Preview Newsletter

Opioid Litigation Daily Media Report - 2/28/18

DOJ Press Conference

U.S. to seek reimbursement from opioid makers, distributors (UPDATE-2)
Feb 27, 2018 | Reuters
By Sarah N. Lynch

The federal government, backing litigation by states and cities, will seek reimbursement from major drug companies and distributors to recover costs it has borne from the opioid epidemic, the U.S. Justice Department said on Tuesday.
Purdue, Opioid Makers Face Federal Reimbursement Demand
Feb 27, 2018 | Bloomberg
By Jef Feeley & Andrew M. Harris

The opioid epidemic just got more painful for Purdue Pharma LP and other makers of the pain-killing drugs as the U.S. government said it’ll seek reimbursement from the companies for tax dollars spent battling the public-health crisis.
Justice Dept. Backs High-Stakes Lawsuit Against Opioid Makers
Feb 27, 2018 | New York Times
By Katie Benner & Jan Hoffman

The Justice Department is throwing its weight behind plaintiffs in a sprawling, high-stakes prescription opioids lawsuit in Ohio, Attorney General Jeff Sessions said on Tuesday.
The Health 202: California's attorney general wants to enforce the nation's health-care laws
Feb 28, 2018 | Washington Post
By Paige Winfield Cunningham

Yesterday, Attorney General Jeff Sessions announced the creation of a new task force focused specifically on targeting opioid manufacturers and distributors, and holding them accountable for unlawful practices, The Post's Lenny Bernstein, Katie Zezima and Sari Horwitz report. The Justice Department has also filed a statement of interest in a case involving hundreds of city and county lawsuits against opioid manufacturers and distributors; Sessions says it will argue that the federal government has borne substantial costs from the opioid epidemic and it seeks reimbursement.
JEFF SESSIONS IS CRACKING DOWN ON OPIOID MANUFACTURERS, DISTRIBUTORS FOR ROLE IN ADDICTION CRISIS
Feb 28, 2018 | Newsweek
By Melina Delkic

Attorney General Jeff Sessions is cracking down on pharmaceutical companies that have contributed to the nation's devastating opioid crisis.
Attorney General Sessions Announces New Federal Opioids Taskforce
Feb 28, 2018 | TheStreet
By Bill Meagher

Attorney General Jeff Sessions announced Tuesday, Feb. 27, the formation of a new task force aimed at opioid manufacturers and distributors.
Attorney General Jeff Sessions says feds will take action in Cleveland opioid lawsuits
Feb 27, 2018 | Cleveland.com (OH)
By Andrew J. Tobias

The U.S. Department of Justice will get involved with a federal case in Cleveland that consolidates hundreds of government lawsuits against opioid manufacturers and distributors, Attorney General Jeff Sessions said Tuesday.

DOJ Press Conference Cont'd

Commentary and FYIs

Washington’s opioid response accelerates
Feb 28, 2018 | Axios
By Sam Baker & Caitlin Owens

The federal response to the opioid epidemic is entering a new phase of intensity. Both the Trump administration and members of Congress announced new steps yesterday that could make a real difference in both law enforcement and public health.
Senators unveil bipartisan bill to fight opioid epidemic
Feb 27, 2018 | The Hill
By Rachel Roubein

A bipartisan group of senators is introducing legislation Tuesday to address the opioid epidemic, framing it as a follow-up bill to the Comprehensive Addiction and Recovery Act (CARA) signed into law in 2016.
New opioid bill would impose sweeping limits on some prescriptions, boost funding
Feb 28, 2018 | STAT News
By Lev Facher

A group of eight senators on Tuesday unveiled bipartisan legislation that would increase funding for addiction treatment and prevention by roughly $1 billion and impose a sweeping three-day limit on opioid prescriptions for initial pain treatment.
Sessions Promises Rapid Release of DEA Data on Opioid Sales
Feb 27, 2018 | WKSU (OH)
By M.L.Schultze

Ohio Attorney General Mike DeWine and his counterparts from a half dozen other states joined U.S. Attorney General Jeff Sessions to announce the next steps in the battle against opioid addiction.
How your brain is wired to just say ‘yes’ to opioids
Feb 27, 2018 | The Conversation
By Paul R. Sanberg & Samantha Portis

The mid-1980s was the era of cocaine and marijuana, when “Just Say No” was the centerpiece of the war on drugs and the government’s efforts to stem drug use and addiction. Since then, prescription opioids have become the nation’s drug scourge. The idea that mere willpower can fight this public health emergency is not only outdated, it’s scientifically misguided.
Medicaid Expansion Dramatically Increased Coverage for People with Opioid-Use Disorders, Latest Data Show
Feb 28, 2018 | Center on Budget and Policy Priorities
By Matt Broaddus, Peggy Bailey and Aviva Aron-Dine

The latest data from the federal Agency for Healthcare Research and Quality highlight the importance of the Affordable Care Act’s (ACA) Medicaid expansion in increasing insurance coverage among people with opioid-use disorders (OUD).[1] Our analysis of these data, which offer a comprehensive picture of opioid-related hospitalizations around the country, finds that the share of hospitalizations in which the patient was uninsured fell dramatically in states that expanded Medicaid: from 13.4 percent in 2013 (the year before expansion took effect) to just 2.9 percent two years later. This steep decline indicates that many uninsured people coping with OUDs have gained coverage through Medicaid expansion.
There's a shortage of opioids where they're needed most - in hospitals
Feb 28, 2018 | The Philadelphia Inquirer (PA)
By Stacey Burling

The streets of America may be awash in opioids, but there’s one surprising group of users that is having trouble getting hold of them: doctors.
Guns and Opioids Are American Scourges Fueled by Availability (Opinion)
Feb 24, 2018 | New York Times
By Sam Quinones

The United States is in the midst of at least two plagues with much in common.

Southeast (LA, AL)

The family of a Louisiana infant born addicted to opioids is suing drug makers
Feb 28, 2018 | The Times Picayenne (LA)
By Maria Clark

A class action lawsuit was filed Monday (Feb. 26) against several pharmaceutical manufacturers and distributers on behalf of babies born in Louisiana with opioid addictions.
AVOYELLES ANTI-OPIOID SUITS SENT TO U.S. COURT
Feb 28, 2018 | Avoyelles Today (LA)
By Raymond Daye

Two local lawsuits seeking to hold painkiller manufacturers accountable for the “opioid epidemic” in Avoyelles Parish have been combined with numerous others from across the nation and assigned to a federal judge in Ohio.
Local lawyers file class action against opioid drug makers, others on behalf of NAS babies in LA.
Feb 28, 2018 | WAFB (LA)
By Sabrina Wilson

The opioid epidemic is not only deadly, but it causes many newborns to enter the world with withdrawal symptoms like tremors, the inability to eat and a shrill, constant cry. And now some prominent local attorneys are going after manufacturers and others in the opioid distribution pipeline.
Lawsuit Seeks Money To Cover Treatment Of Babies Born Addicted To Opioids
Feb 28, 2018 | TechTimes
By Allan Adamson

Parents who are opioid addicts contribute to the worsening opioid epidemic by giving birth to babies who were already exposed to the addictive drug while still developing in their mother's womb.
County leads charge against opioids
Feb 27, 2018 | The Lafayette Sun (AL)
By Alton Mitchell

Chambers County Attorney Skip McCoy is leading an effort against companies that manufacture medications containing Opioids. An addictive agent found in some prescription medications that have been known to create morphine-like effects and can be highly addictive. These agents have created what some have called an Opioid crisis in the state of Alabama, that has created a strain on jail and law enforcement resources in the state and now Chambers County may be the latest to pursue the companies that manufacture these medications.

Northeast (MA)

Lowell to join opioid lawsuits
Feb 27, 2018 | Lowell Sun (MA)
By Todd Feathers

The city will join a growing number of municipalities, counties, and state governments suing prescription opioid manufacturers and distributors, City Solicitor Christine O'Connor told the City Council on Tuesday.

Broadcast Media Coverage

Morning Express With Robin Meade
Feb 28, 2018 | National Programming
By CNN

Video Link: http://app.criticalmention.com/app/#clip/view/33093074?token=85db22bf-b20e-422a-8f81-0ea82b306da7
FOX and Friends First
Feb 28, 2018 | National Programming
By Fox News

Video Link: http://app.criticalmention.com/app/#clip/view/33093100?token=85db22bf-b20e-422a-8f81-0ea82b306da7
PCN Early AM
Feb 28, 2018 | National Programming
By PNC (PCN)

Video Link: http://app.criticalmention.com/app/#clip/view/33093092?token=85db22bf-b20e-422a-8f81-0ea82b306da7
Key Capitol Hill Hearings
Feb 28, 2018 | National Programming
By CSPAN

Video Link: http://app.criticalmention.com/app/#clip/view/33093117?token=85db22bf-b20e-422a-8f81-0ea82b306da7

DOJ Press Conference

U.S. to seek reimbursement from opioid makers, distributors (UPDATE-2)

Feb 27, 2018 | Reuters

By Sarah N. Lynch

The federal government, backing litigation by states and cities, will seek reimbursement from major drug companies and distributors to recover costs it has borne from the opioid epidemic, the U.S. Justice Department said on Tuesday.
Attorney General Jeff Sessions said Washington would side with plaintiffs in the litigation that accuses the drug makers of deceptively marketing opioids and alleges that distributors ignored red flags indicating the painkillers were being diverted for improper uses.
"The hard-working taxpayers of this country deserve to be compensated by any whose illegal activity contributed to these costs," Sessions said.
In 2016, the last year with publicly available data, 42,000 people died from opioid overdoses, according to the U.S. Centers for Disease Control and Prevention.
In the latest step by the Justice Department to tackle the opioid epidemic, the department said it would file a "statement of interest" in litigation consolidated in a federal court in Cleveland.
Named in the litigation are opioid manufacturers Purdue Pharma LP, Johnson & Johnson, Teva Pharmaceutical Industries Ltd, Endo International PLC and Allergan PLC and the three biggest drug distributors in the country - AmerisourceBergen Corp, Cardinal Health Inc and McKesson Corp..
The consolidated litigation pending before U.S. District Judge Dan Polster involves at least 355 lawsuits filed by cities, counties and others.
Polster has been pushing for a quick, global settlement in the litigation and has invited state attorneys general who have cases in state courts or who are conducting a multistate probe of the companies to participate in those talks.
The first settlement hearing was held in January. A second one is expected March on 6.
In a statement, Oxycontin maker Purdue said it was "fully engaged" in the process the judge had set forth, and had taken steps to address the crisis.
Johnson & Johnson said that while it was committed to combating the problem, the allegations against it "are baseless and unsubstantiated." Representatives for the other manufacturers did not respond to requests for comment.
A trade group representing the three distributors said the industry was committed to reducing the misuse and abuse of opioids.
The Justice Department is not expected to participate in the settlement discussions. Its statement of interest in the litigation will allow it to eventually get a share of the final settlement the companies pay.
Plaintiffs' lawyers have not quantified the potential costs involved in the cases but have compared them with the litigation by states against the tobacco industry that led to 1998's $246 billion settlement.
Also on Tuesday, Sessions announced the creation of a task force to combat the opioid crisis by seeking criminal and civil remedies and said he had appointed a federal prosecutor to lead the government's battle.

