-dose starts of opioid drugs in elderly patients most often lead to higher — and higher-risk — doses of the drugs.

    The lawsuit calls Endo’s targeting of the elderly “especially egregious” because the company knew oxymorphone, Opana Extender Release's primary ingredient, was to be used with caution in patients 65 and older.

    Not only is the risk of adverse effects greater, but the amount of the drug that remains stable in the system after repeated doses is 40% higher in elderly patients than in younger ones, making a patient more susceptible to overdosing.

    Between 2005-2015, the number of opioid-related hospitalizations of Tennessee seniors more than tripled — the sixth-highest rate in the nation.

    Opana pills, like many other painkillers, can be ground up and injected. (Photo: MICHAEL HAYMAN)

    Endo described the “aging population” as a “Large and Attractive Opportunity” for selling Opana Extended Release, often shortened to Opana ER. It advertised in geriatric journals, trained reps to promote the drug for osteoarthritis, and unveiled campaigns advertising it as “safe and effective.”

    One ad campaign featured “Joan,” a 76-year-old retired schoolteacher with osteoarthritis in her hip and spine whose pain was not controlled after three months of increasing doses of a different opioid medication. It stated “Joan,” who took other prescriptions including an antidepressant and blood pressure medications, was safe because Opana ER “has no known” drug interactions at “clinically relevant doses.”

    Endo also paid speakers to say “underprescribing” the drug to the elderly “contributes to poor chronic pain management” and to claim nearly half of chronic pain patients “do not achieve adequate relief.”

    Opana (Photo: WBIR)

    Aiming at adolescents
    Both companies targeted the elderly, but Endo also targeted adolescents, the lawsuit asserts.

    Call records show pediatricians and adolescent specialists were among the specialists Endo reps visited who had “a suspect need to prescribe extended-release opioids.” (Reps also visited podiatrists, gynecologists, sleep specialists and even medical geneticists.)

    Before releasing Opana in 2006, Endo hired a consultant to help it prepare for a “negative environment” and a “PR crisis” around the drug, including media coverage about high levels of abuse and reporters digging into the abuse history of Percocet, an older Endo drug.

    Specific situations the company expected included:

    The death of a drug abuser — possibly a teenager or celebrity.
    Crime reports (such as pharmacy break-ins) attributed to Opana ER.
    Parent/anti-drug groups picketing Endo headquarters.
    FDA warnings to doctors about abuse potential of Opana ER.
    Accusations by the media or the public that Endo put profits over child safety by commercializing “another OxyContin like drug that will addict and kill innocent teenagers.”
    “Adolescent misuse of prescription opioids is particularly devastating because it is the time when many individuals, who develop opioid-use disorder, first misuse opioids,” the lawsuit said. “Endo’s push for providers to prescribe more and more of its narcotics has given more young children access to them.”

    And it also affected Tennessee children in a less direct way, the lawsuit said: by making addicts of their parents, which increased children’s risk of death, abuse, neglect and involvement with child welfare, overtaxing the family court and foster-care systems.

    Studies point to the start of a generational cycle, since children whose parents abuse opioid drugs are significantly more likely to abuse opioids themselves. Research is still out on the long-term problems of babies born dependent on drugs. Tennessee’s overall rate of babies born with neonatal abstinence syndrome is three times the national average — but in some parts of East Tennessee, it’s 10 times the national average.

    “But for Endo’s actions, opioid use would not have become so widespread in Tennessee, and the enormous public health hazard of opioid overuse, abuse, and addiction that now exists could have been averted or mitigated,” the lawsuit said. “Endo’s actions have and will continue to injure and harm many residents throughout Tennessee.”

  6. #31
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    David Sackler, whose family owns Purdue Pharma, says the company is not to blame for the opioid epidemic

    (CNN)David Sackler, whose family owns Purdue Pharma, is defending the company and his family against what he describes as "vitriolic hyperbole," saying they're not to blame for the opioid crisis ravaging the nation.

    In an extensive interview with Vanity Fair published Wednesday, Sackler insisted his family had nothing to do with the crisis even though their company unveiled and heavily marketed the drug OxyContin as a new, safe and effective opioid in the 1990s.

    Nevada is suing opioid manufacturers and distributors. There are more than 40 defendants in the case
    "We feel absolutely terrible. Facts will show we didn't cause the crisis, but we want to help," he told the magazine, which described him as emotional -- at times nearly in tears and at other times, furious.
    His family has endured "endless castigation," he said, as the pharmaceutical giant faces lawsuits from several states and local governments for allegedly misrepresenting its opioid products as nonaddictive and appropriate for chronic pain.
    New Jersey sues Sackler family for opioid epidemic
    "I have three young kids," he told the magazine. "My 4-year-old came home from nursery school and asked, 'Why are my friends telling me that our family's work is killing people?'"
    Fast Facts: The Opioid Crisis
    He said Purdue tried to be responsible even as science evolved on the benefits and risks of opioids. As for the lawsuits, he told the magazine, they have no merit.
    "I really don't think there's much in the complaints, frankly," Sackler declared, saying they mostly consist of a claim that the company shouldn't have marketed its products at all.
    States and hundreds of cities take action
    A series of states have taken the company to court over accusations it misrepresented the facts on opioids.
    "By misrepresenting and omitting correct, scientifically supported contrary evidence concerning their opioid product, Purdue offered a product that was materially different from what was purported to be in the marketplace," Pennsylvania Attorney General Josh Shapiro said last month.
    Lisa Marie Presley writes about her opioid addiction

    Shapiro's lawsuit, filed on behalf of the state, alleges that Purdue Pharma misrepresented its opioid products as nonaddictive and appropriate for longterm use for chronic pain.
    A lawsuit filed by Massachusetts in January alleges that the pharmaceutical giant secretly pursued a plan to become "an end-to-end pain provider" by selling both opioids and drugs to treat opioid addiction, reaping more than $4 billion in profits. It alleges the company engaged in a decade of deception to push the painkiller OxyContin on doctors and patients even as it publicly denied what internal documents showed: that the highly addictive medication was resulting in overdoses and deaths.
    Several other states have sued opioid manufacturers and distributors for their parts in the nationwide opioid crisis, including New Jersey, Oklahoma and Arkansas. More than 600 cities, as well as several counties and Native American tribes, have also filed a federal lawsuit against the Sackler family over the crisis.
    The company has maintained that it's being singled out and blamed for the nationwide opioid crisis.
    Tens of thousands of opioid deaths
    New Jersey sues Sackler family for opioid epidemic

    Opioids are a class of pharmaceuticals that include prescription painkillers such as OxyContin, morphine and fentanyl, as well as illicit drugs like heroin. They are at the core of an ongoing public health crisis in America.
    In 2017, there were more than 70,200 overdose deaths in the United States; 47,600 of those involved opioids. More than 130 people died every day from opioid-related drug overdoses in 2016 and 2017, according to the US Department of Health and Human Services.
    Purdue Pharma introduced OxyContin -- a version of oxycodone that slowly releases the drug over 12 hours -- in the 1990s, and aggressively marketed it as a safer pain pill.
    More than a decade later, in 2007, the federal government brought criminal charges against the company for advertising OxyContin as safer and less addictive than other opioids when it was not.
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    The company and three executives were charged with misleading and defrauding physicians and consumers, and they pleaded guilty, agreeing to pay $634.5 million in criminal and civil fines.
    The Sackler family is well known for its philanthropy around the world, including having its name on museums and galleries. Forbes estimates they are worth $13 billion.
    As criticism has grown over their purported connection with the nation's opioid crisis, some art galleries -- including Britain's Tate museum and New York's Metropolitan Museum of Art -- have said they will no longer accept donations from the family.

  7. #32
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    When Oklahoma settled a landmark lawsuit against drugmaker Purdue Pharma in March, the state and some of its cities looked on with irritation as nearly $200 million went to a new addiction treatment and research center at Oklahoma State University.

    The state, which Attorney General Mike Hunter was elected to represent, got nothing in the $270 million deal. Oklahoma’s more than 670 cities and counties, which have absorbed most of the emergency and health-care costs of the opioid epidemic, received just $12.5 million to divvy up. Neither had any say in the agreement, which gave about $60 million to private attorneys hired to work on the case.

