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What Are The Symptoms Of Spina Bifida?

The news that a baby has arrived with the congenital birth defect known as spina bifida must be devastating to any new mother. At birth, the outward signs of spina bifida may not be too dramatic; in some forms, the first indication might just be an abnormal clump of hair or a small birthmark at the site of what will prove to be a spinal defect.

But this problem that occurs in pregnancy during the formation of the embryo’s neural tube – a narrow sheath that will eventually form the brain and the spinal cord – will have lifelong consequences for a child as it grows. They are several types of spina bifida, and the most serious variations can cause partial or even significant paralysis or make the child more prone to infection, and even lesser forms can affect learning or coordination.

Fortunately, spina bifida is not common. There are roughly 4 million babies born in the United States every year, and only about 1,500 to 2,000 will be diagnosed with the condition. Public health officials estimate that the total U.S. population of those afflicted with spina bifida is about 166,000.

The bad news is that another American public health crisis may be increasing the prevalence of this neural tube birth defect – the heartbreak of opioid abuse. Thanks to aggressive marketing by Big Pharma, the growth in prescription painkillers like Purdue Pharma’s Oxycontin since the 1990s has caused a surge in addiction and lethal overdoses.

But despite warnings from the nation’s main public-health agencies going back nearly a decade, there is much less public awareness about the problems encountered by children who are exposed to opioids while the womb, including their elevated chance of birth defects such as spina bifida. In 2011, the federal Centers for Disease Control and Prevention reported that women whose babies had been born with spina bifida where twice as likely to have taken opioids during their pregnancy than mothers whose children had no birth defects.

Justice for kids exposed to opioids in the womb

This finding, when coupled with the many other health problems experienced by children whose mothers took opioid painkillers during pregnancy – including the most common, which is Neonatal Abstinence Syndrome, or NAS – should have been a red flag for America’s physicians to take special care not to prescribe these drugs to women bearing children. Unfortunately, many doctors seemed unaware of the mounting medical evidence.

Our team of lawyers – the Opioid Justice Team – has been fighting for justice for families raising these children who were exposed to opioid medications such as Oxycontin while in the womb. We’re in court and deeply involved in negotiations seeking to make sure that Purdue Pharma – which recently filed for bankruptcy – and the other large pharmaceutical companies pay for long-term monitoring and health care for these kids, the littlest victims of America’s opioid crisis.

In making our case, we’ve consulted with top medical experts who made a startling discovery – that the United States has seriously underestimated the number of children coping with the effects of opioid exposure in the womb. Their research showed that actually about one-in-three pregnant women in America — or roughly 1.3 million out of the 3.8 million women who gave birth — had been given a prescription for opioid painkillers. Their work has established that a baby with serious problems related to opioid exposure is born somewhere in the United States every 19 minutes, which amounts to as much as 250,000 children every year.

Health effects of in-utero opioid exposure

The majority of these children experienced NAS – a form of opioid withdrawal – at birth. In the hospital, NAS causes symptoms such as body shakes, excessive crying or yawns, feeding problems, diarrhea, sleeping problems, fever, or runny noses. But after these babies are sent home — as both experts and parents are increasingly finding – many have struggled with an array of developmental, behavioral and learning difficulties as they grow.

But while NAS is starting to receive some attention in the medical community and the mainstream media, the problem of opioids and birth defects has received far less attention, even after the research and warnings from the CDC.

The CDC research found that rates of gastroschisis — in which a baby is born with its intestines hanging outside the stomach, due to a hole in the abdominal wall, and which affect about 1,800 U.S. newborns every year — are about 60 percent higher in the counties that had the highest rates of prescription opioid use. In addition to spina bifida, other neural tube defects — which often take place during the first month of pregnancy — that showed increased risk in the 2011 CDC study included anencephaly, where most of the brain and skull don’t fully develop

There are four types of spina bifida: occulta, closed neural tube defects, meningocele, and myelomeningocele. The most common form, occulta, in which one or more vertebrae are malformed, rarely causes any major symptoms or disabilities. But the most severe type, myelomeningocele, can lead to partial or complete paralysis below the opening in the spine. Children with this form of spina bifida might be unable to walk, or can have bladder or bowel disfunction.