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Purdue, Opioid Makers Face Federal Reimbursement Demand

Feb 27, 2018 | Bloomberg

By Jef Feeley & Andrew M. Harris

The opioid epidemic just got more painful for Purdue Pharma LP and other makers of the pain-killing drugs as the U.S. government said it’ll seek reimbursement from the companies for tax dollars spent battling the public-health crisis.
The U.S. Justice Department said it’ll argue that it’s entitled to a portion of any settlements or judgments in a consolidated case involving more than 300 lawsuits against Purdue, Johnson & Johnson and other opioid makers and distributors.
“We will seek to hold accountable those whose illegality has cost us billions of taxpayer dollars,” Attorney General Jeff Sessions said in announcing his plan to file a so-called Statement of Interest in the case.
The move by the Justice Department is bound to add to the costs companies incur in resolving claims that they understated opioids’ risks, said Richard Ausness, a University of Kentucky law professor.
“If the plaintiffs were thinking about asking for a certain number from each company in a settlement, now they’ve got to ask for a higher number because they know the feds are going to want part of the total pot,’’ Ausness said.
A federal judge in Cleveland is overseeing suits filed by U.S. cities and counties seeking to recoup the costs of dealing with opioid addictions and overdoses as part of a settlement similar to the 1998 Big Tobacco accord. The judge has said he wants a deal addressing the companies’ business practices and roots of the crisis.
Opioid Crisis Point Man Is Cleveland Judge in Midst of Epidemic
The statement of interest hasn’t appeared in the court filings yet and the Justice Department press office didn’t immediately respond to a request for a copy of it.
Purdue officials said Tuesday they are engaging in settlement talks set up by Judge Daniel Polster in Cleveland and are open to exploring “meaningful solutions” to the opioid crisis. The company already has helped fund state prescription-monitoring programs and given law enforcement officials access to opioid-overdose antidotes, according to John Puskar, a company spokesman.
William Foster, a spokesman for Janssen Pharmaceuticals, said the company isn’t going to speculate on the impact of Sessions’s announcement on any potential settlement.
“We believe our actions in marketing and promotion of these medicines were appropriate and responsible,” Foster said in an emailed statement. “The allegations made against our company are baseless.”
Kathy Profrock, a spokeswoman for Endo International Inc., didn’t immediately return emails and calls for comment.PIL Task Force
Sessions’s announcement came during a press conference unveiling a larger Trump administration initiative to confront the opioid crisis, led by the Prescription Interdiction and Litigation -- or PIL -- Task Force.
Under federal law, Sessions can file a statement to outline the government’s interest in any pending lawsuit. It doesn’t mean the federal government is formally intervening in the case.
“They are sort of like vultures, waiting for the cities and counties to finish litigating the cases so they can swoop in for some of it,’’ Ausness said.
Elizabeth Burch, a University of Georgia law professor who teaches about complex litigation, said it’s the first time she’d seen such a statement filed by federal prosecutors in a consolidated products-liability case.Social Problems
Sessions said the government’s claim is tied to tax dollars spent through “various federal health programs and law enforcement efforts’’ to combat social problems caused by opioid addictions and overdoses.
More than 42,000 people died in the U.S. from opioid-related overdoses in 2016, amounting to 115 per day, according to the Centers for Disease Control and Prevention. That was up from 91 daily opioid overdose deaths the previous year, CDC officials said.
The epidemic cost the American economy $504 billion in 2015 -- the equivalent of 2.8 percent of gross domestic product that year, according to a report last year by the Council of Economic Advisers.
Mark Lanier, a lawyer representing some cities and counties suing over opioid costs, said having the government lurking in the background may put more pressure on Purdue and other opioid makers to settle.
“Whatever deal we come up with is going to have to deal with the future as well as the past,’’ said Lanier, who is part of the plaintiffs’ leadership group in the opioid case. “That’s going to cost a boatload of money.’’
The case is In Re: National Prescription Opiate Litigation, 17-cv-2804, U.S. District Court for the Northern District of Ohio (Cleveland).

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Justice Dept. Backs High-Stakes Lawsuit Against Opioid Makers

Feb 27, 2018 | New York Times

By Katie Benner & Jan Hoffman

The Justice Department is throwing its weight behind plaintiffs in a sprawling, high-stakes prescription opioids lawsuit in Ohio, Attorney General Jeff Sessions said on Tuesday.
Mr. Sessions said that the Justice Department plans to file a so-called statement of interest in the lawsuit, a technique that past administrations have typically reserved for cases that directly affect the federal government’s interests, like diplomacy and national security.
The Obama administration had used statements of interest to expand the boundaries of civil rights laws.
At a news conference, Mr. Sessions said the lawsuit targeted “opioid manufacturers and distributors for allegedly using false, deceptive and unfair marketing of opioid drugs.”
He also announced the creation of a task force to pursue the makers and distributors of prescription opioids and said it will “examine existing state and local government lawsuits against opioid manufacturers to determine if we can be of assistance.”Continue reading the main storyThe Trump White HouseThe historic moments, head-spinning developments and inside-the-White House intrigue.Once Again, Push for Gun Control Collides With Political RealityFEB 28Amid Turkish Assault, Kurdish Forces Are Drawn Away From U.S. Fight With ISISFEB 28Hope Hicks Acknowledges She Sometimes Tells White Lies for TrumpFEB 27Jared Kushner’s Security Clearance DowngradedFEB 27Fed Chair Powell Indicates He’ll Keep Bolstering Growth in Public DebutFEB 27
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“We will use criminal penalties,” Mr. Sessions said. “We will use civil penalties. We will use whatever tools we have to hold people accountable for breaking our laws.”
The lawsuit pending in Federal District Court in Cleveland consolidates more than 400 complaints by cities, counties and Native American tribes nationwide. They accused manufacturers, distributors and dispensers of prescription opioids of using misleading marketing to promote the painkillers.
The lawsuit also accuses the defendants of playing down the addictiveness of the drugs and failing to report suspicious orders by consumers that would indicate the drugs were being abused.
Some of the high-profile defendants include pharmaceutical giants Johnson & Johnson, Purdue Pharma and Teva Pharmaceuticals, large distributors McKesson and Cardinal Health and pharmacy chains like CVS, Rite Aid and Walgreens.
Mr. Sessions called the opioid addiction crisis “beyond imagining” during separate remarks on Tuesday morning at the National Association of Attorneys General. He said the government would take a hard look at doctors who overprescribe prescription painkillers, which can lead to addiction and abuse of illegal drugs like heroin.
Mr. Sessions has described the opioid epidemic as a national health crisis and estimates that 64,000 Americans died of drug overdoses in 2016, a record increase. The vast majority of those deaths, he said, happened after users took opioids like prescription painkillers, heroin and fentanyl.
He also called the opioid crisis a significant drain on federal resources, costing the government $115 billion in 2017 and $1 trillion since 2001. He predicted that it could cost the United States an additional $500 billion over the next three years.
The attorney general is legally able to argue on behalf of the government’s interest in any court in the country via a statement of interest, which does not make the government a plaintiff. Mr. Sessions’s announcement on Tuesday followed a significant dispute in the case in Ohio.
On Monday, lawyers for the Drug Enforcement Administration attended a hearing in the Ohio courtroom about how much data they would share about the national distribution of painkillers.
Insisting that it did not want to compromise ongoing criminal investigations, the agency offered to provide two years’ worth of information in the case. Judge Dan Aaron Polster has given the agency until next Monday to decide whether it will comply with his request to provide the sides with nine years of data. Determining the number of pills, the location and the distributors can be a major factor in assigning liability.
Richard Fields, a lawyer who represents state attorneys general and sovereign Native American nations in opioid litigation, predicted that the statement of interest “will help unlock this data so that we can hold manufacturers, distributors and pharmacies accountable for flooding communities with pills.”

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The Health 202: California's attorney general wants to enforce the nation's health-care laws

Feb 28, 2018 | Washington Post

By Paige Winfield Cunningham

Yesterday, Attorney General Jeff Sessions announced the creation of a new task force focused specifically on targeting opioid manufacturers and distributors, and holding them accountable for unlawful practices, The Post's Lenny Bernstein, Katie Zezima and Sari Horwitz report. The Justice Department has also filed a statement of interest in a case involving hundreds of city and county lawsuits against opioid manufacturers and distributors; Sessions says it will argue that the federal government has borne substantial costs from the opioid epidemic and it seeks reimbursement.
“Opioid abuse is driving the deadliest drug crisis in American history,” Sessions said at a news conference with several U.S. attorneys. “It has strained our public health and law enforcement resources and bankrupted countless families across this country.”
“Sessions’s announcement is part of a flurry of activity this week at the White House, on Capitol Hill, in a U.S. courthouse and elsewhere that may mark the beginning of an intensified federal effort to address the uncontrolled drug epidemic sweeping the country,” Lenny, Katie and Sari write. “This week, the White House is holding a summit on the drug crisis, hearings on eight House bills are beginning on Capitol Hill and the Secretary of Health and Human Services has embraced the expansion of medically assisted drug treatment — in contrast to his predecessor.”

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JEFF SESSIONS IS CRACKING DOWN ON OPIOID MANUFACTURERS, DISTRIBUTORS FOR ROLE IN ADDICTION CRISIS

Feb 28, 2018 | Newsweek

By Melina Delkic

Attorney General Jeff Sessions is cracking down on pharmaceutical companies that have contributed to the nation's devastating opioid crisis.
In a press conference Tuesday afternoon, the attorney general announced that the Department of Justice would file a statement of interest in a lawsuit against "a number of opioid manufacturers and distributors for using false, deceptive, and unfair marketing of opioid drugs." He also outlined additional plans to tackle opioid addiction, one of the deadliest drug crises in United States history.
"The federal government has borne substantial costs as a result of the opioid crisis. The Medicare prescription drug program, for example, paid more than $4 billion for opioids in 2016," Sessions said.
He continued, "The hard-working taxpayers of this country deserve to be compensated by those whose illegal activity contributed to those costs. And we will go to court to ensure that the American people receive the compensation they deserve."
Sessions also announced that federal prosecutor Mary Daly will head the DOJ's anti-opioid efforts. Daly has overseen narcotics prosecution units in New York and Virginia. Additionally, Sessions' new Prescription Interdiction and Litigation Task Force will use criminal and civil penalties, and "whatever tools we have to hold people accountable," to rein in opioid manufacturers and distributors.
It's another step in a lengthy battle against the opioid crisis coming from the DOJ. In his year-long tenure, Sessions has overseen the seizure of AlphaBay—a darknet marketplace often used for the sales of illegal drugs like fentanyl—created a host of new leadership roles and enforcement teams, and implemented a data analytics program to stop over-prescribing.
The statement follows months of increased government scrutiny on the pharmaceutical industry's role in the opioid crisis. Just weeks ago, Senator Claire McCaskill (D-Miss.) released the results of her own investigation into these roles, finding that opioid manufacturers paid millions of dollars over five years to advocacy groups that promoted more opioid use and more opioid prescription. Her investigation, which is the second in a series of reports about Big Pharma's role in the crisis, found that many of the groups may have "played a significant role" in the U.S. opioid epidemic.