    Two months later, Hunter announced an $85 million settlement with a second defendant, Teva Pharmaceutical. The governor, lawmakers and mayors of Oklahoma were not about to make the same mistake twice.

    [Oklahoma, Teva Pharmaceuticals reach $85 million settlement in opioid case]

    State lawmakers and the governor, who enacted a law two days before the Teva announcement to require that all settlement money go into the treasury, went to court last week to ensure the law is followed. Nine cities, including the state’s largest, Oklahoma City, asked four days later to intervene in the case so they might have a say in how dollars are spent to address the drug crisis.

    Looming over the quarrel is a potentially much bigger payday in the state’s ongoing court battle with the last remaining defendant, Johnson & Johnson. Oklahoma is suing the health-care conglomerate for its alleged role in the epidemic, seeking billions of dollars to address future damage from the drug crisis.

    A trial in that case is in its fourth week in Cleveland County District Judge Thad Balkman’s courtroom in Norman, Okla. If it results in a settlement or a verdict for the state, all sides will want a piece of a possibly enormous payment and some voice in how the money is spent on the drug crisis.

    [Spotlight shifts to Johnson & Johnson as first major opioid trial nears in Oklahoma]

    In the meantime, the conflict over how to spend the money already available is providing a sideshow to the main event.

    Cities and counties “need a seat at the table and need to be involved in the decisions to abate the opioid crisis,” said Matt Sill, an attorney for the nine cities that asked Balkman to allow them to intervene in the settlement discussions last week.

    Gov. Kevin Stitt’s office declined to comment, and House Speaker Charles McCall and Senate President Greg Treat did not return telephone calls seeking comment.

    But an official familiar with their position said they were alarmed when one of Hunter’s attorneys suggested at a court hearing June 10 that, despite the new state law, the Teva settlement money should be placed in an escrow account under Balkman’s control until Oklahoma knows how much money it might win from Johnson & Johnson.

    That lawyer, Michael Burrage, also said he does not believe the new law applies to cases such as the current one, which seek funds to abate the “public nuisance” allegedly created by drug companies that sent large amounts of addictive narcotics into communities.

    A Teva representative said the company is ready to pay the money.

    Typically, public nuisance laws have been used to close a neighborhood crack house or take on a factory that pollutes a public waterway. Johnson & Johnson is arguing in court that the state cannot apply the law to drug companies’ legal and regulated activities, nor force them to pay to abate them.

    The Oklahoma case is the first of nearly 50 state lawsuits against pharmaceutical companies to proceed to trial. It is being closely watched by others that have made the same public nuisance argument, as well as 1,900 cities, counties, Native American tribes and others whose lawsuits have been combined into one huge case in federal court in Ohio.

    In the federal case, the plaintiffs have proposed a novel strategy that could make every town, city and county in the United States eligible to share in any settlement with the pharmaceutical companies that have been sued. U.S. District Judge Dan Polster will consider the idea next week.

    Asked for comment on the current conflict, Hunter issued a statement that said, in part: “We are in constructive consultation with state leaders. All three branches of state government are committed to working together. Our goals are aligned and we want to do what is in the best interest of the state.”

    Hunter has argued, however, that the Purdue case had to be settled quickly because of fears the company might declare bankruptcy, leaving Oklahoma with nothing, and that the company insisted the money go toward a national center on addiction treatment and research.

    Advocates watching the wave of opioid litigation are concerned, however, that if settlement money is deposited in state bank accounts without restrictions, nothing would prevent lawmakers from allocating it for roads, law enforcement or needs other than the drug crisis. One study showed that just a tiny portion of the $246 billion settlement reached between states and tobacco companies in 1998 was spent to prevent addiction to tobacco and to help people quit.

    The Teva settlement has not been made public, leaving municipalities unsure about how they might acquire a piece of it. After the Purdue settlement, Sill’s law firm put out a news release noting that one of his clients, Comanche County, would receive just $18,545.99 of the $12.5 million allocated toward local needs.

    Another question Oklahoma cities are asking the court is whether the drug companies’ settlements with the state ended the lawsuits filed by cities and counties. The cities and Hunter contend the agreement does not preclude each city from suing; Purdue argues that the deal applied to all lawsuits filed by any government in Oklahoma.

    This week, Balkman appointed a special master, Steven W. Taylor, a former chief justice of the Oklahoma Supreme Court, to handle the dispute over the Teva settlement. Talks in that mediation are scheduled to begin as soon as Thursday.

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    The Annapolis opioid lawsuit has been relocated to federal court following a complaint the city’s lawsuit inappropriately linked national opioid manufacturers and distributors to local prescribers.

    Endo Pharmaceuticals, a drug manufacturer, filed a notice April 19 moving the case to the U.S. District Court for the District of Maryland. Endo argues the city included a handful of locally based doctors, nurses and “pill mill” centers to fraudulently connect the other defendants, none of which are based or incorporated in Maryland, and avoid the sprawling, nationwide lawsuit filed in Ohio on behalf of more than 1,500 entities around the country.

    The Annapolis lawsuit has proved controversial, as the city retained Mayor Gavin Buckley’s personal attorney F. Joseph Gormley to litigate the case. Buckley defended the choice over another firm, which was pursuing its own multi-jurisdictional suit, arguing the city needs a local litigator to solve a local problem.

    That solution could be in jeopardy, should the transfer stick. The case is now in U.S. District Court for the Northern District of Ohio, where Judge Dan Aaron Polster is considering pre-trial decisions for hundreds of opioid lawsuits across the country.

    Paul Farmer, representing the city alongside Gormley, filed an objection to the transfer. Polster will consider the objection and decide whether or not to remand the lawsuit back to Anne Arundel County Circuit Court. Gormley was not immediately available to comment on the complaint.

    A number of complaints from the big pharmaceutical companies have temporarily sent small city and county cases to federal court — and the success is varied. A similar complaint filed against Anne Arundel County failed and the case was remanded back to the state. Baltimore City’s suit remains in state court after a challenge. But several other suits in Maryland cities and counties have become a permanent part of the nationwide suit.

    Council questions Annapolis opioid lawsuit, mayor defends choice of his lawyer
    City spokeswoman Mitchelle Stephenson said the city is confident the local suit is different from the national suit. Endo sees it differently.

    A case can land in federal court if it meets two criteria: it has to have “complete diversity,” whereby none of the defendants share state citizenship with the plaintiff; and the sought damages top $75,000.

    The city lawsuit seeks $400 million, but names local prescribers, based in the city and Anne Arundel County, as responsible for pushing opioids to Annapolis residents and therefore avoids diversity. Endo attorney John Freedman argues the city included the local prescribers to purposefully avoid and undermine the national case.

    He argues against the inclusion of these defendants, as the city lawsuit does not explicitly tie the action of the local dealers to the national manufacturers and distributors.

    Endo, in the filing, alleges the city failed to take the proper pre-suit steps required by the Maryland Health Care Malpractice Claims Act. While the city’s suit does not allege any offenses under the act, Endo’s complaint argues it applies because the city claims doctors and nurses harmed patients. The damages sought, $50 million per count, also exceeds the maximum damages, $30,000, under the act.

    The city’s suit largely mirrors the county’s, and takes on some of the same manufacturers and distributors recently forced to pay out millions for perpetuating opioid addiction nationwide. They are Purdue Pharma, Teva Pharmaceuticals, Johnson & Johnson, Endo Health Solutions, Insys Therapeutics, Janssen Pharmaceuticals, Cardinal Health, Inc., the McKesson Corp. and the Amerisourcebergen Drug Corp.


    Recently, the state of New York filed a complaint against the Sackler family, owners of Purdue Pharma, and distributors Cardinal Health Inc., the McKesson Corp. and the Amerisourcebergen Drug Corp. for fraud and conspiring to circumvent limits on drug distribution.

    The Annapolis lawsuit names these companies as responsible for pumping opioids into Annapolis. And alongside the manufacturers and distributors are local prescribers William Tham, Kofi Shaw-Taylor, Happiness Aguzie, Tormarco Harris, Minnie Ndem and Lawrence Vidaver, who are accused of overprescribing opioids or participating in schemes to recommend specific drugs for kickbacks.

