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Opioid Litigation Daily Media Report 10/30/17

    Cuyahoga County Suit

  1. County in Cleveland sue drugmakers over opioid surge

    Oct 28, 2017 | The Associated Press

    By Staff

    County officials in Cleveland are suing several large prescription drug companies saying they intentionally misled the public about the dangers of opioids.
  2. Cuyahoga County files lawsuit accusing drug companies of racketeering, leading to opioid epidemic

    Oct 30, 2017 | Cleveland.com (OH)

    By Cory Shaffer

    Cuyahoga County officials on Friday filed a lawsuit accusing several major prescription drug companies of intentionally misleading the public about the dangers of opioids to sell more painkillers as they raked in "blockbuster profits."
  3. Cuyahoga County Announces It's Suing Addictive Painkiller Makers and Distributors

    Oct 30, 2017 | WKSU (OH)

    By Ashton Marra

    Cuyahoga County is suing the manufacturers and distributors of addictive opioidss, adding to a growing list of local governments across Ohio to do so.
  4. Cuyahoga County files lawsuit against opioid manufacturers

    Oct 30, 2017 | WKYC (OH)

    By Staff

    Cuyahoga County officials announced a lawsuit filed against manufacturers and distributors of opioids Friday.
  5. Shareholder Resolutions

  6. Investor group presses US drug companies on opioid controls

    Oct 30, 2017 | Reuters

    By Staff

    U.S. shareholder activists are addressing the soaring death toll from opioid drug abuse, asking companies that make and distribute the painkillers to review the risks their businesses could face from their role in the sector.
  7. $1.3 Trillion Investor Coalition Probes Pharma on Opioid Accountability (PRESS RELEASE)

    Oct 30, 2017 | Investors for Opioid Accountability

    Investors for Opioid Accountability (IOA), a coalition of 30 treasurers, asset managers, faith-based, public and labor funds with over $1.3 trillion in assets is filing multiple shareholder proposals on board oversight of business risks related to opioids at 10 opioid distributor and manufacturer companies. IOA membership is diverse including Treasurers from California, Connecticut, Illinois, West Virginia, Pennsylvania, and Rhode Island, faith-based investors such as Trinity Health, Sisters of Saint Francis and United Church Funds, labor funds such as the International Brotherhood of Teamsters and CTW Investment Services and public funds such as the School Employees Retirement System of Ohio and the New York City Pension Funds. The focus companies include not only opioid distributers McKesson, Cardinal Health and AmerisourceBergen, but also opioid manufacturers Depomed, Endo, Insys, Johnson & Johnson, Mallinckrodt, Mylan and Pernix. IOA is led by the UAW Retiree Medical Benefits Trust and Mercy Investment Services.
  8. Other Coverage

  9. A Bipartisan Drug Cartel? (OPINION)

    Oct 30, 2017 | WSJ

    By The Editorial Board

    Perhaps you’ve heard that President Trump’s drug office nominee colluded with pharmaceutical companies to worsen the opioid crisis, based on a press dispatch this month. The resulting panic could result in reversing a useful law, so allow us to fill in the real story of this grand non-conspiracy that included 535 Members of Congress and Barack Obama.
  10. Founder and Owner of Insys Arrested

    Oct 30, 2017 | Policy & Medicine

    By Thomas Sullivan

    Late last week, John N. Kapoor, the founder and majority owner of Insys Therapeutics, Inc., was arrested and charged with leading a conspiracy to profit by using bribes and fraud to cause the illegal distribution of a Fentanyl spray intended for cancer patients experiencing breakthrough pain.
  11. Opioid king John Kapoor bribed doctors and paid speaker fees to get drugs prescribed

    Oct 28, 2017 | Business Day

    By CYNTHIA KOONS AND JEF FEELEY

    More than a decade after opioid painkillers first exploded across the US, John Kapoor found an aggressive way to sell even more, according to prosecutors: he began bribing doctors to prescribe them.
  12. Cold withdrawal for the pharmaceutical giant (German)

    Oct 27, 2017 | Handelsblatt

    By Katharina Kort

    Tens of thousands dead - countless addicts: The pharmaceutical companies are under pressure because of the drug epidemic in the United States. They are said to have played down addictive drugs. President Trump reacts only half-heartedly.
  13. Opioid lawsuit grouping disputed

    Oct 28, 2017 | The Herald Dispatch (WV)

    By Courtney Hessler

    While several wholesale opioid distributors and manufacturers are in favor of centralizing more than 60 lawsuits across the nation alleging companies fueled the drug epidemic by pumping pills into local areas, several remaining defendants named in West Virginian suits oppose the request.
  14. Paterson Demands Drug Manufacturers Help Solve Epidemic of Opioid Use

    Oct 27, 2017 | TAP into Paterson (NJ)

    By Max Paterson

    Just weeks after local pharmacy owner Warren Cortese joined forces with the body that governs high school athletics in the State of New Jersey to reduce the use opioids by young athletes, the City of Paterson announced that it has filed a lawsuit against some of the nation's largest pharmaceutical companies and distributors.
  15. Communities suing drug distributors want access to transaction information

    Oct 27, 2017 | CantonRep.com

    By Eric Rinehart

    A federal judge in Columbus signed an order Friday allowing communities in Ohio and elsewhere that blame drug companies for the opioid crisis to subpoena a national database that tracks the flow of prescription pills.
  16. Opioid epidemic: Cuyahoga County files lawsuit against drug manufacturers, distributors

    Oct 30, 2017 | Fox.8 Cleveland (OH)

    By Darcie Loreno

    In 2016, Cuyahoga County lost more people to the opioid epidemic than to deaths from homicides, suicides and car crashes combined.
  17. What Trump Declaring Opioid Crisis a Public Health Emergency Means

    Oct 27, 2017 | Insurance Journal

    By Jeff Mason and Yasmeen Abutaleb

    U.S. President Donald Trump declared the opioid crisis a public health emergency on Thursday, stopping short of a national emergency declaration he promised months ago that would have freed up more federal money.
  18. Walthall could join nat’l opioid lawsuit

    Oct 28, 2017 | Enterprise Journal (MS)

    By Mack Spencer

    Walthall County supervisors are mulling whether to join a lawsuit against pharmaceutical distributors.
  19. DeWine announces new opioid initiatives

    Oct 30, 2017 | WSYX (OH)

    By Chris White

    Ohio Attorney General Mike DeWine announced new opioid initiatives Monday.
  20. Broadcast Media Coverage

  21. 10 This Morning Sunday

    Oct 29, 2017 | WBNS (CBS)

    By Columbus, OH

    Video Link: http://app.criticalmention.com/app/#clip/view/30354082?token=5ebeb50e-ba20-41fd-89c1-e8b97e29756b
  22. 21 News 6PM

    Oct 30, 2017 | WFMJ (NBC)

    By Youngstown, Ohio

    Video Link: http://app.criticalmention.com/app/#clip/view/30354161?token=5ebeb50e-ba20-41fd-89c1-e8b97e29756b

    Cuyahoga County Suit

  1. County in Cleveland sue drugmakers over opioid surge

    Oct 28, 2017 | The Associated Press

    By Staff

    County officials in Cleveland are suing several large prescription drug companies saying they intentionally misled the public about the dangers of opioids.

    The lawsuit filed Friday by Cuyahoga (ky-uh-HOH’-guh) County says the drugmakers and distributors sought to increase sales of painkillers and contributed to the opioid abuse crisis.

    The complaint names some of the largest companies in the pharmaceutical industry. The lawsuit also accuses four doctors of downplaying the risk of prescription opioids in research funded by the drug companies.

    The companies have denied wrongdoing in response to similar lawsuits filed around the country.

    More than 540 people fatally overdosed on opioids last year in Cuyahoga County. The county Medical Examiner’s Office estimates close to 800 could die this year.

    The suit seeks an undisclosed amount of damages.

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  2. Cuyahoga County files lawsuit accusing drug companies of racketeering, leading to opioid epidemic

    Oct 30, 2017 | Cleveland.com (OH)

    By Cory Shaffer

    Cuyahoga County officials on Friday filed a lawsuit accusing several major prescription drug companies of intentionally misleading the public about the dangers of opioids to sell more painkillers as they raked in "blockbuster profits."

    The 269-page complaint, filed in Cuyahoga County Common Pleas Court, claims drug manufacturers, distributors and four influential doctors unjustly enriched themselves as they acted as a criminal enterprise and conspired to break numerous state laws meant to protect consumers.

    The conspiracy contributed to the scourge of opioid overdoses that has tormented thousands of families and is now threatening to bust the county's budget, the suit claims.

    "We have had enough," County Executive Armond Budish said. "We're opening a new front in our battle against this opioid epidemic."

    Cuyahoga County Prosecutor Michael O'Malley also said his office would conduct a criminal review of the companies named in the lawsuit, and recused his office from representing the county in the lawsuit.

    The suit names some of the largest and most powerful companies in the pharmaceutical industry, including Purdue Pharma LP, Teva Pharmaceuticals, Cephalon, Janssen Pharmaceuticals, McKesson Corporation, Cardinal Health and AmerisourceBergen Corp. It also accuses four doctors, Robert Portenoy, Perry Fine, Lynn Webster and Scott Fisher, of downplaying the risk of prescription opioids in papers and lectures funded by the drug companies.