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Attorney General Sessions Announces New Federal Opioids Taskforce

Feb 28, 2018 | TheStreet

By Bill Meagher

Attorney General Jeff Sessions announced Tuesday, Feb. 27, the formation of a new task force aimed at opioid manufacturers and distributors.
The "Prescription Interdiction & Litigation Task Force" will team civil and criminal law enforcement officials in an effort to focus on how opioid manufacturers and distributors contribute to the opioid crisis. That focus will include looking at whether "opioid manufacturers are marketing their products truthfully and in accordance with Food and Drug Administration rules."
Sessions also said in a DOJ statement that the task force would "examine existing state and local government lawsuits against opioid manufacturers to determine what assistance, if any, federal law can provide in those lawsuits. The federal government has borne substantial costs from the opioid crisis, and it must be compensated by any party whose illegal activity contributed to those costs."
While the new task force is focused on drug makers and distributors, it will also look at the behavior of
pharmacies, clinics, drug testing facilities, and doctors regarding opioids and unlawful actions.
The federal task force will include officials from the DOJ as well as the Drug Enforcement Administration and the Department of Health and Human Services, according to Sessions.
In 2016, 63,600 people died in opioid related deaths in the U.S. according to the Centers for Disease Control.
Besides the task force, the DOJ also announced that it intends to file a Statement of Interest in a multi-district legal action which includes hundreds of lawsuits against opioid drug makers and distributors brought by cities, counties and states from all over the country. "The Justice Department will primarily argue that the federal government-through various federal health programs and law enforcement efforts-has borne substantial costs from the opioid epidemic and seeks reimbursement."
A federal court in Ohio has joined cases brought against drug makers Purdue Pharma, Endo International plc (ENDP) , Teva Pharmaceutical Industries Ltd. (TEVA) , Johnson & Johnson Inc. (JNJ) , and Allergan plc. (AGN) . Drug distributors such as Cardinal Health Inc. (CAH) , McKesson Corp. (MCK) and AmerisourceBergen Corp. (ABC) have also been sued over their alleged roles in the opioid crisis.
he DOJ did not respond to questions regarding the statement of interest and whether it was tied to the Ohio case.
The task force and statement of interest comes as a surprise given the pace at which the Trump administration has attacked the opioid crisis. While President Trump was campaigning, he promised voters in Ohio, a state where opioids has taken a deadly toll, that he would battle the problem. Once he was in office, he promised to declare the opioid crisis a public health emergency. It took months for the declaration to become a reality, but even then no funding was made available to take action. The emergency status lapsed in January.
A commission was formed to study the opioid crisis and that commission issued a report last year. But to date none of its recommendations have been taken up.
Democratic senators Patty Murray, Wash., and Elizabeth Warren, Mass., asked the Government Accountability Office in January to probe the White House over its response to the opioid scourge. It is unknown whether the GAO has actually taken up an investigation.
And Trump placed Kellyanne Conway in charge of his administration's opioids agenda. Conway has no healthcare or drug policy experience and is a career pollster and political operative.
The commitment by the federal government to pursue criminal action regarding opioids has been questioned in recent months. Last December, the Washington Post and 60 Minutes teamed up on a report that alleged that McKesson, the San Francisco-based drug distributor, had been careless in its distribution and sale of opioids. The DEA wanted to bring a criminal case against McKesson and felt there was more than enough evidence for a conviction. But the case never saw the inside of a courtroom as federal prosecutors refused to file. Instead, the DOJ huddled with lawyers representing McKesson and negotiated a settlement that included a $150 million fine and a suspension involving four of the distributor's warehouses. McKesson also had to hire an independent monitor.
The DEA complained about the case in the media while the DOJ maintained radio silence.
McKesson said it hadn't done anything wrong and said the reporting had been inaccurate.
In 2007, federal and state agencies brought charges against Purdue Pharma, the company that created the original opioid-based pain meds. Purdue paid $470 million to settle allegations that included criminal charges.

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Attorney General Jeff Sessions says feds will take action in Cleveland opioid lawsuits

Feb 27, 2018 | Cleveland.com (OH)

By Andrew J. Tobias

The U.S. Department of Justice will get involved with a federal case in Cleveland that consolidates hundreds of government lawsuits against opioid manufacturers and distributors, Attorney General Jeff Sessions said Tuesday.
Sessions said the Justice Department will file a "statement of interest" in the case, currently being heard by a federal judge in Cleveland, filed by local governments, including Cincinnati and Cuyahoga County. The statement will argue that the federal government "has borne substantial costs from the opioid epidemic" in the form of law enforcement and social service expenditures, and seek to be reimbursed. It could have the effect of putting greater pressure on the drug companies to settle, an outcome for which the federal judge overseeing the case has indicated he prefers.
Ohio Attorney General Mike DeWine joined Sessions and attorneys general from six other states for a news conference on Tuesday in Washington, D.C. to announce the move and others related to fighting the opioid crisis.
Besides the potential implications for the ongoing lawsuits, the news conference had an element of election-year political theater.
DeWine and the other attorneys general who joined DeWine represented an array of states President Donald Trump won in the 2016 presidential election, including Pennsylvania, West Virginia and Wisconsin, states that all have been ravaged by addiction and crime related to heroin and opiate pain pills. It also gave positive visibility to DeWine, a Republican running for governor who has made the opioid crisis a central part of his campaign.
"Thank you for your commitment to helping us deal with this problem," DeWine said.
DeWine has filed a pair of state-level lawsuits against drug manufacturers and distributors, including a new case filed Monday. Depending on how it proceeds, any settlement reached in the federal cases being heard in Cleveland could affect DeWine's lawsuits.
Sessions was asked whether the Justice Department will cooperate with the ongoing attempt from attorneys representing governments to obtain federal prescription data they say will help their case. U.S. District Judge Dan Polster has ordered the U.S. Drug Enforcement Administration, which oversees the federal database, to inform him by Monday if it will consent to releasing some of the data. The federal government opposed the release of the entire database, arguing doing so could jeopardize ongoing investigations and expose confidential information about companies that did nothing wrong.
"We've been looking at that very hard," Sessions said. "I've instructed our attorneys in the last several days to, whatever we know we can produce for them, produce it now, and if there are areas that need additional research before it's revealed, we can get busy about it."
DeWine's campaign officials said DeWine's personal relationship with Sessions was a factor in his lobbying of the federal government to get involved in the Ohio opioid lawsuits. DeWine and Sessions previously served together in the U.S. Senate, and Sessions indicated DeWine had lobbied him on the issue.
The campaign for Lt. Gov. Mary Taylor, DeWine's opponent in the Republican gubernatorial primary, called Tuesday's news conference "a photo-op." It also said the lawsuits only enrich trial attorneys representing the local governments, putting Taylor in the apparent position of opposing the Trump Justice Department's new effort.
"This is a crisis for the entire nation - and Ohio is the epicenter," Taylor said in a statement. "It is the most challenging and dangerous social problem we face. Hiring a bunch of your lawyer buddies to sue and sue some more won't bring help or hope to a single Ohioan living in addiction."

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DOJ Press Conference Cont'd

Commentary and FYIs

Washington’s opioid response accelerates

Feb 28, 2018 | Axios

By Sam Baker & Caitlin Owens

The federal response to the opioid epidemic is entering a new phase of intensity. Both the Trump administration and members of Congress announced new steps yesterday that could make a real difference in both law enforcement and public health.
The Justice Department announced that it will try to join a lawsuit, led by several state and local governments, against drugmakers and distributors that sell or sold prescription opioids.
Show lessThis is a big deal. This lawsuit is modeled after the tobacco litigation of the '90s, accusing drugmakers of pushing painkillers too aggressively and failing to take action when they proved dangerously addictive.By joining the litigation, DOJ could up the total award, if the governments win their case. “We will seek to hold accountable those whose illegality has cost us billions of taxpayer dollars,” Attorney General Jeff Sessions said yesterday.The White House is also planning to roll out more policy proposals on Thursday.
On Capitol Hill, Sens. Rob Portman and Sheldon Whitehouse introduced the sequel to the opioids bill they helped pass in 2016. It would provide $1 billion per year in federal funding and include new policy limits such as a three-day maximum on new opioid prescriptions.Three days matches the most restrictive limit pursued in the states. Kentucky adopted a three-day cap last year, and Florida Gov. Rick Scott wants one, too.
Notable: It’ll likely take more than $1 billion, but Portman and Whitehouse also say they want to enhance the government’s focus on recovery. So far, public resources have mostly been focused on immediate treatment as the death toll from overdoses continues to rise."We know the recovery programs are essential to winning this battle. That if you just have short-term treatment — detox, short-term treatment — that the success rate is very low. If you have longer-term recovery, the success rate is higher," Portman tells my colleague Caitlin Owens.

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Senators unveil bipartisan bill to fight opioid epidemic

Feb 27, 2018 | The Hill

By Rachel Roubein

A bipartisan group of senators is introducing legislation Tuesday to address the opioid epidemic, framing it as a follow-up bill to the Comprehensive Addiction and Recovery Act (CARA) signed into law in 2016.
Dubbed CARA 2.0, the legislation includes a host of policy changes, such as establishing a three-day initial prescribing limit on opioids for acute pain, beefing up services to promote recovery and aiming to increase the availability of treatment.
The legislation is a mixture of policy changes and increased funding authorizations, in light of a two-year budget deal passed earlier this month that includes $6 billion for the opioid and mental health crises.
Those introducing the bill include Sens. Rob Portman (R-Ohio), Sheldon Whitehouse (D-R.I.), Shelley Moore Capito (R-W.Va.), Amy Klobuchar (D-Minn.), Dan Sullivan (R-Alaska), Maggie Hassan (D-N.H.), Bill Cassidy (R-La.) and Maria Cantwell (D-Wash.).
The bipartisan bill includes some measures similar to those removed from the original CARA bill passed in 2016, such as an initiative to bolster youth recovery support services and a provision requiring physicians and pharmacists to use their state prescription drug monitoring program before prescribing or dispensing opioids.
Additionally, the legislation would let states waive the cap on the number of patients a physician can prescribe buprenorphine — a medicine used to treat opioid addiction — and increase penalties for opioid manufacturers failing to report suspicious orders.
CARA 2.0 authorizes $1 billion in additional funding. Some $10 million would fund a national education campaign on opioids; $300 million would increase training for first responders and their access to an opioid overdose reversal drug; another $300 million would expand medication-assisted treatment; and $200 million would help build more recovery support services, for example.
To draft the first CARA bill, Portman and Whitehouse helped convene five national forums comprised of experts on prevention, treatment, law enforcement and recovery.
The opioid epidemic hasn’t shown signs of abating, as overdose deaths increased nearly 28 percent from 2015 to 2016, according to the latest data from the Centers for Disease Control and Prevention (CDC).
On the other side of the Capitol, the House Energy and Commerce Committee is working on legislation aimed at combating the opioid epidemic. Chairman Greg Walden (R-Ore.) hopes to pass the measures out of the House by Memorial Day weekend.