    The suit also names Jackie Syme and Lawrence Vidaver, doctors with practices in Gambrills and Glen Burnie.

    Annapolis decided to go it alone on opioid lawsuit
    Gormley will represent the city alongside Farmer and Frank Lozupone, both associates with Gormley Jarashow and Bowman. Gormley has extensive experience representing businesses and corporations, including in the healthcare industry.

    The city is not yet paying Gormley, as the case is being handled on contingency. Gormley and his firm stand to earn 25 percent of damages, plus reimbursement for expenses, should the city win the case.

    Either Gormley or his firm Gormley, Jarashow and Bowman have represented Annapolis Mayor Gavin Buckley in a number of legal matters since at least 2010, including the city’s suit against his restaurant Tsunami for an unlicensed mural. The firm was also one of Buckley’s earliest financial supporters, donating $2,500 to his campaign in October 2016.

    Buckley said the choice to retain Gormley was not his, but rather made by the Office of Law. Former City Attorney Richard Melnick has said the decision to go with Gormley was made before he joined the city.

    Opioids, mainly synthetic ones like fentanyl, are the leading driver of overdose deaths, which killed more than 70,000 people in the United States in 2017. In the city alone, the rate of drug overdoses has more than quadrupled in the last four years, from 48 in 2015 to 199 in 2018.

    Where opioids in 2015 accounted for 40% of overdoses, they now account for 74%.

    This year, there have been 46 overdoses, one of them fatal.

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    STAMFORD — On June 22, 2017, Dr. Craig Landau was appointed CEO and president of an under-fire Purdue Pharma. The pressure on him and the company has only escalated since then.

    Landau took the top job amid a nationwide push for accountability for the opioid crisis that has unleashed a storm of litigation and grassroots unrest against the OxyContin maker. Two years on, the controversy shows no signs of abating, but the chief executive — who seldom speaks publicly beyond company-issued statements — said this week that he remains committed to leading the fast-changing firm.

    “My first two years as CEO have been exceedingly challenging, but, at the same time, rewarding,” Landau said, in an e-mailed response to questions from Hearst Connecticut Media. “As a physician, my top priority has been to identify and pursue opportunities for our company to help address the opioid crisis. Simultaneously, I have been focused on making changes to the business that would allow us to pursue more non-opioid opportunities today and in the longer term.”

    The company declined to make Landau available for an interview.

    Messages left this week for a spokesperson for the Sackler family members who own Purdue were not returned.

    Nationwide legal pressure

    Now 52, Landau took over after previously serving as the president and CEO of Purdue’s Canadian business and as the company’s chief medical officer. He has worked at Purdue since 1999 and also served 14 years in the U.S. Army.

    When he became CEO, Purdue was facing a new wave of local and state lawsuits alleging that fraudulent OxyContin marketing had exacerbated the country’s epidemic of opioid abuse. Some 218,000 Americans died from overdoses related to prescription opioids, between 1999 and 2017, according to the U.S. Centers for Disease Control and Prevention.

    Two years later, the company is flooded with litigation. Today, 46 states, including Connecticut, are pursuing complaints, in addition to hundreds filed by cities and counties.

    About 1,800 local governments’ lawsuits against Purdue and other opioid makers have been consolidated in a “multidistrict litigation” process in federal court in Cleveland. The first MDL trial is scheduled to start Oct. 21.

    The complaints largely focus on accusations that predate Landau’s arrival as CEO. Many of them, such as Connecticut’s, name as defendants eight Sackler family members who own the company.

    But some of the lawsuits also implicate Landau.

    When he was the chief medical officer, Landau helped to develop the company’s sales strategy and materials, according to Massachusetts’ complaint. Since becoming CEO, he has overseen more than 5,000 visits by Purdue sales representatives to prescribers in the state, the lawsuit also said.

    Among other allegations, Massachusetts said that Landau drafted goals in 2011 that included supporting the approval of OxyContin for children.

    Purdue and the Sacklers have denied the allegations, and they have filed motions to dismiss the Massachusetts complaint.

    Landau declined to comment on the pending lawsuits.

    Under his leadership, the company has shown a willingness to settle.

    In the firm’s largest payout of the past 10 years, it reached a $270 million agreement in March with Oklahoma to resolve that state’s lawsuit.

    “The company has been fairly strategic in dealing with the lawsuits; I think they’re waiting to see how things turn out with the MDL litigation,” said Richard Ausness, a law professor at the University of Kentucky. “I think Landau has done about the best you can expect with the lawsuits, given the circumstances.”

    A Chapter 11 bankruptcy filing could materialize before the lawsuits are sorted out, according to a number of experts. The company has acknowledged exploring such a scenario in recent months — a move that would ostensibly help contain its liability.

    “Purdue continues to assess all options, but it is important to note that the company has not made any decisions regarding this matter,” Landau said.

    Earlier this month, another much-litigated opioid maker, Insys, filed for bankruptcy, days after agreeing to a $225 million settlement of federal criminal and civil cases alleging the company bribed doctors to prescribe its fentanyl-based pain drug.

    “For Purdue, there are just too many lawsuits,” said Eric Snyder, chairman of the bankruptcy department at Manhattan-based law firm Wilk Auslander. “I don’t think they have enough time and money to defend the lawsuits and keep the business going.”

    Under-fire outside the courts

    Amid the glut of allegations of wrongdoing, Purdue officials maintain that the company has worked diligently to combat the epidemic of opioid abuse.

    In the past 20 years, the firm said it has partnered with law enforcement and other government agencies to advance more than 60 initiatives, costing a total of more than $1.5 billion, according to company data.

    “We are laser-focused on doing what is right to help society address the opioid-addiction crisis — including increasing access to naloxone,” a drug that can reverse opioid overdoses, and “developing more potent and longer-lasting overdose rescue options, funding youth education and more,” Landau said.

    But those efforts have hardly quelled the criticism in or out of the courtrooms.

    Last summer, a number of protests took place outside Purdue’s downtown headquarters.

    “What I would like (Landau) to focus on — is their role in this epidemic and paying retribution for treatment, prevention and recovery support; and monies to pay for our children’s burials that we weren’t prepared to pay and support for the children left behind,” said Cheryl Juaire, a co-organizer of a demonstration last August and whose 23-year-old son died of a heroin overdose in 2011. “In all of these settlements and lawsuits, I have seen nothing in support of the children left behind” by parents who fatally overdose.

    Meanwhile, a number of corporate partners have distanced themselves, apparently fretful about the fallout from doing business with the company. The list includes JPMorgan Chase & Co., the country’s largest bank by assets, which had handled cash and bill payments for Purdue.

    Major shifts

    As the outrage persists over the company’s alleged role in the opioid crisis, Purdue has undergone sweeping organizational changes in the past two years.

    Last year, it stopped marketing its opioids to medical prescribers and disbanded its sales force. The sales team’s demise resulted in hundreds of layoffs.

    “While this change was extremely difficult for those affected, ultimately, it was the right thing to do,” Landau said of the end of the opioid marketing.

    The sales group was dissolved amid medical prescribers’ growing wariness of opioids and increasing competition from generic drugs. OxyContin sales totaled $1.8 billion in 2017, down from $2.8 billion five years earlier, according to data from health care analytics company Symphony Health Solutions.

    Purdue is not abandoning opioids — Landau cited Pain Medicine journal data showing that nearly 18 million U.S. patients are taking long-term prescription opioids — but the company is increasingly focusing on other drug types.

    A new Purdue subsidiary gained U.S. Food and Drug Administration approval in March for a drug called Adhansia XR, to treat attention deficit hyperactivity disorder (ADHD).

    Around the same time, another new Purdue subsidiary secured the FDA’s “orphan drug designation” for expedited reviews of drugs to, respectively, treat rare bile-duct cancer and an extremely rare type of leukemia.

    Also in March, Purdue announced an FDA fast-track designation for a “nalmefene hydrochloride” injection that would treat known or suspected opioid overdoses. The company said it would not profit from that medication.

    “Diversifying the product line is a smart thing to do,” said Angela Mattie, a professor in Quinnipiac University’s schools of business and medicine. “But, in trying to improve the reputation of the company, the train has left the station on that one. The public opinion of the company is a cry for accountability and further complicated by the pending legal cases.”