More spina bifida symptoms

Babies who are born with either meningocele and myelomeningocele typically have a fluid-filled sac that is visible on the back and protruding from the spinal canal. In meningocele, the sac may be covered by a thin layer of skin. Typically with myelomeningocele, there is no layer of skin covering the sac; often, some of the abnormally developed spinal cord tissue is exposed.

Generally, the higher on the spinal cord any malformation is located, the more nerves that will be affected, which will lead to greater loss of muscle function and sensation. But neural tube defects can also negatively impact brain development. Cognitive problems – affecting the child’s awareness, thinking and learning abilities – can develop, especially if the frontal portion of the brain’s cortex does not fully develop. Other problems involve CSF, a watery substance that flows in around the brain and spinal cord. Too much CSF can lead to hydrocephalus — pressure on the brain — and ultimately to brain damage.

The fight for justice

Raising a child affected by spina bifida can place enormous pressure on a family. That’s why the Opioid Justice Team is committed to making the pharmaceutical industry pay for its gross negligence in the way these dangerous drugs now linked to spina bifida were marketed to physicians and the public.

Our attorneys have gone into federal court to get children born to prescription opioid-dependent-and-using mothers recognized as their own legal class within the national opioid litigation, which is currently before U.S. District Court Judge Daniel A. Polster in Cleveland. We’ve already filed lawsuits in a number of states seeking recognition for the legal rights of these kids and their families.

Much of what we seek is basic common sense. For example, our team has asked that doctors treating female patients who are in their child-bearing years be given a pregnancy test before they can be prescribed any medication containing opioids – the same precaution currently taken with other prescription drugs such as Accutane. We are also pushing for creation of a medical monitoring fund, which will help doctors better understand the health and other developmental problems of these children as they grow.

Children often get a raw deal from the American legal system. In the current case against Big Pharma, the plaintiffs include many of the exact same states and localities who received billions of dollars in the infamous Big Tobacco settlement of the late 1990s and then used the money to balance their budgets rather than improve public health. We’re on a mission to make sure that doesn’t happen again.

Unfortunately, time is running very short for new plaintiffs to participate in our legal fight against the greed of the big drug companies. We encourage those eligible to join us and make sure that, this time, any settlement dollars go to the families and communities that actually need them.

The post What Are The Symptoms Of Spina Bifida? appeared first on Opioid Justice Team.

from Opioid Justice Team https://opioidjusticeteam.com/symptoms-spina-bifida/

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Spina Bifida Lawsuit

How a spina bifida lawsuit is bringing families hope in the opioid crisis

By Donald Creadore

For years, as an opioid epidemic spread across America, the federal government tried to warn women who were pregnant, or in their child-bearing years, that taking prescription painkillers could cause harmful birth defects. They cited research that drugs such as OxyContin, or codeine, might even double the risk of a baby born with spina bifida, a condition that arises from a failure of the spinal to properly close inside the womb.

The first research establishing a connection between opioid use and spina bifida attracted little attention for nearly an entire decade. Only in 2015 – with abuse and overdoes from both prescription medication and illegal street drugs spiking across America – did the U.S. Centers for Disease Prevention and Control publicly reveal evidence linking spina bifida and other birth defects with opioid exposure while inside the womb.

That 2015 CDC study also reported that a shocking number of women in their child-bearing years were using these painkillers, despite the known increased risk of adverse birth outcomes, such as neural tube defects like spina bifida; gastroschisis, a condition where a baby is born with their intestines erupting from their abdomen; and congenital heart defects.

The CDC research published that year in the Morbidity and Mortality Weekly Report released figures showing that nearly one third of all women on Medicaid who could become pregnant and, in addition, about a quarter of those covered by private insurance, had all been prescribed opioid painkillers over a four-year period studied. Government officials found these figures so alarming they were compelled to urge doctors and other health-care providers to exercise extreme caution in prescribing opioids to pregnant women as well as women of child-bearing age – especially during the most critical early weeks of pregnancy.

