THE OPIOID CRISIS AND URBAN AMERICA: “NOW FIRMLY A PART OF BIG CITY LIFE”

“THE OPIOID CRISIS IS NOW PART OF URBAN AMERICA AND BIG CITY LIFE”

Mark A. York (July 12, 2018)

Trash left by drug users under bridge in Philadelphia.  (Washington Post image)

 

 

 

 

 

 

 

 

 

 

 

(MASS TORT NEXUS MEDIA) According to sources at all levels from police and fire first responders to emergency room physicians across the country and analysts at the CDC, there’s been no slowdown in opiate based medical emergencies in the US over the last 2 years. Emergency response and ER visits for opioid overdoses went way up, with a 30 percent increase in the single year period of June of 2016 to June of 2017, according to the Centers for Disease Control and Prevention.  This is now much more common in big city and urban areas of the country that it was just four years ago.

Center for Disease Control’s Acting Director Dr. Anne Schuchat said overall the most dramatic increases were in the Midwest, where emergency visits went up 70 percent in all ages over 25. The affected populations and demographics are comparative to prior medical crisis deaths during historical healthcare pandemics when a disase struck across entire populations, while sparing no particular class of society.

See OPIOID-CRISIS-BRIEFCASE-INCLUDING-MDL-2804-OPIATE-PRESCRIPTION-LITIGATION

WHY THE HUGE INCREASE IN THE MIDWEST?

ER visits for opioid-related emergencies more than doubled in two states. Wisconsin saw the biggest increase, 109 percent and Delaware saw a 105 percent increase. In Pennsylvania, ER visits were up 81 percent.

“We’re seeing the highest ever death rates in the US,” Schuchat said. She pointed to national statistics that out of 63,000 overdose deaths in 2016, 42,000 of them involved opioids.

https://www.drugabuse.gov/related-topics/trends-statistics/overdose-death-rates

“[This] means 115 people die each day from opioid overdose,” she said. This number has been at or above 100 for most of the last 3 years, with no end in sight and with so many different regions affected it may require more grassroots focus and demands made to elected officials to move faster on a long term solution.

There were some decreases reported in the East, with the largest being a 15 percent reduction in Kentucky, which could reflect fluctuation in drug supplies or interventions.

However, hospital visits in cities of all types increased steadily in each quarter by 51 percent. Schuchat emphasized, “Bottom line — no area of the US is exempt from this epidemic.” Looking closer at causation and access to opiates across the country is required. How are unlimited numbers of federally controlled substances still so readily accessible to so many?

US Surgeon General James Adams was also present during the briefing and mentioned how he witnessed first-hand his own young brother’s struggle with opioid addiction.

“Science is clear: Addiction is a chronic disease and not a moral failing,” the doctor said. Adams outlined that a coordinated effort is necessary to prevent opioid addiction. “To successfully combat this epidemic, everyone must play a role,” he noted.

The Surgeon General explained how health departments, along with public safety and law enforcement officials, have to work together to deal with local opioid-related emergencies.

He stressed the need to make naloxone, a life-saving drug that can reverse the effects of an overdose, more accessible in emergency situations.

URBAN AMERICA AND OPIODS

 

 

 

 

 

 

 

The CDC data shows trends in opioid overdose emergency room

In late 2016 through current medical data from the CDC and hospitals across the country, the opioid epidemic is fast becoming a big city problem.

There was a 54 percent increase in overdoses from July 2016 through September 2017 in the major metro areas of 16 states surveyed by the federal Centers for Disease Control and Prevention — a chunk of the country that includes Chicago, Philadelphia, Milwaukee, Cleveland and Columbus, Ohio.

Nationwide, the scourge that President Donald Trump has vowed to defeat shows no sign of abating, with a 30 percent increase in opioid overdoses reported during that same period, the data released Tuesday shows.

Drug Overdose Death Rates in the U.S. Are Rising Everywhere, CDC Says

Anne Schuchat, the CDC’s acting director, said the grim new arithmetic, which came from emergency room statistics, confirmed some suspicions. “We’re currently seeing the highest drug overdose death rates ever recorded in the United States,” Schuchat said in a Q&A session with reporters. Asked specifically about the rise in urban opioid overdoses, Schuchat said health officials suspect a “change in the toxicity” of drugs on the street.

Major US Cities Filing Suit Against Opioid Big Pharma-New York, Seattle, Chicago Join MDL 2804

Urban heroin dealers have been boosting profits by cutting their drugs with fentanyl, which is 25 to 50 times more powerful. That combination was why Columbus was averaging one fatal overdose per day in the first half of last year.

“The issue of cutting heroin with fentanyl is a very major problem right now,” Schuchat said. “What you are seeing in Columbus is for sure occurring in other

Daniel Raymond, deputy director of the Harm Reduction Coalition, said that initially the opioid overdose rates “were primarily driven by prescription painkillers — they weren’t concentrated in urban areas.”

“But the recent rises are mostly driven by heroin, and particularly fentanyl, and the latter seems particularly prevalent in urban drug markets,” said Raymond, whose organization is based in New York City. “That’s certainly true in places like Ohio and Philadelphia, which are seeing a lot of fentanyl-involved overdose deaths. That doesn’t mean the problems have waned in smaller cities and rural areas, which are also seeing fentanyl, but we are seeing increasing vulnerability in major urban centers.”

The only bright spot — and it’s a dim one at that — was that the CDC found decreases in opioid overdoses in states like West Virginia, New Hampshire and Kentucky that have been leading the nation in the category.

“We hope this is a positive sign,” said Schuchat, who credited leadership, particularly in West Virginia, with taking bold steps to combat the crisis. “But we have to be cautious in the areas that have reported decreases.” Dr. Rahul Gupta, Director of Public Health for West Virginia has been at the forefront of addressing the opioid crisis in not only West Virginia but across the country. Dr. Gupta will be the keynote speaker at the Mass Tort Nexus National “Opioid Crisis Summit, July 20-22, 2018 in Fort Lauderdale, FL where he will be joining other prominent national healthcare and legal speakers on providing solutions to the opioid crisis, see www.opioidcrisissummit.com for attendance information.

“Sometimes places that have had such high rates have no place to go” but down, she added, with West Virginia being one of the states to address the issues pro-actively in all  areas.

The new CDC “Vital Signs” report was released a week after Attorney General Jeff Sessions issued a “statement of interest” in support of local governments that are suing the big pharmaceutical makers and distributors, accusing them of swamping many states with prescription painkillers and turning millions of Americans into junkies.

The new CDC numbers come from analysis of emergency room data from 16 states, including some hardest hit by the plague — Delaware, Illinois, Indiana, Kentucky, Massachusetts, Maine, Missouri, Nevada, New Hampshire, New Mexico, North Carolina, Ohio, Pennsylvania, Rhode Island, West Virginia and Wisconsin.

The CDC Research Shows:

  • Emergency rooms in half of the states surveyed reported “substantial” increases in opioid overdoses, with mammoth jumps in Wisconsin (109 percent), Delaware (105 percent), Illinois (66 percent), Indiana (35 percent), Maine (34 percent) and North Carolina (31 percent).
  • The Midwest, in particular, saw a 70 percent increase in opioid overdoses.
  • The only state with a “statistically significant decrease” was Kentucky (15 percent). “The decrease in Kentucky may reflect some fluctuations in drug supply,” Schuchat said.
  • “Nonsignificant” decreases of 10 percent or less were reported in Massachusetts, New Hampshire, Rhode Island and West Virginia.
  • The highest rate of increases were in large metro areas, which the CDC defines as a population of 1 million or more “and covering a major city.”
  • Every demographic group saw a substantial increase in overdose rates, including men (30 percent), women (24 percent), people ages 25 to 34 (31 percent), 35 to 54 (36 percent), and 55 or older (32 percent).

Is Fentanyl The New Crack Cocaine?

https://www.drugabuse.gov/publications/drugfacts/fentanyl

The Centers for Disease Control and Prevention issued a Health Alert Network warning about the increased supply of the illicit drugs, which are many times stronger than fentanyl, the prescription painkiller.

“The dramatic rise in the supply of illicitly manufactured fentanyl and fentanyl analogs has been mirrored by an equally dramatic rise in deaths involving synthetic opioids other than methadone, a category which includes fentanyl and fentanyl analogs,” the CDC said in its alert.

Death rates doubled between 2015 and 2016, the CDC said. “More than 55 percent of opioid overdose deaths occurring nationally in the 12 months ending November 2017 involved synthetic opioids, accounting for more than 27,000 overdose deaths,” the CDC said in the health alert, citing preliminary numbers.

That’s up from 20,000 overdose deaths from synthetic opioids in 2016.

Other illicit synthetic opioids include furanylfentanyl and acrylfentanyl. “Finally, drug submissions testing positive for a synthetic illicit opioid known as U-47700, first encountered by the DEA in 2016, increased from 533 submissions in 2016 to 1,087 during January–June, 2017,” the CDC said in the alert, referring to the Drug Enforcement Administration.

What Is Fentanyl?

Fact Sheet: Fentanyl-Laced Heroin and Cocaine (fentanyl-analogues)

  • Fentanyl, a schedule II prescription narcotic analgesic, is roughly 50-80 times more potent than morphine. This medication is used to manage both pain during surgery and chronic moderate to severe pain for persons who already are physically tolerant to opiates. • However, fentanyl also can be produced in clandestine laboratories in powder form and mixed with or substituted for heroin.

“Ohio alone reported more than 1,700 opioid overdose deaths testing positive for fentanyl analogs during July 2016–June 2017, with more than 1,100 of those deaths involving carfentanil.”

Emergency responders and physicians may not know that people overdosing on the synthetics may need extra care, the CDC said.

Fentanyl and Fentanyl Analogs Defined

For updated information on the opioid crisis and MDL 2804 (Opiate Prescription Litigation USDC Northern District of Ohio, Judge Daniel Polster) subscribe to www.masstortnexus.com/news

 

 

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Opiate Rx Big Pharma And “Profits Before Patients” Have Taken A Toll On American Children – Now A Part Of Daily Life In The USA

Opioid Industry Model of “Profits Before Patients” and The Impact on American Children

By Mark A. York (July 5, 2018)

 

 

 

 

 

 

 

 

 

 

(MASS TORT NEXUS MEDIA) In West Virginia, home of the highest overdose rates in the nation, the foster population has increased by 42 percent since 2014. 

The number of children in state or foster care hit a record low in Massachusetts earlier this decade. Since then, that number has risen by a quarter, and there are now more children in state care than ever before.

In Ohio, the number of children in state custody has grown by 28 percent since 2015. Foster populations are up more than 30 percent in Alabama, Alaska, California, Idaho, Indiana, Minnesota and New Hampshire since 2014. states like Illinois, Oklahoma, Massachusetts, Pennsylvania, Colorado and New Jersey now adopting new approaches to help keep parents and children together, even as parents are receiving treatment for their addictions.

“We are now seeing major opioid related social issues in areas not previously seen, including white suburban communities, urban areas, rural areas, crossing gender lines, racial lines, economic disparity, this flew under the mainstream radar for 15 years”

>States, Counties, Cities and others are now suing opioid drug makers and distributor in both state and federal courts, see Mass Tort Nexus Briefcase “Opioid Litigation Versus Opiate Prescription Industry MDL 2804, US District Court of Ohio”

The opioid epidemic plaguing the nation is taking a catastrophic toll on our most  vulnerable group, the children of the opiate addicts and those with substance use disorders. Many children are sent to live with grandparents or other family members, often due to a parent overdose or other addiction displays other problems but tragically, a growing number are being placed in the foster-care system, with many states unable to keep up with the demand from both a budget as well as staffing is struggling to keep up with demand.

From 2013 to 2015, the number of children in foster care nationwide jumped almost 7 percent to nearly 429,000, according to the U.S. Department of Health and Human Services’ Administration on Children and Families, the 2016 to 2018 numbers have moved that number closer to 550,000. Parental substance use was cited as a factor in about 32 percent of all foster placements. From 2000 to 2015, more than half a million people died of an overdose, and currently 91 people a day die from opiate overdoses.

Unfortunately, many children, the indirect victims of the crisis, are not getting the care and services they need. “This is a neglected subpopulation,” says John Kelly, PhD, associate professor of psychiatry in addiction medicine at Harvard Medical School, and the founder and director of the at Massachusetts General Hospital. “Because we’re trying to put out the fire in terms of stopping overdose deaths, we haven’t really been attending to other casualties, including kids most importantly.”

To lessen the long-term effects on children, psychologists are treating children in the foster-care system in outpatient, inpatient and residential treatment programs and in school-based mental health programs.

“Treating Women Who Are Pregnant and Parenting for Opioid Use Disorder and the Concurrent Care of Their Infants and Children: Literature Review to Support National Guidance.  https://www.ncbi.nlm.nih.gov/pubmed/28406856

[STUDY OBJECTIVES: The prevalence of opioid use disorder (OUD) during pregnancy is increasing. Practical recommendations will help providers treat pregnant women with OUD and reduce potentially negative health consequences for mother, fetus, and child. This article summarizes the literature review conducted using the RAND/University of California, Los Angeles Appropriateness Method project completed by the US Department of Health and Human Services Substance Abuse and Mental Health Services Administration to obtain current evidence on treatment approaches for pregnant and parenting women with OUD and their infants and children]

Everett Washington Schools and Opioids

The front office at an elementary school was never intended as an intake center for drug-counseling and social-services referral hub.  For 31 year old Tiffany Smith and others in Everett, it has become just that for the last two years, as she attempts to end her heroin addiction while raising three children.

Smith often chats with the office staff and updates Principal Celia O’Connor-Weaver on her progress in treatment. The first time she ventured inside, Smith carried paperwork from Child Protective Services, and needed to tell the principal that her children, who taken into foster care months before might still get visits from state social workers, even now that the kids were returned home.

Explaining all of this to the principal meant describing what led to the boys’ removal, which meant confessing that she had been addicted to opiates, at times living in her car, the kids staying at her grandmother’s house, until her grandmother finally called state authorities.

“I was afraid of the judgment, that my kids would be affected at school , but it wasn’t that way at all. They said they have a lot of parents that have gone through opiate addictions and what can we do to help? It was not what I was expecting.”

In her six years as principal at the elementary school in Everett, an epicenter of the opioid crisis in Washington, 525 Snohomish County kids were removed from addicted parents just in 2017, in Seattle’s King County, more than 1,000 children were removed.

This problem is now prevalent across the United States where schools, social service agencies and public-health workers scramble to stem adult addictions, less visible have been the reverberations downstream, the children of opioid addicts. Educators and child-welfare workers have reported increased learning problems and behavioral outbursts from the kids of addicted parents. Research suggests dire life-outcomes for these students. Yet the potential for school-based interventions has been underutilized — even as public-health investigators say schools offer the most efficient hope for stemming a looming social crisis.

During the most mundane moments, like recess, teachers watch and 8-year-olds pretend to revive overdosed patients, or hearing how a parent confesses that they’ve relapsed.

The focus of schools should be learning and teaching kids, but often many kids’ minds are not focused on that, they’re worried about their parents, about their next meal and who’s going to be home to take care of them. When a parent becomes addicted or goes into rehab, it changes everything for a family.