    Looking ahead

    As he enters his third year, Landau’s agenda will probably continue to be dominated by the litigation until it is resolved by trials or settlements.

    Landau’s relationship with the Sacklers is more difficult to discern. In his responses to Hearst Connecticut Media, he did not comment on his interactions with the owners.

    All of the Sacklers have left the board in the past two years — with the last of them stepping down around the turn of the year. But they still own the company and likely still have the last word on executive personnel decisions.

    In the first interview given by one of the Sackler defendants since they were named in the current round of lawsuits, David Sackler — a grandson of Purdue’s late co-founder Raymond Sackler and a former board member — said in a Vanity Fair profile published this week that his family should not be blamed for the opioid catastrophe. He did not mention Landau.

    At the same time, Landau said that he wants to continue tackling the opioid crisis and developing new Purdue products, focusing on non-opioid pain medications, central-nervous-system treatments and oncological projects.

    “I’m personally very excited about the prospects for our pipeline, as well as for the company, on the whole, going forward,” Landau said. “Those that work for Purdue are committed to seeing it through, so that, through our medicines, patients in need can receive the benefit they deserve.”

    These people should be charged and executed for sparking drug addictions.

  11. #36
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    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.

    STANDARD PRACTICE: West Virginia Judge Booker T. Stephens, like many judges after him, allowed evidence about Purdue?s aggressive marketing of its blockbuster opioid OxyContin to remain under seal. REUTERS/Benjamin Lesser
    ?Heartbreaking and sickening.?

    Massachusetts Congresswoman Katherine Clark, describing judges? decisions to conceal evidence about OxyContin
    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.

    STRICTLY CONFIDENTIAL: Federal Judge Dan Polster has maintained a consistent secrecy in the nearly 2,000 lawsuits against the opioid industry consolidated in his Cleveland court, allowing evidence drawn from millions of records on industry practices to be filed under seal. Northern District of Ohio/Handout via REUTERS
    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.?

    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.

  12. #37
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    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.

    Under wraps

    Judges sealed evidence related to public health and safety in about half of the 115 biggest defective-product cases consolidated before federal judges over the past 20 years. In 85 percent of those cases, judges did not explain their reasons for allowing secrecy, though they are required to do so. Consolidated cases are scaled by total actions.

    Sealed evidence related to public health and safetySealed without explanation for allowing secrecy






    Xarelto blood thinner


    Johnson & Johnson Baby Powder


    Ethicon pelvic mesh



    Welding fume exposure


    Opioid painkillers


    Pinnacle hip implants

    Sources: The Judicial Panel on Multidistrict Litigation and a Reuters review of federal court records maintained by Westlaw.

    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.”


    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.

    EXPOSED: Over Purdue’s objections, a Massachusetts judge agreed to remove the redactions from this court complaint, which revealed some of the company’s marketing practices for its drug OxyContin.
    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 Walgreens Co – contributed to the public-health disaster by using misleading marketing and other ruses to boost sales at the expense of public safety.

  13. #38
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    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.

    “He’s not allowed to do that without providing reasons.”

    Professor Jennifer Oliva, West Virginia University College of Law, on Judge Stephens’s decision to allow evidence in West Virginia’s lawsuit against Purdue to be sealed
    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.

    Such evidence entered into the court record to support a pretrial motion is generally the only way, short of a trial, that discovery material is made public – though that evidence often represents only a tiny fraction of what’s produced in discovery. Here, too, secrecy prevailed. Lawyers for Purdue and the state agreed between themselves that the state would file its motion and supporting evidence under seal. Stephens did not evaluate the material to determine whether secrecy was warranted, as required by state law, and he provided no rationale.

    “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.

  14. #39
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    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.”


    In the years following Stephens’s ruling, Purdue benefited from the secrecy that had shrouded the West Virginia and similar cases.

    Tragic toll

    Opioid-related deaths rose steadily as judge after judge left information about Purdue’s conduct under seal.

    There were attempts to unseal documents in two cases.Cases with sealed evidence Cumulative opioid deaths, 000s
    1999 8
    2000 16.5
    2001 25.9
    2002 37.9
    2003 50.8
    2004 64.6
    2005 79.5
    2006 97.0
    2007 115.5
    2008 135.1
    2009 155.5
    Sources: The National Institute on Drug Abuse and a Reuters review of court records.

    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.

    ON A MISSION: Dr David Egilman, an expert witness in some of the opioid litigation, ultimately failed in his efforts in court to get the Massachusetts attorney general to release evidence about Purdue’s sales practices. REUTERS/Faith Ninivaggi
    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.

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    CONCORD, NH — A local man has been sentenced to many years in jail for selling drugs that took the life of Lakes Region man in 2017. Spencer Grayson, 23, formerly of Concord, was sentenced in Merrimack County Superior Court to an 8.5- to 20-years in prison for selling a fatal mix of fentanyl and methamphetamine to Ryan Smith, 30, of Laconia, in July 2017, causing his death. Grayson was also sentenced to two 5- to 10-year terms for selling methamphetamine and fentanyl on two other occasions.

    Those counts will be suspended for 10 years from the date of his release and conditioned on good behavior, completion of a drug treatment program, and fulfillment of his sentencing obligations, according to Deputy Attorney General Jane Young.

    Grayson pleaded guilty to the charges in April.

    Grayson – who was previously convicted of control drug; acts prohibited in Hooksett District Court in August 2016– was out on bail at the time he sold the fatal fentanyl-meth mix to Smith. Smith ingested the drugs behind the Cumberland Farms on North Main Street in Concord, overdosed, and died later at Concord Hospital.

    Grayson was arrested after Northfield Police were sent to an emergency call and he was at the scene of the call. One of the officers recognized him, confirmed active Concord warrants, and arrested him.

    Smith, according to his obituary, waged a 16-year battle with addiction. He was beloved by his family, was an avid music and movie fan, and loved animals, writing, and drawing.

    "This epidemic is proving yet again, to be another powerful, tragic, heartbreaking disease to all who go about battling it and leaving it untreated," the family stated in the obit. "Anyone that knew Ryan would say he was a giant teddy bear, and just another big kid. He enjoyed making people laugh and had a contagious smile that made his eyes shine every time. He was the best uncle a kid could ask for, a gentle son, a protective big brother, loyal to friends, and intelligent beyond words. At the time of his death he chose to be homeless, withdrawn from his family and unwilling to accept any kind of treatment."

    Grayson had a lengthy criminal history. Along with the drug dealing charge in Hooksett, he previous charges in Concord include assault, domestic violence-simple assault, obstructing report of a crime or injury, default or breach of bail conditions, warrants, driving charges, and domestic violence-obstructing report of a crime or injury.

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    OKLAHOMA CITY (AP) ? The U.S. government wants a portion of Oklahoma?s $270 million settlement with Purdue Pharma that stemmed from the state?s ongoing lawsuit against opioid makers.

    The U.S. Centers for Medicare and Medicaid Services wrote to the head of Oklahoma?s Medicaid agency that it has determined the federal government is entitled to part of Oklahoma?s proceeds.

    The June 12 letter from CMS? regional director Bill Brooks also seeks detailed information from the Oklahoma Health Care Authority and warns that failure to return a portion of the settlement money could result in the withholding of federal funds. Medicaid is jointly funded by the federal government and states.

    Details of the letter were first reported Thursday by The Washington Post.

    The Oklahoma Health Care Authority requested a 90-day extension from CMS to provide the federal agency with the requested information, and that request was granted this week, giving the state until Oct. 12 to provide its response.

    A spokesman for Attorney General Mike Hunter says his office is reviewing the CMS request. Spokesman Alex Gerszewski also said the federal government?s request won?t affect state revenue.

    It?s not clear how much of the state?s settlement the federal government is seeking or where the money would come from. Oklahoma?s settlement in March with Purdue, the maker of OxyContin, and the company?s controlling family called for nearly $200 million to go into a trust for the creation of a National Center for Addiction Studies and Treatment at Oklahoma State University in Tulsa. Private attorneys who handled the case for Oklahoma received about $60 million, while an additional $12.5 million was earmarked for local governments.