“Taking opioid medications early in pregnancy can cause birth defects and serious problems for the infant and the mother,”, said Dr. Tom Frieden then Director of the CDC. “Many women of reproductive age are taking these medicines and may not know they are pregnant and therefore may be unknowingly exposing their unborn child. That’s why it’s critical for health care professionals to take a thorough health assessment before prescribing these medicines to women of reproductive age.”

An underwhelming response to a crisis

To say that the response to these CDC warnings was underwhelming is a gross understatement. Across America, doctors continued to prescribe medications, including Purdue Pharma’s OxyContin, to women who then bore children – even though these same doctors had to perform mandated pregnancy tests for other drugs that had been linked to potential birth defects; one example is the popular acne-fighting drug, Accutane. It appears that, for two decades, giant pharmaceutical companies knew both the addiction and health risks associated with using opioid drugs yet did nothing.

Today, however, there is new hope for mothers struggling to raise children born with crippling and life-altering birth defects. I’m working together with a nationwide group of lawyers leading a coast-to-coast legal effort to ensure that children who were exposed to opioids while in utero get the medical monitoring and quality care that they deserve – all of it being funded by the same pharmaceutical entities that caused the problem, the big corporations that comprise Big Pharma.

With little fanfare, an entire generation of American infants–unquestionably faultless and entirely innocent– are destined to become the most forgotten victims of America’s opioid crisis. As Opioid Justice investigated and researched these issues on behalf of these kids, we discovered the problem is much bigger than the government has so far conceded. Our research from publicly-available data establishes that nearly 33% of all pregnant women in America — or roughly 1.3 million out of the 3.8 million women who gave birth — were given a prescription for opioid painkillers. This figure highlights the sad fact that a baby with serious problems related to opioid exposure is born somewhere in the United States every 19 minutes, amounting to as many as 250,000 children every year.

The most common medical outcome from opioid exposure in the womb is neonatal abstinence syndrome, or NAS, a medical diagnosis (for neonates) that few among us had ever heard of until recently. The symptoms of NAS emerge following birth and during a baby’s first few weeks such, and include uncontrollable body shakes; excessive crying or yawning; complications with breastfeeding and difficulties sleeping; , diarrhea; fever. For too many families the difficulties are just beginning. Later childhood will bring behavioral problems, cognitive delays, mental or motor deficits and disorders, like attention-deficit disorder (ADD).

The link between spina bifida and opioids

Many families may not even be aware of the possibility that opioid exposure could be responsible for birth defects, and that is probably the case for spina bifida. It’s a birth defect that occurs in about 7 out of every 10,000 births in America, meaning it affects about 1,500 pregnancies annually, according to the CDC. That CDC study, from 2011, reported upon the significant linkage between opioid exposure during pregnancy and spina bifida; finding that women taking opioids while pregnant are twice as likely to have a baby with spina bifida.

Experts are reporting that birth defects are more likely to occur whenever an expectant mother takes opioid painkillers during the 4th to 10th weeks of pregnancy; unfortunately, many women are unaware of their pregnancy during this timeframe and, by extension, are also unaware of best practices for prenatal care. It stands to reason that the risk for neural tube defects, like spina bifida, is greatest during the early weeks of pregnancy.

Other neural tube disorders that pose an increased risk to neonates, described in the same 2011 CDC study, include anencephaly, a medical condition typified by a brain and skull that can’t fully develop, in addition to hypoplastic left heart syndrome, a condition that prevents the left side of the heart from developing properly which, left untreated with surgery, is fatal. Parents raising children with these conditions pay an enormous toll – both financially and emotionally – which is why legal actions against Big Pharma are so important.

Seeking justice for America’s children

In 2019, our lawyers went to federal court seeking to get children born to prescription opioid-dependent-and-using mothers recognized as their own legal class within the national opioid litigation, which is currently before U.S. District Court Judge Daniel A. Polster in Cleveland. As part of this effort, we’ve filed lawsuits in a number of states seeking recognition for the legal rights of these kids and their families.

Lawyers for hundreds of interested parties, including states, cities and counties from coast to coast, are in the process of trying to negotiate a global settlement with Big Pharma. We are seeking a number of changes to make any deal more family friendly. Our demands include a requirement that doctors conduct pregnancy testing for women of child-bearing age before prescribing opioids, very much like the protocol now in place for Accutane.