Drug users’ children flooding to foster care

In Tiffany Smith’s case, three years of methadone treatment have helped her regain solid enough footing to secure housing and begin working toward a GED, in hopes of becoming a drug and alcohol counselor. But her children are still reeling. Smith’s 6-year-old cannot stand to be apart from his mother and struggles with speech, cognitive and learning delays.

“He was talking fine before foster care,” Smith said. “But when he came out, he couldn’t pronounce some words. They said it was due to the trauma.”

Her older son, now 7, was born prematurely and spent his first two days of life trembling from heroin withdrawal as his mother watched, devastated. “Seeing my baby shake from detoxing really hurt — I knew it was my fault,” she said.

In Washington state, this number is alarming, but not widely known, 10,000 high-school seniors said they’d used heroin or gotten high on opioid-derived painkillers in 2016, those numbers were about the same as two years prior, but foster care placements have surged.

Between 2011 and 2017, the state took children from drug-abusing parents nearly 14,000 times. Last year’s rate was the highest for drug-related causes since 2010 — up 16 percent over 2015 — while state hospitals report a steady increase in substance-exposed newborns.

Child-welfare workers hear complaints about increasingly severe problems in school — more physical violence toward peers, or kids who need to be taught separately — from students whose parents are staggering through addiction, said Jenna Kiser, who oversees intake at the state Children’s Administration.

Jenny Heddin, a state agency supervisor stated, “These numbers are very concerning, when children from these homes come into foster care, they can be very difficult to serve.”

This represent one corner of a national wave. More than 37 states report unprecedented numbers of kids entering foster care, many of them for reasons related to a parent’s substance abuse, according to the federal Department of Education.

Damaging children’s futures

By the time Child Protective Services is knocking on someone’s door, the problem is already severe. And so far, efforts to respond might best be described as triage — focused more on addiction treatment than prevention, both in Washington and across the country.

As in many other states political infighting prevents treatment, earlier this year, Washington Gov. Jay Inslee proposed spending $20 million on a multipronged effort to combat opioid addiction. The bill never made it to the floor for a full vote, and it contained little funding for prevention. (But $1.7 million targeted for youth did get funding.)

Yet researchers warn that ignoring that aspect of the crisis virtually guarantees costly problems to come as the children of addicts grow into adulthood. Kevin Haggerty, a professor at the University of Washington who studies risk factors for drug abuse, authored one of the few peer-reviewed studies tracking life outcomes for these young people.

In the early 1990s, he identified 151 elementary and middle-school children in Washington who were growing up with heroin-addicted parents. Fifteen years later, as young adults, 33 percent had dropped out of high school. The vast majority were addicts themselves, and half had criminal records. Only 2 percent had made it through college. (Nationally, 33 percent of all kindergartners in 1992 grew up to earn a college degree.)

“The results are astounding at how poor the outcomes are, having a drug-addicted parent,” said Caleb Banta-Green, principal research scientist at the Alcohol and Drug Abuse Institute at the University of Washington’s School of Public Health.

“We need to be doing a lot more for kids being parented by opiate-addicted parents — and we’re not.”

“Families literally bring their problems to our door now to help them navigate their lives,” Harrington-Bacote said. “Public schools are doing things that fall way outside of regular academic education. But if they don’t, it’s not going to get addressed at all.”

OHIO EXAMPLES OF HOW BIG PHARMA OPIOID Rx MONEY DESTROYS LIVES

Way before social workers showed up in his living room this March, Matt McLaughlin, a 16-year-old with diabetes, had taken to a routine not of his doing, trying to scrounge up enough change for food while his mom, Kelly, went out to use heroin. On a good night, the high school junior would walk his neighborhood in Andover, Ohio to pick up frozen pizza from the dollar store, and on bad nights, he’d play video games to keep his mind off his hunger and unknown blood sugar levels.

When Matt was little, his mom Kelly was a Head Start caseworker who taught parents how to manage their autistic children, who hosted potlucks and played Barbie with Matt’s sister, Brianna. “Growing up, we were the house that everyone wanted to come to,” remembered Brianna, now 20. “I loved every minute of it.”

Kelly had neck surgery and got addicted to OxyContin, and by 2015, she was spending her days napping, disappearing for hours at a time, or going to her neighbor’s house, where she would exchange cash for packets of heroin. She started yelling at the kids, food became scarce, life changed for the worse, “It’s like her personality did a 180,” Brianna said. “I felt like I lost my mom to this pit that I couldn’t pull her out of.”

Ashtabula County Children Services a tip when someone called the police and urged them to check on the family.

She’d been to detox several times over the years, trying to rid herself of what felt like a demon that had taken over her brain. Last year, she managed to stay clean for 63 days, until a friend came over “and laid out a line—and that was all it took.” There are five heroin dealers within a five-mile radius and all more than willing to provide an addict the opiate of choice, which is the norm for rural Ohio anymore.

He kids were once again forced to pack their bags as Kelly would go to detox another time, they were lucky to have relatives nearby: The spiraling opioid epidemic has disrupted so many families that all the foster homes in Ashtabula County are full, this story is repeated across the country every day.

The scourge of addiction to painkillers, heroin, and fentanyl sweeping the country has produced a flood of bewildered children who, having lost their parents to drug use or overdose, are now living with foster families or relatives. In Ashtabula County, in Ohio’s northeast corner, the number of children in court custody quadrupled from 69 in 2014 to 279 last year. “I can’t remember the last time I removed a kid and it didn’t have to do with drugs,” says a child services supervisor.  Her clients range from preschoolers who know to call 911 when a parent overdoses to steely teenagers who cook and clean while Mom and Dad spend all day in the bathroom. Often, the kids marvel at how quickly everything changed—how a loving mom could transform, as one teenager put it, into a “zombie.”

The pattern mirrors a national trend: Largely because of the opioid epidemic, there were 30,000 more children in foster care in 2015 than there were in 2012—an 8 percent increase. In 14 states, from New Hampshire to North Dakota, the number of foster kids rose by more than a quarter between 2011 and 2015, according to data amassed by the Annie E. Casey Foundation. In Texas, Florida, Oregon, and elsewhere, kids have been forced to sleep in state buildings because there were no foster homes available, says advocacy group Children’s Rights. Federal child welfare money has been dwindling for years, leaving state and local funding to fill in the gaps. But Ashtabula County is one of the poorest counties in Ohio, and despite a recent boost in funding, the state contributes the lowest share toward children’s services of any state in the country. 

More Broken Families, Less Funding

Ohio also has one of the nation’s highest overdose rates. In 2016, at least 4,149 Ohioans died of drug overdose—a 36 percent jump from the year before, according to the Columbus Dispatch. In 2015, 1 in 9 US heroin deaths occurred in Ohio.

It’s hard to overstate just how pervasive the epidemic feels here. Detective Taylor Cleveland, who investigates drug cases in Ashtabula, told me, “I’m dealing with ruined homes two and three times a day.” Cleveland, who coaches youth soccer and recently adopted a 17-year-old player whose mom overdosed, leads a task force that responds to every overdose in the county. Once, he arrived at an overdose scene only to realize that the victim slouched over in the motel room was his cousin, whose young daughter had called 911. “Every OD that happens, I get a text. I’ve gotten two texts while we’ve been talking.” We’d been talking for less than an hour.

Given the scale of the crisis, it’s not hard to understand why, when Donald Trump promised Ohioans on the campaign trail to “spend the money” to confront the opioid crisis and build a wall so drugs would stop flowing in, locals in this historically blue county took notice. In late October, Trump became the first presidential candidate since John F. Kennedy to visit Ashtabula County. He promised to bring back jobs, to open the long-shuttered steel plants, to build the wall. Twelve days later, Ashtabula residents voted for a Republican president for the first time since Ronald Reagan in 1984.

WHITE HOUSE PROMISED ON OPIOIDS BUT DIDN’T DELIVER

But since he took office, Trump’s plans to tackle the epidemic head-on have fizzled. Republicans’ recent effort to repeal and replace Obamacare would slash funding for Medicaid, which is the country’s largest payer for addiction services—and which covers nearly half of Ohio’s prescriptions for the opioid addiction medication buprenorphine. The bill would enable insurers in some states to get out of the Obamacare requirement to cover substance abuse treatment. A memo leaked in May revealed Trump’s plans to effectively eliminate the White House’s drug policy office, cutting its budget by 95 percent. (The administration has since backpedaled on the plans, following bipartisan criticism.) Trump’s 2018 budget proposes substantial cuts to the Administration for Children and Families, the Substance Abuse and Mental Health Services Administration, and the Temporary Assistance for Needy Families program.

“I think some people felt as though nothing else is working,” said one Ashtabula resident when I asked why so many in a Medicaid-dependent area would vote for Trump. Now, she says, “I’m really, really scared. You don’t get it until you live in a small town and you see people die every day.”

Like so many other Midwest Rust Belt counties, Ashtabula, Ohio has seen better days. Locals proudly tell me that the Port of Ashtabula used to be one of the biggest in the world, where barges unloaded iron mined from Minnesota’s Mesabi Range onto trains headed for the steel mills of the Ohio River Valley. Today, once-bustling streets have given way to vacant storefronts and fast-food chains; the surrounding countryside is made up of farm fields, trailer parks, and junkyards. One in three kids now live below the federal poverty line, less than half of adults have a high school education. The financial downturn accelerated in the ’90s, when manufacturing jobs started disappearing.

Then Opiate Big Pharma and their marketing campaigns introduced newer “less addictive” painkillers like OxyContin and others like Vicodin were liberally prescribed in communities wrestling with dwindling economic opportunity and rife with workplace injuries common to mines, lumberyards, and factories. As authorities started to tighten the rules on prescribing drugs like OxyContin, the use of heroin, which is chemically nearly identical to opioid painkillers, crept up. But the tipping point, for Ohio and the country, came over the past couple of years, when illicit fentanyl, an opioid up to 100 times more powerful than morphine, started making its way into the heroin supply. Since then, says Dr. Thomas Gilson, the medical examiner for nearby Cuyahoga County, the deaths have been coming “like a tidal wave.”

About five years ago, Ohio noticed a major uptick in the number of parents using heroin. More recently, elected officials have learned more about the parasitic way that opioids co-opt the brain and the complex pull of addictions attitudes have softened, with most realizing, there is no good guy or bad guy, once addiction takes hold. The long term problems are often multiplied many times over by lack of short term treatment.

Gov. John Kasich, a notorious budget hawk, made national news when he pushed Medicaid expansion through Ohio’s conservative Legislature. “When you die and get to the meeting with St. Peter,” he told one lawmaker, “he’s probably not going to ask you much about what you did about keeping government small. But he is going to ask you what you did for the poor.” He made news yet again last week, when he signed a 2018 budget that will, for the first time in years, increase the state’s funding for children’s services. Yet the $30 million boost in funding over two years, which will pay foster parents and provide counseling for the kids, won’t make up for the $55 million increase in child placement costs over the past three years. Other than county pilot programs, “No policy or state investment has focused specifically on the children flooding into county agency custody as a result of the opioid epidemic,” concluded a report by the Public Children Services Association of Ohio this spring.

Meanwhile, federal funding for children’s services decreased by 16 percent between 2004 and 2014. That’s due in part to an arcane law stipulating that the largest pot of federal money for children’s services applies only to kids from below a certain income threshold. In many states, that threshold is about half the poverty level—in Ohio, it’s roughly $14,000 per year for a family of four. But the opioid epidemic has afflicted families of all stripes. “A few years ago, I was constantly just in homes that were clearly in poverty,” says Mongenel. Now she’s struck by her new clients’ well-kept houses: “You pull up to it and it’s like, ‘Really?’”

The director of one Ohio county stated “that more caseworkers are quitting than ever before, unable to reconcile the overwhelming caseload with the paltry salary, which starts at $28,500..’”

Another addiction case is Amber, a 16-year-old whose mother, Emily, was in and out of rehab for a year, while Emily cycled in and out of rehab. In December, officials got the phone call that Emily had been found dead, slumped over in a motel bed, and a social services worker had to break the news to Amber that they had run out of chances, her mother had died.  Today, Amber lives in a what is her new home, a bustling house with nine other foster kids.

Then there is Jake, another 6-year-old with boy-band looks who lived for months in a motel over the 2017 winter with his two younger siblings, taking courses online and playing video games, while his mom went out to use. “He just wanted her to go into rehab and get right,” he told a reporter earlier this year, “If that could be my birthday present or my Christmas present, that’s what it would be.”

Lisa is a 10-year-old, introduced to Ohio social services for the first time in a conference room at her elementary school, the agency rep told her “We’re from children’s services have you ever heard of that before?” Lisa nodded and replied “they’re the people who go to her friend’s house once a month to make sure everything is okay,” in a matter of fact way.

Lisa was asked, “Do you have enough to eat?” and “Do you like where you’re staying?” and Do you know what drug use is?”  but it wasn’t mentioned that CPS had just visited Lisa’s house and found her father strung out on heroin in the bedroom they share. Lisa’s bed was a pink sleeping bag on a piece of foam surrounded by pill bottles.

Children in Lisa’s situation are subject to incredible psychological stress. There’s the immediate trauma of living with an unstable parent or being taken from family and sometimes from school and friends. But there’s also the long-term impact. Dozens of studies have found that kids who undergo traumatic events early in life are more likely to suffer mental and physical repercussions later on, be it substance abuse, depression, heart disease, or cancer. Among the 10 so-called Adverse Childhood Experiences, or ACEs, are emotional abuse, physical abuse, separation from parents, and parental substance abuse.

“Every time a child gets into a scary or dangerous situation, it activates their stress response,” explains Dr. Nadine Burke Harris, a pediatrician and founder of the Center for Youth Wellness, which focuses on the developmental effects of childhood trauma. “The repeated activation of their stress response is what leads to the biological condition that we in pediatrics are now calling toxic stress.” Looking at the brains of kids of drug users, Burke Harris says, one would expect to see the signs associated with other types of trauma: an enlarged amygdala, the brain’s fear center; decreased functioning of the nucleus accumbens, the brain’s pleasure and rewards center; and less activity in the prefrontal cortex, which oversees a child’s ability to control impulses and pay attention.

CPS and affiliated social services agencies across the United States are now becoming much more familiar with the latest addiction research on ACEs and impacts on young children. They know that a child with four or more ACEs is twice as likely as other kids to develop cancer and ten times more likely to inject drugs themselves. When they encounter someone like Lisa, they are torn between mitigating one ACE, exposure to parental substance abuse, and catalyzing another: separating a child from her parents. Which is what makes these conversations so heart-wrenching.

For county and state professionals, one of the most difficult things about managing opioid cases is how unpredictable they can be, never knowing how a client’s drug-addicted parent will do after detox. Some thrive and are quickly reunited with their families. Others can’t pull themselves out of the black hole of addiction.