    CMS says it is entitled to a portion of the funds under a provision of the federal Social Security Act that applies to money recovered by the state. A CMS spokesman says anytime the agency becomes aware of a settlement that might involve a Medicaid overpayment, the agency works with states to determine what portion may need to be returned to the federal government.

    Federal agencies requesting a portion of such money is not unprecedented. In 2015, the federal government received half of a $1.375 billion settlement agreement with the rating agency Standard & Poor?s Financial Services LLC, but in that case the U.S. Department of Justice was involved in the lawsuit, along with 19 states and the District of Columbia.

    The letter did not reference Oklahoma?s $85 million settlement with Israeli-owned Teva Pharmaceuticals or the state?s ongoing public nuisance lawsuit against consumer products giant Johnson & Johnson. Witnesses for the state have suggested the cost of abating the opioid crisis in Oklahoma could be as much as $17.5 billion over the next 30 years.

    The idea the state could be on the hook to pay millions of dollars to the federal government didn?t sit well with Oklahoma state Rep. Mark McBride, R-Moore.

    ?As far as I?m concerned, that?s the state?s money,? said McBride, one of several lawmakers critical of the way the Purdue settlement was structured. ?It seems like the federal government is seeing that the attorney general won with these two settlements, and now they have their hand out, and I think that?s just wrong.?

    After the Purdue settlement was announced, the Oklahoma Legislature approved a new law clarifying that any settlement proceeds go directly into the state treasury.


  17. #42
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    Fentanyl continues to kill.

    Over a thousand people died of opioid overdose in Ontario in the first nine months of 2018.

    There were 3200 such deaths across the country during that period. Most of these deaths, 93%, were accidental.

    About 75% involved fentanyl.

    All those unintended deaths attest to the toxicity of fentanyl and to the fact that almost all types of street drugs now contain the synthetic opioid. Fentanyl is about 100 times stronger than morphine and kills people every day.

    This is not anybody’s idea of a silver lining, but the certain knowledge that fentanyl is deadly now permits police to charge drug dealers with manslaughter.

  18. #43
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    Every six months over the past two decades, Pedro Garc?a has planted a small crop of opium poppies alongside the maize and beans in his hillside field. The modest profits from the flowers’ sticky sap – known in Spanish as goma – paid for his children’s schooling, but now, Garc?a, 50, can no longer eke out a living.

    “I knew it was illegal, but I took the risk – and thanks to la goma I raised my family,” said Garc?a as he regarded the red, pink and purple flowers. “But now it’s over: my children are grown, the goma era is finished.”

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    Mexico is the main source of heroin trafficked to the US, with some 75,000 acres of opium poppy production in 2017.

    But drug use in the US has shifted: addicts have increasingly swapped heroin for fentanyl – an ultra-potent synthetic opioid often manufactured in China. As a result, the market price for opium in Mexico’s top poppy-growing state, Guerrero, has plummeted from $1,300 a kilo to $200.

    The fentanyl crisis has been responsible for tens of thousands of deaths in the US. But it also seems likely to bring about what half a century of the militarized war on drugs has been unable to achieve: forcing impoverished farmers in rural Mexico to abandon the narcotics trade.

    The opium decline is wreaking social and economic havoc in countless rural communities where peasant farmers like Garc?a now face tough choices: persuade Mexican authorities to help introduce alternative cash crops, accept environmentally destructive mining projects – or migrate north.

    Zilacayota is a picturesque village of indigenous Tlapaneco people living in adobe houses with no phone signal, doctor or paved roads. It lies in the municipality of Acatepec – the biggest opium producer in Guerrero’s La Monta?a region.

    The poppy trade began here in the 1970s: community elders remember military officers bringing seeds and experienced farmhands from Sinaloa state – a move some believe was later used to justify a crackdown on the region’s guerrilla movements.

    The trade gained widespread popularity in the 1990s, after disease outbreaks and free trade agreements like Nafta made traditional crops such as coffee and maize unprofitable.

    In some parts of Guerrero, vast poppy plantations are controlled by organised crime groups whose turf wars have turned rural communities into battle zones. It was in northern Guerrero that 43 trainee teachers were forcibly disappeared by corrupt police in September 2014; independent investigators believe they unwittingly commandeered a bus loaded with heroin.

    Quick guide
    Mexico's war on drugs

    But in La Monta?a, opium production has thrived thanks to an abundance of campesinos with small plots. Opium buyers known as burreros visited isolated communities and transported the morphine-rich sap to labs controlled by criminal gangs to be processed into heroin.

    “La goma is the only crop that paid – nothing else sold at the market,” said Julia S?nchez, a widow with 10 children, who harvested 100 grammes or so of opium twice a year until forced to sell the family land to pay for her husband’s funeral.

    The medics braving drug wars to treat people in Mexico's brutal Guerrero
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    The global drug trade is worth an estimated $320bn annually, according to the UN, but profits are mostly shared by traffickers and retailers in consumer countries.

    After more than 30 years at the bottom rung of the drug trade, 97% of the population in Acatepec still live in poverty, with a staggering 69% in extreme poverty, according to the latest official figures, compared with the national average of 44% poverty and 8% extreme poverty.

    The poppy boom in La Monta?a resulted from the lack of alternatives, said Abel Barrera Hern?ndez, founder of local human rights organisation Tlachinollan. “Here, people don’t see la goma as a criminal problem. For them it’s always been an issue of survival.”

    Nevertheless, the trade did bring disposable income to the region: boozy village fiestas became legendary, children were clothed and well-fed, and out-of-town vendors made the arduous uphill journey to sell everything from school supplies and junk food to guns and stolen cars.


    Now, the fiestas have downsized, children come to school hungry, and the vendors have stopped coming – as have the burreros.

    After her husband’s death, S?nchez earned $4 (80 pesos) a day farming her neighbours’ poppy crops, while her daughters cleaned their houses. This year, no one is hiring and the family is living off shop credit and occasional remittances from her sons who migrated to nearby towns.

    “I don’t know what la goma is used for – they say drugs but I don’t know what that means. All I know is the only thing we know how to farm doesn’t sell any more. We’re desperate.”

    Many here believe the opium price crash is linked to the downfall of Joaqu?n “El Chapo” Guzm?n; a minority have heard it is linked to a new Chinese drug.

    So far, the Mexican government has failed to address the crisis, and some claim things have got worse since President Andr?s Manuel L?pez Obrador took power in December 2018.

    A man harvests poppy plants to produce opium paste.
    A man harvests poppy plants to produce opium paste. Photograph: C?sar Rodr?guez/The Guardian
    In January, military helicopters sprayed parts of the valley with a white liquid chemical that destroyed not just poppies, but also courgettes, chickpeas and bean crops. It was the first aerial fumigation in Zilacayota in over a decade. (The army claims to have destroyed 221,000 hectares of poppies across Guerrero in the past 30 years, including almost 6,000 hectares in Acatepec.)

    Environmental factors linked to soil erosion and climate change are also starting to affect the viability of poppy farming in Guerrero.

    The unseen driver behind the migrant caravan: climate change
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    David Navarro, 26, an ambitious father of two who produced 4kg of opium last year, is now contemplating migrating to the US. “This work isn’t secure. Even if the price goes back up for a while, climate change will end the poppy business here – the weather is changing, it’s getting drier,” he said.

    Amid the chaos and crackdowns at the US border, the going rate charged by local coyotes stands at $8,000 to $10,000. Navarro has some opium stashed away, hoping the price will rise a little, but it wouldn’t cover the migration passage.

    Instead, he will probably join thousands of mostly indigenous campesinos travelling to northern Mexico as seasonal agricultural workers.

    The US fentanyl crisis could mark the end of an era for Mexico – but what comes next depends on what fills the opium vacuum. Violence could increase as criminal gangs compensate for falling drug profits by ramping up extortion, vehicle thefts and kidnappings.

    “This [price drop] could be a great opportunity to help communities regenerate traditional agriculture. But it could also open the door for mining companies” said Barrera Hern?ndez.

    Growing numbers of farmers seem resigned to the end of the opium era, but others are finding it hard to let go.

    Miguel Romero, 30, started farming poppies as a school boy. He has harvested as much as 14kg in recent years, living relatively well as a result – but saved nothing. “We thought the good times would last forever, never imagined that the price would fall.”