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New opioid bill would impose sweeping limits on some prescriptions, boost funding

Feb 28, 2018 | STAT News

By Lev Facher

A group of eight senators on Tuesday unveiled bipartisan legislation that would increase funding for addiction treatment and prevention by roughly $1 billion and impose a sweeping three-day limit on opioid prescriptions for initial pain treatment.
The CARA 2.0 Act, billed as the sequel to the Comprehensive Addiction and Recovery Act of late 2016, would be the most substantive action Congress has taken to address the opioid crisis since President Trump took office.
The legislation’s unveiling comes as Republicans in both chambers of Congress are ramping up their legislative efforts to address the opioids crisis. The two-year budget deal Congress passed earlier this year included $6 billion in extra funding to address the crisis in 2018 and 2019, but offered only broad outlines of how the funds would be used. Now, legislators, lobbyists, and policy advocates are hurrying to identify policies that could fit into that funding framework.
The bill’s eight co-sponsors are divided evenly between Democrats and Republicans, and include the authors of CARA’s first iteration, Sens. Rob Portman (R-Ohio) and Sheldon Whitehouse (D-R.I.).
The bill would aggressively limit doctors’ ability to hand out lengthy opioids prescriptions, exempting only cancer, chronic pain, and hospice treatment from the three-day initial prescription limits. The Centers for Disease Control and Prevention issued new prescription guidelines in 2016 that indicate three-day prescriptions are typically sufficient and seven-day prescriptions are rarely necessary. A number of states have already enacted laws limiting first-time opioid prescriptions to three, five, or seven days.
The bill would also make permanent temporary provisions that allow nurse practitioners to prescribe buprenorphine, a form of medication-assisted treatment, and that waive the current 100-patient limit for physicians wishing to prescribe the drug. It would fund $300 million in training and expanded access to the overdose-reversal drug naloxone for first responders, more stringently require physician use of prescription drug monitoring programs, and fund a variety of other new treatment and outreach programs.
The bill’s quick introduction matches the aggressive timeline congressional leaders had recently begun to outline for opioids-related packages in 2018. The chairmen of the two primary health committees in Congress pledged to push major legislation to address the opioid crisis within the next several months. Energy and Commerce Committee Chairman Greg Walden of Oregon has said he will push the House to pass legislation before Memorial Day, and convened the first of three legislative hearings this week.
Senate Health, Education, Labor, and Pensions Committee Chairman Lamar Alexander of Tennessee has said his committee’s markup could come as soon as the end of March.
The initial CARA, in combination with the 21st Century Cures Act, authorized roughly $1 billion in annual spending on a more limited scope of programs.
Some provisions in the new bill mirror the 56 recommendations issued by the White House commission last November. Members of that commission and treatment experts alike had openly fretted that much of the document was likely to be ignored.
The White House is also holding an “opioids summit” on Thursday, at which Trump adviser Kellyanne Conway — who has largely taken over the White House addiction policy portfolio — and other federal officials are expected to tout steps they have taken since the administration declared a national public health emergency in October.

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Sessions Promises Rapid Release of DEA Data on Opioid Sales

Feb 27, 2018 | WKSU (OH)

By M.L.Schultze

Ohio Attorney General Mike DeWine and his counterparts from a half dozen other states joined U.S. Attorney General Jeff Sessions to announce the next steps in the battle against opioid addiction.
Sessions announced the federal government will join Ohio and hundreds of other local and state governments suing the companies that make and distribute opioid drugs.
Those suits have been consolidated in the Cleveland courtroom of federal Judge Dan Polster, who is pressuring the DEA to release the full database of painkiller sales and distribution. Sessions said he wants the DEA to cooperate.
“We are looking at that very hard. I’ve instructed our attorneys in the last several days actually to make sure whatever we can produce for them – we know we can produce – let’s do it now. And if there are areas that need additional research before its revealed we should do that, we’ll get busy about it.”
DeWine praised Sessions for filing what’s called a “statement of interest” that accuses the drug companies of “false, deceptive, and unfair marketing of opioid drugs.” He also said Sessions has shown special interest in the spread of fentanyl, which DeWine said is largely responsible for the continuing escalation of Ohio’s overdose deaths.
DeWine joined Sessions and a half-dozen other state attorneys general in announcing the Justice Department's actions.
“Thank you for your administration’s focus in regard to the manufacturers of these drugs. We now have 14 states that have filed lawsuits against the drug manufacturers and the fact that you have filed as a party of interest is, I think, a game changer.”
Sessions also announced he’s creating a prescription interdiction and litigation task force to target opioid manufacturers and distributors. He’s also appointing a former assistant U.S. attorney as director of opioid enforcement and prevention efforts.

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How your brain is wired to just say ‘yes’ to opioids

Feb 27, 2018 | The Conversation

By Paul R. Sanberg & Samantha Portis

The mid-1980s was the era of cocaine and marijuana, when “Just Say No” was the centerpiece of the war on drugs and the government’s efforts to stem drug use and addiction. Since then, prescription opioids have become the nation’s drug scourge. The idea that mere willpower can fight this public health emergency is not only outdated, it’s scientifically misguided.
Medical history tells us that almost as long as there have been opioids – their use dates back to the third century – there have been opioid addicts.
Thirty years ago, I was a research scientist focused on addiction when I was asked to co-author a volume on prescription narcotics for the “Encyclopedia of Psychoactive Drugs.” I wrote the same assessment of opioid abuse then that I would write today: For many people, opioids are substances their brains are wired to crave in ways that make personal resolve nearly impossible.Your brain on opioids
Our understanding of the human brain’s mechanisms make a compelling argument for a national research effort to develop non-opioid painkillers and new medical devices to treat chronic pain, which remains the nation’s number one cause of disability. The good, if somewhat little noticed, news is that there is meaningful action on this front led by the National Institutes of Health, which is working in conjunction with pharmaceutical companies to develop nonaddictive, non-opioid pain killers that might finally end our somewhat tortured dependence on this formidable drug.
Brain scientists have known for decades that opioids are complex and difficult substances to manage when it comes to addiction. The National Institute on Drug Abuse reports that more than 20 percent of the patients prescribed opioids for chronic pain misuse them, and between 8 and 12 percent of those who use prescription opioids develop a use disorder.
Given how addictive these drugs are, doctors should have foreseen the looming danger of prescription opioids long before their use was liberalized for non-cancer related pain in the 1990s. Opioid abuse has instead ballooned over the last decade. In 2014, federal officials estimated nearly 2 million people in the United States suffer from substance use disorders related to prescription opioid pain medicines. Each day, more than 1,000 people are treatedin emergency rooms for misusing prescription opioids, the CDC reports.
The reason? Many people’s brains are wired to want this drug.How opioids affect the brain
The simplified explanation of this complex brain science is this: When opioids enter the brain, they bind to receptors known as μ (mu) opioid receptors on brain cells, or neurons. These receptors stimulate the “reward center” of the brain. This occurs in a part of the brain known as the ventral tegmental area, which results in the release of the neurotransmitter chemical dopamine. Over time, those receptors become less sensitive, and more of the drug is needed to stimulate the reward center.
A brain that has become dependent on opioids can produce a strong desire to avoid the very real physical pain of withdrawal. When opioids are absent in the body after the person has become dependent, another neurotransmitter called noradrenaline is produced in excess. Excessive production of NA results in withdrawal symptoms that include shaking, tremors, anxiety, muscle cramps, and other uncomfortable and painful physiological responses. Users self-correct this brain chemistry by continuing to take the drug to stimulate dopamine production in their brain.
Our learning and memory processes also become engaged in addiction to a substance. A few brain areas are involved in the continued use of opioids after the pleasure factor has subsided and the person is still using the drug in order to avoid withdrawal. These areas include the paraventricular nucleus of the thalamus, bed nucleus of the stria terminalis, the amygdala and other areas. A user’s brain can literally create a strong aversion to opioid withdrawal and compel them to keep using even if they know they are nearing an overdose.The research community responds
Brain science is only one part of an addiction problem, but, I believe an important one deserving of more consideration than we’ve shown in past drug abuse crises. NIH Director Francis S. Collins has recognized this in his leadership of the medical and scientific response to the opioid use epidemic.
The NIH is taking important steps in building a public-private partnership that will seek scientific solutions to the opioid crisis, including the development of non-opioid painkillers. Collins has committed his agency’s resources in this quest, including implementing the Fast Track and Breakthrough Therapy designations that exist to facilitate development and expedite review of products that address an unmet medical need. The agency is calling for more emphasis on non-drug alternatives for pain, such as medical devices that can deliver more localized analgesia.
Expediency and proper funding of this effort is critical to get effective alternatives to those who need it most – the people fully intending to “Just Say No” but whose brains will fight them every step of the way.