One positive outcome amid the many negatives, is the mother of Matt, the diabetic teenager, Kelly had sailed through detox and been sober for nearly a month, her daughter Brianna had moved back in to help her mom. In the fall Brianna is leaving for college—training to be a social worker, Kelly joked “I’m going to be her first case,” and added “When I was using, I would sleep half the day away” and wake up feeling sick from heroin cravings, she said. “Now I’ve been setting my alarm. I wake up early, enjoy my coffee, open the blinds, and let in the sunshine.” On her walks to town, she said, she crossed the street and looked straight ahead to avoid catching a glimpse of her dealer’s house, an ever-present temptation.  Brianna and Matt often visit Kelly at an addiction treatment center.

Every 19 minutes, an opioid addicted baby is born in America., while many of us are well aware of the repercussions of addiction in adults, but very little is understood about the impact it has on infants. After months of being fed opioids through the mother, these babies suffer through excruciating pain.

Imagine, then, how it feels for a baby. Infants who have been exposed to opioid painkillers like morphine, codeine, oxycodone, methadone treatment or street drugs such as heroin while in utero are literally cut off from the drugs when they are born. Within their first 72 hours of life, about half of the babies who have been exposed begin having withdrawal symptoms.

The medical term for this is neonatal abstinence syndrome, or NAS, and rates of babies born with it are rising along with the exponential increase of painkiller use and abuse.

A recent analysis by the Centers for Disease Control estimated that nearly six out of every 1,000 infants born in the U.S. are now diagnosed with NAS. However, experts say that rate is likely higher, as not all states regularly collect such data.

In the USA, Opioid use by women in rural areas is driving the increasing numbers. Tennessee is part of a cluster of states, including Alabama and Kentucky, experiencing some of the highest rates of NAS births. In East Tennessee the problem is particularly acute: Sullivan County alone reported a rate of 50.5 cases of NAS per 1,000 births, the highest rate in the state for five years running.

Tennessee is currently the only state in the country that equates substance abuse while pregnant with aggravated assault, punishable by a 15-year prison sentence. Eighteen other states consider it to be child abuse, and three say its grounds for civil commitment. Four states require drug testing of mothers and 18 require that healthcare professionals report when drug abuse is suspected. There are also 19 states that have created funding for targeted drug treatment programs for pregnant women.

Opponents of the punishment philosophy claim that punishing addicted pregnant women will not stop them from abusing drugs – instead it will stop them from seeking prenatal care. Many also claim that these policies would unfairly punish mothers for drug use compared to fathers. Organizations, such as the American Civil Liberties Union (ACLU) and the American Congress of Obstetricians and Gynecologists (ACOG), have encouraged a treatment over punishment approach for pregnant mothers with drug addictions.

Opioid use by women in rural areas is driving the increasing numbers. Tennessee is part of a cluster of states, including Alabama and Kentucky, experiencing some of the highest rates of NAS births. In East Tennessee the problem is particularly acute: Sullivan County alone reported a rate of 50.5 cases of NAS per 1,000 births, the highest rate in the state for five years running.

In Canada, in the past decade, the number of babies exposed to opioids in the womb has increased 16-fold in Ontario. And according to Ontario’s Provincial Council for Maternal and Child Health (PCMCH), more than 950 infants were born to opioid-addicted mothers last year. Just over half of them will live the toughest days of their lives in their first week outside the womb.

Until the governments at the federal, state and local levels can all agree on a long term viable solution to the opioid crisis and the impact on school age children, infants born addicted and society as a whole, the opiate drug crisis will linger for generations long into the future.

 

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INDIVIDUAL CLAIMS = INFANT “NAS”, RICO, WRONGFUL DEATH, NEGLIGENCE AND MORE…

Individual Opioid Injury Claim Types

 

A MASS TORT NEXUS OVERVIEW:

by John Ray

A great deal of media attention has focused on lawsuits filed by States, Counties and Cities against the manufacturers of opioids, yet less attention has been given to viable individual opioid patient claims against these same companies. This article is the second in a series published by Mass Tort Nexus to have you gain a better understanding of the vast number of opioid claims, which may be filed on behalf of individual victims of the opioid crisis. Please also read the first article in the series (link to the first article).

This article is intended to cover the major categories or types of potential opioid individual claims based on injury or adverse event type.

  1. Overdose resulting in death

  2. Overdose without death

  3. Opioid Addiction

  4. Neonatal Abstinence Syndrome

  5. Birth Defects

  6. Heart attack

Attend the July 20-22, 2018 Mass Tort Nexus Opioid Crisis Summit to learn more about what your firm can do to help individual victims of the opioid epidemic.

In addition to providing information related to the types of claims that may be brought against the opioid defendants on behalf of individual plaintiffs, you will also receive information related to marketing to obtain these clients, as well as vital information related to the complex issues related to qualifying clients for each category of opioid injury.

To register for the Opioid Summit contact Jenny Levine at 954-530-9892 or email at jenny@masstortnexus.com. You may also register online at  https://www.opioidcrisissummit.com

Opioid Litigation Individual Claims

Given the publicity surrounding the opioid crisis gripping our nation, most of the country is aware that opioid addiction and overdose risk is far greater than the opioid litigation defendants, their Key Opinion Leaders and Front Groups led us to believe.

The researchers at Mass Tort Nexus estimate that there are approximately 250,000 individuals and families with viable claims against the opioid litigation defendants; however, yet few firms have engaged in an effort to retain these clients and provide the legal representation they desperately need and deserve. This fact is somewhat astounding given that many of these potential plaintiffs have been represented by your personal injury firm in the past.

Overdose Resulting in Death

  When an individual, often a juvenile, dies from an opioid overdose, family members are left behind to suffer the pain and costs.

Significant evidence exists to demonstrate that the opioid manufacturers negligently and wantonly deceived doctors and the public about the risks associated with opioids. They continued to do so, even after it was apparent that their deceptions were resulting in loss of life and other severe injuries caused by their products.

The potential number of wrongful death claims which could be brought against the opioid defendants, could exceed the total number of wrongful death claims brought for any other reason over the next decade.

 Overdose Deaths Soared as Big Pharma Reaped the Profits

According to the National Institute for Drug Abuse revised report from March 2018, despite the efforts to stem the opioid crisis, 115 people in the United States die from an Opioid overdose every day.

Overdose deaths, once rare, are now the leading cause of accidental death in the U.S., surpassing peak annual deaths caused by motor vehicle accidents, guns and HIV infection.

More Americans died from drug overdoses in 2016 than the number of American lives lost in the entirety of the Vietnam War, which totaled 58,200.

 

 

 

 

 

 

 

 

 

 

Prescription opioid deaths account for the majority of the increase in overdose deaths since 1999. It is no coincidence that the astounding increase in drug over dose statics beginning in 1999 coincides with the opioid manufactures campaign (beginning in the late 1990s) to convince doctors, based on false information, that past concerns related to opioids were unwarranted.

The opioid manufacturers are accused of using big tobacco style techniques to increase the consumption (and their profits) from increased sales of opioids. The manufacturers are accused of taking a page from the big tobacco play book, using front groups and key opinion leaders in the health field to promote the narrative that the risk associated with opioids was not significant.  The false narrative promoted by the opioid manufacturers has been unveiled at the cost of an enormous loss of human life and suffering.

The link between the success of the opioid manufacturers deceptions, and the devasting effects caused by their fraudulent acts can be seen in a single chart. As the opioid manufacturers made billions of dollars, individual patients relying on these companies paid the price.

 

 

 

 

 

 

 

Overdose Without Death

Opioid overdose deaths are devasting to the family of the victim. Opioid overdoses that do not result in death can be equally or even more devasting.

Victims of opioid overdoses often suffer brain damage, heart damage and other adverse events that will impact their lives and their families permanently.

In many cases, the financial and other damages caused by an overdose not resulting in death will exceed those of overdose cases resulting in death.

Opioid Addiction

Despite the opioid litigation defendants attempts to blame the victims and their doctors, the blame for the meteoric rise in opioid addiction coincided with the opioid manufacturers fraudulent practices designed to deceive doctors and the public about the risk of opioid use.

According to the CDC, by 2016 2.1 million Americans suffered from opioid addiction (opioid use disorder) and 2.1 million more Americans received their first opioid prescription in the same year, guaranteeing the continuation of the Country’s opioid addiction epidemic.

 

Not every opioid addict will have a viable claim for damages against the opioid manufacturers.

Qualifying opioid addiction clients is complex. Attend the Mass Tort Nexus July 20 -22

Opioid Crisis Summit to learn more about qualifying clients with viable opioid addiction claims.

Neonatal Abstinence Syndrome

 By 2012, the National Institute for Health had recognized a dramatic increase in Neonatal Abstinence Syndrome (NAS) and the number of babies born with NAS has continued to increase since that time.

 

 

 

 

 

 

 

 

 

NAS occurs when a mother ingests opioids during pregnancy. Despite the risks associated with NAS and opioids, the opioid manufacturers are accused of aggressively promoting the use of opioids for pain commonly associated with pregnancy.

In addition to damage to the fetus before birth, opioid consumption during pregnancy often results in the infant being born addicted to opioids. The long term impact of NAS, often results in consequences that will plague the infant for the remainder of their lives.

Impaired cognitive abilities, severe behavioral issues, as well as an increased susceptibility to opioid use and addiction later in life are among a long list of complications associated with NAS.

Babies born with NAS and opioid related birth defects will often suffer from the day they are born until the day they die. The opioid defendant’s actions leading to the harm of infants should be a great source of shame for the opioid defendants; however, at this point, it appears that the opioid defendants have no shame.  They continue to blame others for what is clearly their fault.

Birth Defects

There is significant support in the medical literature demonstrating opioids cause numerous severe birth defects.

One of the types of birth defects potentially caused by maternal opioid use is Tetralogy of Fallot.

 

 

 

 

 

 

 

Tetraolgy of Fallot is a heart defect that presents with some or all of the following defects in the infants heart: Overriding Aorta, Pulmonary Stenosis, Ventricular Septal Defect and Right Ventrial Hypertrophy.

Any of the defects associated with Tetraolgy of Fallot can result in infant death or the need for multiple cardiac surgeries and a permeant decrease in quality of life.

Neural Tube Defects may also be caused by maternal opioid use. Neural Tube Defects include Spina Bifida, Anencephaly and Encephalocele. Any of these birth defects can result in infant death, the need for multiple corrective surgeries over numerous years, as well as a permanent decrease in quality of life.

 

 

 

 

 

 

 

The above is only a partial list of birth defects which are associated with maternal opioid use. Given the increase in clinical interest and study surrounding opioid use, we expect to see additions to the medical literature demonstrating a large number of opioid associated birth defects, in the near future.

HEART ATTACK

      There is overwhelming support in the medical literature demonstrating an increased incident of heart attack and other coronary issues associated with opioid use.

Cardiac damage and heart attack are common secondary issues related to opioid overdose; however, these adverse events appear to occur at a high rate in all opioid users without regard to the occurrence of an overdose.  The increased risk appears to exist for patients that are predisposed to cardiac problems, as well as those who are not.

The conditions and adverse events associated with opioid use covered in this article do not include all the medical issues associated with opioid use.

Attend the July Mass Tort Nexus Opioid summit for a more through understanding of the medical conditions which may give rise to viable individual claims against the opioid defendants.

To register for the Opioid Summit contact Jenny Levine at 954-530-9892 or by email at jenny@masstortnexus.com.

You can also register online at https://www.opioidcrisissummit.com

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Purdue Pharma Executives and the Sackler Family Named in Massachusetts Opioid Crisis Lawsuit

Oxycontin Founding Family Are Now Forced to Defend Profits In Court

Complaint: “State of Massachusetts vs. Purdue Pharma and the Sackler Family” June 13, 2018

By Mark A. York (June 20, 2018)

 

 

 

 

 

 

 

 

 

(MASS TORT NEXUS MEDIA) As more states and federal agencies continue to scrutinize the opioid drug manufacturers across the country, a clear high value target is emerging in Purdue Pharma, L.P.  and the Sackler family that founded the company. The family has profited to the tune of about $13 billion to date, and have somehow avoided the legal spotlight for the last 10 years. The Sackler family have always been protected by the company shield, even though their most profitable selling opioid drug Oxycontin and its boardroom coordinated marketing campaign was the brainchild and a direct result of the Purdue Pharma company founders, the Sackler brothers and their tried and true business model.

Complaint: “State of Massachusetts vs. Purdue Pharma and the Sackler Family” June13, 2018

That is now changing, as the State of Massachusetts, filed a lawsuit against Purdue Pharma and the Sackler family as well as various Purdue executives over the prescription painkiller OxyContin. Oxycontin is now recognized as the opioid fuse that ignited America’s opioid crisis. This is the first time where Purdue’s leading executives and members of the multibillionaire Sackler family, now known to be feuding over the opioid crisis have been named in civil litigation.

The Sacklers named in the lawsuits include Theresa and Beverly, widows of Purdue founders, brothers Mortimer and Raymond Sackler and Ilene, Kathe and Mortimer David Alfons Sackler, three of Mortimer’s children; Jonathan and Richard Sackler, Raymond’s two sons; and David Sackler, Raymond’s grandson. The Sackler family is worth conservatively, an estimated$13 billion, according to Forbes, which has been generated from sales of OxyContin.  As is normal procedure by the Sackler family and the company itself, the Sackler family feuding members always decline requests for comment on the catastrophic opioid crisis and avoid discussing any Purdue Pharma links to how the crisis came about.

PURDUE PHARMA NAMED IN 600 OPIOID LAWSUITS

Dozens of states, counties and local governments have independently sued opioid drugmakers in both state and federal courts across the country, (see OPIOID-CRISIS-BRIEFCASE-MDL-2804-OPIATE-PRESCRIPTION-LITIGATION by Mass Tort Nexus) with claims alleging all opiate drug makers, distributors and now the pharmacies engaged in fraudulent marketing to sell the powerful painkillers. They also failed to monitor and report the massive increases in opioid prescriptions flooding the US marketplace. Which has now resulted in fueling the nationwide epidemic, that’s reported to have killed over a quarter million people. The now organized approach steps up those efforts as officials sift evidence and are now holding not only the companies, but the executives and owners culpable in the designing the opioid crisis.

Purdue Pharma is facing a legal assault on many fronts, as cities, counties and states have either filed suit or are probing the company for an alleged role in the United States’ opioid and addiction epidemic. Now, a lawsuit from Massachusetts’ attorney general Maura Healey is the first to bring the company’s current and former execs into the mix, including the billionaire family with sole ownership of Purdue.

At a news conference this week, Healey said she’s filing suit against the drugmaker, plus current and former executives and board members, “for their role in creating and profiting from this epidemic that has killed so many.” The suit alleges Purdue downplayed risks and overstated benefits of opioid painkillers, including OxyContin. It seeks to link the deaths of 670 Massachusetts residents to actions at the company.

A Purdue spokesman said the company shares concern about the opioid crisis. Purdue is “disappointed, however, that in the midst of good faith negotiations with many states, the Commonwealth has decided to pursue a costly and protracted litigation process,” he said.