    "They manufactured and distributed these addictive drugs in violation of the law, endangering the lives of thousands of our residents, just to make huge profits," Budish said. 

    The lawsuit was announced Friday morning at a news conference in front of the county's headquarters in downtown Cleveland.

    The lawsuit asks a jury to make the companies pay the county for costs associated with the epidemic, and to punish the companies for creating a public nuisance that created a "plague of drug-addicted residents," the suit claims.

    The county is the latest entity to sue prescription drug companies over their roles in the current opioid epidemic sweeping the nation. Several counties in West Virginia have filed similar lawsuits against the same three distributors, and Ohio Attorney General Mike DeWine filed a similar lawsuit against some of the same manufacturers named in the county's lawsuit.

    Law Director Robert Triozzi said the county's lawsuit is unique in that it names both manufacturers and distributors, and alleges that the players acted in concert with one another.

    Summit County Executive Ilene Shapiro unveiled plans earlier this week to file a similar lawsuit against the manufacturers and distributors of prescription opioids.

    The companies have denied wrongdoing in response to previous lawsuits.

    Cuyahoga County's suit alleges that the companies knew that prescription opioids like oxycodone, could be addictive and were best used to treat short-term pain in small doses, and that little to no research supported long-term use to treat chronic pain.

    But in a quest for profits, the companies launched a years-long and misleading advertisement campaign to underplay the dangers and addictiveness of the drugs and convince doctors to prescribe -- and patients to take -- opioids to treat long-term, chronic pain, the suit claims. 

    The companies deployed sales representatives, elevated doctors who supported the long-term use of the drugs as paid speakers and funded research that showed the drugs were safe, the suit says. The companies also funded and supported committees and patient advocacy groups to produce educational materials that touted the benefits of using opioids to treat long-term pain, the lawsuit says.

    The companies achieved their goal, and doctors, clinics and pharmacists began pouring prescription painkillers into communities across the nation, Ohio and Cuyahoga County, the lawsuit alleges.

    The three distributors named in the lawsuit were required to report to the U.S. Drug Enforcement Administration any suspicious orders from clinics. But the companies, the suit claims, repeatedly failed to report suspicious orders and concealed from the DEA the amount of pills being dumped into communities.

    The huge orders would have been clear evidence that the pills were being diverted and abused, the suit says.

    The lawsuit doesn't point to any specific suspicious orders in Cuyahoga County that the distributors should have flagged to the DEA. But the county pointed out that they expected the lawsuit to pry that information from the companies and the Ohio Pharmacy Board through discovery.

    At the same time, authorities began cracking down on pill mills, spurious pain clinics that were doling out huge amounts of fraudulent prescriptions. The crackdown drove up the price of pills and the street price of heroin down, and addicts turned to the streets.

    The result was a spike in heroin overdose deaths that has devastated families and choked resources. 

    In 2010, the county logged 159 unintentional opioid overdose deaths. That number spiked to 212 in 2011 and hovered in the 200s until last year, when it spiked to unprecedented levels.

    More than 540 people fatally overdosed on opioids last year, and the county medical examiner's office estimates that upwards of 800 lives could die this year.

    The spike in deaths have overwhelmed the county's resources. 

    The medical examiner's office has rented two mobile storage units to store the surge in bodies and requested $200,000 to hire new pathologists to conduct autopsies to keep the office afloat. It also spent more than $300,000 to buy new equipment to detect small amounts of drugs.

    There are 2,000 children in foster care, the highest number since 2011, and the number of babies born to drug-addicted mothers who lack resources to treat their addiction has significantly increased, the lawsuit says.

    More and more prisoners and inmates in the Cuyahoga County Jail come in addicted to drugs and require treatment, and deputies have spent more money and time responding to calls for overdoses and deploying the opioid-reversal drug naloxone.

    The county has also promised the Alcohol Drug Addiction Mental Health Services Board, or ADAMHS Board, $39 million in next year's budget.

    Though O'Malley appeared at the announcement and supported the lawsuit, he said his office has recused itself from representing the county to avoid any conflict of interest should criminal charges arise. 

    The county has hired a team of lawyers, including New York-based personal injury attorney Paul Napoli from the Napoli Shkolnik law firm, which has filed numerous lawsuits against pharmaceutical companies in the past. Cleveland attorneys Frank Gallucci, Leo Spellacy and Columbus-based attorney Scott Elliot Smith will also work on the lawsuit.

    The lawyers have agreed to pay any court costs on behalf of the county as the suit moves forward. If the county loses, the lawyers will not bill the county. If the county wins any money, the lawyers will collect 25 percent of that award.

    The county opted to file the lawsuit in state court, and allege state-specific infractions, so they could have more control over the direction of the lawsuit, and get to present the case to either a locally elected judge or a jury of Cuyahoga County citizens.

    It would also ensure that any settlement money or a jury award received as a result of the lawsuit would go directly into the county's coffers, and not diverted through the state.

    Officials would not put a number on the amount of money, but the cost of the entire epidemic is in the "tens of millions" of dollars, they said.

    John Parker, senior vice president of Healthcare Distribution Alliance, a national trade group that represents prescription drug distributors including McKesson, AmerisourceBergen and Cardinal Health, said in an emailed statement that health distributors do not make, market, prescribe or dispense medicines to patients.

    "As distributors, we understand the tragic impact the opioid epidemic has on communities across the country. We are deeply engaged in the issue and are taking our own steps to be part of the solution - but we aren't willing to be scapegoats," Parker said.

    He added, "we are ready to have a serious conversation about solving a complex problem and are eager to work with political leaders and all stakeholders in finding forward-looking solutions."

    The move comes one day after President Donald Trump declared the scourge of opioid overdoses a public health crisis. That move, though not providing any additional money to combat the epidemic, would free-up other funding to respond to the nationwide increase in deaths.

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  3. Cuyahoga County Announces It's Suing Addictive Painkiller Makers and Distributors

    Oct 30, 2017 | WKSU (OH)

    By Ashton Marra

    Cuyahoga County is suing the manufacturers and distributors of addictive opioidss, adding to a growing list of local governments across Ohio to do so.

    “If we’re waiting for help from Washington, it is not coming,” says Mike O'Malley.

    Cuyahoga County Prosecutor O’Malley joined county Executive Armond Budish to announce the civil case Friday. The county is suing pharmaceutical manufacturers and distributors for the cost it’s incurred for medical, emergency, social and law enforcement services as a result of the region's opioid epidemic.

    The suit alleges the manufacturers misrepresented the addictiveness of the drugs and the distributors failed to notify government agencies of sthe uspiciously large number of pills being sold by certain pharmacies and doctors who operated pill mills.

    Budish says more than 600 county residents died from opioid-related overdoses last year.

    “They manufactured and distributed these addictive drugs in violation of the law, endangering the lives of thousands of our residents, and they did it just to make huge profits,” says Budish.

    Ohio’s Attorney General filed a lawsuit earlier this year against about a half dozen drug makers, some of which are included in the Cuyahoga County case. He did not sue the distributors, including Cardinal Health, which is based in Ohio. Summit County announced earlier this week it -- along with Akron, Barberton and Cuyahoga Falls -- expect to sue the drug makers and distributors in a few weeks.

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  4. Cuyahoga County files lawsuit against opioid manufacturers

    Oct 30, 2017 | WKYC (OH)

    By Staff

    Cuyahoga County officials announced a lawsuit filed against manufacturers and distributors of opioids Friday.

    Officials noted a significant spike in overdoses since 2011. Over the last five years, the county recorded a 23.5 percent drug overdose death rate per 100,000 population.

    Last year, Cuyahoga County had more than 500 overdose deaths. This year, the county is on pace to exceed 800, according to County Executive Armond Budish.

    "There is a direct correlation between the over prescription of opioid pain pills and addiction and subsequent deaths of our mothers, fathers and loved ones," Budish said.

    The lawsuit targets manufacturers, distributors and four individuals who played a role in promoting opioids for sale and distribution both nationally and within Cuyahoga County.

    The county has requested a $200,000 budget increase due to rising costs in combating opioids. 

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  5. Shareholder Resolutions

  6. Investor group presses US drug companies on opioid controls

    Oct 30, 2017 | Reuters

    By Staff

    U.S. shareholder activists are addressing the soaring death toll from opioid drug abuse, asking companies that make and distribute the painkillers to review the risks their businesses could face from their role in the sector.

    Leaders of a 30-fund group that includes state pension officials and religious and labor organizations plan to reveal on Monday they have begun filing shareholder resolutions at 10 companies, including distributors AmerisourceBergen Corp and Cardinal Health Inc and manufacturers including Johnson & Johnson and Insys Therapeutics.

    In resolutions aimed at annual shareholder meetings to be held in 2018 and in letters to the companies, activists are calling for independent directors to review and report on how the boards are managing the legal, financial and reputational risks their enterprises face as a result of their involvement with opioids.

    They also seek corporate-governance reforms such as allowing more grounds to claw back pay from executives who inappropriately promote the drugs, or creating independent board chairs to provide better oversight.