    In recent months Romero found construction work in a nearby town, and has experimented with fish and chicken farming, but his heart is not in it. “La goma is what I know, I don’t want to do anything else. I still have hope the price will go back up.”

    Some names have been changed to protect identities

  19. #44
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    The defendants in Oklahoma’s trial against drugmakers are asking a judge to rule in their favor, arguing the state has failed to prove they’re responsible for the opioid epidemic.

    Attorneys for consumer products giant Johnson & Johnson and Janssen Pharmaceuticals filed a motion for judgment Wednesday after the state rested its case.

    Oklahoma called its last witness on Tuesday, a former sales representative for Johnson & Johnson. The drugmakers’ case is expected to take about four more weeks.

    Oklahoma Attorney General Mike Hunter has called Johnson & Johnson and its subsidiaries a “kingpin” responsible for the state’s ongoing opioid epidemic.

    Johnson & Johnson attorney John Sparks says the state is seeking damages from the company without any evidence that it caused the problem.

  20. #45
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    British company Reckitt Benckiser has agreed to pay $1.4 billion to resolve all U.S. government investigations and claims in what is the biggest drug industry settlement to date stemming from the nation's deadly opioid epidemic.

    In a statement Thursday, Reckitt Benckiser denied wrongdoing but said the settlement deal "avoids the costs, uncertainty and distraction associated with continued investigations, litigation and the potential for an indictment."

    The company's former Indivior division, spun off in 2014, makes an opioid-addiction drug called Suboxone Film that dissolves under the tongue. In April, the Justice Department charged Indivior with felony fraud and conspiracy.

    Federal prosecutors said that starting in 2010, Indivior falsely marketed its film as being safer and less prone to abuse than cheaper tablet forms, illegally earning billions of dollars in a "nationwide scheme" to bilk healthcare providers and insurers including Medicaid.

    Opioid-Maker Charged With Fraud In Marketing Drug As Less Prone To Abuse
    Opioid-Maker Charged With Fraud In Marketing Drug As Less Prone To Abuse
    Indivior has denied the allegations. Prosecutors say the company should forfeit at least $3 billion in penalties if found guilty.

    In announcing the Reckitt Benckiser settlement, the Justice Department noted that Suboxone is a medication designed to help people suffering from opioid dependency. "Drug manufacturers marketing products to help opioid addicts are expected to do so honestly and responsibly," said Assistant Attorney General Jody Hunt.

    Most of the $1.4 billion will go to various federal agencies, but $200 million will be divided up among states that sign on to the settlement deal, with the money going to reimburse their Medicaid budgets.

    While the payout is noteworthy for its size, this has been a year of reckoning across the pharmaceutical industry. Insys Therapeutics, Purdue Pharma and Teva Pharmaceutical Industries have agreed to pay state and federal agencies a combined total of more than half a billion dollars to settle opioid-related claims.

    In May, seven current and former Insys executives pleaded guilty to or were convicted of federal racketeering conspiracy charges tied to the marketing of opioid medications. That company later declared bankruptcy. Purdue Phama has talked openly about filing for Chapter 11.

    Meanwhile, Johnson & Johnson is in court in Oklahoma, with that state's attorney general demanding $17 billion in compensation. That trial is expected to wrap up early next week.

    Another big trial begins in October involving lawsuits filed against Big Pharma by more than 1,200 local governments around the U.S. That consolidated case will be heard by a federal court in Ohio.

    This is the kind of opioid-related legal chaos Reckitt Benckiser hopes to avoid, but it may not be completely in the clear. One of the industry's big fears is that companies will make big payouts but face lingering liability.

    Reckitt Benckiser is still facing lawsuits from dozens of state attorneys general. Some officials may choose to take part in this federal settlement, but others may keep fighting in court, pushing for separate opioid settlements.

    The Centers for Disease Control and Prevention reports more than 200,000 people died from prescription opioid overdoses in the U.S. from 1999 to 2017. Advocates hope much of the settlement money will eventually go to help communities and individuals struggling with high rates of addiction and overdose deaths.

  21. #46
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    In May 2008, as the opioid epidemic was raging in America, a representative of the nation?s largest manufacturer of opioid pain pills sent an email to a client at a wholesale drug distributor in Ohio.

    Victor Borelli, a national account manager for Mallinckrodt, told Steve Cochrane, the vice president of sales for KeySource Medical, to check his inventories and ?[i]f you are low, order more. If you are okay, order a little more, Capesce??

    Then Borelli joked, ?destroy this email. . .Is that really possible? Oh Well. . .?

    Previously, Borelli used the phrase ?ship, ship, ship? to describe his job.

    Those email excerpts are quoted in a 144-page plaintiffs? filing along with thousands of pages of documents unsealed by a judge?s order Friday in a landmark case in Cleveland against many of the largest companies in the drug industry. A Drug Enforcement Administration database released earlier in the week revealed that the companies had inundated the nation with 76 billion oxycodone and hydrocodone pills from 2006 through 2012. Nearly 2,000 cities, counties and towns are alleging that the companies knowingly flooded their communities with opioids, fueling an epidemic that has killed more than 200,000 since 1996.

    The filing by plaintiffs depict some drug company employees as driven by profits and undeterred by the knowledge that their products were wreaking havoc across the country. The defendants? response to the motion is due July 31.

    In January 2009, Borelli told Cochrane in another email that 1,200 bottles of oxycodone 30 mg tablets had been shipped.

    ?Keep ?em comin?!? Cochrane responded. ?Flyin? out of there. It?s like people are addicted to these things or something. Oh, wait, people are. . .?

    Borelli responded: ?Just like Doritos keep eating. We?ll make more.?

    Borelli and Cochrane did not return calls for comment Friday night.

    In a statement Friday night, a spokesman for Mallinckrodt sought to distance the company from Borelli?s email: ?This is an outrageously callous email from an individual who has not been employed by the company for many years. It is antithetical to everything that Mallinckrodt stands for and has done to combat opioid abuse and misuse.?

    An attorney for KeySource Medical on Saturday declined to comment, citing ongoing litigation.

    The Controlled Substances Act requires drug companies to control against diversion, and to design and operate systems to identify ?suspicious orders,? defined as ?orders of unusual size, orders deviating substantially from a normal pattern, and orders of unusual frequency.? The companies are supposed to report such orders to the DEA and refrain from shipping them unless they can determine the drugs are unlikely to be diverted to the black market. The plaintiffs, in the filing, allege that the companies ignored red flags and failed at every level.

    [76 billion opioid pills: An epidemic unmasked]

    At Cardinal Health, one of the nation?s largest drug distributors, then-CEO Kerry Clark in January 2008 wrote in an email to Cardinal senior officials that the company?s ?results-oriented culture? was perhaps ?leading to ill-advised or shortsighted decisions,? the filing contends.

    In the previous 18 months, Cardinal had been hit with nearly $1 billion in ?fines, settlements, and lost business as a result of multiple regulatory actions,? the filing alleges, including the suspension of licenses at some of its distribution centers for failing to maintain effective controls against opioid diversion.

    Cardinal Health did not immediately return a request for comment Friday night.

    On Aug. 31, 2011, McKesson Corp.?s then-director of regulatory affairs, David B. Gustin, told his colleagues he was concerned about the ?number of accounts we have that have large gaps between the amount of Oxy or Hydro they are allowed to buy (their threshold) and the amount they really need,? according to the filing, which cites Gustin?s statements. ?This increases the ?opportunity? for diversion by exposing more product for introduction into the pipeline than may be being used for legitimate purposes.?

    According to the filing, he had earlier noted to his colleagues that they ?need to get out visiting more customers and away from our laptops or the company is going to end up paying the price . . . big time.?

    Another McKesson regulatory affairs director responded: ?I am overwhelmed. I feel that I am going down a river without a paddle and fighting the rapids. Sooner or later, hopefully later I feel we will be burned by a customer that did not get enough due diligence,? according to the filing.

    McKesson is the largest drug distributor in the United States. It distributed 14.1 billion oxycodone and hydrocodone pills from 2006 to 2012, about 18 percent of the market, according to the DEA database.