Purdue is no stranger to litigation, in 2007 Purdue agreed to pay $19.5million in civil penalties, but did not admit wrongdoing, to settle lawsuits with 26 states – including Massachusetts – and the District of Columbia after being accused of aggressively marketing OxyContin to doctors while downplaying the risk of addiction. This is a consistent pattern, including the 2007 criminal indictment and plea of senior Purdue Pharma executives, where they agreed to pay over $600 million and plead guilty to a greatly reduced charge of “mislabeling drugs” which seems to have set the stage for the Purdue legal strategy of throwing money at all claim of abuse, thereby setting the Purdue Pharma marketing model loose on the US consumers and the healthcare industry, see USA vs. Purdue Criminal Plea “Oxycontin” usdc.virginia.gov/OPINIONS July 2007

PURDUE PHARMA FIRES ENTIRE SALES FORCE

In what is either an amazing coincidence or a look at corporate political maneuvering, just a week after the Sacklers and company executives were named individually in the latest Purdue Pharma opiate lawsuit, the OxyContin maker laid off its entire sales force.  This puts an end to an era for Purdue that at one point, was the top-selling opioid drug in the country, and became synonymous with the nation’s opioid crisis, while the Sacklers collected billions in profits from Oxycontin sales.

Purdue, had already laid off half of its 600 sales reps in February 2018, as part of the corporate political maneuvering to curry favor with the numerous state and federal investigation that were taking place, when it announced that it would no longer be promoting OxyContin to doctors. On July 19, 2018 six days after the State of Massachusetts filed a complaint naming the company, the founding Sackler family and the executive suite as defendants in a an opioid litigation complaint,  Purdue Pharma confirmed that they had terminated the the remaining 220 employees in its sales force.

While Purdue still manufactures Oxycontin, which accounts for more than 80 percent of the company’s, they will be shifting its focus away from the highly lucrative opiate painkiller market, according to company sources.

PURDUE PHARMA DENIES ALL CLAIMS

We vigorously deny the Commonwealth’s allegations and look forward to presenting our substantial defenses to these claims,” Purdue’s spokesman said in a statement.

Executives named in the suit are current and former Purdue CEOs Craig Landau, John Stewart and Mark Timney, as well as current and former members of the Purdue board of directors, including members of the Sackler family. Dr. John Purdue Gray and George Frederick Bingham founded the company in 1892, and Mortimer and Raymond Sackler purchased Purdue in 1952, which is now owned solely by the Sackler family,.

The lawsuit alleges the company violated Massachusetts’ consumer protection statute, created a public nuisance, and that it was negligent. It seeks restitution, damages and penalties related to the alleged actions, plus injunctive relief. The company has generated more than $500 million in revenue in Massachusetts since 2008, the AG says.

“Time after time, in doctor visit after doctor visit—and there were thousands of doctor visits made to hundreds of doctors around this state—there were misrepresentations,” Healey said at a news conference. “There were lies about the efficacy, about the safety, about the supposed nonaddictive nature of their product.”

The State of Massachusetts lawsuit is the latest in a wave of complaints against the company and Big Pharma opiate drug makers involved in making and distributing opioids. Hundreds of cities and counties have filed lawsuits, and the cases are now grouped in federal court in Cleveland in MDL 2804, Opiate Prescription Litigation in front of Judge Daniel Polster. Early this year, the judge in the multidistrict litigation indicated that the sides might be able to reach a settlement, but the negotiations later hit “barriers.” The judge charted a course for a few cases to go to bellwether trials.

Aside from cities and counties, dozens of state officials and the feds have gotten involved. Attorneys general from 41 states are investigating and discussing a possible settlement with the company. Last month, six states sued Purdue over its role in the epidemic, according to USA Today. The U.S. Department of Justice is also backing cities and counties in their legal efforts.

The Sackler family name graces some of the nation’s most prestigious bastions of culture and learning — the Sackler Center for Arts Education at the Guggenheim Museum, the Sackler Lefcourt Center for Child Development in Manhattan and the Sackler Institute for Developmental Psychobiology at Columbia University, to name a few.

Now for the first time since the opioid crisis came to the attention of America, the Sackler name is front and center in a lawsuit accusing the family and the company they own and run, Purdue Pharma, of helping to fuel the deadly opioid crisis that has killed thousands of Americans.

Congratulations to the Massachusetts Attorney General Maura Healey took the unusual step of naming the eight members of the Sackler family listed above as part of the conspiracy that profited from and cause the catastrophic opioid crisis that’s gripping the USA to this day.

The 80-page complaint (Complaint: “State of Massachusetts vs. Purdue Pharma and the Sackler Family” June13, 2018) that accuses Purdue Pharma of spinning a “web of illegal deceit” to boost profits.

While prosecutors in more than a dozen other states hit hard by the opioid epidemic have sued Purdue Pharma, Healey is the first to name individual Sackler family members, along with eight company executives.

(The Sackler family regularly notes that Arthur Sackler, whose philanthropy got his name on the Smithsonian’s Sackler Gallery in Washington and other cultural institutions, died before Purdue began selling OxyContin. Several of his nieces and nephews help run the company.)

Filed on behalf of 670 Massachusetts residents who were prescribed OxyContin, became addicted to opioids and later died, the suit alleges that Purdue deceived doctors and patients about the risks, pushed prescribers to keep patients on the drugs and aggressively targeted veterans and the elderly.

The civil suit doesn’t name a dollar figure, but Healey asked a judge to order the Sacklers and Purdue to “pay full and complete restitution to every person who has suffered any ascertainable loss by reason of their unlawful conduct.”

Mike Moore, the former Mississippi attorney general who took down Big Tobaccotwo decades ago and is now going after Big Pharma, called Healey’s move “a brilliant legal strategy.”

“It pulls up the corporate curtain of protection that these people hide behind,” Moore said in an email to NBC News. “The Sacklers personally made billions of dollars while tens of thousands of overdose deaths were occurring as a direct result of their lies about the addictiveness and effectiveness of OxyContin, the drug they created and marketed. Just as these folks like to be honored when they write big checks to museums and have their names inscribed on plaques for their contributions to so many causes, they should be held accountable for how they made that money in the first place.”

SACKLER FAMILY KNOWN FOR PHILANTHROPY

Juliet Sorensen, a former federal prosecutor in Chicago who is now a professor at Northwestern University’s Pritzker School of Law, said that the Sacklers are known for their philanthropy — “not for being the driving force behind the opioid epidemic through which they gained their billions.”

“The Sacklers’ collective silence signals a lack of remorse for their role in the opioid epidemic,” she said in an email. “The complaint is a form of exposure.”

“If the Sacklers were not actually defendants that were sued, but rather named and discussed in the body of the complaint, that would be naming and shaming but without legal consequences,” she said. “In this case, however, they are named as defendants, so the naming and shaming ‘pitiless publicity’ effect comes along with potential legal liability.”

The Sacklers named in the complaint are now used to defending thensleves individually and when asked to cooment, the standard Purdue reply was offered by Purdue Pharma spokesman Bob Josephson in an email not a personal quote, “Not at this time.”

Purdue Pharma denied the allegations in the lawsuit, saying it was “disappointed” that, amid negotiations with other states that have sued, Massachusetts “decided to pursue a costly and protracted litigation process.”

“We will continue to work collaboratively with the states towards bringing meaningful solutions,” the company said.

MASSACHUSETTS HOLDS SACKLERS LIABLE

Emalie Gainey, a spokeswoman for Healey, said the attorney general’s intent in naming the Sacklers was “to hold them individually liable for the role we allege they played.”

“Not only did we name the company today, but we’ve also chose to name executives and directors,” Healey said when the lawsuit was announced. “Ours is the first lawsuit in the country to name those executives personally and tell the story of how they contributed to this deadly crisis.”

Mississippi was the first state to sue Purdue Pharma and the other big pharmaceutical companies, and the state’s attorney general, Jim Hood, said he approved of the message Massachusetts is sending.

“No individual should be above the law and allowed to hide behind corporate protections to shield them from personal responsibility,” Hood said via a spokeswoman. “That includes the Sackler family. Mississippi applauds the efforts of Massachusetts in joining our efforts and seeking accountability wherever it lies.”

In Ohio, the second state to go after the drug companies, including Purdue Pharma, Dan Tierney, a spokesman for Attorney General Mike DeWine, said individual Sackler family members “would certainly be covered” by the state’s action.

The Sackler family is the 19th richest in the nation, with an estimated fortune of $13 billion, according to Forbes.

The Sacklers involved with Purdue Pharma are the descendants of brothers Mortimer and Raymond Sackler. Their eldest brother, Arthur, died in 1987, well before Purdue began making and selling OxyContin. Arthur also worked in pharmaceuticals and developed a reputation for cleverly marketing new drugs directly to doctors, convincing them to prescribe medications including tranquilizers to their patients.

Arthur was inducted into the Medical Advertising Hall of Fame after his death, but he has also been criticized for originating “most of the questionable practices that propelled the pharmaceutical industry into the scourge it is today,” as Allen Frances, the former chair of psychiatry at Duke University School of Medicine, told the New Yorker last year.

Arthur’s family has made a point of noting that he was not involved in the sale of OxyContin and would prefer him to be remembered for his philanthropy, including funding the Arthur M. Sackler Gallery of Chinese Stone Sculpture at The Metropolitan Museum in Manhattan and the Arthur M. Sackler Museum at Harvard University.

“None of the charitable donations made by Arthur prior to his death, nor that I made on his behalf after his death, were funded by the production, distribution or sale of OxyContin or other revenue from Purdue Pharma,” his widow, Jillian Sackler, said in a February statement. “Period.”

Seven of the Sacklers named in the suit have been on the Purdue board since the 1990s, according to the suit, while David Sackler, the grandson, has served since 2012.

The board met on a weekly — sometimes daily — basis while the company was being investigated by 26 states and the Justice Department from 2001 to 2007, according to the lawsuit. In 2007, the board settled and agreed to pay a $700 million fine after the company’s CEO at the time, Michael Friedman, and two other high-ranking company officials pleaded guilty to misleading doctors and patients about opioids.

KENTUCKY LEGAL FIGHT TO KEEP SACKLER TESTIMONY SEALED

In an example of the past coming back to haunt the present, in 2015 Purdue Pharma agreed to pay $24 million to settle a lawsuit filed by Kentucky, December 22, 2015 Purdue Pharma Settlement With State of Kentucky,  which Purdue thought would end that problem by paying a fine and moving on, which isn’t the case it seems. See Purdue Pharma settles with Kentucky over Oxycontin claim(statnews.com/pharmalot) for information on the claims in Kentucky.

That state court litigation is now subject to an ongoing legal battle in the Kentucky courts where Purdue is fighting to keep the original court records from that settlement sealed, due to the only deposition testimony of one of the Sackler brothers is known to be located. The Purdue court records were unsealed by Pike County Judge, Stephen Combs in May 2016 and Purdue immediately appealed with oral arguments taking place June 26, 2017 in front of a three judge panel of the Kentucky Court of Appeals, which as of June 20, 2018 has not issued a ruling on releasing the records. The original Kentucky vs. Purdue docket information is case no. 07-CI-01303, Judge Stephen Combs, Pike County Circuit Court of Kentucky.

OxyContin was hailed as a medical marvel when it debuted in 1995. Pitched as balm for people suffering from moderate to severe pain, it reportedly generated more than $35 billion in revenue for Purdue Pharma.

But its chief ingredient is oxycodone, a cousin of heroin. And prosecutors say Purdue played down the dangers of addiction while getting hundreds of thousands of Americans hooked on opioids.

Purdue has argued that OxyContin is approved by the Food and Drug Administration and accounts for just 2 percent of the opioid prescriptions nationwide.

There are now more than 600 lawsuits naming Purdue Pharma, LP as a defendant in both federal and state court actions, this does not include the potential criminal indictments of not only the company but the Purdue family members that may be emerging. Damages are expected to easily exceed $100 billion versus the company and now that the Sacklers and company executives have been named individually the whole scope of litigation may be changing for the better, as those who profited most from the opioid crisis are now being held accountable.

 

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New York And Other State Court Opioid Litigation Moves Forward Along With Federal Opiate Rx MDL 2804

“LAWSUIT FLOOD VERSUS ENTIRE OPIOID INDUSTRY IS GETTING BIG PHARMA’S ATTENTION”

By Mark A. York (June 11, 2018)

 

 

 

 

 

 

Opioid litigation in New York and other state courts, where hundreds of counties and cities have filed lawsuits against opioid manufacturers and distributors,  are now moving forward even with the explosion in the Federal Opiate Litigation MDL 2804 OPIOID-CRISIS-BRIEFCASE -MDL-2804-OPIATE-PRESCRIPTION-LITIGATION, where more than 500 states, counties, cities as well as unions, hospitals and individuals have filed lawsuits against the opioid industry as a whole.

At one point, the opiate industry attempted to raise arguments stating that the Food and Drug Administration hasn’t yet determined whether narcotic painkillers are unnecessarily dangerous – a central question in any litigation, which was quickly denied and seems to show that Opiate Big Pharma is once again attempting to hide behind the FDA shield.

In a two-page order issued in March by Judge Jerry Garguilo of the Suffolk County Supreme Court, New York where he ruled that there is “no compelling reason to impose a stay of proceedings” until the FDA completes its own review of the benefits and risks of opioids. The lawsuits by most of the counties in New York, which have been consolidated in Garguilo’s court, are “backward-looking” toward allegedly fraudulent marketing materials and tactics the drug companies used to convince doctors and patients their products had low risk of addiction.

In another state court, the first of many opioid litigation trials to be scheduled is now set in Oklahoma, where Cleveland County District Judge Thad Balkman set May 28, 2019 for the start of the trial. ate has been set for a lawsuit by a state against pharmaceutical companies over the opioid epidemic, according to Oklahoma‘s attorney general. See Original Complaint – State of Oklahoma vs. Purdue Pharma et al, June 30, 2017 (Cleveland County, OK District Court)

Oklahoma, one of at least 20 states besides New York that have opioid lawsuit dockets against drugmakers, alleges fraudulent marketing of drugs that fueled the opioid epidemic in the lawsuit filed in June 2017, and seeks unspecified damages from Purdue Pharma, Allergan, Janssen Pharmaceuticals, Teva Pharmaceuticals and several of their subsidiaries.

The New York state court lawsuits are joined by another somewhat unique group of plaintiffs in the legal battle over the opioid-epidemic with class actions filed by consumers who claim they’re seeing skyrocketing health insurance costs as a result of the crisis.

The suits, filed in New York and four other states, were brought by individual persons against opioid manufacturers and distributors, and are among the few class actions filed against drug makers and marketers. The vast majority of cases have been separate actions brought by government entities like cities and counties.

The plaintiffs in this new wave of cases have filed across the country in federal courts in  USDC SD New York (Complaint) , a New Jersey Complaint,  a Massachusetts Complaint, an Illinois Complaint as well as a California Complaint  where they’ve filed lawsuits on behalf of those who paid increased health insurance costs–including higher premiums, deductibles and co-payments–because of effects attributable to the opioid epidemic.

The proposed classes include businesses and individuals who paid for health insurance as part of employer-sponsored plans.

“We don’t know anyone who in the litigation is addressing the private sector harms to consumers and businesses from increased premiums and other insurance costs that flow to anyone in the health insurance market as a result of the fact that insurers are paying more for addictions,” said Travis Lenkner, one of the plaintiffs attorneys filing the cases.