    Representatives of AmerisourceBergen, Cardinal and Insys did not immediately respond to requests for comment.

    Johnson & Johnson spokesman Ernie Knewitz said the company is preparing a response to the investors, and that the company has acted responsibly.

    "Opioid abuse is a serious public health issue that must be addressed, and doing so will require collaboration among many stakeholders, and our company is committed to working with federal, state and local officials to help find meaningful solutions," he said in an e-mailed statement.

    At its annual meeting on Nov. 8, Cardinal Health will face a resolution calling for an independent board chair in order to improve oversight.

    "These considerations are especially critical at Cardinal given the potential reputational, legal and regulatory risks Cardinal faces over its role in the nation's opioid epidemic, including its history of compliance challenges concerning the distribution of controlled substances," the resolution's sponsors, including the International Brotherhood of Teamsters, said in a supporting statement. The statement cited Cardinal's payment of tens of millions of dollar to settle various federal and state charges related to opioids.

    In a securities filing Cardinal calls the change unnecessary, noting it already has an independent lead director and "state-of-the-art controls" over its pain medications.

    Officials at all levels of government in the United States are struggling to respond to a surge in deaths from opioid abuse, which hit 33,000 in 2015, the last year for which there is complete federal data.

    In many cases patients prescribed opioid painkillers become addicted to them and then move on to acquiring the drugs illegally, or turn to heroin or fentanyl, a highly potent synthetic opiate.

    U.S. President Donald Trump on Thursday declared the opioid epidemic a national public health emergency.

    State attorneys general have also taken on opioid manufacturers, with lawsuits charging that deceptive marketing practices helped fuel an epidemic of abuse. Federal prosecutors on Thursday charged the founder of Insys, John Kapoor, with participating in a scheme to bribe doctors to prescribe a particularly potent opioid.

    A lawyer for Kapoor said in a statement that Kapoor is innocent and will fight the charges.

    Shareholder activists said healthcare providers may have underestimated how addictive the drugs were, but said the crisis points to a need for stronger oversight within drugmakers.

    "We believe these companies have played an important role in this epidemic," said Donna Meyer, director of shareholder advocacy for Mercy Investment Services, an investment fund for Roman Catholic nuns. It is leading the resolutions push along with the UAW Retiree Medical Benefits Trust, which oversees benefits for about 700,000 retirees of the United Auto Workers.

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  7. $1.3 Trillion Investor Coalition Probes Pharma on Opioid Accountability (PRESS RELEASE)

    Oct 30, 2017 | Investors for Opioid Accountability

    Investors for Opioid Accountability (IOA), a coalition of 30 treasurers, asset managers, faith-based, public and labor funds with over $1.3 trillion in assets is filing multiple shareholder proposals on board oversight of business risks related to opioids at 10 opioid distributor and manufacturer companies.  IOA membership is diverse including Treasurers from California, Connecticut, Illinois, West Virginia, Pennsylvania, and Rhode Island, faith-based investors such as Trinity Health, Sisters of Saint Francis and United Church Funds, labor funds such as the International Brotherhood of Teamsters and CTW Investment Services and public funds such as the School Employees Retirement System of Ohio and the New York City Pension Funds. The focus companies include not only opioid distributers McKesson, Cardinal Health and AmerisourceBergen, but also opioid manufacturers Depomed, Endo, Insys, Johnson & Johnson, Mallinckrodt, Mylan and Pernix.  IOA is led by the UAW Retiree Medical Benefits Trust and Mercy Investment Services.

    "The Investors for Opioid Accountability came together out of escalating concerns that opioid company business risks can both threaten shareholder value and have profound long-term implications for the economy and society," said Meredith Miller, Chief Corporate Governance Officer for the UAW Retiree Medical Benefits Trust.  "With 91 opioid-related deaths a day in the U.S. and studies showing the potential impact on workforce productivity and labor force participation, we have to pay attention to opioid business risks."  

    Opioid manufacturers and distributors have come under heightened legal and legislative scrutiny over whether they failed to adequately disclose the addictive potential of opioids or failed to report suspicious spikes in the sale or distribution of opioids to drug enforcement authorities as mandated under federal law. 

    "Faith and values-based investors at the Interfaith Center for Corporate Responsibility have long advocated for improved accountability in the health care industry—particularly in the pharmaceutical sector.  We have witnessed first-hand the ravages of opioid misuse in the communities in which we serve and believe corporations must play an important role in responding to this crisis. Improved oversight and risk management structures to prevent opioid misuse are an essential first step in this response," said Donna Meyer of Mercy Investment Services.  

    IOA is asking the independent directors of the boards of the 10 companies to investigate how they are responding to increasing business risks related to opioids. In addition to the board investigation, IOA believes that good corporate governance practices that traditionally serve as risk mitigators are critical to implement going forward. Such provisions aim to increase board accountability through strengthened independent board leadership and compensation policies to deter misconduct.  

    This approach builds and expands on a shareholder campaign for accountability that the International Brotherhood of Teamsters and the Treasurers of Illinois, Pennsylvania, West Virginia and California initiated earlier this year at opioid distributors. In response to this initiative, McKesson set a precedent for other opioid companies by taking three important actions: (1) launching an investigation, led by independent board members, of its opioid-related business practices; (2) committing to separate the roles of chief executive officer and board chairman when the current CEO retires; and (3) pledging to review its pay practices after 73% of investors rejected its pay package in 2017 as excessive in light of the problems the company faced due to opioid distribution practices.  Early next month, focus company Cardinal Health will hold its annual meeting.  The International Brotherhood of Teamsters has sponsored a proposal that will appear in Cardinal's proxy, urging the Company to move to an independent board chair.  

    Members of the Investors for Opioid Accountability

    The Socially Responsive Investing Group of 1919
          Investment Counsel
    AEGON Asset Management
    Benedictine Sisters, Boerne, Texas
    California State Teachers' Retirement System 
    California State Treasurer John Chiang
    Catholic Health Initiatives
    CtW Investment Group
    Connecticut State Treasurer Denise L. Nappier,
        Connecticut Retirement Plans and Trust Funds 
    Daughters of Charity, Province of St. Louise
    Dignity Health
    Illinois State Treasurer Michael Frerichs  
    Interfaith Center on Corporate Responsibility
    International Brotherhood of Teamsters
    JLens Investor Network
    Mercy Health
    Mercy Investment Services
    NEI Investments
    New York City Comptroller Scott M. Stringer
    Northwest Coalition for Responsible Investment
    Pennsylvania State Treasurer Joe Torsella
    Rhode Island General Treasurer Seth Magaziner
    School Employees Retirement System of Ohio
    Segal Marco Advisors
    Sisters of St. Francis of Philadelphia
    Socially Responsible Investment Coalition 
    Trinity Health 
    UAW Retiree Medical Benefits Trust 
    United Church Funds 
    Walden Asset Management
    West Virginia State Treasurer John Perdue

    Focus Companies

    Manufacturers                  Depomed, Endo, Insys, Johnson & Johnson, Mallinckrodt, Mylan, Pernix

    Distributors                        AmerisourceBergen, Cardinal Health, McKesson

    ******

    ADDENDUM

    Investor Comments, Perspectives on the IOA Initiative

    California State Treasurer John Chiang
    "Pharmaceutical companies must take responsibility for damage done by their products. While they are making enormous profits, suffering from opioid abuse continues to increase, especially in poor communities in California and throughout the country, where jobs are few and hopelessness fuels the crises."

    -California Treasurer John Chiang

    Connecticut State Treasurer Denise L. Nappier
    "The opioid crisis has already taken many lives and is a blight on the pharmaceutical industry.  It is imperative that Independent board chairs and directors of companies that manufacture and distribute opioids fortify their leadership roles in protecting shareholder interests.  This means addressing -- and mitigating -- the risks associated with reputational harm, escalating fines, and mounting legal costs arising from the toll that misuse of opioids is causing nationwide. Of equal importance is the need for the companies to explore ways to strengthen their opioid risk management programs as a best practice for promoting long-term shareholder value and the well-being of the communities they rely on for business."

    -Denise L. Nappier, Connecticut State Treasurer and principal fiduciary of the $34 billion Connecticut Retirement Plans and Trust Funds

    International Brotherhood of Teamsters
    "Recent weeks have brought disturbing new details about the wholesale drug distributors' efforts to rig the system and evade accountability, all while the opioid epidemic continues to engulf our communities. What is clear now more than ever is the need for structural, operational and cultural changes across the drug industry to address the opioid crisis.  We're proud to be part of a broad coalition of investors whose diverse membership is committed to fighting for greater accountability across the drug supply chain."

    -Ken Hall, General Secretary-Treasurer of the International Brotherhood of Teamsters which has called for sweeping governance and executive pay reforms at pharmaceutical wholesale distributors: McKesson, Cardinal Health, and AmerisourceBergen.

    Mercy Health
    "The opioid epidemic's devastating effect on our country includes enormous stress on our healthcare system. Health providers must balance providing these medicines to those who truly need them with proper monitoring to prevent inappropriate use. In addition to the record number of deaths, in 2014 alone, nonfatal unintentional drug poisoning accounted for 420,000 emergency department visits and 260,000 hospitalizations, putting a strain on healthcare facilities nationwide. This public health crisis demands a meaningful response from all organizations with any capacity to influence change."