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Medicaid Expansion Dramatically Increased Coverage for People with Opioid-Use Disorders, Latest Data Show

Feb 28, 2018 | Center on Budget and Policy Priorities

By Matt Broaddus, Peggy Bailey and Aviva Aron-Dine

The latest data from the federal Agency for Healthcare Research and Quality highlight the importance of the Affordable Care Act’s (ACA) Medicaid expansion in increasing insurance coverage among people with opioid-use disorders (OUD).[1] Our analysis of these data, which offer a comprehensive picture of opioid-related hospitalizations around the country, finds that the share of hospitalizations in which the patient was uninsured fell dramatically in states that expanded Medicaid: from 13.4 percent in 2013 (the year before expansion took effect) to just 2.9 percent two years later. This steep decline indicates that many uninsured people coping with OUDs have gained coverage through Medicaid expansion.
In addition, the data rebut claims that Medicaid expansion contributed to the opioid crisis. Opioid-related hospitalizations were higher in expansion than non-expansion states as early as 2011, three years before Medicaid expansion took effect, and have been growing at roughly the same rate in expansion and non-expansion states since expansion took effect. Medicaid is part of the solution to the opioid crisis, not a cause. Medicaid Expansion Increased Coverage and Access to Treatment
The need for substance use disorder (SUD) treatment, particularly as related to OUDs, is acute. A record 63,600 people died of drug overdoses in 2016, with 42,200 due to opioid use. Drug overdose death rates rose by statistically significant amounts in 27 states between 2013 and 2015 and in 34 states between 2013 and 2016, according to the Centers for Disease Control and Prevention.[2]
By itself, having a SUD isn’t considered a disabling condition under Medicaid rules, so before the ACA expanded Medicaid, low-income adults with SUDs generally didn’t qualify for Medicaid unless they also had a physical or mental health disability. States’ recent Medicaid expansions under the ACA allow adults with incomes below 138 percent of the poverty line to enroll regardless of disability, opening the door to coverage for far more adults with SUDs.
Recently released data from the Healthcare Cost and Utilization Project (HCUP) at the Agency for Healthcare Research and Quality shed new light on how expansion affects coverage for people with OUDs. For states with available data, the HCUP provides a complete picture of opioid-use-related hospitalizations, including whether the patient was covered by Medicaid, Medicare, or private insurance or was uninsured. We analyzed these data for the states with data available from 2011 through 2015, and which either expanded Medicaid in January 2014 or had not expanded by the end of 2015. (See the methods note for details.)
In Medicaid expansion states, the uninsured rate for opioid-related hospitalizations plummeted by 79 percent, from 13.4 percent in 2013 (the year before expansion implementation) to 2.9 percent in 2015. The decline in non-expansion states was a much more modest 5 percent, from 17.3 percent in 2013 to 16.4 percent in 2015 (see Figure 1). While both expansion and non-expansion states saw sizable declines in their overall uninsured rates during this period, Medicaid expansion appears to have been especially critical for expanding coverage to those with OUDs.
The expansion states with the largest drops in the uninsured rate for opioid-related hospitalizations were Kentucky (90 percent), Oregon (89 percent), West Virginia (86 percent), Arizona (84 percent), and Illinois (83 percent).[4] (See Appendix Table 1 for additional state-level data.)
These data are consistent with other evidence that Medicaid expansion is improving access to care for people with opioid use and other substance use disorders. Medicaid makes medications like buprenorphine and naloxone, which are prescribed to combat opioid use disorders, affordable for beneficiaries. Medicaid spending on prescription drug treatment for opioid use disorders more than doubled between 2011 and 2016, from $394 million to $930 million. Five states with particularly high overdose mortality rates — West Virginia, Massachusetts, Ohio, Rhode Island, and Kentucky — have also seen especially rapid growth in Medicaid spending for these drugs; all of these states are Medicaid expansion states.[5] Evidence also suggests that Medicaid expansion improved access to substance use treatment services more broadly. After expanding Medicaid, Kentucky experienced a 700 percent increase in Medicaid beneficiaries using substance use treatment services.[6] Use of treatment services rose nationally as well; one study found that expanding Medicaid reduced the unmet need for substance use treatment by 18.3 percent.[7]
Moreover, substance use disorders usually don’t occur in isolation; people with SUDs also need access to physical and mental health services. Medicaid expansion has been shown to help people get these services, too. For example, an Ohio study found that 59 percent of people with opioid-use disorders who had gained Medicaid coverage under expansion reported improved access to mental health care.[8] Nationwide, the share of people forgoing mental health care due to cost fell by about one-third as the ACA, including Medicaid expansion, took effect.[9] And more generally, studies find that Medicaid expansion has increased access to primary and preventive care, increased the share of people getting regular care for chronic conditions, and reduced the share of people forgoing needed care due to cost.[10]Research Also Refutes Claims That Expansion Is Driving Opioid Crisis
At a recent hearing of the Senate Homeland Security and Government Reform Committee,[11] Chairman Ron Johnson claimed that Medicaid expansion contributed to the opioid crisis.[12] But the evidence doesn’t support this claim; to the contrary, as discussed above, the expansion has increased access to treatment. And the HCUP data show that opioid-related hospitalizations have been growing — since before the expansion took effect — in both expansion and non-expansion states, and at roughly the same rate.
The HCUP data show that opioid-related hospitalizations are increasing across the nation, regardless of Medicaid expansion. They are more prevalent in Medicaid expansion states, reflecting the fact that many of the northeastern and midwestern states at the epicenter of the crisis opted to expand. But these rates were higher as early as 2011 — well before expansion took effect. After expansion, hospitalization rates rose at similar rates in expansion and non-expansion states. Nationally, opioid-related hospitalizations rose by 11 percent between 2013 and 2015, from 208 to 231 per 100,000 people. Medicaid expansion states saw a 12 percent increase, from 241 to 270 per 100,000 people. Non-expansion states saw a 10 percent increase, from 169 to 185 per 100,000 people.
These results, which belie claims that Medicaid expansion has caused a disproportionate increase in OUDs, are consistent with other researchers’ analysis of drug overdose rates.[13] They are also consistent with new research from the Oregon Health Insurance Experiment. In 2008, prior to the ACA, Oregon undertook its own expansion of Medicaid to low-income adults. But because of limited funding, Oregon assigned Medicaid slots by lottery, which researchers have used as a randomized experiment to evaluate the impact of Medicaid coverage. A new study finds that those enrolled in Oregon’s Medicaid expansion program were no more likely to be prescribed opioids — or to be prescribed more opioids — than low-income adults not enrolled in Medicaid. However, Medicaid enrollees were almost twice as likely to be prescribed treatment medications for opioid use disorder as those not enrolled, although this finding falls just short of statistical significance due to a small sample size.
Furthermore, virtually no Medicaid enrollees in Oregon possessed prescription drugs not originally prescribed to them.[14] This is an important finding, given the serious health risks associated with prescription medication sharing; and it is especially significant in relation to opioids, given the concern that opioid prescription sharing is prevalent.[15]
Of course, some people enrolled in Medicaid have received inappropriate opioid prescriptions. But the problem of people receiving inappropriate opioid prescriptions is not unique to Medicaid. It also exists with private insurers and Medicare, which experience the same challenges in implementing solutions such as improving prescription tracking, identifying providers who overprescribe medications, and researching non-opioid interventions for pain.[16] It is also important to understand that the rise in opioid-related overdose deaths is now largely due to non-prescription drugs like heroin and fentanyl.[17]States Are Using Medicaid to Help Address Opioid Crisis
Now that more people with SUDs are eligible for Medicaid, states can significantly improve treatment for people with SUDs by improving Medicaid-covered services. Medicaid can be a sustainable funding source for providers, as opposed to capped, short-term grant funding, and states like California, Kentucky, Maryland, Massachusetts, New Hampshire, New Jersey, and West Virginia have new Medicaid initiatives for people with SUDs underway. These states are providing services such as inpatient treatment or short-term residential treatment and innovative evidence-based services like peer supports; they also are providing wraparound supports such as housing and employment to increase the impact of treatment. Other states, including Illinois, North Carolina, and New Mexico, are seeking federal approval for similar proposals.[18]
Among a panel of experts dealing directly with the opioid crisis — public health and law enforcement officials, policymakers, and policy experts — Medicaid expansion was among the policies consistently named as most critical for addressing the crisis.[19] Claims that Medicaid coverage has worsened the epidemic aren’t supported by the available evidence and shouldn’t deter states that have not yet expanded Medicaid from taking advantage of the opportunity to improve coverage and treatment for people struggling with opioid use and other substance use disorders.

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There's a shortage of opioids where they're needed most - in hospitals

Feb 28, 2018 | The Philadelphia Inquirer (PA)

By Stacey Burling

The streets of America may be awash in opioids, but there’s one surprising group of users that is having trouble getting hold of them: doctors.
Local health officials said the injectable versions of morphine, hydromorphone (Dilaudid), and fentanyl — staples of pain control and sedation in hospitals and hospices — are in short supply.
“The shortage of hydromorphone is beyond acute,” said Beverly Philip, vice president of scientific affairs for the American Society of Anesthesiologists.
As a result, pharmacists are scrambling daily to find more and to figure out alternative dosing regimens. The constant changes put extra stress on hospital pharmacists, increase the risk of mistakes, and lead to waste and higher costs. Nishaminy Kasbekar, director of pharmacy at Penn Presbyterian Medical Center, said her hospital has had to turn to more expensive alternatives at an extra cost of $30,000 over the last three months. Three months ago, she said, the hospital could get 20 percent to 30 percent less of those three drugs than it wanted. Now, it’s 50 percent to 60 percent less.
There are plenty of opioid pills, but they are often not appropriate for hospitalized patients or those in hospice.
Erin Fox, senior director of drug information at University of Utah Health, said the hard-to-get drugs are “absolutely essential, and hospitals use a very, very large amount of these.”
The shortage stems from manufacturing problems and may be exacerbated by government regulations meant to prevent street sales of addictive drugs. A coalition of medical organizations on Tuesday urged the Drug Enforcement Administration to loosen its rules to help combat the shortages. The letter, signed by the American Hospital Association, the American Society of Anesthesiologists, the American Society of Clinical Oncology, the American Society of Health-System Pharmacists, and the Institute for Safe Medication Practices, raised the specter of postponed or canceled surgeries. “In some cases,” it said, “this could prove life-threatening to the patient.”
Small syringes and vials are in most demand, because they are safest and have long shelf lives. Pharmacies can split larger vials in a clean room, but drugs may be wasted and the resulting syringes expire much more quickly than the preloaded syringes that are in short supply.
Health officials said that so far, they have been able to avoid mistakes and keep patients’ pain under control, but Louis Iobbi, pharmacy director at Doylestown Hospital, said he is worried. The hospital has enough opioids to care for patients for the next 2½ to three months, he said, but Pfizer, the dominant manufacturer, has told health-care providers that “some of this stuff might not be available until July, and that’s a nightmare.”
Pfizer has said its “full recovery date” is in early 2019, the letter to the DEA said.
At the Visiting Nurse Association of Greater Philadelphia’s inpatient hospice, medical director Stanley Savinese said his morphine supply will last about two weeks. His supplier can find enough hydromorphone to get the hospice through March. The hospice is switching patients to oral drugs whenever possible and may soon have to rely more on suppositories. “The staff is not that crazy about that, and neither are our patients or the families,” he said.
Terri Maxwell, vice president of clinical education at Philadelphia-based Enclara Pharmacia, which supplies medications to the VNA and other hospices, said her company was asking clients to “ration” injectable morphine and hydromorphone. Enclara can get the liquid morphine that caregivers give hospice patients at home, but people in inpatient hospice often need stronger stuff. “We have been strongly recommending that people reserve [injectables] for only people who have intractable and rapidly escalating pain,” she said.
The shortage of opioids comes on top of a national shortage of intravenous solutions. Like other hospital pharmacy leaders, Kasbekar has a daily meeting — at 7:30 a.m. — to discuss what will and will not be available. While the IV-solutions shortage has been attributed largely to plant problems in Puerto Rico in the wake of Hurricane Maria, the opioids shortage is more complicated.
In some ways, it is a typical drug shortage. These are happening more and more, Fox said, when a dominant producer has manufacturing problems and smaller companies can’t ramp up enough to meet demand. In this case, Pfizer controls 65 percent to 70 percent of the market for the injectable opioids now in short supply, she said. Steven Danehy, a Pfizer spokesman, said there is a “technical and process issue” with a supplier that makes a “key component” of the pre-filled syringe systems Pfizer uses.
What complicates the picture further is that these drugs are controlled substances, and the DEA limits how much can be sold. Over the last two years, the DEA has reduced the annual quotas for morphine, hydromorphone, and fentanyl by 35 percent to 46 percent. Barbara Carreno, a DEA spokeswoman, said the rules are meant to reduce diversion to illicit drug users and reflect actual medical usage of the drugs. The limits, she said, should not be causing shortages.
However, each producer gets its own quota. Danehy said Pfizer still expects to be able to meet its annual allotment eventually, but it clearly isn’t meeting expectations now. Meanwhile, Fox said two smaller companies that make the same products have said they asked the DEA to produce more but received lower increases than they wanted. The DEA considers data on individual companies’ quotas “proprietary” and doesn’t release it, Carreno said. Fresenius Kabi and West-Ward Pharmaceuticals, the two firms, did not respond to requests for comment.
Tuesday’s letter to the DEA asked it to “temporarily reallocate or revise” its quotas.
The shortage comes at a time when many medical providers have been working to reduce opioid usage to prevent patients from becoming dependent on them.
“We will learn a lot from these shortages,” said Michael Ganio, director of pharmacy practice and quality for the American Society of Health-System Pharmacists. “We may find that some of these efforts to conserve or use alternative treatments are just as effective.”
Jeanmarie Perrone, an emergency medicine physician at Penn Medicine, said the shortage has given another reason to stress to residents that some patients may get some pain relief from non-opioids. But, she added, “it’s pretty hard to run an emergency department without IV opioids.”
Fox doesn’t see much of a silver lining in the shortage. The last time there was a shortage of these drugs two people died because of dosing errors, she said. “It’s just a huge amount of work for hospitals to deal with this,” she said. “All that labor takes away from other things.”
Perrone also volunteers at a medical clinic for Prevention Point, a needle-exchange program in Philadelphia’s opioid-ravaged Kensington neighborhood. “There’s been unfortunately no shortage of heroin and fentanyl on the streets in Philadelphia,” she said.

