(MASS TORT NEXUS MEDIA) The state of New York has joined in the opiate litigation being filed against Purdue Pharma claiming that Purdue misled doctors and patients about the risks and benefits of its opioids, including its multi-billion dollar per year seller OxyContin. The complaint states that Purdue continued to deceptively market its products after pleading guilty to criminal conduct in 2007 and agreeing to cease the misleading marketing per the 2015 agreement with the New York state Attorney General’s Office.
“Our investigation found a pattern of deception and reckless disregard for New Yorkers’ health and well-being — as Purdue lined its own pockets by deliberately exploiting our communities and fueling an opioid epidemic that’s destroyed families across the state,” New York state Attorney Gen. Barbara Underwood said in a statement. “We’re now holding Purdue to account for this reprehensible and illegal conduct.
According to the complaint filed in the state supreme court in Suffolk County, this enabled privately held Purdue to boost prescriptions and profits, at the cost of lost lives and “devastation” in communities now “awash” with the painkillers
Since the beginning of May, the attorneys general of Florida, Nevada, Massachusetts, North Carolina, North Dakota, Tennessee, Texas, Utah and Virginia have also filed lawsuits against the company.
New York City previously filed a $500 million suit a lawsuit against pharmaceutical companies that make or distribute prescription opioids, on Tuesday the complaint was filed in New York state court, Superior Court of Manhattan, which is a break from other Opioid lawsuits filed by cities, who filed into federal court, see Mass Tort Nexus Briefcase, OPIOID-CRISIS: MDL-2804-OPIATE-PRESCRIPTION-LITIGATION. The primary claims state that the opiate drug companies fueled the deadly epidemic now afflicting the most populous U.S. city, joining Chicago, Seattle, Milwaukee and other major cities across the country in holding Big Pharma drug makers accountable for the opioid crisis. The case docket information is: City of New York v Purdue Pharma LP et al, New York State Supreme Court, New York County, No. 450133/2018.
Gov. Andrew Cuomo said in a statement “The opioid epidemic was manufactured by unscrupulous manufacturers and distributors who developed a $400 billion industry pumping human misery into our communities”.
The suit comes three months after Underwood first announced her intention to sue the pharma giant, joining several other states that have already targeted Purdue for its alleged role in the epidemic that saw more than 3,000 New Yorkers die of opioid overdoses in 2016. Daniel Raymond, deputy director of the Harm Reduction Coalition, said that the cities and states are forced to file suits now, after realizing initially that the opioid overdose rates “were primarily driven by prescription painkillers — they weren’t concentrated in urban areas.”
“But the recent rises in prescription overdoses, which in turn has accelerated a major increase in heroin overdoses, 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, he stated “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 same affects are in New York and other major metropolitan areas now based on the ongoing marketing abuses by Purdue Pharma and other opiate industry drug makers and distributors.
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.
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 “mislabelling 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
In a statement, Purdue said it “vigorously” denies the allegations laid out in the state’s suit.
“The state claims Purdue acted improperly by communicating with prescribers about scientific and medical information that FDA has expressly considered and continues to approve. We believe it is inappropriate for the state to substitute its judgment for the judgment of the regulatory, scientific and medical experts at FDA,” the statement reads
In a statement, Purdue denied New York’s allegations but said it shared the state’s concerns about the “opioid crisis.”
The Stamford, Connecticut-based company said the U.S. Food and Drug Administration “continues to approve” of scientific and medical information it has provided to doctors.
New York is seeking to impose civil fines, recoup profits and obtain other damages, including for creating an alleged “criminal nuisance.”
Purdue sold $1.74 billion of OxyContin in 2017, according to Symphony Health Solutions.
Opioid makers and distributors face hundreds of lawsuits by U.S. states, counties and cities accusing them of using deceptive marketing to sell the painkillers.
New York joined at least 26 other U.S. states and Puerto Rico in filing lawsuits against Purdue Pharma over opioids and there is a 41-state coalition investigating the opioid industry.
Opioids, including prescription painkillers and heroin, played a role in a record 42,249 U.S. deaths in 2016, according to the U.S. Centers for Disease Control and Prevention.
This included at least 3,086 deaths in New York state and more than 1,100 in New York City.
As Purdue Pharma comes to grips with the fact that they are being designated as the primary litigation targets of states, counties and cities across the country for being the Opiate Big Pharma leader in creating the current opioid crisis in the United States, they may need to determine how they will pay the billions of dollars in jury verdicts and affiliated legal settlements resulting from the lawsuits that now number close to one thousand in state and federal courts.
Employer Costs Pass $2.6 Billion Per Year With 50% Used to Cover Children
By Mark A. York (August 3, 2018)
Employers spent $2.6 billion on opioid addiction in 2016
$1.5 billion+ was spent on children with opiate addiction issues
(MASS TORT NEXUS MEDIA) The now commonly known costs associated with employers treating opioid addiction and the affiliated issues have increased eight hundred percent since 2004 to an eye-watering $2.6 billion in 2016, a new report reveals.
The latest analysis shows that half of the cost was spent covering employees’ children.
A recent Kaiser Family Foundation report found that prescription use of addictive painkillers among people with employer offered health coverage is now at the lowest levels in 10 years.
This comes shortly after a CDC study revealed there was been a nearly 30 percent increase in overdoses between 2015 and 2016.
According to the Centers for Disease Control and Prevention, opioids killed more than 42,000 people in 2016, more than any year on record.