    -John Starcher, President & CEO of Mercy Health 

    Aberdeen Standard Investments
    "Aberdeen Standard Investments is supportive of the work of the Investors for Opioid Accountability and will be carrying out its own review of investee companies with exposure to the issue. Aberdeen Standard Investments is a UK listed company with $871 billion of assets under management as of June 30, 2017."

    -Andrew Mason, Responsible Investment Analyst, Aberdeen Standard Investments

    NEI Investments
    "In Canada, the second largest opioid consumer in the world after the U.S., the effect of the opioid crisis is devastating. Companies involved in opioid manufacturing and distribution have a societal obligation to put measures in place that prevent a crisis like this from occurring again, and need to regain stakeholder trust by acting on their purpose and responsibility as health care businesses: making sick people better." 

    -Bob Walker, Vice President ESG Services, NEI Investments

    New York City Comptroller Scott M. Stringer\
    "This is a national emergency that is devastating lives across our country. Questionable practices by pharmaceutical companies have only exacerbated the crisis, exposing those companies to legal and regulatory scrutiny as well as increased reputational risk. As a result, strong governance reforms are absolutely essential."

    -Scott M. Stringer, New York City Comptroller

     Illinois State Treasurer Michael Frerichs
    "The opioid epidemic is destroying American families. We need drug companies to step up and take action now.  If they fail to do so, not only will families across the country continue to lose loved ones, but drug companies will likely face more lawsuits, government regulations, and financial consequences in their stock prices."

    -Illinois State Treasurer Michael Frerichs

    Rhode Island General Treasurer Seth Magaziner
    "The devastating increase of opioid-related deaths in Rhode Islandrequires that state, federal, non-profit and private sector all work together to curb opioid misuse and abuse. The pharmaceutical industry must do more to end this epidemic - not profit from it."

    - Rhode Island General Treasurer Seth Magaziner

    United Church Funds
    "The opioid epidemic is dragging our economic prosperity and is having a profound impact on the fabric of our society. Opioid manufacturers and distributors, like all corporations in the health sector, have a social license to operate based on their ability to keep communities healthy. When corporations are not fulfilling this promise, they have an obligation to review and revise their operations."

    -Donald G. Hart, President, United Church Funds

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  8. Other Coverage

  9. A Bipartisan Drug Cartel? (OPINION)

    Oct 30, 2017 | WSJ

    By The Editorial Board

    Perhaps you’ve heard that President Trump’s drug office nominee colluded with pharmaceutical companies to worsen the opioid crisis, based on a press dispatch this month. The resulting panic could result in reversing a useful law, so allow us to fill in the real story of this grand non-conspiracy that included 535 Members of Congress and Barack Obama. 

    Pennsylvania Rep. Tom Marino recently withdrew his name to run the Office of National Drug Control Policy. A Washington Post and “60 Minutes” investigation implied that a bill Mr. Marino sponsored choked off the Drug Enforcement Administration’s authority to go after illegal shipments of prescription drugs. The narrative drums along that Mr. Marino was a shill for the pharmaceutical lobby. Members of Congress are now calling to repeal the law that passed both chambers unanimously and Mr. Obama signed last year.

    Let’s look at this nefarious plan to abet criminals, the “Ensuring Patient Access and Effective Drug Enforcement Act,” which requires knowing something about how DEA operates. The agency’s typical action is known as a show cause order, which can allow DEA to suspend a distributor’s “registration,” or license. The order merely requires an agency process that allows some semblance of due process for the accused.

    But DEA also has authority to issue “immediate suspension orders” when there’s an “imminent danger to public health or safety,” and halt a company’s shipments without the hassle of a proceeding. The agency deployed this tool in 2012 against Cardinal Health , which contested the suspension in court. The Controlled Substances Act for years didn’t clarify what represents “an imminent danger” to the public, so DEA could more or less issue suspensions as it deemed fit, as Utah’s Senator Orrin Hatch, who sponsored the Senate version of the bill, explained last week.

    Yet these processes makes no distinction between shipments to pill mills and appropriate medical use. The orders simply padlock medical warehouses. The effect can be to cut off access to pain medication for patients with chronic pain or a tough disease. More to the point, a high volume of painkiller prescriptions may look unusual or suspicious but isn’t a reliable proxy for abuse. Consider a pharmacy near a hospital.

    Distributors are required to report suspicious shipments to DEA, and they have deployed technology to detect abnormalities, which can be challenging without more information about the underlying prescriptions. The Healthcare Distribution Alliance noted that wholesalers have flagged “tens of thousands” of suspicious order reports. Only DEA can see across the entire supply chain, but pressing cases against individual bad actors is time consuming.

    Enter Congress, which hoped to strike a better balance between enforcement and appropriate medical use. Rep. Marino sponsored one version of legislation, but the eventual bill said that “imminent danger” is defined as “substantial likelihood” of an immediate threat. That’s right: This explosive bill that “gutted” agency authority to stop shipments merely tweaked the threshold of one DEA tool. The accused would also have more leeway to make corrective action plans, which is sensible.

    Senator Hatch has also noted that the language for the standard was written by Obama Administration officials at the Justice Department and DEA, and both supported the final bill. Also on board were many patient groups and the Academy of Integrative Pain Management, which reiterated its support this month.

    The media narrative now is that the pharmaceuticals lobby spent big to hoodwink Congress to pass a bill Members didn’t understand. The reality is that the trade group the Pharmaceutical Research and Manufacturers of America, known as PhRMA, took no position on the bill. That’s no surprise given that enforcement actions tend to hit distributors, not manufacturers.

    To understand what’s going on here, zero in on former DEA official Joe Rannazzisi, the star source for “60 Minutes” and the Washington Post. Mr. Rannazzisi, the story notes, now consults for lawyers suing the opioid industry. Where there is pain and suffering, there are trial lawyers looking to make a buck. And the plaintiffs bar is using state lawsuits to turn opioids into the next tobacco. “Opioids: The Next Tobacco?” ran a trial lawyer seminar in Washington last month, as the American Tort Reform Association has noted.

    All of this matters because Congress may soon try to whoop through a repeal bill, and Democrats fresh off scuttling Mr. Marino will now indict every GOP Member of Congress as a drug dealer. Rep. Marsha Blackburn of Tennessee, who is running for the Senate, co-sponsored a version of the bill and has since walked back her support, which is unfortunate. If anything, Congress ought to do more to restrict DEA actions that can blow up the supply chain and interfere with medical decision-making outside its jurisdiction.

    More broadly, note the cynicism of accusing one Republican of deepening a social crisis that had claimed tens of thousands of lives before Congress thought up this bill. The horrors of opioid addiction come from many dysfunctions, including too many prescriptions; a decline in work; heroin and fentanyl; easy access from Medicaid; and others. The story that a Member of Congress led a bipartisan conspiracy to worsen drug addiction is as false as it is implausible.

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  10. Founder and Owner of Insys Arrested

    Oct 30, 2017 | Policy & Medicine

    By Thomas Sullivan

    Late last week, John N. Kapoor, the founder and majority owner of Insys Therapeutics, Inc., was arrested and charged with leading a conspiracy to profit by using bribes and fraud to cause the illegal distribution of a Fentanyl spray intended for cancer patients experiencing breakthrough pain.

    The superseding indictment includes allegations of RICO conspiracy, conspiracy to commit mail and wire fraud, and conspiracy to violate the Anti-Kickback law. It also includes additional allegations against former Insys executives and managers who were initially indicted in December 2016.

    The Justice Department claims that Kapoor and other Insys executives offered bribes in the form of kickbacks to doctors who wrote “large numbers of prescriptions” for patients, many of whom did not have cancer. The Department also alleged that the executives defrauded insurers by forming a “reimbursement unit” dedicated to obtaining prior authorization from insurers who were reluctant to pay for the drug.

    Insys allegedly encouraged doctors to write more prescriptions by hiring their friends and family members to serve as “business liaisons’’ and “business-relation managers,’’ prosecutors said. These support-staff employees worked in the doctors’ offices but were paid by Insys in what the indictment called bribes and kickbacks. The company even made a video featuring a sales rep dressed as a giant fentanyl spray bottle, rapping and dancing to a song that pushed the idea of getting doctors to prescribe higher doses, prosecutors said.

    The indictment also alleges that Kapoor and the six former executives conspired to mislead and defraud health insurance providers who were reluctant to approve payment for the drug when it was prescribed for non-cancer patients.  They achieved this goal by setting up the “reimbursement unit,” which was dedicated to obtaining prior authorization directly from insurers and pharmacy benefit managers. 

    Charged with racketeering conspiracy and other felonies, Kapoor is the highest-ranking pharma executive to be accused of an opioid-related crime, and his arrest may portend charges against companies far larger than Insys, which has a modest $417 million market capitalization.

    In Connecticut, prosecutors have begun a criminal probe of Purdue Pharmaceutical Inc.’s marketing of OxyContin. Scores of states, cities and counties have sued companies including Purdue, Endo International Plc, and  Janssen Pharmaceuticals, alleging they triggered the opioid epidemic by minimizing the addiction and overdose risks of painkillers such as Percocet.