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Guns and Opioids Are American Scourges Fueled by Availability (Opinion)

Feb 24, 2018 | New York Times

By Sam Quinones

The United States is in the midst of at least two plagues with much in common.
One is gun-fueled mass murder; the other is addiction to opioids — pain pills, heroin, fentanyl.
Both are uniquely American afflictions, killing in alarming numbers. Both are revved in part by commercial interests and in part by the collapse of community in American culture. Both persist because of the erroneous belief that there’s an easy answer to these complicated problems.
Above all, both are about supply.
Laid on top of a culture of increasing social isolation for many, our vast supply of easily accessible opioids has sent overdose deaths skyrocketing. So, too, a vast supply of easily accessible guns has produced a similarly rising death toll.
I wrote a book about our opioid-addiction epidemic. I first thought the book was about drug marketing — both from pharmaceutical companies and from Mexican heroin traffickers. But it was bigger than that; it was about who we were as Americans. The root of the scourge, I believe, is in isolation and a conviction that we are entitled to a life free of pain — all of which forms heroin’s natural habitat.
We exalted the private, the individual, at the expense of community. We once played kick the can in the streets until late on summer evenings. Now those streets are empty as we huddle at home. More than 12 percent of the population served in the military during World War II, and nearly every American sacrificed to beat the Nazis. Today, less than 1 percent join the armed services. Kids are dosed with weeks’ worth of narcotics to keep them from the three days of pain that accompany a wisdom-tooth extraction. We’ve seen parents prosecuted for letting their kids go to the park alone. College students wilt when exposed to ideas they disagree with, and 24-hour cable news shrieks at us, forcing us into ideological bubbles.Continue reading the main storyRELATED COVERAGE1 Son, 4 Overdoses, 6 Hours JAN. 21, 2018
All of this has provided fertile soil for a two-decade dosing with opioids — promoted by drug companies, prescribed by doctors, demanded by many of us — that led a national explosion of addiction and death.
I was a newspaper reporter for almost 30 years before writing that book. I covered seven mass murders — six involving guns. I was in Tucson after Jared Loughner shot 19 people, six of whom died, including a federal judge; among the wounded was Gabrielle Giffords, a member of the House of Representatives at the time. Over the phone, I covered the shootings at a movie theater in Aurora, Colo., and an elementary school in Newtown, Conn.
Long before all that, I covered perhaps the first school shooting of our era of gun massacres — in Stockton, Calif., in 1989. I was the crime reporter for The Stockton Record when a loner with an AK-47 opened fire on a playground full of children at recess at Cleveland Elementary School. Five of them died; some 30 others were wounded.
My job was to find out as much about each assailant as possible. As years passed, I realized I was telling the same story over and over — a lost, isolated, unbalanced (usually white) young man with legal access to firearms.
Now, Nikolas Cruz, who has been charged with the Parkland, Fla., school shooting, has taken his place among those lost boys, all products of our searing American isolation and ready supply of guns.
I learned writing my book that when you unleash a vast new supply of potent legal drugs on a population as bereft of community as ours, the consequences are painful, enduring and nationwide. Enormous supply creates enormous abuse.
That’s the lesson we should take from our gun scourge as well.
It’s not just that each gunman procured these weapons legally, but that our supply is so immense that finding a gun — legally or not — is easy. Mass shootings plague us, but so does a decades-old torment of gun violence and suicide.
Most gun owners are law abiding, just as many people have no trouble taking narcotic painkillers according to the prescribed instructions. Yet when guns, or opioids, are accessible in plentiful supply to everyone, without much monitoring of consumers’ backgrounds, and are then mixed with the isolation and disconnection in American culture today, havoc results.
The end to our opioid addiction epidemic, I believe, will come from a symphony of small solutions, many of them unsexy: expanding treatment options, using jails as recovery centers, creating syringe exchanges, broadening the use of Narcan and widening the curriculums in medical schools to include pain and addiction studies. Law enforcement’s role is crucial. Recovering addicts need supply reduced. The supply of opioids on our streets is so vast and potent that when a recovering addict relapses, the result is often death. Insurance companies, meanwhile, need to reimburse for non-opioid pain treatment, as they once did. Up to now, we’ve lowered pain pill prescribing but without raising the numbers of pain strategies available for chronic-pain patients, and for which doctors are trained. Those patients thus turn to the black market for pills, but also for heroin and fentanyl, the supply of which is booming.
All this, in other words, is a community approach to a plague feeding on our isolation.
Mass murder calls for the same.
Restoring the ban on assault rifles is essential, as is banning gun ownership among people convicted of domestic abuse, those with domestic abuse restraining orders, and the mentally ill. So is banning gun possession among those repeatedly convicted of driving while intoxicated. We need to change the law to let the Centers for Disease Control and Prevention study gun violence as a public health issue. We need longer prison terms for stealing a gun or possessing one that’s stolen; possessing a stolen gun has very different potential consequences from possessing a stolen X-Box.
The problem is, both the opioid epidemic and mass murder are bedeviled by our isolation. Some treatment advocates, stung by the war on drugs, won’t recognize law enforcement’s necessary role in our attack on addiction as a robust player in a multipronged approach. The Republican Party — which understands that an enormous opioid supply fuels our addiction scourge — fails, or doesn’t want, to understand that the supply of firearms is at the root of our problem of mass shootings. Moreover, the party’s response to each horror, apart from the by-now rote “thoughts and prayers,” has been the claim that this or that proposed reform wouldn’t have stopped the shooter. If one grand and easy answer wouldn’t have saved the day then we’re narcotized to inaction.
To get beyond all that, we must again act as bold, resilient Americans, tackling a problem with a can-do attitude. We must stop believing in one easy answer to complicated problems, and shamefully giving up when one doesn’t magically appear.
Those attitudes are just more symptoms of our culture of isolation, in which we’ve lost the habit of collaborating with our neighbors. And that, in turn, is the natural habitat not just of heroin but of that next young killer now planning to roam a school corridor.
Sam Quinones is a freelance journalist based in Los Angeles and the author of “Dreamland: The True Tale of America’s Opiate Epidemic.”

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Southeast (LA, AL)

The family of a Louisiana infant born addicted to opioids is suing drug makers

Feb 28, 2018 | The Times Picayenne (LA)

By Maria Clark

A class action lawsuit was filed Monday (Feb. 26) against several pharmaceutical manufacturers and distributers on behalf of babies born in Louisiana with opioid addictions.
The suit, filed in the 22nd Judicial District Court in St. Tammany Parish on behalf of a child identified by the initials K.E.R, seeks money to cover long-term treatment for K.E.R. and other infants who are born suffering opioid withdrawals.
Defendants named in the lawsuit include Johnson & Johnson, Purdue Pharma, Janssen Pharmaceuticals, and Teva Pharmaceuticals among other drug manufacturers and distributors.
The child identified in the suit was born addicted to opioids with a condition called Neonatal Abstinence Syndrome, or NAS, according to the lawsuit. The condition is typically diagnosed in babies that have had chronic fetal exposure to substances that were used or abused by their mother during pregnancy. NAS sets in once the baby is abruptly removed from exposure after birth.
K.E.R.'s mother was prescribed opioid pain killers to treat lower back pain after she was involved in a car accident before becoming pregnant. She became addicted and continued to use opioids, including while she was pregnant with K.E.R., according to the lawsuit.
K.E.R., now 3 years-old, has undergone behavioral, speech and hearing therapy to manage the long-term effects of opioid exposure while in the womb, the lawsuit says.
The legal team representing the toddler is seeking damage payments to fund long-term treatment for K.E.R. as well as any families with babies born in Louisiana with opioid-related NAS who wish to join the lawsuit. The suit does not list the total amount of damages it seeks.
The case does not cite the exact number of children born with NAS resulting from prescription opioid addiction in Louisiana, but the legal team behind it estimates the population is large based on the number of Medicaid enrollees who were also consuming opioids at some point during their pregnancy, a figure tracked by the federal social insurance program.
Louisiana has more than 1.4 million Medicaid enrollees. One out of every five Medicaid-served mothers consumed opioids at some point during their pregnancy, according to figures cited in the lawsuit.
The National Institute on Drug Abuse estimates that from 2000 to 2012 there was a five-fold increase in the number of babies born with NAS syndrome as a result of opioid use in the United States. In 2012 the organization estimated a total of 21,732 babies were born suffering from opioid withdrawals.
The group now estimates a baby suffering from opioid withdrawals is born every 25 minutes in the U.S.
K.E.R is the only named plaintiff in the St. Tammany lawsuit, but attorneys representing the family say the case is open to all families with babies born with opioid-related NAS in Louisiana. The New Orleans law firm Martzell, Bickford & Centola A.P.C. and the Cooper Law Firm are representing K.E.R.'s family.
The suit accuses the companies named as defendants of "developing a well-funded, sophisticated and deceptive marketing scheme targeted at physicians and consumers," resulting in widespread addiction.
"Facts show that pharmaceutical drug companies and their distribution partners exaggerated the benefits of opioids and downplayed risks and consequences," said Scott Bickford, an attorney with Martzell, Bickford & Centola. "They knew the drugs were being overly prescribed yet failed to warn doctors of the extremely addictive nature of the narcotics and the need to strictly limit and monitor the dose."
The lawsuit was crafted by a team of legal and medical experts including Dr. Kanwaljeet J.S. "Sunny" Anand, the chief of neonatal pediatrics at Stanford University School of Medicine, and Brent Bell, a Houston-based physician assistant with 26 years in the field of radiation oncology.
"Newborn babies are the most vulnerable citizens, their lives and developmental potential are disrupted by Neonatal Abstinence Syndrome, but arrangements for their short-term and long-term care have been ignored until now," Anand said in a statement.
At a Tuesday (Feb. 27) press conference, Bell explained one of the main reasons for this lawsuit is to assure there is a legal structure in place to ensure any damages paid out by pharmaceutical companies and manufacturers go to rehabilitation programs, substance abuse treatment facilities, inpatient treatment facilities and programs in rural areas with less access to substance-abuse help.
Bell pointed to the 1990s class action tobacco suits as an example of what can happen when that structure is absent. At the time, lawsuits were filed against the four major tobacco companies by attorneys general of 46 states to cover the healthcare related costs from tobacco use. Tobacco companies eventually agreed to pay Louisiana $206 billion over 25 years in a 1998 agreement.
Bell and others on the team representing K.E.R noted there was no path for how states should have set aside the tobacco money to treat patients with healthcare costs related to tobacco use.
"We do not want the money obtained by the lawyers to be distributed by political interest as it was in the tobacco settlement," Bell said. "The big tobacco money did not go to treat cancers or educate kids."
Bell said the settlement structure the lawsuit seeks to establish would direct settlement dollars to academic and research institutions, including institutions that specialize in neonatal training, and integrative medicine and prevention.