The opioid cases add a new type of plaintiff into the wide-reaching opioid litigation, which have also includes states, Native American tribes, pension funds and hospitals.

John Parker, senior vice president of the Healthcare Distribution Alliance, speaking on behalf of distributors AmerisourceBergen Drug Corp., Cardinal Health Inc. and McKesson Corp., all named as defendants, called the opioid epidemic a “complex public health challenge.”

“Given our role, the idea that distributors are responsible for the number of opioid prescriptions written defies common sense and lacks understanding of how the pharmaceutical supply chain actually works and is regulated,” he said in a statement. “Those bringing lawsuits would be better served addressing the root causes, rather than trying to redirect blame through litigation.”

Purdue Pharma spokesman Bob Josephson noted that his company’s products account for less than 2 percent of all opioid prescriptions. Johnson & Johnson’s Janssen Pharmaceuticals defended the labels on its prescription opioids and called the allegations “baseless and unsubstantiated.”

Representatives of the other manufacturing defendants, which include Endo Health Solutions, Teva Pharmaceutical Industries and Insys Therapeutics Inc., did not respond to requests for comment.

It is now fairly common knowledge in the legal world that there is more than enough data that links increased health insurance costs to the opioid epidemic as well as the overall catastrophic impact of the flood of opioids into the America marketplace.

The suits cite statistics. In California, for instance, health insurance premiums for family coverage increased 233.5 percent from 2002 to 2016. Monthly premiums for the plaintiff in that case, Jordan Chu, jumped from $160.52 in 2016 to $240.76 this year. New Jersey residents with private health insurance spent $5,081 in insurance premiums in 2014, up from $2,454 in 2001. And an average family plan in New York with annual costs of $9,439 in 2003 had jumped to $19,375 in 2016.

Plaintiff counsel stated that they will be filing suits in more states and fight any attempts to transfer these cases to the Northern District of Ohio, where U.S. District Judge Dan Polster is overseeing the opioid multidistrict litigation, MDL 2804, even though the cases were filed in federal courts. A damaging discovery win for the plaintiffs was the order of May 18, 2018, see DEA ARCOS Database Access Order May 8, 2018 MDL 2804, where Judge Polster ordered the DEA to turn over distribution data for all 50 states based on the revelations in a prior DEA related order where the Opioid Drug distribution data provided very solid information on all the parties involved in creating the opioid crisis over the last 15 years.

The New York court docket parallels the federal and many other opioid based complaints, filed in state courts across the country where parties have decided to pursue their claims in their state courts versus the federal docket. These filings in both state and federal courts, will only increases the pressure on manufacturers and wholesalers to either win dismissal of these cases or prepare for an accelerated trial schedule.

There are currently more than 500 of the nation’s 3,200 counties have sued and plaintiff lawyers hope to soon get that number to 1,500, which some lawyers consider critical mass for a settlement.

The defendant companies argue they can’t be held liable for selling a legal product sold only with a doctor’s prescription whose distribution was controlled and overseen, from manufacturing to retail sales, by federal and state regulators.

The plaintiffs argue manufacturers used a variety of tactics, including misleading marketing materials and highly paid physician-influencers, to convince prescribing physicians their products were safe for treating chronic pain when, in fact, they were highly addictive.

In the March order, Judge Garguilo rejected the defendants’ claim that the FDA has exclusive authority to determine whether, in effect, opioids should be sold for anything other than relieving the pain of terminal illness. Regardless of what the FDA determines, the judge said, the municipal plaintiffs have the right to seek redress for their costs associated with addiction.

“Because the focus of this lawsuit is on the state of scientific knowledge that existed when the defendants made their marketing claims, there is no risk of inconsistent rulings, and none of the current studies will have any bearing on whether the defendants’ representations were misleading when made,” the judge wrote. The court isn’t being asked to decide the risks and benefits of opioids but whether the defendants misrepresented those risks and benefits, he added.

In case the defendants didn’t grasp the judge’s ultimate goal, the judge restated his “previously expressed desire” for a “prompt resolution of this matter.” The federal judge overseeing multidistrict litigation in Ohio, Judge Dan Aaron Polster, has similarly urged defendants to engage in settlement talks, although a global resolution of the litigation could prove difficult to negotiate.

In addition to hundreds of cases consolidated in federal court, the defendants face a wave of litigation in state court, like the New York cases, as well as lawsuits and investigations by state attorneys general and the federal government. Any settlement would have to protect the defendant companies from future lawsuits over the same issue and that may be difficult to negotiate given all the concurrent litigation in different courts. The time has now arrived for Opioid Big Pharma, in all forms to face the facts that for close to 20 years they have flooded the mainstream commerce of America with massive amounts of opiates with little to no oversight, which whether caused by a catastrophic systemic failure on many levels, or simple greed, the time has now come for the opiate industry to face the music of complex litigation in state and federal court venues across the country.

For those looking to tap into the opioid litigation or learn what the current status is in both state and federal court opioid litigation, please visit www.opioidcrisissummit.com where Mass Tort Nexus is hosting national political leaders and lead opiate counsel who are active in the day to day opioid crisis and have the most up to date case information during the two day event taking place July 21-22, 2018 in Fort Lauderdale.

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How Insys Theraputics, Inc. Sold Stock And Killed Americans With The Help Of Doctors

How Insys Theraputics, Inc. Sold Stock And Killed Americans At The Same Time 

The Opioid Crisis Behind The Scenes

by Mark A. York (June 8, 2018)

Subsys – an Insys Therapeutics, Inc. Pharmaceutical Opioid Product

 

 

 

 

 

 

 

 

 

 

 (MASS TORT NEXUS MEDIA)  Here’s a perfect example of how corporate greed and licensed medical providers helped create the now rampant US opioid crisis– how payments to doctors and prescribers across the country caused addictive painkillers, like “Subsys” a fentanyl based opioid, to suddenly rip through our country like a flash fire.

Insys Therapeutics,a publicly traded pharmaceutical company based in Arizona, is just one small example of what Big Pharma has been doing for the last 10 years in every city and state in the United States, often increasing corporate earnings right alongside the catastrophic opioid related death rates. For Insys Theraputics executives, the sales team and its nationwide cadre of fraudulent doctors, the results have been felony indictments and long federal prison sentences, with many more to come.

INSYS EXECUTIVES INDICTED

December 2016 saw Insys Therapeutics CEO Michael Babich and five other senior executives indicted on criminal charges for paying kickbacks and bribes to medical professionals and committing fraud against insurance companies across the country for offering a highly addictive Fentanyl prescription product “Subsys” to the masses. The Insys boardroom was indicted in the US District Court of Massachusetts, where the entire team has engaged a stable of top national law firms to defend the indictments. The “Subsys” sales teams were charged in federal indictments across the country, including Arkansas, Connecticut, Alaska and New York and the indictments will only increase as those cases proceed and “cooperating witnesses” decide that prison isn’t an option.

To compound further harsh scrutiny for Insys, it’s new CEO Saeed Motahari, moved over from Purdue Pharmaceuticals, the Oxycontin maker, who’s also a major target of criminal and civil investigations across the country by local state and federal agencies. Purdue is charged with false marketing, off-label use and ignoring the Oxycontin highly addictive dangers for years, while bringing in literally billions of dollars in profits, but Purdue’s transgressions are in Part 2 of our ongoing reports on big pharma and opioid abuses.

DOCTORS FACING NUMEROUS CHARGES

Doctors and their pain clinics, medical centers and other healthcare facilities have been indicted for fraudulent prescription writing, submitting false claims to insurance companies and numerous other federal charges and all face a minimum of 20 to 50 years in federal prison. Two of the busiest “Subsys” prescription writers in the country were Alabama doctors, John Couch and Xiulu Ruan, who earned over $40 million from Insys, and were charged with running a pill mill between 2013 and 2015, have been convicted and sentenced to 20 years each in federal prison. The top “Subsys: prescriber of all, Dr. Gavin Awerbach, of Saginaw, MI pled guilty to defrauding Medicare and Blue Cross out of $3.1 million in improper Subsys prescriptions, his criminal sentence is pending. To show the far reach of Insys and it’s corporate plans to saturate the US market with opioids, in Anchorage, Alaska Dr. Mahmood Ahmad, was charged with heading a massive Subsys prescribing operation, which he denies, but immediately surrendered his Alaska medical license which the caused the revocation of his medical license in Arkansas.

INSURANCE COMPANIES FILED SUIT

Adding weight to this tragedy is Anthem Insurance — you may recognize them as Blue Cross, one of the largest insurers in the country, now setting their sights on Insys Theraputics and it’s executives.

Anthem is suing Insys Therapeutics, the maker of the powerful opioid Subsys, for allegedly lying, cheating and defrauding its way into the medicine cabinets of Anthem clients across the country. The drug according to Anthem’s complaint, was off market prescribed to thousands of patients for years. Review shows that 54% of patients who are taking Subsys don’t really have cancer — one of the requirements for prescribing the drug, Subsys was FDA approved for “treatment of pain related to cancer” and any other use is unauthorized or off-label use.

Anthem says that’s because Insys devised an elaborate scheme to get around Anthem’s system — by falsifying records and posing as medical professionals, often with the complete knowledge and cooperation of medical doctors across the country who then received thousands of dollars in kickbacks. These doctors chose to exchange high fees from Insys in exchange for writing off-label prescriptions to patients seeking pain relief for non-life threatening conditions.

Anthem claims it ultimately paid $19 million more for Subsys than it should have. “But the harm inflicted by Insys’s conduct is not merely financial in nature,” the complaint states “Insys put Anthem’s members’ health at risk.”

THE OFF LABEL CAMPAIGN

The only people who are supposed to be taking Subsys are adult cancer patients, according to the FDA “Subsys” approval files, anything other than that is an “off label” indication. Now you can take a drug to treat something off label if you want to, but you have to get your doctor to get pass a prior authorization.

Anthem alleges that Insys has an entire unit to get around this requirement — it’s titled the “reimbursement unit.” Investigative journalists exposed this fraud initially as far back as 2015 on behalf of the Southern Investigative Reporting Foundation, see Insys Therapeutics “Subsys” Off Label Rx Fraud.

The Reimbursement Unit claim was basically the company’s fraudulent  prescription approval factory, which helped participating doctors process claims (the doctors had so many they couldn’t handle them all). The unit falsified records to show patients had cancer and called insurers, pretending to be patients or other medical professionals, to facilitate approval of payment for off-label treatment.

This is the Unit’s script for obtaining off-label approval (taken from the Anthem suit):

The script read: “The physician is aware that the medication is intended for the management of breakthrough pain in cancer patients. The physician is treating the patient for their pain (or breakthrough pain, whichever is applicable).” The script deliberately omitted the word “cancer as applied to the patient treatment under discussion.”

DO STOCKS RISE AND FALL ON INDICTMENTS

 

 

 

 

 

 

 

 

In late 2016 the entire top level of Insys executives, including former CEO Michael Babich, and five others were indicted and charged with multiple counts of fraud and conspiracy. Since then a number of sales reps and medical practitioners have pled guilty to charges that they gave or accepted kickbacks in furtherance of the fraudulent prescription scheme. The manager of reimbursement services, Elizabeth Gurrieri, pleaded guilty to wire fraud in June. There have been numerous deaths and related overdoses attributed to the over prescribing of Subsys across the country, which to date, show most parties involved being able to avoid the scrutiny of criminal charges related to off-label marketing and prescribing. Insys has tried to re-shuffle the executive board by bringing in new members, but business as usual in the Big Pharma boardroom goes on, as they simply brought in other more experienced “opioid industry” insiders to help further the continued use of “Subsys” and purportedly the major Insys New Pharma” entry, a line of complex medical marijuana products, that may enable them to shake off the current Insys label as the United States leading “opioid abuse by boardroom design” corporation.

As part of the boardroom strategy to get doctors to prescribe Subsys, Insys spent millions paying them off through a fraudulent “speakers program” meant to educate medical professionals about the drug. The speaking engagements were a veiled attempt to cover-up the direct payment to doctors for writing prescriptions, the more prescriptions you wrote, the higher your “speaking fees” increased. There are e-mails, texts and other Insys communications from all levels of company personnel stating “if they not writing prescription, they’re off the speaking program”, this policy resulted in one Alabama sales rep being paid over $700 thousand in Subsys based Rx commissions for one year, while her base salary was $40 thousand.

“While the exact amount of those kickbacks has yet to be determined, criminal indictments of the recipients indicate that Insys paid “speaker fees” of millions, of dollars, which may result in additional criminal charges against the doctors as well as the doctors facility staff who often worked hand in hand with Insys staff.

SALES REP NATALIE REED PERHAC

In the plea, Perhacs admitted that she was hired to be the personal sales representative for one of Insys’s most important prescribers, Dr. Xiulu Ruan. Ruan is one of two Alabama doctors who picked up over $115,000 in speaker fees from 2012 to 2015, and earned in excess of $40 million in related medical earnings during the same period. Earlier this year they were sentenced to 20 years in jail each for running a “pill mill” and helping Insys sales rep Natalie Reed Perhacs sell Subsys, for which she was paid in excess of $700 thousand in commissions, see Perhac Guilty Plea in Alabama Federal Court.

Perhac Plea Excerpts:

Admision No. 78: . Perhacs admitted that her primary responsibility at Insys was to increase the volume of Subsys® prescribed by Dr. Ruan, and his partner Dr. John Patrick Couch. This… was accomplished by (1) handling prior authorizations for their patients who had been prescribed Subsys®; (2) identifying patients who had been at the same strength of Subsys® for several months and recommending that Dr. Ruan or Dr. Couch increase the patients’ prescription strength; and (3) setting up and attending paid speaker programs.

Admission No. 79:. Ms. Perhac admitted that because of her involvement in the prior authorization process, she knew that the vast majority of Dr. Ruan and Dr. Couch’s patients did not have breakthrough cancer pain.

As you can see by the Perhac admissions, numbers 78 and 79, which reflect the vast number of charges lodged against her, the federal government is cracking down on everyone involved with the “Subsys” fraud. According to confidential sources, the recent June 2017 FDA “Opioid Crisis” Conference and related strategic review of the opioid crisis, will result in many more indictments and charges against drug makers and the medical providers who’ve helped facilitate the opioid epidemic that is currently in place across the United States.

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HOW CAN WE SOLVE THE OPIOID CRISIS STARTING NOW? With An Opioid Crisis Summit Like No Other

A Definitive Opioid Crisis Solutions Event

By Mark A. York (May 29, 2018)

 

 

 

 

 

 

 

(MASS TORT NEXUS MEDIA) It’s been called the most perilous drug crisis ever in the United States, the epicenter of the opioid epidemic, overdose deaths have quadrupled since 1999, killing more than 100 people every day. Pharmaceutical opiate pain relief is an essential clinical tool, but with physicians writing over 240 million opioid prescriptions to Americans every year, the potential for catastrophe is enormous. Now it seems to be coming into realization that the opioid crisis is here and the damage is catastrophic, gauged against the devastating impact on families and communities across the United States.  How can we get the message out that addiction is now  recognized as a medical, not a criminal problem, and new treatments are on the horizon. How do we protect the population from misusing opioids? An Opioid Crisis Summit featuring national leaders who are involved in the day to day efforts to fight this opiate crisis on all levels, including Ohio Lieutenant Governor Mary Taylor, Dr. Rahul Gupta, West Virginia Director of Public Health and others who are involved in providing real time solutions to the opiate epidemic as well as treating physicians and legal professionals who are active in offering solutions.