    The charges of conspiracy to commit RICO and conspiracy to commit mail and wire fraud each provide for a sentence of no greater than 20 years in prison, three years of supervised release and a fine of $250,000, or twice the amount of pecuniary gain or loss.  The charges of conspiracy to violate the Anti-Kickback Law provide for a sentence of no greater than five years in prison, three years of supervised release and a $25,000 fine. Sentences are imposed by a federal district court judge based upon the U.S. Sentencing Guidelines and other statutory factors.

    Insys Reaction

    A spokesman for Arizona-based Insys said this week that the company is under new management and has replaced nearly all its original sales staff. It says it takes responsibility for the actions of its former employees.

    "We have taken necessary and appropriate steps to prevent past mistakes from happening in the future, and are committed to conducting business according to high ethical standards and the interests of patients," the company said in a statement Wednesday. "We also continue to work with relevant authorities to resolve issues related to the misdeeds of former employees."

    Kapoor Defense Lawyer Reaction

    "He is not guilty of these charges, he intends to fight it vigorously," defense attorney Brian T. Kelly said outside court. Kelly is a high-profile Boston lawyer and former federal prosecutor who successfully tried imprisoned gangster James "Whitey" Bulger.

    Government Reaction

    As the investigation spanned – and used the resources of – many government agencies, multiple agencies had a comment on the investigation and charges. Some of the comments are below.

    “In the midst of a nationwide opioid epidemic that has reached crisis proportions, Mr. Kapoor and his company stand accused of bribing doctors to overprescribe a potent opioid and committing fraud on insurance companies solely for profit,” said Acting United States Attorney William D. Weinreb. “Today's arrest and charges reflect our ongoing efforts to attack the opioid crisis from all angles. We must hold the industry and its leadership accountable - just as we would the cartels or a street-level drug dealer.”

    “These Insys executives allegedly fueled the opioid epidemic by paying doctors to needlessly prescribe an extremely dangerous and addictive form of fentanyl,” said Phillip Coyne, Special Agent in Charge for the Office of Inspector General of the U.S. Department of Health and Human Services.  “Corporate executives intent on illegally driving up profits need to be aware they are now squarely in the sights of law enforcement.”

    “As alleged, John Kapoor and other top executives committed fraud, placing profit before patient safety, to sell a highly potent and addictive opioid.  EBSA will take every opportunity to work collaboratively with our law enforcement partners in these important investigations to protect participants in private sector health plans and contribute in fighting the opioid epidemic,” said Susan A. Hensley, Regional Director of the U.S. Department of Labor, Employee Benefits Security Administration, Boston Regional Office.

    Congressional Reaction

    Insys has also been the subject of an investigation by Sen. Claire McCaskill (D-Mo.). After Kapoor's arrest on Wednesday, McCaskill said "anyone, including top executives, who potentially violated criminal law should be aggressively prosecuted."

    "Evidence from our investigation suggests that Insys was engaged in systemic fraud and took actions that directly harmed their own customers and public health as a whole. This company has repeatedly gotten away with fines that amounted to a slap on the wrist for actions that helped fuel a nationwide epidemic that's claimed hundreds of thousands of American lives," she said.

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  11. Opioid king John Kapoor bribed doctors and paid speaker fees to get drugs prescribed

    Oct 28, 2017 | Business Day

    By CYNTHIA KOONS AND JEF FEELEY

    More than a decade after opioid painkillers first exploded across the US, John Kapoor found an aggressive way to sell even more, according to prosecutors: he began bribing doctors to prescribe them.

    Speakers’ fees, dinners, entertainment, cash — federal charges unsealed on Thursday claim Kapoor’s striving company, Insys Therapeutics, employed all of that and more to spur prescriptions of a highly addictive fentanyl-based drug intended only for cancer patients.

    As US President Donald Trump declared at a White House event that opioid abuse represented a public-health emergency, authorities arrested Kapoor in Arizona and painted a stark portrait of how Insys allegedly worked hand in glove with doctors to expand the market for the powerful agents.

    "Selling a highly addictive opioid-cancer pain drug to patients who did not have cancer makes them no better than street-level drug dealers," Harold Shaw, the top FBI agent in Boston, said of Kapoor and other Insys executives charged earlier in the case.

    The story of the 74-year-old billionaire and the company he founded traces the arc of a crisis that claims 175 lives each day. What began with the over-prescription of painkillers in the late 1990s soon became a race by manufacturers to dispense more and more pills.

    Overdose risks

    Charged with racketeering conspiracy and other felonies, Kapoor became the highest-ranking pharma executive to be accused of an opioid-related crime, and his arrest may portend charges against companies far larger than Insys, which has a modest $417m market capitalisation.

    In Connecticut, prosecutors have begun a criminal probe of Purdue Pharmaceutical’s marketing of OxyContin. Scores of states, cities and counties have sued companies including Purdue, Endo International and Johnson & Johnson’s Janssen Pharmaceuticals, alleging they triggered the opioid epidemic by minimising the addiction and overdose risks of painkillers such as Percocet.

    But so far, no recent case has been so sweeping as the one against the executives including Kapoor, who made his initial court appearance late on Thursday in Phoenix. A US magistrate judge set bail at $1m and ordered Kapoor to surrender his passport and submit to electronic monitoring. His lawyer, Brian Kelly, said Kapoor posted bail after the hearing.

    This week, a Rhode Island doctor admitted accepting kickbacks from Insys in exchange for writing prescriptions. Earlier in 2017, two doctors were sentenced to more than 20 years behind bars for accepting bribes from companies including Insys to sell fentanyl-based medications.

    The Kapoor indictment pinpoints the start of the alleged scheme.

    Oral spray

    It was early 2012, and Insys’s new oral spray of the opioid fentanyl wasn’t selling well. Because it was so addictive, the pain-relief drug was subject to a tightly controlled distribution system, and regulators demanded to be notified about suspicious orders by manufacturers, wholesalers and pharmacies. And the drug was not cheap, so insurers set up barriers for patients seeking it.

    That was when Kapoor and others at Insys went to extremes to dramatically boost sales of the painkiller, prosecutors said. Doling out speaker fees, marketing payments and food and entertainment perks, they allegedly began bribing doctors to prescribe the drug, and then tricked insurers into paying for it.

    One Insys sales executive told subordinates that it didn’t matter whether doctors were entertaining, according to the indictment: "They do not need to be good speakers, they need to write a lot of" Subsys prescriptions, the official said, referring to the brand name of the painkiller.

    Over a two-year period starting in 2013, Insys set aside more than $12.2m for doctors’ speaking fees, prosecutors said. One doctor received as much as $229,640 in speaker fees for appearing at what amounted to "sham events that were mere social gatherings also attended by friends and office staff", according to the indictment.

    The company encouraged doctors to write more prescriptions by hiring their friends and family members to serve as "business liaisons" and "business-relation managers", prosecutors said. These support-staff employees worked in the doctors’ offices but were paid by Insys in what the indictment called bribes and kickbacks.

    Insys even made a video featuring a sales rep dressed as a giant fentanyl spray bottle, rapping and dancing to a song that pushed the idea of getting doctors to prescribe higher doses, prosecutors said.

    Others previously charged include Michael Babich, Insys’s former CEO, Alec Burlakoff, the former vice-president of sales, and Richard Simon, once the company’s national sales director. They all deny wrongdoing.

    Joe McGrath, an Insys spokesman, declined to comment on Kapoor’s indictment in Boston federal court. The company, which wasn’t charged, has reportedly been in settlement talks with the US justice department to resolve a probe into its Subsys marketing. The company’s shares fell more than 22% to $5.74 in Nasdaq trading.

    The first person in his family to attend college, Kapoor rose from modest means in India to become a wealthy healthcare entrepreneur, after earning a doctorate in medicinal chemistry at the University of Buffalo in 1972, according to a work-history the school posted.

    He was a plant manager at Invenex Laboratories in New York and later became CEO of LyphoMed, a hospital-products company. He sold LyphoMed to Fujisawa Pharmaceuticals and formed a venture capital firm that invested in healthcare companies.

    In 2010, he merged privately held Insys with NeoPharm to get access to technology to develop pain drugs for cancer patients. Even though he has stepped down as Insys’s chairperson and CEO, he still holds more than 60% of its stock.

    Kapoor and Babich are also accused of misleading insurers about patients’ diagnoses and the types of pain they suffered that were covered by the Subsys prescriptions tied to the payment scheme, prosecutors said.

    The company’s agents allegedly told insurers that patients were receiving Subsys for "breakthrough pain" to secure coverage. They also misled insurers about what other pain drugs patients had tried before being proscribed Subsys, according to the indictment.

    Some lower-level Insys employees have pleaded guilty and are co-operating with prosecutors, according to court papers. Elizabeth Gurrieri, a former manager who oversaw insurance reimbursements, pleaded guilty to one count of conspiring to commit wire fraud in June.

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  12. Cold withdrawal for the pharmaceutical giant (German)

    Oct 27, 2017 | Handelsblatt

    By Katharina Kort

    Tens of thousands dead - countless addicts: The pharmaceutical companies are under pressure because of the drug epidemic in the United States. They are said to have played down addictive drugs. President Trump reacts only half-heartedly.