More importantly, we are looking for a legal settlement in which the Big Pharma giants that manufactured and aggressively marketed these painkillers knowing the risks– including Purdue Pharma, the firm behind Oxycontin – agree to pay to create a medical marketing fund for these kids. This would allow public health experts to collect data that’s critical to our understanding of both the extent of America’s opioid crisis as well as the best practices to alleviate them. And we want the funds to pay for the long-term care of these children.

The inspiration behind this strategy is our collective memories of the Big Tobacco settlement of the 1990s, in which the multi-billion-dollar payout agreed to by the nation’s cigarette makers for their public lies about the real health hazards of smoking were arguably squandered by states and cities challenged by budget crises — with little or no money toward public-health programs. We believe our 21st century approach will ensure that won’t happen to children and parents who’ve been harmed during the opioid crisis.

There is limited time for new plaintiffs to connect with our team of attorneys in our legal fight. Please join us and help us make sure that any national financial settlement over the opioid crisis goes to the families and the communities that need these dollars the most.

The post Spina Bifida Lawsuit appeared first on Opioid Justice Team.

from Opioid Justice Team https://opioidjusticeteam.com/spina-bifida-lawsuit/

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Does Oxycontin Or Opioids Cause Spina Bifida?

A Legal Action Brings Hope

In 2011 – more than a decade after the nation’s big pharmaceutical companies began aggressively marketing opioid painkillers, but before overdoses and abuse became a national crisis – researchers started asking questions about a possible link between popular drugs likes Oxycontin and codeine and birth defects.

The project, which was led by the federal Centers for Disease Control and Prevention (CDC) in Atlanta, collected information on about 24,000 women and their babies from 1997 to 2005 – many of them born with birth defects – to learn whether using opioid painkillers increased the risk of something going wrong.

Some of their findings were troubling when it came to common birth defects such as heart defects or cleft palate, but the greatest increase in risk involved spina bifida, the condition in which the spinal column doesn’t close properly in the womb. The CDC paper found that women whose babies had been born with spina bifida where twice as likely to have taken opioids during their pregnancy than mothers whose children had no birth defects.

Sometimes, a significant finding such as this will trigger strong preventive measures. For example, when researchers established a link between the drug Accutane — which is taken for skin conditions such as acne — and birth defects, doctors began demanding pregnancy tests for women of child-bearing age before it was prescribed. But doctors in the early 2010s downplayed the risk from painkillers backed by the marketing might of Big Pharma.

Nearly a decade ago, Dr. David Haas of the Indiana Institute for Personalized Medicine told the Reuters news service that – despite the CDC findings – the risk of birth defects seemed low to him when compared to what he saw as the benefits of alleviating pain that these new medicines provided. Most doctors did the same.

In 2020, we know better. As the use – and increasingly, abuse – of opioids like OxyContin or codeine as well as street drugs that were later embraced by addicts increased, not only did birth defects rise but there also was a spike in cases of babies with the drug-withdrawal condition Neonatal Abstinence Syndrome, or NAS, linked to women using their drugs when pregnant.

But we still need smarter medical decisions, as well as long-term care for the children who were affected by this, and a fund for medical monitoring. I’m part of a team of lawyers who are mounting a sweeping legal challenge that aims to make these things happen, and to get the Big Pharma giants behind the opioid crisis to pay for it.

A crisis in plain sight

In preparing to take on these large, deep pocketed companies in court, we learned something appalling: That American officials have been grossly underestimating the annual number of babies born with medical issues or on track for behavioral or developmental problems because of their exposure to opioids in the womb. In fact, a national epidemic, affecting our most vulnerable young people, has been hiding in plain sight.

Our experts came to discover that actually about one-in-three pregnant women in America — or roughly 1.3 million out of the 3.8 million women who gave birth — were given a prescription for opioid painkillers. We estimated that a baby with serious problems related to opioid exposure is born somewhere in the United States every 19 minutes, which amounts to as much as 250,000 children every year.

Some specialists say that birth defects are often likely to occur when an expectant mother takes opioid painkillers in the 4th to 10th week of a pregnancy, which is often before a women knows she is pregnant or given good guidance on pre-natal care.