    The Post had made public a significant portion of a government database that records the flood of prescription opioid pain pills distributed across the U.S. VIEW GRAPHIC
    The Post had made public a significant portion of a government database that records the flood of prescription opioid pain pills distributed across the U.S.
    ?Suggesting that these two employees? emails from nearly a decade ago are evidence of wrongdoing ignores the context in which McKesson and our employees were operating,? McKesson spokeswoman Kristin Chasen said in a statement Friday. ?Doctors around the country were writing millions of additional opioid prescriptions year over year. Our regulator, the DEA, consistently raised the annual quota of pills that could be produced and distributed, which was a clear statement that the increase in prescriptions was appropriate, expected, and medically necessary. To imply that distributors should have second-guessed or overruled those decisions by the government and the medical community reflects a fundamental misunderstanding of our role. For decades, McKesson has consistently reported opioid transactions to the DEA. We have also invested heavily in further strengthening our anti-diversion program.?

    Until Friday, the documents had been sealed under a protective order issued by U.S. District Judge Dan Polster. The order was lifted a year after The Washington Post and HD Media, which publishes the Charleston Gazette-Mail in West Virginia, filed a lawsuit for access to the documents and a DEA database tracking opioid sales, known as the Automation of Reports and Consolidated Orders System, or ARCOS.

    [Follow The Post?s investigation of the opioid epidemic]

    The drug companies and the DEA strenuously opposed the release of the data and the documents, and Polster agreed with them. But a three-judge panel of the U.S. Court of Appeals for the 6th Circuit in Ohio ordered that some of the information should be released with reasonable redactions and the database should be made public.

    By consolidating cases from around the nation, the Cleveland case, for the first time, provides specific information about how and in what quantity the drugs flowed around the country, from manufacturers and distributors to pharmacies. The case also brings to light internal documents and deliberations by the companies as they sought to promote their products and contend with enforcement efforts by the DEA.

    The local and state government plaintiffs in the case argue that the actions of some of America?s biggest and best-known companies ? including Mallinckrodt, Cardinal Health, McKesson, Walgreens, CVS, Walmart and Purdue Pharma ? amounted to a civil racketeering enterprise that had a devastating effect on the plaintiffs? communities.
    Part 1

  22. #47
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    The case is a civil action under the Racketeer Influenced and Corrupt Organizations (RICO) Act, making use of a law originally developed to attack organized crime.

    In statements to The Post on Tuesday in response to the release of the DEA database, the drug companies issued broad defenses of their actions during the opioid epidemic. They have said previously that they were trying to sell legal painkillers to legitimate pain patients who had prescriptions. They have blamed the epidemic on overprescribing by physicians and also on corrupt doctors and pharmacists who worked in “pill mills” that handed out drugs with few questions asked. The companies also said they should not be held responsible for the actions of people who abused the drugs.

    The companies said that they were diligent about reporting their sales to the DEA and that the agency should have worked with them to do more to fight the epidemic, a point former DEA agents dispute. The companies also note that the DEA set the quotas for opioid production.

    “We report those suspicious orders to state boards of pharmacy and to the DEA but we do not know what those government entities do with those reports, if anything,” Cardinal Health said in a statement.

    The companies issued statements rejecting the plaintiffs’ allegations.

    McKesson said in its statement: “The allegations made by the plaintiffs are just that — allegations. They are unproven, untrue and greatly oversimplify the evolution of this health crisis as well as the roles and responsibilities of the many players in the pharmaceutical supply chain.”

    [Read the responses from distributors, pharmacies and manufacturers ]

    Mallinckrodt said the company “has for years been at the forefront of preventing prescription drug diversion and abuse, and has invested millions of dollars in a multipronged program to address opioid abuse.”

    Drug Enforcement Administration agents raid a pain management clinic in Delray Beach, Fla., in February 2011. A DEA database released this week revealed that drug companies had inundated the nation with 76 billion oxycodone and hydrocodone pills from 2006 through 2012. (Carline Jean/South Florida Sun-Sentinel/AP)
    ‘Kingpin within the drug cartel’
    One of the biggest points of contention in the lawsuit is whether the nation’s largest drug companies did enough to identify suspicious orders of opioids. What exactly constitutes a suspicious order is at the heart of the case.

    The DEA has long said there should be no confusion because the agency has given frequent guidance and briefings to the industry, and repeatedly defined what constitutes a suspicious order.

    The plaintiffs argue that the companies failed to “design serious suspicious order monitoring systems that would identify suspicious orders to the DEA” and shipped the drugs anyway.

    [As lawyers zero in on drug companies, a reckoning may be coming]

    “Their failure to identify suspicious orders was their business model: they turned a blind eye and called themselves mere ‘deliverymen’ with no responsibility for what they delivered or to whom,” according to the plaintiffs’ filing.

    Between 1996 and 2018, the plaintiffs alleged in the filing, drug companies shipped hundreds of millions of opioid pills into Summit and Cuyahoga counties in Ohio, filling orders that were suspicious and “should never have been shipped.”

    “They made no effort actually to identify suspicious orders, failed to flag orders that, under any reasonable algorithm, represented between one-quarter and 90 percent of their business, and kept the flow of drugs coming into Summit and Cuyahoga Counties,” the plaintiffs’ lawyers wrote.

    In rural Virginia, 'ground zero' for America's opioid crisis
    Norton, Va. was flooded with 306 pain pills per person per year from 2006-2012, according to previously undisclosed data obtained by The Washington Post. (Video: Joyce Koh/Photo: Charles Mostoller for The Washington Post/The Washington Post)

    In 2007, the DEA told Mallinckrodt that the numeric formula it used to monitor suspicious orders was insufficient, the filing contended. It alleges the company’s suspicious order monitoring program from 2008 through 2009 consisted of solely verifying that the customer had a valid DEA registration and that the order was accurately logged into the DEA’s tracking database.

    From 2003 to 2011, Mallinckrodt shipped a total of 53 million orders, flagged 37,817 as suspicious but stopped only 33 orders, the plaintiffs’ filing states.

    A Mallinckrodt employee said in a deposition that the DEA had described the company as the “kingpin within the drug cartel” in a meeting with the agency in July 2010, according to a footnote in the filing.

    In 2011, the filing cites a Justice Department document in which the DEA alleged that Mallinckrodt “sold excessive amounts of the most highly abused forms of oxycodone, 30 mg and 15 mg tablets, placing them into a stream of commerce that would result in diversion.”

    According to the DEA, the filing states, “even though Mallinckrodt knew of the pattern of excessive sales of its oxycodone feeding massive diversion, it continued to incentivize and supply these suspicious sales,” and never notified the DEA of the suspicious orders.

    In a settlement with the DEA, Mallinckrodt agreed that from Jan. 1, 2008, through Jan. 1, 2012, “certain aspects of Mallinckrodt’s system to monitor and detect suspicious orders did not meet the standards” outlined in letters from the DEA deputy administrator for diversion control.

    Mallinckrodt was the nation’s leading manufacturer of oxycodone and hydrocodone, with 28.8 billion pills from 2006 to 2012, 37.7 percent of the market, according to the DEA database. It has since created a subsidiary for its generic opioids called SpecGx.

    The Post reported in 2017 that federal prosecutors said 500 million of the company’s 30 mg oxycodone pills wound up in Florida between 2008 and 2012 — 66 percent of all oxycodone sold in the state. Pills at that dosage are among the most widely abused.

    Prosecutors said the company failed to report suspicious orders, and Mallinckrodt that year settled the case by paying a $35 million fine.

    “Mallinckrodt’s actions and omissions formed a link in the chain of supply that resulted in millions of oxycodone pills being sold on the street,” then-Attorney General Jeff Sessions said at the time.

    McKesson Corp., the nation’s largest opioid distributor, doled out 14.1 billion oxycodone and hydrocodone pills from 2006 to 2012, about 18 percent of the market, according to the newly released DEA database. (Kris Tripplaar/Sipa USA)
    ‘Business as usual’
    The same year that Mallinckrodt paid its fine, McKesson, the nation’s largest drug distributor, was fined a record $150 million by the Justice Department.

    According to allegations in the new court filing, McKesson frequently increased the amount of opioid pills it sent to its pharmacy customers.

    “McKesson has a long history of absolute deference to retail national account customers when it comes to [opioid] threshold increases,” the plaintiffs argue in their filing, citing a deposition of McKesson’s senior director of distribution operations.