    New York Lindsey Rigney was 15 when she was injured in a car accident. For the pain the doctors prescribed her opioid-containing medication. They were so strong that the teenager became dependent. When Lindsey stopped getting prescriptions from the doctor, she switched to heroin, which is cheap to buy in the US . To get away from it, she later went to the detox clinic. But 24 hours after returning home, Lindsey took heroin again. An overdose. The parents were able to revive her and take her to the hospital. But she died a few hours after she was released. There was Lindsey 21.

    Stories like Lindsey's are commonplace in the US. Last year alone, around 60,000 people died of opioid-containing drugs or painkillers - six times as many as in 1990.

    US President Donald Trump declared the opioid epidemic a national health emergency on Thursday. Especially in rural areas and in the white middle and lower classes, there is hardly a family that knows no drug or drug addicts in their environment.

    "The number of drug-related deaths from prescription painkillers has surpassed those of cocaine and heroin since 2002," writes the US Drug Control Authority (DEA) in its latest study this week. "Prescription painkillers are used by more people than cocaine, heroin, MDMA, methamphetamine, and PCP together," the study notes.

    Many family members and also prosecutors see the responsibility of the pharmaceutical companies and other players in the health system. Too easy in their opinion in the US prescribes strong painkillers that make addictive: In chronic pain as well as after the visit to the dentist, and often without any warning.

    Almost one in five Americans was prescribed opioid-containing drugs last year. Many people get used to the medicine and if the doctors no longer prescribe it, they get it illegally. Or they go for heroin, which is often cheaper. Four out of five heroin users claim to have previously taken prescription opioid painkillers. Like Lindsey.

    Ten states and dozens of communities have already sued pharmaceutical companies such as Purdue, Endo, Johnson & Johnson and Allergan . They accuse them of having downplayed the danger of dependency. "The evidence will show that these companies have made thousands upon thousands of people in Ohio - our friends, relatives, employees, children - addicted to opioid painkillers, which has often led to the use of cheaper alternatives such as heroin or synthetic opioids." For example, Ohio Attorney General Mike DeWine is convinced.Unscrupulous managers, corrupt doctors

    The pharmaceutical manufacturers would have made the doctors believe "that opioids are not addictive, that addiction is easy to survive, or that the addiction can even be treated by taking more opioids". De Wine is convinced that the companies knew they were telling the untruth, "and they did it to increase sales," he says

    Against PurduePharma, the producer of the potent painkiller OxyContin, has also been investigating the federal prosecutor's office since Wednesday. More than 40 states have also joined forces to find out who is responsible for the latest opioid epidemic in the US in the network of pharmaceuticals, physicians and insurers ."Since 1999, the prescriptions for prescription painkillers have tripled with opiods. Some areas have more recipes than residents. That can not be! ", Says the New York general prosecutor Eric Schneidermann, who coordinates the investigation.  

    Even well-known lawyers from the days of tobacco lawsuits have their say. One of them is Mike Moore. The now retired 65-year-old prosecutor once brought the tobacco industry to its knees. With his lawsuits against Big Tobacco Moore 1998 reached a 246 billion dollar agreement against the cigarette manufacturers.

    To date, this is the highest amount companies have ever paid. His triumph brought him even a Hollywood role: In the movie "The Insider" with Russel Crowe and Al Pacino about a whistleblower in the tobacco industry, he played himself.

    This time, the retired prosecutor takes on the pharmaceutical industry. He supports the lawsuits against the drug manufacturers. For one thing he has learned in his time as a prosecutor: "Complaints are a crude instrument. This is not a surgical tool, "he admits in an interview with" Business Week ". "But they generate interest faster than anything I've ever seen." This time, Moore is also on a personal crusade: His nephew - for the Moore is a father figure - is also dependent on painkillers.

    For Purdue Pharma, this is not the first time it has to defend itself because of OxyContin. In 2007, the company and three top Connecticut executives found themselves guilty of training their agents to downplay OxyContin's risks to physicians. A payment of $ 630 million was the result. The managers did not have to go to jail. But they did social work at a detox clinic. The company said this week it will work with prosecutors in the new investigation.Trump calls the emergency - a bit

    It was above all Purdue, who in the 1990s initiated a debate in the world of medicine on the use of analgesics in order to open up a larger market for OxyContin, a proprietary drug. With quite controversial studies, the company has paved the way for new pain therapies. It was all about no longer interpret pain primarily as a symptom whose cause must be combated, but to treat pain as such.

    Economically, the bill came up: In 1996, Purdue implemented just 42 million with OxyContin. In 2016, according to an estimate by the brokerage firm Sanford Bernstein, it was $ 1.3 billion. The new approach has also helped other manufacturers of opioid-containing agents. Last year alone, every fifth American was prescribed such pain medications. So not only after heavy surgery, but also after the visit to the dentist as well as with back or headache.


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  13. Opioid lawsuit grouping disputed

    Oct 28, 2017 | The Herald Dispatch (WV)

    By Courtney Hessler

    While several wholesale opioid distributors and manufacturers are in favor of centralizing more than 60 lawsuits across the nation alleging companies fueled the drug epidemic by pumping pills into local areas, several remaining defendants named in West Virginian suits oppose the request.

    A request, filed with the U.S. Judicial Panel on Multidistrict Litigation, was made in September asking to group together 66 lawsuits filed in 11 districts accusing opioid wholesale distributors, manufacturers and smaller pharmacy distributors of fueling a national drug epidemic by pumping opioids into various areas nationwide.

    A Charleston attorney representing a majority of the lawsuits made the request to create better cohesion and efficiency as the cases move forward.

    The "Big Three" distributors - McKesson Corp., Cardinal Health and AmerisourceBergen Drug Corp. - and five manufacturers who are named in dozens of the 66 lawsuits said the move would be ideal. Among the manufacturers in that group are Purdue Pharma and Johnson & Johnson.

    But other pharmaceutical distribution businesses - including Walgreens, Kroger, Walmart, CVS and Rite Aid - who are named in just a handful of lawsuits opposed the consolidation and taking the lawsuits out of the state of West Virginia.

    The parties will meet at 8 a.m. Nov. 30 at the Thomas F. Eagleton U.S. Courthouse in St. Louis to make arguments in the case.

    The original allegations made against the wholesale distributors were made in West Virginia at the beginning of 2017 and started a rippling effect leading to the filing of more lawsuits in West Virginia, Illinois, Alabama, California, Kentucky, Ohio, New Hampshire, Tennessee and Washington.

    The West Virginia filings started after a Charleston Gazette-Mail investigation revealed that between 2007 and 2012, McKesson, Cardinal Health and AmerisourceBergen shipped 423 million pain pills to West Virginia, which has about 1.8 million citizens, before the number of pills started to decrease.

    The 66 cities and counties allege drug firms breached their duty to monitor, detect, investigate, refuse and report suspicious orders of prescription opiates coming into the states over the past several years - a duty the lawsuits claim companies have under the Controlled Substances Act of 1970. They seek damages and reimbursement for "the costs associated with past efforts to eliminate the hazards to public health and safety" the plaintiffs claim were created by the defendants' alleged negligence and corrupt practices.

    The lawsuits have grown to include 13 governments in the Tri-State, including Scioto, Gallia and Lawrence counties and the city of Portsmouth in Ohio, and McDowell, Kanawha, Boone, Wyoming, Logan, Lincoln, Cabell and Wayne counties and the city of Huntington in West Virginia.

    In total, there are 16 lawsuits in Ohio, 17 in West Virginia and 19 in Kentucky.

    In a joint motion agreeing with the centralized grouping, the "Big Three" said the complaints were nearly identical and the move would better streamline the process. The trio wants the cases to be heard by Southern District of West Virginia Judge David A. Faber, where the first lawsuits were filed against opioid distributors.

    Smaller pharmacy distributors named in local lawsuits oppose the centralization of dozens of cases they are not named in, stating the parties and claims in the West Virginia actions are unique from lawsuits in other jurisdictions. The move would be unfair and dramatically increase burdens and costs associated with the move, several claimed.

    If the panel finds the lawsuit grouping to be the proper move, some of the pharmacy distributors requested the actions against them be separated from those against the "Big Three" to allow their cases to stay in West Virginia, where the claims involve smaller areas as opposed to identical claims made nationwide against the "Big Three."

    The pill manufacturers are not yet listed in any of the lawsuits in our coverage area, according to their joint motion requesting the case be grouped and centralized in the Northern District of Illinois. Other areas would not provide the same resources, experience or accessibility, the group argued. They name a lawsuit filed by the city of Chicago as the first-filed and most advanced case against the manufacturers.

    Charleston attorney James C. Peterson, who requested the grouping, said the best location for the cases would be Ohio because of its central and easily accessible location.

    The city of Huntington waived its right to make oral arguments at the hearing. H.D. Smith Wholesale Drug Co., a defendant named in four lawsuits in Boone, Logan, Cabell and Wyoming counties, also waived its right and said it took no position on the matter.