The Definitive Opioid Crisis Summit For All of America:

July 21-22, 2018

www.opioidcrisissummit.com

OPIOD CRISIS SUMMIT

By Mass Tort Nexus

Fort Lauderdale, FL

 How did the opioid crisis happen?

In the late 1990s, pharmaceutical companies reassured the medical community that patients would not become addicted to prescription opioid pain relievers, and healthcare providers began to prescribe them at greater rates. This subsequently led to widespread diversion and misuse of these medications before it became clear that these medications could indeed be highly addictive. Opioid overdose rates began to increase. In 2015, more than 33,000 Americans died as a result of an opioid overdose, including prescription opioids, heroin, and illicitly manufactured fentanyl, a powerful synthetic opioid.1That same year, an estimated 2 million people in the United States suffered from substance use disorders related to prescription opioid pain relievers, and 591,000 suffered from a heroin use disorder (not mutually exclusive).

 What do we know about the opioid crisis?

  • Roughly 21 to 29 percent of patients prescribed opioids for chronic pain misuse them.
  • Between 8 and 12 percent develop an opioid use disorder.
  • An estimated 4 to 6 percent who misuse prescription opioids transition to heroin.
  • About 80 percent of people who use heroin first misused prescription opioids.
  • Opioid overdoses increased 30 percent from July 2016 through September 2017 in 52 areas in 45 states.
  • The Midwestern region saw opioid overdoses increase 70 percent from July 2016 through September 2017.
  • Opioid overdoses in large cities increase by 54 percent in 16 states.

Quarterly rate of suspected opioid overdose, by US region
Source: Centers for Disease Control and Prevention.

This issue has become a public health crisis with devastating consequences including increases in opioid misuse and related overdoses, as well as the rising incidence of neonatal abstinence syndrome due to opioid use and misuse during pregnancy. The increase in injection drug use has also contributed to the spread of infectious diseases including HIV and hepatitis C. As seen throughout the history of medicine, science can be an important part of the solution in resolving such a public health crisis.

 The Opioid Crisis Summit Agenda

An unprecedented group of elected officials, political and medical experts, and academic leaders from around the country are set to examine the crisis and offer insight and solutions.

On July 21-22, 2018, the definitive Opioid Crisis Summit presented by Mass Tort Nexus will convene a symposium to present a firsthand account as to the depth and severity of the crisis. The research team at Mass Tort Nexus has brought together influential speakers including the Lieutenant Governor of Ohio, Mary Taylor; State Attorney for Palm Beach County Florida, Dave Aronberg, Esq.; Director of Public Health, State of West Virginia, Rahul Gupta, MD; Executive Director, Novus Medical Detox Centers, Kent Runyon; The Amy Winehouse Project Addiction Recovery Center, Susan Anderson and Blades Williamson; Opioid Crisis Advocate, Stephen Gelfand, MD and Opioid Crisis Expert, John Ray.  These speakers are coming together to give our attendees a firsthand look at just how dramatic the impact of the opioid crisis is within our communities.

Summit attendees including attorneys, elected officials and healthcare officials will be giving specific information regarding the legal aspects of the Opioid Crisis as well. This relates to the Opiate Prescription MDL 2804, where hundreds of counties, states and cities across the country have filed lawsuits against the opiate pharmaceutical industry as a whole. This includes key MDL 2804 leadership counsel who will discuss signing of both entity and individual cases, regarding case criteria, damage models and estimated timeframes for settlement. See MDL 2804 Opiate Prescription Litigation US District Court of Ohio, for the National Prescription Opiate Litigation docket information.

This level of professional expertise and real time awareness of the issues regarding the opioid crisis in the United States has never been assembled on a scale such as this and if you are wanting to get the most critical and complete information, please contact someone at Mass Tort Nexus before all seats are taken.

Media Contact: media@masstortnexus.com 954.870.7323, Mark A. York

Event Contact:

Barbara Capasso

Jenny Levine

954.530.9892

barbara@masstortnexus.com

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First State Court Opioid Crisis Trial Set In Oklahoma With May 2019 Start Date

By Mark A. York (May 24, 2018)

 

 

 

 

 

 

 

May 28, 2019 trial date set in the first opioid litigation case to go to trial where a  state filed suit versus the opioid pharmaceutical companies

(MASS TORT NEXUS MEDIA) The first of many opioid litigation trials where states, counties and cities have filed lawsuits against the Opioid Big Pharma industry and it’s affiliates, is now set in Oklahoma where Cleveland County District Judge Thad Balkman set May 28, 2019 for the start of the trial.  The trial date date has been anticipated in the lawsuit by the State of Oklahoma against pharmaceutical companies over the opioid epidemic, according to Oklahoma‘s attorney general Mike Hunter. See Original Complaint – State of Oklahoma vs. Purdue Pharma et al, June 30, 2017 (Cleveland County, OK District Court)

To summarize the view in Oklahoma and other states who are pursuing the Opioid prescription drugmakers in courts all across the country, Oklahoma Attorney General Mike Hunter stated in his filings  “Defendants created the worst public health crisis in modern history. Families destroyed,”adding “Children killed. Babies addicted. Morgues overflowing. Prisons full.” This is a common view across the entire United States at this point.

Oklahoma, one of at least 13 states that have filed lawsuits against drugmakers, alleges fraudulent marketing of drugs that fueled the opioid epidemic in the lawsuit filed in June 2017, and seeks unspecified damages from Purdue Pharma, Allergan, Janssen Pharmaceuticals, Teva Pharmaceuticals and several of their subsidiaries.

“We appreciate the urgency Judge (Thad) Balkman saw in getting the case to trial,” Attorney General Mike Hunter said. “Oklahomans who have suffered immeasurably from the years of fraudulent marketing campaigns will see this case resolved sooner rather than later.” Hunter said Balkman scheduled the trial to begin May 28, 2019.

For up to date information on the Opioid Litigation across the country see, OPIOID-CRISIS-BRIEFCASE-INCLUDING-MDL-2804-OPIATE-PRESCRIPTION-LITIGATION (https://www.masstortnexus.com/Briefcases/Drugs/254/)

Within the last 2 weeks, state attorneys general of Nevada, Texas, Florida, North Carolina, North Dakota and Tennessee lawsuits have now joined many other states who have filed lawsuits asserting that Purdue Pharma violated state consumer protection laws by falsely denying or downplaying the addiction risk while overstating the benefits of opioids. The lawsuits also names pharmaceutical manufacturers Endo Pharmaceuticals, Allergan, Teva Pharmaceutical Industries and Mallinckrodt, as well as drug distributors AmerisourceBergen, Cardinal Health and McKesson Corporation.

“It’s time the defendants pay for the pain and the destruction they’ve caused,” Florida State Attorney General Pam Bondi told a press conference.

Joining, Oklahoma are states who’ve previously filed claims against opiate drugmakers are Ohio, AlaskaKentuckyLouisianaMississippiMissouriMontanaNew HampshireNew JerseyNew MexicoSouth Carolina and Washington state. West Virginia has been catastrophically affected by the opioid crisis and has previously attempted to stop Opioid Big Pharma from pushing opiates into their communities, without much success.  See How drug companies submerged West Virginia in opioids for years: “A small West Virginia town of 3,000 people got 21 million pills”

Medical professionals say a shift in the 1990s to “institutionalize” pain management opened the doors for pharmaceutical companies to encourage doctors to massively increase painkiller prescriptions, and Purdue Pharma led that effort. Which is now directly linked to the massive increase in drug overdoses, now see as the leading cause of accidental death for Americans under age 50, killing more than 64,000 people in 2016, according to the Centers for Disease Control and Prevention.

OxyContin was launched in the mid-90s by Purdue Pharma and aggressively marketed as a safe way to treat chronic pain. But it created dependency in many even as prescribed, and the pills were easy to abuse. Mass overprescribing has led to an addiction and overdose catastrophe across the US, more recently rippling out into rising heroin and fentanyl deaths.

Opioid overdoses made up a staggering 66 percent of all drug overdose deaths in 2016, surpassing the annual number of lives lost to breast cancer.

Florida and the other states also, named drug makers Endo Pharmaceuticals Inc., Allergan, units of Johnson & Johnson and Teva Pharmaceutical Industries, and Mallinckrodt, as well as drug distributors AmerisourceBergen Corp., Cardinal Health Inc. and McKesson Corp. The distributors played a part in opioid abuse through oversupply, including failing to identify suspicious orders and report them to authorities, including the DEA and other oversight agencies, contributing to an illegal secondary market in prescription opioids, such as Purdue’s OxyContin, Endo’s Percocet and Insys Therapeutics fentanyl drug Subsys, a fast acting and extremely addictive drug.

The companies deny wrongdoing and say they complied with Federal Drug Administration requirements that include warning labels showing potential risks that come with using their drugs. “We are deeply troubled by the prescription and illicit opioid abuse crisis, and are dedicated to being part of the solution,” Purdue Pharma said in a statement Friday. “We vigorously deny these allegations and look forward to the opportunity to present our defense.”

Ohio Filed First

In announcing his office’s lawsuit in May 2017, Ohio Attorney General DeWine said the drug companies helped unleash the crisis by spending millions of dollars marketing and promoting such drugs as Purdue’s OxyContin, without consideration of the long term effects of the related addiction, which Purdue was absolutely aware of throughout the years of profits that now total billions of dollars.

The lawsuit said the drug companies disseminated misleading statements about the risks and benefits of opioids as part of a marketing scheme aimed at persuading doctors and patients that drugs should be used for chronic rather than short-term pain.  Pain centers and medical practices across the country started writing an ever increasing number of high dose opioid prescriptions for what would be considered low to mid-level pain treatment.

Similar lawsuits have been filed by local governments, including those in several California counties, as well as the cities of Chicago, Illinois and Dayton, Ohio, three Tennessee district attorneys, and nine New York counties have also filed individual suits.

It is unknown at this time, if all of the legal actions filed by governmental entities across the country will be consolidated into MDL 2804, which may be the most effective way to manage the soon to be massive number of legal claims against Big Pharma and their long term opiate profit centers. Municipalities across the country seeking to recoup the enormous financial losses brought on by the opioid crisis.

The state lawsuits are separate from pending lawsuits in Ohio by dozens of local governments, and lawsuits by Native American tribes in the Dakotas and Oklahoma.

In South Dakota, the Rosebud Sioux Tribe, Flandreau Santee Sioux Tribe and the Sisseton Wahpeton Oyate filed a federal lawsuit in January against 24 opioid industry groups. See https://www.indianz.com/News/2018/04/11/navajonationopioid.pdf.  n Oklahoma, a federal judge has ruled that another similar lawsuit by the Cherokee Nation cannot be tried in tribal court, and Cherokee Nation Attorney General Todd Hembree told the Tulsa World that the tribe will re-file the lawsuit in state court.

Lawsuits have already been filed by 16 other U.S. states and Puerto Rico against Purdue and the related opioid drug companies and distributors. Purdue, which is a privately held company, owned by the Sackler brothers and family, in February said it stopped promoting opioids to physicians after widespread criticism of the ways drugmakers market highly addictive painkillers.

Purdue Pharma is owned by the Sackler family, listed at 19th on the annual Forbes list of wealthiest families in the country at a worth of $13 billion. The family’s fortune largely comes from OxyContin sales, which its company branded and introduced as an extended release painkiller in 1995.

Two branches of the Sackler family control Purdue, which developed and continues to make OxyContin, the narcotic prescription painkiller regarded as the “ground zero” of America’s opioids crisis.

Bondi said state attorneys general from New York, California and Massachusetts were preparing similar lawsuits, with Massachusetts last week sending a letter to Purdue notifying the company of its intention to sue. The California and New York attorney general offices did not immediately respond to a request for comment.

Stamford, Connecticut-based Purdue, in a statement, denied the accusations, saying its drugs were approved by the U.S. Food and Drug Administration and accounted for only 2 percent of all opioid prescriptions, seemingly ignoring the 600 lawsuits filed against them in the last year, as well as the minimum of 15 federal and state criminal investigations that are underway across the country.  At the forefront of the criminal investigations is the U.S. Attorney, John H. Durham, District of Connecticut, U.S. Department of Justice, Criminal Division, based in New Haven, CT the state which is also where Purdue Pharma is headquartered, who is leading a multi-group task force looking into the potential criminal conduct of not only Purdue, but the entire Opiate Big Pharma industry as a whole.

“We are disappointed that after months of good faith negotiations working toward a meaningful resolution to help these states address the opioid crisis, this group of attorneys general have unilaterally decided to pursue a costly and protracted litigation process,” Purdue said.

Opioids were involved in more than 42,000 overdose deaths in 2016, the last year for which data was available, according to the U.S. Centers for Disease Control and Prevention. Kentucky, one of the nation’s hardest-hit states, lost more than 1,400 people to drug overdoses that year.

Separate litigation involving at least 433 lawsuits by U.S. cities and counties were consolidated in a federal court in Cleveland, Ohio. The defendants include Purdue, J&J, Teva, Endo, AmerisourceBergen, Cardinal Health and McKesson. The federal litigation is growing daily see, Opiate Prescription MDL 2804, US District Court of Ohio link.

The federal lawsuits which accuse drugmakers and the opioid industry as a whole, of deceptively marketing opioids and the distributors of ignoring indications that the painkillers were being diverted for improper uses.

U.S. District Judge Dan Polster, who is overseeing the consolidated litigation, has been pushing for a global settlement. He had previously invited state attorneys general with cases not before him to participate in those talks, from the start of the MDL 2804 litigation being assigned to his courtroom.

Despite filing separate lawsuits, the six attorneys general on Tuesday said they would continue to engage in settlement discussions with Purdue and other companies. “You always want to settle and prevent a prolonged litigation,” said Florida’s Bondi. “But we’re sending a message that we’re fully prepared to go to war.”

Will litigation in most every state in the union paired with the National Opiate Prescription MDL 2804 reign in the Opioid industry that’s earned billions and billions of dollars over the last 20 years, all at the expense of the people of the United States and their families?  If history is a gauge of how things will end up, chances are a big “NO” as money and greed at the corporate levels have traditionally overruled anything affiliated with long term public health concerns in our for-profit healthcare system currently entrenched in the United States.

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Opiate Prescribing and Use Keeps Rising While Research Data Shows A Diminishing Return

Opiate Use Has Increased While Realtime Data Shows There’s A Diminishing Return

By Mark A. York (May 11, 2018)

Why was there a 30% rise  in opioid overdoses in 2017 

 

 

 

 

 

 

 

 

 

 

 

 

  • (MASS TORT NEXUS MEDIA) From 2000 to 2016, government research data shows that more than 600,000 people died from drug overdoses — nearly 64,000 in 2016 alone.