    McKesson had set limits on the amount of opioids its customers could order, the filing contends, but those limits were often lifted.

    “In August 2014, DOJ noted that McKesson appeared to be willing to approve threshold increases for opioids for the flimsiest of reasons,” the filing contends.

    For shipments to pharmacies in Summit and Cuyahoga counties, McKesson did not report a single suspicious order between May 2008 and July 2013, the filing says. During that time, McKesson filled 366,000 opioid orders in those two counties.

    McKesson reached its settlement with the government in January 2017 for allegations of failing to report suspicious orders. It was the second time the company was fined over suspicious orders. Nine years earlier, it paid $13 million.

    The government said in 2017 that McKesson “failed to design and implement an effective system to detect and report ‘suspicious orders.’ ” The company shipped more than 1.6 million orders of opioid pills between 2008 and 2013 but reported just 16 as suspicious, according to the Justice Department.

    However, “before the ink of the settlement agreement was even dry,” the new filing argues , McKesson was already reassuring customers who were concern

    Part 2

  23. #48
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    Death rates from opioids soared in the towns, cities and counties that were saturated with billions of prescription pain pills from 2006 through 2012, according to government death data and a previously undisclosed database of opioid shipments made public this week.

    The highest per capita death rates nationwide from opioids during those years were in rural communities in West Virginia, Kentucky and Virginia. In those seven years, those communities also were flooded with a disproportionate share of the 76 billion oxycodone and hydrocodone pain pills from some of the country’s largest drug companies, an analysis by The Washington Post reveals.

    The national death rate from opioids was 4.6 deaths per 100,000 residents. But the counties that had the most pills distributed per person experienced more than three times that rate on average. Thirteen of those counties had an opioid death rate more than eight times the national rate, according to the government data. Seven of them were in West Virginia.

    Norton, Va. was flooded with 306 pain pills per person per year from 2006-2012, according to previously undisclosed data obtained by The Washington Post. (Video: Joyce Koh/Photo: Charles Mostoller for The Washington Post/The Washington Post)

    “What they did legally to my state is criminal,” Sen. Joe Manchin III (D-W.Va.) said. “The companies, the distributors, were unconscionable. This was not a health plan. This was a targeted business plan. I cannot believe that we have not gone after them with criminal charges.”


    For the first time, The Post is able to reveal where prescription opioid pills were shipped county-by-county and compare that information with federal data that logs deaths caused by prescription opioids.

    [An epidemic unmasked: 76 billion opioid pills]

    The Post obtained and analyzed a previously unreleased database maintained by the Drug Enforcement Administration that tracks the path of every pain pill sold in the United States — by manufacturers and distributors to pharmacies in every town and city. That data was compared with individual death records from the Centers for Disease Control and Prevention, which were obtained and analyzed by The Post.

    A map of the deaths and shipments reveals a virtual opioid belt of more than 90 counties stretching southwest from Webster County, W.Va., through southern Virginia and ending in Monroe County, Ky.

    This swath includes 18 of the top 20 counties ranked by per capita prescription opioid deaths nationwide and 12 of the top 20 counties for opioid pills distributed per capita. In the belt from 2006 through 2012, death rates from opioid abuse were 4.5 times the national average.

    [Listen to Post Reports: How The Post gained access to the DEA’s pain pill database ]

    Nowhere is this more stark than in Norton, Va., a rural city of about 4,000 people, that lies in the eastern edge of the opioid belt.

    In Norton, considered a county by the federal government, the per capita death rate from prescription opioid overdoses was 18 times the national rate. At the same time, drug companies shipped 306 pain pills per person per year, The Post analysis shows.

    “That number blows me away,” said Joseph Fawbush, Norton’s mayor. “I believe the manufacturers misled the doctors. It is addictive and they were telling the doctors it’s not addictive.”

    Fawbush said opioids have devastated his town.

    “Our jails are overflowing, a high percentage of children now have to be raised by their grandparents, and our court system and emergency services are strained,” Fawbush said.

    [Interactive: Drill into the DEA’s pain pill database]

    The analysis shows that McDowell County in the southern part of West Virginia along the Appalachian Mountains ranked second for rate of death from prescription opioids from 2006 through 2012.

    In that period, the per capita death rate was 13 times higher than the national average in a county where drug companies shipped 96 pain pills per person per year. West Virginia also had the highest opioid death rate in the nation during this period.

    Grappling with the epidemic, the McDowell County sheriff and others from the county came to Washington last year to meet with officials in Congress and the White House about the crisis and the lack of treatment resources.

    “They have pumped a bunch of pills in here. It’s such a bad situation,” said Cecil Patterson, 64, a McDowell County commissioner and coal miner. “Every family has been affected by this. It’s just overwhelming what’s going on here. We are hard-working people. We’ll survive this. But it has been tough. We’ve all had family members and friends we have lost to drugs.”

    Trump’s claim of ‘amazing’ success in cutting opioid prescriptions | Fact Checker
    Trump suggests he reached a three-year goal in one year. But the trend started under President Obama. (Meg Kelly/The Washington Post)

    The DEA database was released Monday by a judge in the largest civil action in U.S. history. About two dozen companies are being sued in federal court in Cleveland by nearly 2,000 cities, towns and counties.

    “Now that we’re seeing these things that we knew and couldn’t prove, and now that we have these records, I think we should go after the living daylights of these people,” Manchin said.

    On Monday, U.S. District Judge Dan Polster lifted a protective order concealing the database from the public. The database, the Automation of Reports and Consolidated Order System, known as ARCOS, contained seven years of data. The Post and HD Media, which publishes the Charleston Gazette-Mail in West Virginia, waged a year-long legal battle for access to the database and other documents. Last June, The Post and the Charleston Gazette-Mail asked Polster to lift the protective order covering the ARCOS database and the court filings. He declined, but the news organizations won access to the database on appeal.

    The Post analysis shows that the volumes of the pills handled by the companies climbed as the epidemic surged, increasing 51 percent from 8.4 billion in 2006 to 12.6 billion in 2012. The overall number — 76 billion oxycodone and hydrocodone pills shipped over the seven years — eclipsed what was previously known about opioid distribution by orders of magnitude.

    [Have opioids affected your community? Share your story.]

    The prescription pill crisis was the first wave of an ongoing epidemic that hit rural areas particularly hard in West Virginia, Kentucky, South Carolina, Tennessee and Nevada, according to the database.

    When the federal government began imposing hundreds of millions of dollars of fines on the largest drug distributors and pharmacies between 2008 and 2015, the supply began to tighten and pill addicts turned to heroin, triggering the second wave of the epidemic.

    Increased heroin use ultimately led to the third wave of the epidemic, as Mexican drug cartels began blending their heroin with fentanyl, the deadly synthetic opioid shipped from China. Drug dealers in the United States also began selling fentanyl, leading to more than 67,000 overdose deaths from fentanyl from 2013 to 2017.

    [Obama officials failed to focus as fentanyl burned its way across America]

    As the epidemic raged, local governments fought back. Norton and other communities filed lawsuits against the drug companies, alleging that opioids from the companies were destroying their towns. Some of the lawsuits allege the companies not only failed to report suspicious orders, but they also sought to maximize profits.

    As hundreds of lawsuits began to pile up, many were consolidated into the one centralized case in U.S. District Court in Cleveland. The opioid litigation is now larger in scope than the tobacco litigation of the 1980s, which resulted in a $246 billion settlement over 25 years.

    Keith Humphreys, a Stanford University professor who served as a drug policy adviser to the George W. Bush and Obama administrations, said the correlation of opioid deaths and pain pill distribution could be expected.

    “These horrible death rates should not surprise anyone,” Humphreys said. “The supply of drugs matters enormously no matter what else we try to do. When there’s a flood of addictive drugs, lots of people end up being harmed.”

  24. #49
    Senior Member
    Join Date
    Nov 2017
    San Francisco
    Rep Power
    Spiraling out of control for opioids. In terms of deaths and addictions.

  25. #50
    Senior Member blighted star's Avatar
    Join Date
    Jan 2013
    Probably South Of You
    Rep Power
    I hope they destroy every evil fucker who grew wealthy through this company. Every last one of them

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