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  14. Paterson Demands Drug Manufacturers Help Solve Epidemic of Opioid Use

    Oct 27, 2017 | TAP into Paterson (NJ)

    By Max Paterson

    Just weeks after local pharmacy owner Warren Cortese joined forces with the body that governs high school athletics in the State of New Jersey to reduce the use opioids by young athletes, the City of Paterson announced that it has filed a lawsuit against some of the nation's largest pharmaceutical companies and distributors.

    The defendants, according to the suit, have engaged in a campaign of misinformation to mislead the public about the effects and dangers of prescription opioids and include a number of big-name drug manufacturers including Purdue Pharma, Teva Pharmaceuticals, and Johnson & Johnson.

    Also named in the suit are several distribution corporations including McKesson, AmerisourceBergen, and Cardinal Health.

    The suit claims that these companies colluded in misleading the public on the true nature of their products through inaccurate articles in medical journals, unsupported literature, the employment of established physicians to substantiate their compromised research, and the publicizing of incorrect statements. This decades-long campaign was allegedly modeled on the success of similar efforts made in the past by tobacco companies in duping the public about the harmful effects of their products.

    Explaining why he felt the suit needed to be filed David Scott, managing partner at Scott+Scott, the law firm handling the complaint, said that “the pharmaceutical manufacturers and wholesale distributors must be held responsible for their actions, which are the root cause of so much human and financial loss.”

    Declared a public health emergency by President Trump on Thursday, the opioid epidemic has left a wake of devastation as it has spread across communities all over the country for the past 20 years. According to the Centers for Disease Control and Prevention, the number of opioid related deaths has more than quadrupled since 1999, turning overdose into the leading cause of death of Americans under 50.

    Much of this crisis coincides with the increased use of synthetic alternatives. According to the National Institute on Drug Abuse, nearly 80 percent of heroin users tried prescription opioids before switching to the real thing. In 2015, over one-third of the US population took a legitimately prescribed opioid.

    Paterson has been hit especially hard by opioid use. In 2016, the New Jersey Department of Human Services reported 1096 opioid related admissions to drug treatment providers in Paterson, the second largest figure in the state. The city believes that this disproportionate impact has taken a massive toll on its citizens and its workforce of approximately 1600 public employees including police officers, firefighters, and first responders.

    “This lawsuit seeks to hold responsible those companies whose practices created a crisis that has drained the coffers of cities like Paterson, which operates on meager resources but is relied on to provide critical, life-saving services,” says Domenick Stampone, the city's corporation counsel.

    Councilman William McKoy lamented the fact that Paterson has served as a hub for those looking to purchase drugs or seek treatment, dropping an immense burden on the city's doorstep. “The lawsuit is a signal and a cry to highlight the problem” of opioid use. “We are sending a message that drug makers must help us find a solution.”

    Paterson joins a growing list of New Jersey cities filing or exploring similar lawsuits against drug manufacturers including Newark, Toms River, and Brick.

    Earlier this month, New Jersey Attorney General Chris Porrino announced a lawsuit against manufacturer Insys Therapeutics, Inc, which was also named in the Paterson suit. Further complaints are expected as the Porrino’s office continues its probe into the crisis.

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  15. Communities suing drug distributors want access to transaction information

    Oct 27, 2017 | CantonRep.com

    By Eric Rinehart

    A federal judge in Columbus signed an order Friday allowing communities in Ohio and elsewhere that blame drug companies for the opioid crisis to subpoena a national database that tracks the flow of prescription pills.

    Manufacturers and distributors use the Automated Reports and Consolidated Ordering System (ARCOS) to report their controlled substance transactions to the U.S. Drug Enforcement Administration.

    U.S. District Judge Edmund A. Sargus Jr., chief judge of the U.S. Southern District of Ohio, based in Columbus, signed the order for the ARCOS data-collection system subpoena Friday. The DEA is likely to oppose releasing the data, said David J. Butler, who is among the attorneys representing the plaintiffs.

    Sargus is scheduled to hear arguments Dec. 13 at the next status conference.

    Attorneys for the communities that have sued the companies in federal court in Columbus and elsewhere want to know if the data support their allegations that the companies should have known they were sending an inordinate amount of drugs to their towns and counties.

    Commissioners in Vinton County, which has a population of 13,000, said enough pills were sent there in 2015 that every man, woman and child could have taken 105 doses. That number was down to 89 last year, according to information from the Ohio Pharmacy Board.

    “It’s pretty obvious” that the three companies are not reporting suspicious orders of oxycodone and hydrocodone, Vinton County Commissioner Mark Fout has said. Distributors Cardinal Health, AmerisourceBergen Corp. and McKesson Corp were named as defendants. AmerisourceBergen and McKesson have operations in central Ohio but are headquartered in other states.

    Columbus-based Cardinal Health issued a statement in August saying, “We operate as part of a multifaceted and highly regulated health-care system ... and believe everyone in that chain, including us, must do their part, which is ultimately why we believe these copycat lawsuits filed against us are misguided and do nothing to stem the crisis.”

    Cincinnati, Dayton, Lorain, Parma and Portsmouth are among the 14 plaintiffs from Ohio that filed in the U.S. District Court for Southern Ohio in Columbus. There are an estimated 66 lawsuits filed in 11 federal court districts, including West Virginia, Kentucky, Alabama, Illinois, New Hampshire, Tennessee, California and Washington.

    Columbus, which is home to Cardinal Health, has not sued. Columbus City Attorney Richard C. Pfeiffer Jr. said Friday the city would not join the other communities in their suit. He declined to give more details, except to say the city was exploring options.

    “It could mean anything,” he said.

    The plaintiffs also have requested all the lawsuits be combined as a “multidistrict litigation” case or MDL. The MDL rule allows lawsuits that “involve common questions of fact” to be combined into one case to promote efficiency and consistent court rulings. Test cases would be tried to give other attorneys an idea of how their cases would fare. That could prompt some to settle or withdraw their cases, or continue to trial.

    A panel of judges will meet in St. Louis on Nov. 30 to consider the request for a MDL, then decide within two weeks whether to approve it. If approved, the panel also would decide which federal district court would get the assignment.

    Butler said the plaintiffs prefer the southern district of Ohio and Sargus because of the judge’s experience with the DuPont MDL. That case involved 3,500 suits claiming DuPont tainted water sources along the Ohio River with a chemical used to make Teflon, sickening residents who contracted cancers and other ailments.

    The DuPont case lasted almost four years and involved four trials before DuPont settled for $670 million in February.

    “That’s pretty incredible,” Butler said, considering the complexity and number of litigants.

    The drug distributors favor a judge in West Virginia where, they said, attorneys for 47 of the 66 cases filed their first opioid cases.

    The drug manufacturers argued an MDL should be heard in a federal court in the Chicago area, where the first and most advanced federal case filed against the manufacturers is pending, or in New York City, which is centrally located among the companies’ headquarters.

    The manufacturers are Purdue Pharma, Purdue Pharma Inc., and the Purdue Frederick Company Inc.; Teva Pharmaceuticals and Cephalon Inc.; Johnson & Johnson; Janssen Pharmaceuticals; Ortho-McNeil-Janssen Pharmaceuticals and Janssen Pharmaceutica; Endo Health Solutions and Endo Pharmaceuticals; and Allergan Finance.

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  16. Opioid epidemic: Cuyahoga County files lawsuit against drug manufacturers, distributors

    Oct 30, 2017 | Fox.8 Cleveland (OH)

    By Darcie Loreno

    In 2016, Cuyahoga County lost more people to the opioid epidemic than to deaths from homicides, suicides and car crashes combined.

    Now, the county has filed a suit against manufacturers, distributors and four individuals accused of promoting opioids for sale and distribution that's led to such statistics locally and nationally.

    According to a release from Cuyahoga County, the manufacturer defendants include: Purdue Pharma LP, Teva Pharmaceuticals, Cephalon, Janssen Pharmaceuticals. The distributors include McKeeson Corporation, Cardinal Health and AmerisourceBergen Corp.

    “We need to hold the drug manufacturers and distributors accountable whose corporate strategy was to push these opiates into our community for the sake of profit,” Cuyahoga County Prosecutor Michael C. O’Malley said in a release.  “They are drug pushers on a national level.”

    The release states that between 2011 and 2016, Cuyahoga County had a 23.5 drug overdose death rate per 100,000 population. In January 2017, there were 46 fatal overdoses. In June, it was predicted that the number of overdose deaths in 2017 would reach 775.

    The epidemic is also causing an uptick in the number of children in foster care in the county as well.

    Cuyahoga County is seeking to recoup damages for monies paid for increased health services, law enforcement services, social services, and other expenditures required by the opioid epidemic.

    "This year alone, we have had to bear the burden of increased costs to the Medical Examiner’s office, increased costs of supplying drugs like Narcan to save victims of overdose, and additional cost of children in the foster care system because of a parent’s death or drug addiction," Cuyahoga County Executive Armond Budish said in the release. "This is an emergency."

    The lawsuit has been filed with the State Court and the Cuyahoga County Court of Common Pleas.

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  17. What Trump Declaring Opioid Crisis a Public Health Emergency Means

    Oct 27, 2017 | Insurance Journal

    By Jeff Mason and Yasmeen Abutaleb

    U.S. President Donald Trump declared the opioid crisis a public health emergency on Thursday, stopping short of a national emergency declaration he promised months ago that would have freed up more federal money.