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AVOYELLES ANTI-OPIOID SUITS SENT TO U.S. COURT

Feb 28, 2018 | Avoyelles Today (LA)

By Raymond Daye

Two local lawsuits seeking to hold painkiller manufacturers accountable for the “opioid epidemic” in Avoyelles Parish have been combined with numerous others from across the nation and assigned to a federal judge in Ohio.
Attorney Derrick “Digger” Earles said the suits brought by the Avoyelles Parish Sheriff’s Office and the Avoyelles Police Jury were filed in state court late last year but were removed and placed in the federal court system because the defendants are located out-of-state.
The suits were then taken from the federal court in this state and sent to a “multi-district litigation” action that was assigned to U.S. District Judge Dan Polster in Cleveland, Ohio.
No trial date has been set. In fact, Polster is hoping a court trial can be avoided.
“The judge has shut down all litigation action and discovery while both parties negotiate a settlement,” Earles said. “He wants us to try to reach an agreement before we start the litigation process.”
Earles said the arrangement is complicated because each of the many suits involved are still independent legal actions, but they are being treated as one case being heard by one judge.
ONE COURT INSTEAD OF MANY
“This is not something we asked for,” Earles said. “In fact, we argued against it. The defendants asked for it because they only have to make one argument in one court instead of appearing in many courts across the country and presenting their argument.”
Earles said the advantage to a multi-district litigation case is that it avoids the possibility of conflicting decisions by the various state courts.
“That would result in the district court decision being appealed to the state appeals court, then to the state supreme court and then to the U.S. Supreme Court,” which would hopefully render a decision binding on all parties in all states.
However, that process would take many years to reach that final, binding conclusion, he added.
State and local government entities in Louisiana and elsewhere are seeking payment of damages and penalties from the drug manufacturers due to the costs they have incurred and will incur due to excessive opioid prescriptions in their jurisdictions. Health-related costs due to addiction, crimes committed by addicts and other issues have been cited by those filing suit.
The suits allege the drug companies intentionally misled physicians and the public concerning the risk of addiction to the painkillers.
There is a growing number of states and local government agencies filing similar lawsuits in reaction to alarmingly high rates of addiction and opioid-related deaths nationwide.
STATE COORDINATING ANTI-OPIOID EFFORTS
Louisiana officials are also moving to mount a coordinated effort against “Big Pharma.”
Earles said those actions will not affect the local suits’ progress.
Gov. John Bel Edwards and Attorney General Jeff Landry announced Tuesday (Feb. 20) that they are mounting a coordinated legal effort against opioid manufacturers.
The Louisiana Department of Health (LDH) filed suit on behalf of the state.
In making his announcement, Edwards said the “opioid crisis is sweeping the nation, and this is due in large part to the drug companies that mislead physicians and the public.”
Edwards said a “coordinated effort from the State will produce the best results for the families who have lost loved ones to this epidemic. Justice for them is our number one priority.”

He said Landry’s office will pursue the claims vigorously and “hold the opioid manufacturers responsible for flooding our state with these highly addictive drugs and misleading the public about their addictive nature.”
Landry called the issue “one of the most challenging and complex problems facing the state” and said it will take a “concerted effort on many fronts” to coordinate the state’s legal fight and attain the “best interest of the people of Louisiana.”
Landry said he will work hard to hold drug companies accountable for their role in what is commonly called the “opioid epidemic” of abuse, misuse and addiction to the painkilling drugs “that have destroyed so many Louisiana families.”
LIKE BIG TOBACCO OR BIG GUNS?
Those in support of the anti-opioid suits compare it to the lawsuits against Big Tobacco, which resulted in annual payments to states presumably to fund smoking prevention and cessation programs.
That argument claims the manufacturers misled the public concerning the health risk of using their product, which resulted in people damaging their health. The argument further contends that many of those who used the product would not have done so had they been aware of the real health risk.
Those opposed to the legal action compare it to municipalities who filed suit against gun manufacturers in the 1990s, seeking payment to cover the cost of gun-related crimes, deaths and injuries. Those actions were unsuccessful for the most part as courts were reluctant to find gunmakers liable for the misuse of what is a completely lawful product when used as intended.
That argument notes that for a pistol to be misused, someone else -- a criminal, a person intent on suicide, a child -- has to take an action that turns the firearm into an instrument of injury and death. The company, they claim, cannot be held responsible for the misuse of the product.
The drug companies extend that example to their FDA-approved, legal and effective products that become personal and societal problems due to the intentional or accidental misuse of the drugs by individuals.
Pharmaceutical companies say they make the pills. Those pills are sold to wholesalers who sell to pharmacies. Doctors prescribe those pills to their patients. If that process is maintained, the drugs do what they are intended to do. If the individual deviates from the prescribed use of the drug -- or if other “bad actors,” such as pill traffickers and “pill pushing” doctors become involved -- that’s when problems occur.
DOWNPLAYED RISKS
There is no allegation that the painkillers do not do what they promise to do. They treat and reduce pain.
There is also no claim that the product is defective or that the warnings -- which often go unread -- are inadequate.
The allegation of wrongdoing is that manufacturers downplayed or even failed to mention the drugs’ potential for addiction in their marketing campaign to doctors.
The manufacturers claim they addressed that issue many years ago. Those involved in the anti-opioid suits disagree.
Individuals who have sued the painkiller giants have usually lost. Courts found individual victims to be mostly responsible for their own addiction issues and those who died often did not use pills as instructed and acquired them illegally.
State and local governments are considered to be a more “sympathetic victim” in a lawsuit because they have incurred costs even though they have done nothing to contribute to the cause of that cost.
In discussing the issue with police jurors prior to filing a suit on their behalf, Earles said no individual local doctors would be named as defendants in the suit.
However, in previous suits that have gone to trial, the drug companies’ strategy has been to shift any blame for misuse to the doctors who prescribed -- and, presumably, over-prescribed -- the painkillers to the individual suing the company.
It is likely that same tactic will be used should the government entities’ suits go to trial, national legal system observers have commented.

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Local lawyers file class action against opioid drug makers, others on behalf of NAS babies in LA.

Feb 28, 2018 | WAFB (LA)

By Sabrina Wilson

The opioid epidemic is not only deadly, but it causes many newborns to enter the world with withdrawal symptoms like tremors, the inability to eat and a shrill, constant cry. And now some prominent local attorneys are going after manufacturers and others in the opioid distribution pipeline.
"The opioid crisis is the single largest industry created health crisis that this country has seen,” said attorney Scott Bickford.
He and others filed a class action lawsuit in St. Tammany Parish on behalf of Tyler M. Roach, on behalf of his minor child, as well as a class of babies statewide with neonatal abstinence syndrome or NAS.
“The plaintiff and class representative is Baby R. His mother became addicted to opioids when she, her husband and her 5-year old child were involved in a severe car accident,” Bickford continued.
The lawyers said the woman became pregnant while still taking the potent prescription drugs.
"She chose to carry the child, who unfortunately was born addicted, like her, to opiates,” Bickford stated.
The lawsuit not only seeks damages for families with babies born with NAS, but also funds for lifelong medical monitoring. The suit names among the long list of defendants, McKesson Corporation, John & Johnson and Allergan.
Pharmacies are targeted, too.
"Pharmacists have, under the law, obligations when dispensing narcotics such as opiates, particularly narcotics such as opiates, and the lawsuit alleges that they have violated their duties under the law because of the sheer volume of the opioids running through the pharmacies in Louisiana and out to patients,” he said.
Last year, the state health department filed its own suit against a long list of companies, alleging that drug manufacturers “undertook an orchestrated campaign to flood Louisiana with highly addictive and dangerous opioids.”
Mollye Demosthenidy is a health policy expert in Tulane’s School of Public Health. She has not taken a position on the lawsuits.
"I think you're seeing states, parishes, counties, local governments, everybody's trying to figure out a way to tackle the epidemic, right? And that means tackling the consequences of addiction as well as addressing the sources of addiction,” Demosthenidy said.
Of course, there are questions about the long-term impact on children born with NAS and the effect on society as a whole.
"There are a host of long-term costs related not just to the treatment but to the social safety net that's required to support children and families and really help communities that have been hit hard by the epidemic,” Demosthenidy added.
"Baby “R” now suffers from developmental disorders,” said Bickford.
The legal team and their medical advisers also said damages will be directed to academic and research institutions, long-term treatment centers and training for doctors and nurses.