  • See the data on the 30% rise in opioid overdoses between 2016 and  2017, click CDC link here.

MIDWEST AMERICA WAS TARGETED

According to sources at all levels from police and fire first responders to emergency room physicians across the country and analysts at the CDC, there’s been no slowdown in opiate based medical emergencies in the US over the last 2 years. Emergency response and ER visits for opioid overdoses went way up, with a 30 percent increase in the single year period of June of 2016 to June of 2017, according to the Centers for Disease Control and Prevention. 

The increased emergency room visits also include more young children aged three to fourteen years old, which truly reflects on the unknown number still available opiates that are readily accessible to anyone who has an interest in getting them, and often with an inadvertent and tragic risk to younger victims who somehow are exposed and now being swept up in the opioid crisis.

Center for Disease Control’s Acting Director Dr. Anne Schuchat said overall the most dramatic increases were in the Midwest, where emergency visits went up 70 percent in all ages over 25. This is a figure that’s is comparative to prior medical emergency spikes during pandemic healthcare  

Recently two important medical reports on opiate abuse have emerged indicating that the opioid crisis may be at its worst point ever.

The first study comes from the Centers for Disease Control and Prevention (CDC), a federal agency tasked with studying – and stopping – the spread of diseases, including everything from viral infections like the flu to mental health issues including drug addiction. Published in the agency’s monthly Vital Signs report, the study demonstrates that the number of opioid overdoses increased by 30% in a little more than one year from July 2016 to September 2017.

The second study comes from a group of VA medical personnel and public health researchers publishing in the Journal of the American Medical Association (JAMA), who wanted to learn how effective opioid prescription drugs were at managing long-term and chronic pain. As it turns out, opioid drugs showed less efficacy than non-opioid pain medications over a 12-month period – and in fact, over time opioids became worse for patients who had to deal with side effects that patients taking non-opioid medications did not have to deal with. Taken together, these two studies show that current opioid drug policies, procedures, prescription practices and standards of patient care clearly need to be rethought.

“A small West Virginia town of 3,000 people got 21 million pills”

Drug companies deluged tiny towns in West Virginia with a monsoon of addictive and deadly opioid pills over the last decade, according to ongoing investigations by various public and private entities. After Opioid Big Pharma has reaped billions in profits over the last 15 years at the expense of US citizens, often those in the most rural and distressed areas of the country, it now appears that the time has come for Big Pharma to be called to answer for its conduct.

For instance, drug companies collectively poured 20.8 million hydrocodone and oxycodone pills into the small city of Williamson, West Virginia, between 2006 and 2016, according to a set of letters the committee released Tuesday. Williamson’s population was just 3,191 in 2010, according to US Census data.  These numbers are outrageous, and we will get to the bottom of how this destruction was able to be unleashed across West Virginia,” committee Chairman Greg Walden (R-Ore.) and ranking member Frank Pallone Jr. (D-N.J.) said in a joint statement to the Charleston Gazette-Mail.

The nation is currently grappling with an epidemic of opioid addiction and overdose deaths. The Centers for Disease Control and Prevention estimate that, on average, 115 Americans die each day from opioid overdoses. West Virginia currently has the highest rate of drug overdose deaths in the country. Hardest hit have been the regions of West Virginia, Ohio and Kentucky where for some reason the opioid industry chose to focus on, the how and why will be address in the federal and state courts across the country, as the opioid crisis has caused the “Opiate Prescription Multidistrict Litigation MDL 2804”, to be created and heard in the US District Court-Northern District of Ohio, in front of Judge Dan Polster, see Opiate Prescription MDL 2804 Briefcase.

WHERE WAS THE OFFICIAL OVERSIGHT?

The House committee repeatedly asked if the company thought these orders were appropriate and what limits—if any—it would set on such small towns.  Miami-Luken would not respond to a request for comment. The committee had similar questions for HD Smith, who delivered 1.3 million hydrocodone and oxycodone pills to a pharmacy in Kermit—the 406-person town—in 2008.

“If these figures are accurate, HD Smith supplied this pharmacy with nearly five times the amount a rural pharmacy would be expected to receive,” the committee wrote. It noted that the owner of that Kermit pharmacy later spent time in federal prison for violations of the Controlled Substance Act. Still, the committee pressed the question of whether HD Smith thought its distribution practices were appropriate.

“We will continue to investigate these distributors’ shipments of large quantities of powerful opioids across West Virginia, including what seems to be a shocking lack of oversight over their distribution, all the while collecting record breaking profits and paying sale reps in the field enormous bonuses.  This is the pattern that all Opioid Big Pharma has followed across the United states for the last 20 years, pay field sales rep many thousands of dollars on bonuses, to push opiates on doctors, hospitals and anyone else who can move drugs into the healthcare treatment assembly line.

 OPIOIDS FOR CASUAL PAIN MANAGEMENT PUSHED BY BIG PHARMA

Why did the emphasis on pain management in the 1990s result in a focus on opioid prescriptions? One reason may have been aggressive marketing efforts by opioid drug makers. For example, from 1996 to 2001, Purdue Pharma held more than 40 pain management conferences for healthcare providers to promote the use of its new OxyContin® extended-release formula of oxycodone. Sales surged from $45 million in 1996 to $1.1 billion a year in 2000—an increase of well over 2000%.

“We were told way back in the ’90s that these drugs were safe, that they wouldn’t hurt people, and that it was imperative to control pain,” Dr. Kalliainen recalls. Then, in 2007, Purdue admitted it had misled doctors into thinking OxyContin was less easily abused than other drugs in its class. It agreed to pay $600 million in fines and other fees to the Justice Department. Something else has changed in the culture as well, says Dr. Kalliainen. Patients seem to be in as much emotional pain as physical pain. “I’ve been in practice for 16 years now, and there’s been a huge increase in free-floating anxiety in patients,” she says.

US physicians often that find writing a prescription for an opioid is the most convenient way to respond to their patients’ demands, Dr. Kallianen says. As a resident in the 1990s, she remembers being told by the attending physician to write prescriptions for 60 or 70 opioid tablets for nearly every surgery patient. “You started a whole generation of physicians who are out there saying, ‘Write them for 60 [tablets] so they don’t call in.’”

One reason the practice has persisted is that surgeons often don’t know what effect their prescriptions are having, says Dr. Kalliainen. “We don’t see somebody dying of an overdose or becoming addicted. We don’t know if somebody is coming in and stealing their medications from their medicine cabinet and then having a problem. All the negative effects are away from our direct vision. So we’re not taking as much responsibility.” But research shows that once they have received opioid drugs, many patients can’t stop using them. One study found that 8.2% of patients who took opioids for the first time after total knee arthroplasty were still using them 6 months later, despite weak evidence that the drugs are effective for chronic pain management.

Among people already abusing drugs, some studies suggest that the opioids serve as a bridge between other substances and heroin.] Even when patients don’t abuse the opioids themselves, the drugs prescribed to them may end up in the hands of people who do. Surveys of people who abuse opioids show that as many as 23.8% obtained the drugs from clinicians, and 53% obtained them from friends or relatives, most of whom obtained them from clinicians.

“It’s not like these are stolen off the truck,” says Brent J. Morris, MD, a shoulder and elbow surgeon at the Shoulder Center of Kentucky in Lexington, who has published extensively on opioid prescribing patterns. “Certainly, physicians play a role in this.”

RECENT FDA COMMENTS ON OPIOIDS

Opana ER: June 2017  U.S. Food and Drug Administration requested that Endo Pharmaceuticals remove its opioid pain medication, reformulated Opana ER (oxymorphone hydrochloride), from the market. After careful consideration, the agency is seeking removal based on its concern that the benefits of the drug may no longer outweigh its risks.

Codeine and Tramadol Can Cause Breathing Problems for Children

FDA Drug Safety Communication: FDA restricts use of prescription codeine pain and cough medicines and tramadol pain medicines in children; recommends against use in breastfeeding women issued on April 20, 2017.

These medicines can cause life-threatening breathing problems in children. Some children and adults break down codeine and tramadol into their active forms faster than other people. That can cause the level of opioids in these people to rise too high and too quickly.

January 2018 FDA Drug Safety Communication: FDA requires labeling changes for prescription opioid cough and cold medicines to limit their use to adults 18 years and older

The U.S. Food and Drug Administration (FDA) is requiring safety labeling changes for prescription cough and cold medicines containing codeine or hydrocodone to limit the use of these products to adults 18 years and older because the risks of these medicines outweigh their benefits in children younger than 18.

FIGHTING THE OPIOiD FIGHT

In the United States, has been fighting a losing opioid battle for a long time now. With one study reporting that Americans consume approximately 80% of the world’s opioid drug supply. Given that painkillers make up the one of the largest classes of drugs manufactured around the globe, second only to cancer drugs, this is a rather staggering statistic: According to the CDC, more than a quarter of a billion prescriptions for opioid painkillers were written in 2013, the latest year for which data is available, and that number has almost certainly risen in recent years.

As these two latest studies show, not only are we losing the battle against opioid use – and, more importantly, abuse – but the battle itself is largely one that we should never have had to wage in the first place. A large portion of people who become addicted to opioids do so after receiving a prescription for long-term pain management. But as the JAMA study shows, it appears opioids are actually worse at managing chronic pain than non-opioid medications.

The primary reason for addiction and the correlating social problems is the casual acceptance by so many that opioids prescribed by a doctor are well intended and okay to use, not realizing that over time people tend to build up a tolerance for them. This means that patients have to take larger and larger doses in order to receive the same benefit as they did previously with smaller doses. This has been long known by doctors and researchers, including the Big Pharma Opioid marketing and sales teams, which was reinforced in the JAMA study. Participants reported that opioids were more effective than non-opioids early in the study, but at around six months they started to report that opioids the same or even less effective at managing pain than their non-opioid counterparts.

Other side effects include nausea and vomiting, mental health problems (including everything from confusion to depression), and full-blown chemical dependence. Then, there are the problems associated with opioid withdrawal. The upshot of all these side effects is that, even when opioids are working, they well may wind up causing the patient harm in other ways.

Combined with the increase in overdoses, the fact that opioids are less effective than presumed creates a substantial public health problem. We are throwing large sums of public and private money at treating opioid addiction and related issues caused by a problem that could have been completely avoided by using more effective (and less habit-forming) medications.

IS THERE A SOLUTION FOR THE OPIOID CRISIS?

People in many different professional areas are looking for ways to address the addiction problem that has arisen while simultaneously working to prevent future addictions. The concern is having the crisis split along political lines where conservative push for draconian solutions and liberals push for free treatment for everyone. Both solution are untenable and misdirected, but there are proponents for both strategies forming in camps across the country. .

Given the reduced effectiveness of opioid painkillers over time, doctors must look at finding newer and better ways to treat long-term and chronic pain, with a more fully evolved treatment protocol. This includes research and developing into safer medications, more active lifestyle review and changes by patients and a wider acceptance by the medical community of complementary therapies, such as meditation, yoga, tai chi, and massage – including the use of medical marijhuana.  Awareness about these alternative pain relief methods need to be be included as part of any sincere program that provides solutions to the opioid crisis.

THE PRESCRIPTION OPIATES BEING PRESCRIBED

  • oxycodone (OxyContin, Percodan, Percocet)

  • hydrocodone (Vicodin, Lortab, Lorcet)

  • diphenoxylate (Lomotil)

  • morphine (Kadian, Avinza, MS Contin)

  • codeine

  • fentanyl (Duragesic)

  • propoxyphene (Darvon)

  • hydromorphone (Dilaudid)

  • meperidine (Demerol)

  • methadone

For another thing, public policy on illegal drugs needs to be significantly reconsidered, especially for less-addictive drugs like marijuana.  A study published last year in the American Journal of Public Health showed that legalizing marijuana for recreational use can significantly reduce the number of opioid deaths. Considering there have been no known reports of a marijuana overdose ever according to the U.S. Drug Enforcement Administration (DEA), that seems like a pretty good tradeoff from a simple public health policy perspective.

Another way to fight the problem is to increase the availability of opioid agonist drugs, such as naloxone, not only to health care providers and emergency department staff but to trained first responders and others as well. Naloxone reverses the effects of both prescription opioids and illegal drugs, such as heroin, and it can be an important first step toward helping those with substance use disorders become well.

Finally, IN the emerging MDL 2804 (Opiate Prescription Litigation) the opioid drugmakers, distributors and pharmacies are being held accountable for marketing tactics and self-funded studies that may have overblown the effectiveness of their drugs.  Many state, county, and local governments are bringing lawsuits, including RICO claims, against pharmaceutical companies in an attempt to offset costs for public health services that have been used to treat addictions and other medical conditions caused by opioid abuse. The DEA and the Department of Justice recently agreed to provide its data on prescription opioid sales to states and municipalities that are pursuing lawsuits.

The comparison is made to the Tobacco Litigation of the 1990’s which settled in 1998 for $200 billion, WITH he Opiate MDL 2804 litigation being expected to easily surpass that figure with conservative estimates reaching between $750 and $900 billion dollars.

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The Immigrant Doctor Who’s Solving West Virginia’s Opioid Crisis

 

A data-driven commissioner of public health figured out a way to slow overdose deaths. But treating addiction is a much harder problem.

Politico Magazine, May 2, 2018

By Brianna Ehley

Dr. Rahul Gupta, West Virginia Commissioner of Public Health

 

 

 

 

 

 

 

 

CHARLESTON, W.Va.—Last fall, after watching the death toll from opioids climb unchecked for years, Dr. Rahul Gupta, the man in charge of combating one of the worst health crises in America, decided to do something no one had ever tried. He ordered staff to do an in-depth analysis of every person in his state who had died of a drug overdose over the preceding year—all 887 of them.

Since 2014, West Virginia has held the grim distinction of having the highest overdose death rate in the country, according to Centers for Disease Control figures. In 2016, West Virginia’s death rate, according to the most recent federal data, was 52 per 100,000 people—nearly three times the national average. The next highest state, neighboring Ohio, had 39 deaths per 100,000. What West Virginia lacked, though, were the hard numbers that might point officials to a way out of a disaster that showed no signs of abating.

“We wanted to know who each person was and what we could have done to help them,” Gupta, West Virginia’s public health commissioner, told me when I interviewed him in his Charleston office recently. Doctors, he said, know the risk factors for heart disease and use them to screen patients and prescribe treatment. “We didn’t have something like that for opioids. We’re all sort of trying to address a problem without a lot of data to know how to approach it from a prevention aspect. So we wanted to develop those risk factors.”

Over the next 10 weeks, Gupta’s staff combed through public databases, Medicaid rolls, medical examiner reports, birth certificates, death certificates and criminal records. They wanted to find out who was at highest risk of an overdose in West Virginia so they could produce a report for the state legislature before its session began in January. The idea was to give policymakers a data-driven road map of how to get the death rate down, who to focus resources on, and what programs and policies might help them achieve it.