With 40 percent of those deaths involving a prescription opioid such as Oxycontin and Vicodin and other widely prescribed opiates. This has also resulted in the multi-billion lawsuits filed against Opioid Big Pharma drug makers and distributors by cities, counties and states across the country, see Mass Tort Nexus Briefcase “Opioid Litigation Versus Opiate Prescription Industry MDL 2804, US District Court of Ohio”with the drug makers and distributors scrambling to defend the opiate marketing strategies that have caused billions and billions of dollars in costs, medical damages and loss of productivity annually in the United States.
The Kaiser Family Foundation found that the $2.6 billion spending cost companies and workers about $26 per enrollee in 2016, which now appears to be a “man-made” healthcare cost increase associated with the widely accepted Opiate Big Pharma marketing practices over the last 20 years. This include telling doctors and the healthcare industry that “opiates are not as addictive as they used to be” and “we’ve altered the drug compound to control opiate release” which was the widely used Purdue Pharma marketing strategy.
Employers have been limiting insurance coverage of opioids because of concerns about addiction. The report found that spending on opioid prescriptions falling 27 percent from a peak in 2009 – when 17.3 percent of large employer plan enrollees had at least one opioid prescription during that year. However, by 2016, that number dropped to 13.6 percent.
These drugs relieve pain by attaching to specific proteins called opioid receptors, which are found on nerve cells in the brain, spinal cord, gastrointestinal tract, and other organs in the body. When they attach to these receptors, they reduce the perception of pain.
[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]
Prescription opioids and illicit drugs have become incredibly pervasive throughout the US, and things are only getting worse.
In the early 2000s, the FDA and CDC started to notice a steady increase in cases of opioid addiction and overdose. In 2013, they issued guidelines to curb addiction.
However, that same year – now regarded as the year the epidemic took hold – a CDC report revealed an unprecedented surge in rates of opioid addiction.
Overdose deaths are now the leading cause of death among young Americans – killing more in a year than were ever killed annually by HIV, gun violence or car crashes.
Preliminary CDC data published by the New York Times shows US drug overdose deaths surged 19 percent to at least 59,000 in 2016.
That is up from 52,404 in 2015, and double the death rate a decade ago.
It means that for the first time drug overdoses are the leading cause of death for Americans under 50 years old.
The data lays bare the bleak state of America’s opioid addiction crisis fueled by deadly manufactured drugs like fentanyl.
These drugs also effect the brain regions involved in reward, so it can also produce a sense of pleasure by triggering the same processes that make people feel good when they are having fun or sex.
Experts say many people’s first contact with opioids is through some form of social contact: either a friend who was sent home with Oxycontin after a surgical procedure or a relative who received an opioid prescription for chronic pain.
‘Opioids are not infectious in terms of [being] an agent,’ Columbia University epidemiologist Dr Guohua Li previously told Daily Mail Online.
‘Opioids, are not a bacteria virus, but the drug, in this case, spreads through social networks…even in some ways a virus, like HIV, is spread to a great degree through social networks,’ he added.
Due to the link between hospitals and the opioid crisis, doctors have been coming up with innovative ways to curb the epidemic.
However, hospitals have been doing their part in trying to curb the opioid epidemic.
For instance, the ER department at St. Joseph University Medical Center in New Jersey managed to halve the rate of opioid prescriptions by using dry needles and laughing gas to treat chronic pain.
In 2016, the department launched an Alternative to Opiates program that uses trigger point injections and a local anesthetics in lieu of opioids to relieve pain. Other alternative pain relieving methods they used was warm compressors and music – they have a harpist roam the halls playing tunes to soothe the patients.
Dr Mark Rosenberg, chair of emergency medicine, said he and his colleagues founded the program after they realized chronic pain was one of the reasons most patients came to their emergency department.
‘We wanted to develop an aggressive acute pain management program that focused on evidence based principles but avoided opioids,’ Dr Rosenberg said.
St. Joseph University Medical Center isn’t the only hospital to implement this program, Kaiser Permanente has implemented an Integrated Pain Service, an eight-week course designed to educate high-risk opioid patients about pain management.
Some experts have stated that the beginning of the end of the epidemic may be near due to tightened regulations on opioid prescription monitoring, local-level efforts to make naloxone, an anti-overdose drug, and drug-assisted rehabilitation more accessible to high-risk populations. Then there are many more “experts” who state that the opioid crisis and the future affiliated issues are going to be on the healthcare, insurance and socio-economic forefront of America for at least the next generation.
Broken Families, Less Funding
The patterns of parent addiction that overflows into child addiction is something that wasn’t part of the opiate equation until fairly recently, where employer issues now mirror a national trend of multiple generations being addicted to opiates. 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.
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 â€“ 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
Local efforts are now seen as the primary way to address the opioid crisis in children- the attempt to secure federal intervention and support to help curb the opioid crisis has not been a priority of the Trump Administration..
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.
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.
“THE OPIOID CRISIS IS NOW PART OF URBAN AMERICA AND BIG CITY LIFE”
Mark A. York (July 12, 2018)
(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.
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.
“[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.
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.
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.comfor 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).
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.
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.
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.
Overdose resulting in death
Overdose without death
Neonatal Abstinence Syndrome
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.
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.
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.
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.
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.
“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.
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 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.
(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:
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.
Opiate Use Has Increased While Realtime Data Shows There’s A Diminishing Return
By Mark A. York (May 11, 2018)
(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 CDClink 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)
morphine (Kadian, Avinza, MS Contin)
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.
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
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 CDCsnapshot 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.”