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Lawsuit Seeks Money To Cover Treatment Of Babies Born Addicted To Opioids

Feb 28, 2018 | TechTimes

By Allan Adamson

Parents who are opioid addicts contribute to the worsening opioid epidemic by giving birth to babies who were already exposed to the addictive drug while still developing in their mother's womb.Lawsuit May Protect Opiate-Dependent Children
A medical-legal team has decided to change this by filing the first lawsuit in the United States that may potentially protect opiate-dependent children. The suit was filed at a court in Louisiana, which has the highest Medicaid insurance claims in the country.
The lawsuit cited that one of every five mothers served by Medicaid consumed opioid at some point during their pregnancy.K.E.R
The suit was filed against drug makers and distributors, which include Janssen Pharmaceuticals, Purdue Pharma, Johnson & Johnson, and Teva Pharmaceuticals, on behalf of a child identified as K.E.R.
The child was born with Neonatal Abstinence Syndrome, or NAS, which happens when a baby is exposed to addictive drugs in the womb. After birth, babies with NAS go through drug withdrawal when they are removed from exposure to the addictive substance. The condition occurs when a woman takes opioids during pregnancy.
The child's mother was prescribed opioid painkiller to treat lower back pain linked to a car accident she had before her pregnancy. She became addicted to the drug and continued to use it even while pregnant with K.E.R.Lawsuit Seeks Money To Cover Treatment Costs Of Children With NAS
The lawsuit seeks money to cover the long-term treatment of the child and others who were born suffering from opioid withdrawals. K.E.R. is now 3 years old and has went through speech, hearing, and behavioral therapy to manage the effects of opioid exposure in the womb.
The suit did not provide exact number of children in Louisiana who were born with NAS, but the legal team has estimates based on the number of Medicaid enrollees who used opioid during pregnancy.
"It is high time that the medical and legal communities stand up to demand comprehensive treatment and care for the most needy and vulnerable citizens of our great country," said Kanwaljeet J. S. Anand, from Stanford University School of Medicine, who plays a part in the team that filed the lawsuit.Opioid Epidemic In The United States
United States faces a serious opioid epidemic. Figures from the U.S. Centers for Disease Control and Prevention show that that 115 Americans die daily due to opioid overdose.

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County leads charge against opioids

Feb 27, 2018 | The Lafayette Sun (AL)

By Alton Mitchell

Chambers County Attorney Skip McCoy is leading an effort against companies that manufacture medications containing Opioids. An addictive agent found in some prescription medications that have been known to create morphine-like effects and can be highly addictive. These agents have created what some have called an Opioid crisis in the state of Alabama, that has created a strain on jail and law enforcement resources in the state and now Chambers County may be the latest to pursue the companies that manufacture these medications.
“This Opioid Crisis that we have going on throughout the state is very impactful here in Chambers County and has resulted in more incarcerations, more uses of the jail, more uses of law enforcement, and this all stems from we believe an addiction that has been perpetrated on citizens through the use of prescriptions pain pills”, explained Attorney McCoy.
A post-contract was presented to members of the Commission asking for permission for Attorney McCoy and the Beasley-Allen firm to work together and seek to bring an action against Johnson and Johnson and Pharmaco and other pharmaceutical carriers to have a recovery for Chambers County.
Attorney McCoy asked for commission members to approve the contract which will cost the County nothing, but if recovery is made then the County would gain two-thirds of that recovery. Several other local governments across Alabama and the United States have sought similar measures against pharmaceutical carriers
Commissioners unanimously approved the contract to allow Attorney McCoy and the Beasley-Allen law firm to work together to begin the possible recovery efforts for Chambers County.

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Northeast (MA)

Lowell to join opioid lawsuits

Feb 27, 2018 | Lowell Sun (MA)

By Todd Feathers

The city will join a growing number of municipalities, counties, and state governments suing prescription opioid manufacturers and distributors, City Solicitor Christine O'Connor told the City Council on Tuesday.
The suits seek reimbursement for past and future costs of emergency services training, law enforcement actions, Narcan, and worker compensation benefits stemming from the governments' response to the opioid epidemic.
The City Council discussed joining such a lawsuit at its last meeting and appeared to unanimously support the idea. Law Department staff had already been meeting with law firms representing Massachusetts communities in similar lawsuits and decided to join a group represented by a consortium of law firms, including Rodman, Rodman & Sandman.
Richard Sandman, a partner at the firm, will brief the City Council on the suit in the coming weeks.

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Broadcast Media Coverage

Morning Express With Robin Meade

Feb 28, 2018 | National Programming

By CNN

Video Link: http://app.criticalmention.com/app/#clip/view/33093074?token=85db22bf-b20e-422a-8f81-0ea82b306da7
Rough Transcript: a new task force will go after drugmakers and distributors that fuel the opioid epidemic. >> we must reduce the overdose deaths and the amount of prescriptions of opioids in the country today. >> and he said the task force will help with lawsuits already filed by cities and states that claim some drug companies used deceptive marketing to sell opioids. by the way, the u.s. hit a record 64,000 overdose deaths in 2016. most of those are related to opioids. painkillers. sessions said the number for 2017 is expected to come in higher than that.

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FOX and Friends First

Feb 28, 2018 | National Programming

By Fox News

Video Link: http://app.criticalmention.com/app/#clip/view/33093100?token=85db22bf-b20e-422a-8f81-0ea82b306da7
Rough Transcript: Jeff sessions forming a brand-new task force taking aim at drugmakers, manufactures accused of deceptive marketing leading to the opioid crisis. >> resolute policy of this administration and the department of justice to reduce these overdose deaths, reduce addiction and the amount of prescription opioids put in our country. >> the department of justice seeking reimbursement for medical costs which total $4 billion in 2016.

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PCN Early AM

Feb 28, 2018 | National Programming

By PNC (PCN)

Video Link: http://app.criticalmention.com/app/#clip/view/33093092?token=85db22bf-b20e-422a-8f81-0ea82b306da7
Rough Transcript: i wrote a letter to the attorney general back in may of this past year to join with the lawsuits that -- to go after these drug manufacturers. they did not tell us of the addictive nature of those drugs and they should be heavening us with the millions and billions 5:44 AMof dollars that those companies made, they should be helping us get the folks that are addicted the services that they need and i believe they should be reaching into their pockets and i know one company has already stopped advertising or pushing it, they know they're wrong. they wronged us, most of these families that have lost a loved one, rich, poor, black, white, everybody got affected, most of those families because i believe -- today you read on a new drug and all of the things that can go wrong if you took that drug. well, there was nothing in those ads that said it's addictive, be very careful how you use it. in some cases, too, depending on the individual, it could be even more adistridictive -- something to do with the brain cells, the chemistry and all. so i applaud the attorney general because he did finally announce he was going after them and i believe a lot of those dollars can come right from 5:45 AMthose lawsuits. >> i agree 100% with that. i was going to say a couple things about the opioid cris. it was predatory of the industry. i read an article recently and the numbers aren't act but like a town of 45,000 people where they had 1.8 million pills subscribed. i know i had minor back surgery a few years ago and they gave me percocet, i took two and made the mistake of doing a tv interview, but i took two -- >> did you take some this evening? >> i took the rers st of the bottle this evening. but they gave me 60 pills so what happens is the other 58 sit around and if you have kids, that i wind up -- there's a lot of reasons they wind up. i'm proud of states with the medical marijuana protocol, i went to ribbon cuttings, we're having dispensaries and that's going to be growing exponentially. 5:46 AMstates have a 25% lower rate of opioid deaths and that's significant, there's a big article today on how opioids can reduce -- cannabis can reduce opioid addiction. we're on pace this year, 5500 opioid deaths in pennsylvania. 5500 opioid deaths. that's breathtaking. so if we cut that by a thousand, that's something to feel good about. and last year in our nation we lost more people in one year to drug overdoses than we did in the whole vietnam war combined. over 55,000 people. >> and with the fentanyl and things, it's so toxic. >> in the old days they say don't talk about drugs, every opportunity i get i talk to students. i tell them the first time you try this it could be the last time and i explain the elephant tranquilizer. the fentanyl. that stuff can taken a el haven't down. 5:47 AM>> i have a bill that i've just -- i''m drafted and introducing requiring first responders to carry narcan. most of them do, there have been a few -- there's been some pushback and there have been a few people who said well, we've revived this guy three times already so we're done with him, we won't give it to him anymore and that's not -- i think that's morally atrocious but it doesn't aren't what addiction is, addiction is a disease. someone said today at the appropriations committee, it's like diabetes, you give insulin to a diabetic. addiction is a disease, it's not a character flaw and we have to help people. >> this happened where the guy would just before he takes, he calls 911 knowing that if it's -- he'll be okay. he did that in one week three times. could you imagine if that ambulance was need somewhere to save someone's life? i say after the second time he should have been arrested. get him what he needs. force -- >> i'm far. >> he's got to be forced into a program because one of those calls he's going to make that ambulance won't be able to get there to help him. >> i agree with that but i don't think the answer is just saying we gave him his last dose of narcan. you have to save a life. after that anything is possible but you have to save a life.

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Key Capitol Hill Hearings

Feb 28, 2018 | National Programming

By CSPAN

Video Link: http://app.criticalmention.com/app/#clip/view/33093117?token=85db22bf-b20e-422a-8f81-0ea82b306da7
Rough Transcript: attorney general jeff sessions announced the establishment of a task force that would target opioid manufacturers and distributors. the attorney general also said the justice department would make an announcement on so-called bump stocks, which is a gun accessory that enables a rifle to shoot hundreds of rounds a minute. >> today i'm announcing our next steps. first, the department has hired an experienced federal prosecutor to lead our anti-opioid efforts, mary daley. 7:33 PMshe previously served as an assistant u.s. attorney in the eastern district of new york and in the eastern district of virginia where she supervised the narcotics unit and was the opioid coordinator. over her 13 years as a federal prosecutor, mary has focused on the prosecution of transnational drug trafficking organizations. mary will serve as director of our opioid enforcement and prevention efforts. she will help us formulate and implement initiatives, policies, federal grants, and programs related to opioids and coordinate these efforts with law enforcement. second, we are attacking this crisis at its root, the diversion and overprescription of opioid pain killers. today i am announcing the prescription interdiction and litigation unit, p.i.l.l. wsh 7:34 PMago we call it. task force. it focus z on targeting opioid manufacturers and distributors who contributed to epidemic. we will use criminal penalties and civil penalties. we will use whatever laws and tools we have to hold people accountable if they break our laws. the task force will work enclosely with the department of health and human services and will coordinate with law enforcement at all levels. a task force will examine potential legislative and regulatory changes in existing laws. i'm also ordering the task force to examine existing state and local government lawsuits against opioid manufacturers to determine where we can be of assistance. we have worked on this and talked about it before. and in fact we are already getting involved in these case. i am announcing today that the department will file a statement of interest in a lawsuit against a number of op oid manufacturers and distributors for allegedly using false, did he secht oive and unfair marketing of opioid drugs. the federal government has borne substantial cost as a result of this crisis. a medicare prescription drug program, for example, paid out more than $4 billion for opioids in 2016 alone. the hard working taxpayers of this country deserve to be compensated by any whose illegal activity contributed to the costs. we will go to court to ensure the american people receive the compensation they deserve. the day after the tragedy the president made a commitment to take action, not just talk, to do some things. he pointed out that we need results.

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