The findings ultimately would show a depressing pattern of vulnerability: Men were twice as likely as women to die of an overdose. And those with jobs in blue-collar industries like construction had a higher risk of overdosing than the general population, likely because they take prescription opioids or illicit substances to deal with chronic pain from injuries. “If you’re a male between the ages of 35 to 54, with less than a high school education, you’re single and you’ve worked in a blue-collar industry,” Gupta said, “you pretty much are at a very, very high risk of overdosing.”

Top left and top right: The Health Right Clinic in Charleston, West Virginia. Bottom left: Dr. Rahul Gupta has a laugh with clinical coordinator Rhonda Francis. Bottom right: Dr. Rahul Gupta passes a large mobile healthcare station on his way into the clinic. | Craig Hudson for POLITICO Magazine

The report included recommendations ranging from limiting initial prescriptions for acute pain to seven days to expanding access to medication-assisted therapies by exempting doctors from federal licensing to administer the treatment. Those recommendations were absorbed into legislation that was signed into law by Governor Jim Justice in March.

But there was another finding, one so obvious and urgent Gupta felt his agency had to act on it immediately. In November, Gupta’s team realized that about 71 percent of people who had fatally overdosed had received emergency medical treatment sometime before they died. But only about half of that group had been administered naloxone, a medicine that when injected can reverse the effects of opioids within minutes.

“We saw this was clearly a missed opportunity where we could have saved people … so it’s critical that whenever these individuals do come into contact with one of the health systems, we take advantage of that opportunity and we do not let that slide.”

Over the past three months, the state has also engaged in a full-court press to get naloxone into the hands of as many people as possible. That includes a recent mandate passed by the state legislature (price tag: $1 million) requiring all first responders to carry the overdose antidote and encouraging libraries and public schools—elementary through high school—to stock up on the lifesaving drug. In January, Gupta issued a standing order for naloxone so that individuals don’t have to pay out of pocket for the drug, which can cost around $40 per dose. In Cabell County, which surrounds Huntington, the city considered to be the epicenter of the West Virginia epidemic, the number of EMS overdose responses declined 36 percent between the first quarter of 2017 and the first quarter of 2018, according to county figures.

The emergency distribution of naloxone may finally be having an effect on the seemingly unstoppable death toll in West Virginia. Although overdose fatalities in 2017 increased 2 percent to 909 from the year before, deaths slowed by about 25 percent in the second half of the year. Officials caution that number could change as there is often a lag in data. Death reports from 2016 are still trickling in. But federal data also shows a slowdown of overdoses in West Virginia. A CDC snapshot of 2017 hospital data showed that hospitalizations for drug overdoses were slightly down in West Virginia, even at a time when most other states across the country saw a dramatic increase.

“We are expecting improvements in overdose deaths this year with all of these things we’re putting into place,” Gupta told POLITICO Magazine. “We’re thrilled about it, but we still feel that we have a long way to go.”

West Virginia’s work to get a handle on the drug abuse epidemic comes as Congress and the Trump administration continue to debate the best ways to tackle the crisis nationwide. Congress recently appropriated an additional $4 billion to help address drug abuse, including for programs to help states expand access to treatment and prevention programs as well as law enforcement activities. Surgeon General Jerome Adams recently issued a rare public advisory encouraging more people across the country to carry naloxone.

But as Gupta and most public health experts warn, naloxone isn’t going to end the opioid crisis. It’s a temporary bandage that saves people but does not treat them. Often many of the same patients who get revived from an overdose end up overdosing again. “We’re doing a good job of saving lives,” said Jack Luikart, the director of correctional substance abuse control under West Virginia’s Military Affairs and Public Safety Department, “but treating addiction, that’s where we need to step up our game.”

Gupta, the son of an Indian diplomat, was born in India but grew up in a Maryland suburb of Washington. He came to West Virginia in 2009 to lead the Kanawha-Charleston Health Department after doing stints as a local health official in Tennessee and Alabama. He was appointed state public health commissioner by former Democratic Governor Earl Ray Tomblin in December 2014, following his work overseeing the response to the massive chemical spill near Charleston in January 2014.

While leading the local health department, Gupta, 47, watched the opioid crisis develop and then explode. He lobbied the state legislature to require special opioid prescribing training for physicians and pushed measures to crack down on “pill dumping,” in which opioid manufacturers send mass quantities of pills to one area, far outpacing demand. Most of the focus then was on limiting prescription opioids, but by the time he took over as state public health commissioner, the opioid crisis had evolved from prescription drug abuse to illicit drug use like heroin and the powerful synthetic opioid fentanyl.

In his first two years as state public health commissioner, the state approved guidelines for opioid prescribers and passed Good Samaritan laws, but, Gupta said, the overdose death data revealed that their work wasn’t saving lives. Despite those efforts, the overdose death rate continued to climb. In 2015, 735 West Virginians died of an overdose, according to state figures. The next year that number climbed to 887.

“For me, it was the second year in a row that I was seeing the numbers continue to incline,” he said. “That’s when I said we have to do something different.”

The state in 2017 applied for, and received, a number of federal grants that officials used to buy naloxone kits to distribute to communities. The federal government also approved a waiver for West Virginia last fall to allow Medicaid to pay for inpatient substance abuse treatment at certain facilities as part of a push to expand access to care.

But Gupta wanted a more immediate way to get a handle on the deaths, and that’s where his overdose analysis project came in. “We were in a rush for time because if there was an opportunity to have legislation passed this year, this was it,” he said. His team turned the report around in three months, partnering with Johns Hopkins University, West Virginia University and Marshall University to come up with a set of 12 policy recommendations. “We didn’t want it to sit on the shelf. We wanted to present practical steps that we could put into place immediately,” Gupta said.

“We often don’t get data-driven policy making in times of an epidemic or a crisis,” Gupta said. “We were using this social autopsy of West Virginians who had died to create policy … and that’s very hard to push back against.”

Roughly 91 percent of all overdose victims had a documented history within the state’s prescription drug monitoring program, meaning they had previously filled a prescription for an opioid. About half of all female victims had filled an opioid prescription within 30 days of their death. From this finding, lawmakers crafted, and approved, legislation that limited initial opioid prescribing and cracked down on providers found to be inappropriately prescribing opioids to patients.

“The problem is there is so much of it in circulation,” Gupta said of prescription opioids.

West Virginia, in the past few years, has taken action to prevent pill dumping, after mass quantities of prescription painkillers flooded into small towns far surpassing necessary amounts. According to a congressional probe by the House Energy and Commerce Committee, over the past 10 years, drug manufacturers have shipped 20 million prescription painkillers to two pharmacies in Williamson, Virginia, a town of about 3,000 people. The Drug Enforcement Administration last month released a proposed rule that would limit how many opioids drug makers can manufacture in an effort to prevent pill dumping.

Gupta said the state is trying to be cautious not to restrict opioids so much that people who actually need them can’t access them. “It’s very important that we don’t forget about those people with legitimate pain. We want minimum disruptors for them,” he said, adding that “there’s still a role for opioids to play.”

Four out of five West Virginians who died from an overdose in 2016 had come into contact with the health system, whether it was during a visit to the emergency room from a prior overdose, or a visit to a clinic for a routine checkup. About 71 percent had or were eligible for Medicaid coverage.

More than half of West Virginians who died of an overdose in 2016 had been incarcerated at some point. That told policy makers that there needed to be more policies built around the incarcerated population.

After that finding, Gupta partnered with the Department of Corrections to develop a number of programs aimed at helping prison and jail inmates who are struggling with addiction. One pilot program, which will be expanded statewide in the summer, gives assisted treatment to inmates with an opioid medication upon their release and then helps connect them to longer term care in the community.

“First, we were like, why do we want to get involved in treatment? That’s not our thing … but when we took a look at this, one of the reasons we have contraband in our facilities is because of inmates with addiction,” said Luikart, of West Virginia’s Military Affairs and Public Safety Department. “So, if we can provide treatment in our prisons and jails, there will be less demand for contraband.” He added that by treating addiction, they also hope to cut recidivism, which is high among people with addiction. “That will help with prison overcrowding.”

Gupta is data-driven, but he also knows the value of gathering anecdotal evidence. Once a month, Gupta works on the front lines of the epidemic, treating patients with drug addiction at West Virginia Health Right, a charity clinic in Charleston that is also one of the city’s two needle exchanges. He treats patients with chronic pain, who became hooked on prescription painkillers and are now self-medicating with illicit drugs that are cheap and easy to find. He tries to direct them into longer-term treatment. “These are mainstream individuals that got entangled into the grips of addiction, and the data shows us that,” Gupta said.

He sees patients who have overdosed a half dozen times and who are still not given any kind of follow through or long-term help. On a recent visit to the clinic, he spoke with a woman who had been resuscitated nine times by paramedics.

Michelle Spencer, 37, has been in and out of treatment for several years. After she was rescued from her latest overdose, she was told by paramedics that they wouldn’t use the antidote on her again. “They narcanned me so much that they said they aren’t willing to do it anymore,” Spencer told Gupta during one of his volunteer shifts at West Virginia Health Right. She came to the clinic with her teenage daughter, who is encouraging her to get into, and stick with, treatment. “It’s so easy to go and do more,” she says.

Spencer’s addiction started like many, with prescription drugs, which she stole or bought from friends. Then she switched to methamphetamine, which was easier to find. She says she has bipolar disorder and has been self-medicating for at least a decade. She went to prison for drug possession and was released about three years ago. That’s when she started using heroin. Like meth, it was cheap and easy to find. She says she uses several times a day.

The treatment program Gupta has recommended for Spencer, who is on Medicaid, takes several days to get into. Because she was suffering extreme withdrawal symptoms, she begged him to get her into more immediate treatment, fearful that she might use again if she didn’t get help immediately.

Spencer was in a common predicament. Out of the more than 2.1 million Americans with opioid use disorder, just 20 percent receive specialty addiction treatment, according to the Substance Abuse and Mental Health Services Administration. It can be particularly challenging to find medication-assisted treatment, which has a proven track record of treating addiction, in rural areas. One of the challenges West Virginia and many other states across the country are facing is how to expand access to that treatment, which is not widely available across the country for a variety of reasons.

Doctors who administer medication-assisted treatment like buprenorphine are required to have federal licensing and waivers that some say are burdensome and deter doctors from getting them. West Virginia recently passed a measure that allows primary care doctors with smaller practices to administer medication-assisted treatment without having to be licensed federally.

West Virginia state Sen. Ron Stollings, who is also a primary care doctor in Madison, West Virginia, said the waiver allows physicians like him, who don’t specialize in substance use treatment but come across many patients struggling with addiction.

“You need to realize that if you don’t treat them right away, they’re more likely to become a statistic—dead from overdose,” Stollings said. “The idea is to get someone on medication-assisted treatment early on.” He added that he isn’t sure how many fellow primary care providers will want to take part in the program, but “it’s a tool in the toolbox.”

On a recent Tuesday, Chris Rauhecker, a recovering heroin addict who now counsels people with drug addiction, and Lindsey Harmon, a Cabell County paramedic, jumped into an old, unmarked police car and drove into downtown Huntington on a mission to find a homeless man who had overdosed in the public library the day before.

They knew nothing more about him than his name and the county paramedic’s report that detailed the overdose incident. He was discovered unconscious on the library’s second floor and was revived by paramedics with naloxone. When he woke up, he walked out of the library and back onto the streets.

The scenario is all too common in Huntington, the rural, Appalachian community that’s become the epicenter for the opioid abuse epidemic: A person overdoses, paramedics rush to the scene to revive him, and once he’s awake, he’s free to walk away with an untreated drug addiction and a high chance of overdosing again, with the next time even more likely to be fatal.

Rauhecker and Harmon are part of a small but persistent team that is working to break that cycle. With federal funding and assistance from Gupta’s office, Cabell County’s Quick Response Team was launched last December to be the link to care for people who suffer from drug overdoses.

The team follows up with drug overdose victims within 72 hours of the incident and helps connect them to long-term treatment. If a patient has a home address, they’ll make house visits. If not, they’ll check the local shelters and drive around town until they find them. Gupta said Charleston is in the stages of developing its own “QRT” and thinks Huntington’s program could serve as a model for other communities nationally that are looking to get a handle on drug overdose deaths.

Rauhecker and Harmon eventually located the man about five blocks from the library near a Sheetz convenience store—known as a local hangout for drug users and dealers. They approached him, introduced themselves as the Cabell County’s Quick Response Team and assured him they were there to help, not implicate him. After some convincing, he agreed to go to an inpatient detox facility. They called a local treatment center, secured a bed for him and drove him there.

“By the end of the week, hopefully, if he’s still receptive, we’ll try to get him into long-term care,” Rauhecker says, cautioning that not everyone the team encounters is ready to be helped, and they know there is a process to gaining a patient’s trust. Word is catching on about the Quick Response Team. He said more and more often people are expecting them to show up, “sometimes they’re even relieved.”

Since December 4, the Huntington QRT has connected with 179 patients who had previously suffered a drug overdose. Of that group, 61 people are now in a form of long-term treatment including medication-assisted therapies, residential treatment centers and sober living homes. That’s about a 34 percent success rate, which county officials are pleased with since the program is only four months old.

The key to QRT, Larrecsa Cox, a paramedic on the team, explained, is that they treat each patient they meet differently, based on their needs. They spend time talking to the individuals to learn what kind of treatment, if any, they are interested in pursuing. This often means either medication-assisted treatment or an abstinence-based program like a recovery home.

People aren’t always receptive. “I wouldn’t say they’re always glad to see us. Some people don’t want us there,” Cox said. That doesn’t deter the team, which often makes multiple trips a week to a patient’s home to follow up and make sure he’s sticking to his appointments. QRT members also stay in touch with patients by texting and talking on the phone.

Top: The QRT make a home visit in Huntington. Bottom: Cox and Prestera counselor Sue Howland, center, make a home visit to two clients. Howland is a recovering alcoholic now seven years without a drink, and is often a familiar face to new clients. Frequently during QRT visits, other users living in the same household will reach out for help. | Craig Hudson for POLITICO Magazine

“If they aren’t interested, we come back later,” Cox said.

Harmon, another paramedic, said she once knocked on the door of a patient’s home every day for a month before finally the woman agreed to hear her out. Her persistence paid off: The woman is now in an inpatient facility in another town, and Harmon still texts her to check in.

“Some of these people, you deal with them so much, you kind of get attached to them,” Harmon said. She added that many of the people they visit don’t have family support systems to help them cope. “In some cases, we become their friends and their family,” she said.

“I wish there would have been someone that would have done this for me,” said Rauhecker, who has been clean from heroin for 26 months and now works as a recovery coach at Recovery Point, a sober living home in Huntington. He said he is certain he would have gotten help earlier if a team of people had knocked on his door and dedicated their time to getting him treatment.

Rauhecker rides along with the group and uses his own experiences recovering from heroin addiction to relate to patients and help them get connected to longer term care. The QRT also employs someone from a clinic that provides medication-assisted treatment to represent that option.

“What works for one person isn’t always going to work for someone else,” he said, adding that sometimes patients want to go to a sober living home, while others prefer medication-assisted treatment. Either way, “the biggest thing is that they have to be ready and want to get help; otherwise it’s not going to work.”

 

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