    Responding to a growing problem, particularly in rural areas, Trump’s declaration will redirect federal resources and loosen regulations to combat opioid abuse, senior administration officials said.

    But it does not result in more money to combat the crisis. Some critics, including Democratic lawmakers, said the declaration was meaningless without additional funding.

    Republican lawmakers called the president’s declaration an important step in combating the crisis.

    “This epidemic is a national health emergency,” Trump, a Republican, said at the White House. “As Americans, we cannot allow this to continue.”

    Trump, who also called the epidemic a “national shame” and “human tragedy,” was introduced by his wife, Melania, who said she had made fighting the epidemic one of her top priorities as first lady. “This can happen to any of us,” she said.

    The president also made a personal reference to addiction in his family by citing his deceased brother Fred, an alcoholic whose advice not to imbibe made an impression on Trump, who does not drink alcohol.

    The announcement disappointed some advocates and experts in the addiction fight, who said it was inadequate to fight a scourge that played a role in more than 33,000 deaths in 2015, according to the U.S. Centers for Disease Control and Prevention. The death rate has kept rising, estimates show.

    Opioids, primarily prescription painkillers, heroin and fentanyl, are fueling the drug overdoses. More than 100 Americans die daily from related overdoses, according to the CDC.

    A White House commission on the drug crisis had urged Trump to declare a national emergency. On Wednesday, the president told Fox Business Network he would do so.

    Officials told reporters on the conference call that Federal Emergency Management Agency funds that would have been released under a national emergency are already exhausted from recent storms that struck Puerto Rico, Texas and Florida.

    The administration would have to work with Congress to help provide additional funding to address drug abuse, they added. They said they determined that a public health emergency declaration was most appropriate after an expansive review.

    Under Thursday’s declaration, treatment would be made more accessible for abusers of prescription painkillers, heroin and fentanyl, while ensuring fewer delays in staffing the Department of Health and Human Services to help states grapple with the crisis.‘BAD ACTORS’

    Trump said he would discuss stopping the flow of fentanyl, a drug 50 to 100 times more powerful than morphine, with Chinese President Xi Jinping during his visit to Asia next month.

    In his remarks, Trump said the U.S. Postal Service and Department of Homeland Security were “strengthening the inspection of packages coming into our country to hold back the flood of cheap and deadly fentanyl, a synthetic opioid manufactured in China.”

    In Beijing, Foreign Ministry spokesman Geng Shuang said China had always paid a great deal of attention to international cooperation against narcotics and had listed 23 components of fentanyl as controlled substances, despite not having a fentanyl abuse problem.

    Trump added he would consider bringing lawsuits against “bad actors” in the epidemic. Several states have sued opioid manufacturers for deceptive marketing. Congress is investigating the business practices of manufacturers.

    The president also said the government should focus on teaching young people not to take drugs. “There is nothing desirable about drugs. They’re bad,” he said.

    Thursday’s declaration allows the Department of Labor to issue grants to help dislocated workers affected by the crisis. HIV/AIDS health funding would also be prioritized for those who need substance abuse treatment, officials said.

    As a candidate, Trump promised to address the crisis, including by building a wall on the U.S.-Mexico border to stop the flow of illicit drugs, which he touched on in his speech.

    Additional actions under the move would be announced in coming weeks by various agencies, officials said.

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  18. Walthall could join nat’l opioid lawsuit

    Oct 28, 2017 | Enterprise Journal (MS)

    By Mack Spencer

    Walthall County supervisors are mulling whether to join a lawsuit against pharmaceutical distributors.

    Mike Fuller, a partner in Fuller McHugh Law Group of Hattiesburg, said he is part of a consortium of lawyers signing on counties as parties to the lawsuit while the state attorney general’s office pursues action against opioid manufacturers.

    “In Ronald Reagan’s war on drugs, the focus was on the cartels,” Fuller told supervisors Wednesday. “The wholesale distributors hold the spigot on opioids. This lawsuit is the same idea” as the Reagan-era effort.

    Fuller said the state of West Virginia, where the consortium is also gathering clients for the suit, has only 1.8 million people, but had had 760 million opioid pills shipped into its borders in a single year — about 422 pills for every resident.

    The wholesale distribution system was mandated by Congress, Fuller said, as a way to help keep drugs off the black market.

    Large or otherwise suspicious orders are supposed to reported by the distributors to the federal Drug Enforcement Administration.

    On large orders, however, “if people can make money, they will,” Fuller said.

    While the attorney general is pursuing the manufacturers on consumer protection grounds, alleging false or misleading advertising and claims on the addictive nature of medications such as oxycodone or fentanyl, the lawsuit against distributors is based on grounds of public nuisance.

    On those grounds, Fuller’s clients could seek damages to recover not only such things as drug court and rehabilitation costs that might be covered by Medicaid, but also ancillary costs such as foster care for children removed from an addict’s home or whose parents die of an overdose.

    Fuller said the attorneys would also be working to help the client cities and counties around the country to develop a three-pronged model to address the opioid epidemic: education for medical providers, treatment for addicts and tactics for law enforcement.

    While counties in Mississippi and West Virginia are joining as clients, Fuller said the legal team would seek to file the suit  in another hard-hit region covered by the federal Southern District Court of Ohio, and have it heard by Chief Judge Edmund Sargus Jr.

    Ohio is also home to one of the largest wholesale distributors, Cardinal Health of Columbus.

    Fuller noted that the wholesalers are quite able to pay a multibillion-dollar settlement, as they collectively clear more than $450 billion each year.

    The Mississippi Department of Health reports that about 3.8 million prescriptions for opioid medications were written in the state in 2014, of which fewer than 200,000 were for drug treatment and about 250,000 were for cough medicines.

    Mississippi’s population is just less than 3 million.

    Fuller said nine Mississippi counties have signed on as clients so far: Benton, Copiah, Forrest, Jefferson Davis, Lamar, Lawrence, Marion, Prentiss and Union. Cities such as Birmingham, Ala., have also signed on.

    The Walthall supervisors took Fuller’s pitch under advisement. If they decide to join the suit, they will pass a public nuisance resolution and approve a retainer agreement. The plaintiff lawyers will receive a percentage of any damages if they win; the governmental entities signing on as clients pay nothing.

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  19. DeWine announces new opioid initiatives

    Oct 30, 2017 | WSYX (OH)

    By Chris White

    Ohio Attorney General Mike DeWine announced new opioid initiatives Monday.

    DeWine said a series of new initiatives will help combat the crisis. 

    The AG said he has sued the five largest manufacturers of prescription opioids for their alleged roles in misleading doctors about how addictive prescription opioids are.

    The lawsuit seeked a remedy from the manufacturers to help remediate the damage caused by the proliferation of opioids in Ohio per DeWine.

    "An estimated 14 Ohioans die every day from overdoses, while an estimated half of all children in Ohio's foster care system are in care due to one or both parents being addicted to drugs," said DeWine in a release.

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  20. Broadcast Media Coverage

  21. 10 This Morning Sunday

    Oct 29, 2017 | WBNS (CBS)

    By Columbus, OH

    Video Link: http://app.criticalmention.com/app/#clip/view/30354082?token=5ebeb50e-ba20-41fd-89c1-e8b97e29756b

    Rough Transcript: the federal government is sending law enforcement teams to cities in ohio and four other states -- to help stop the flow of heroin and synthetic opioids. the drug enforcement administration will send teams to cincinnati and cleveland. the agency considered deadly overdose rates and levels of opioid seizures to pick the locations. cleveland is also battling the opioid epidemic -- by targeting prescription drug companies. cuyahoga county officials are suing those companies -- claiming they misled the public about the dangers of opioids. the lawsuit says the drugmakers sought to increase the sales of painkillers, and contributed to the opioid abuse. all companies denied any wrongdoing. all across the country -- and here in central ohio -- people dropped off their old prescription medication. it was part of national prescription drug take back day. law enforcement, county offices, hospitals and fire stations collected and properly disposed of unwanted, unused or expired prescription medications. "...we know four out of fiv heroin users by using or misusing an opiate painkiller. this is a small step that residence can take to help prevent addiction. ..." melissa green also says flushing or throwing away those old prescriptions could contaminate waste water and get into the ground -- harming the environment. last week -- president donald trump declared the opioid epidemic a public health emergency.

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  22. 21 News 6PM

    Oct 30, 2017 | WFMJ (NBC)

    By Youngstown, Ohio

    Video Link: http://app.criticalmention.com/app/#clip/view/30354161?token=5ebeb50e-ba20-41fd-89c1-e8b97e29756b

    Rough Transcript: cuyahoga county officials are suing several prescription drug companies... saying they intentionally misled the public about the dangers of opioids. the lawsuit filed friday says the drug-makers and distributors sought to increase sales of pain-killes... thus contributing to the opioid abuse crisis. it also accuses four doctors of downplaying the risk of prescription opioids in research funded by those same drug companies. the companies have denied any wrong doing on their end. more than five hundred 40 people fatally overdosed on opioids in cuyahoga county last year. the county medical examiner's office estimates that number to be close to eight hundred this year. in an effort to help stop the opioid epidemic-

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