The most common, and increasingly the best known, consequence of exposing children to opioids in the womb is NAS. In the early weeks of a child’s life, NAS causes symptoms such as body shakes, excessive crying or yawns, feeding problems, diarrhea, sleeping problems, fever, or runny noses. But mothers say that coming home from the hospital is often just the beginning of their problems, which in later childhood can include behavioral problems, cognitive delays, mental or motor deficits, or attention-deficit disorder (ADD).

Painkillers and spina bifida

Less is known about other types of birth defects that have been linked to OxyContin, codeine or other types of painkillers. One such ailment is gastroschisis, in which a baby is born with its intestines hanging outside the stomach, due to a hole in the abdominal wall. There are about 1,800 American cases of this rare illness every year. The CDC research found that rates of gastroschisis are about 60 percent higher in the counties that had the highest rates of prescription opioid use.

In addition to spina bifida, other neural tube defects — which often take place during the first month of pregnancy — that showed increased risk in the 2011 CDC study included anencephaly, where most of the brain and skull don’t fully develop. Heart defects posted the highest gain in the CDC’s study, including hypoplastic left heart syndrome, in which the left side of the heart doesn’t develop properly. It’s fatal if not treated with surgery.

It’s important to note that spina bifida remains rare in the United States, and the overall numbers had been showing some decline. It’s a defect that occurs during about 1,500 American pregnancies every year, meaning that it occurs in about 7 out of every 10,000 live births. But anything that would cause a spike in those numbers would be a cause for great concern.

The neural tube is usually fully formed by the 28th day of pregnancy, but spina bifida occurs when part of the tube doesn’t close perfectly or is otherwise improperly formed. The resulting health impacts can be mild or severe and may require surgery at an early age.

The most severe kind is known as myelomeningocele, or open spina bifida, which causes membranes and spinal nerves to push through the opening in the spinal cord at birth. As a result, these newborns are prone to prone to life-threatening infections; the condition may also cause paralysis and bladder and bowel dysfunction. As people with spina bifida grow, the condition can affect how the person goes to the bathroom or create a feeling in the person’s legs or feet, or an inability to move the legs.

A fight for justice

There is new hope that the mothers of children who were exposed to opioids in the womb – including those with spina bifida – can gain justice in the courts. Our lawyers have gone into federal court to get children born to prescription opioid-dependent-and-using mothers recognized as their own legal class within the national opioid litigation, which is currently before U.S. District Court Judge Daniel A. Polster in Cleveland. We’ve already filed lawsuits in a number of states seeking recognition for the legal rights of these kids and their families.

We are seeking a number of changes, including a requirement that doctors conduct pregnancy testing for women of child-bearing age before prescribing opioids, very much like the protocol now in place for Accutane. More importantly, we are looking for a legal settlement in which the pharmaceutical companies that manufactured and aggressively marketed these painkillers – including Purdue Pharma, the firm behind Oxycontin – pay to create a medical marketing fund for these kids. This would allow public health experts to collect data that will help doctors understand the scope of the problem and share best practices.

We developed this approach because many of us, as lawyers, remember the Big Tobacco settlement of the 1990s, in which the billions of dollars paid out by America’s cigarette makers for decades of dishonesty about the health hazards of smoking were sucked up by cash-strapped states and cities — with little or no money toward making people healthier. Our goal is not to let that happen to the kids and parents harmed by Big Pharma.

There is limited time for new plaintiffs to connect with our team of attorneys in our legal fight. Please join us, and help us make sure that any national financial settlement over the opioid crisis goes to the families and the communities that need the money the most.

The post Does Oxycontin Or Opioids Cause Spina Bifida? appeared first on Opioid Justice Team.

from Opioid Justice Team https://opioidjusticeteam.com/oxycontin-opioids-cause-spina-bifida/

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What Are Symptoms Of NAS?

What are the symptoms of NAS? How one mom found hope

By Donald Creadore

Jeramay Martinez went through extensive training before she was approved to become a foster mom living in of Espanola, New Mexico. But no one warned her how to look for the symptoms of Neonatal Abstinence Syndrome, or NAS – a medical diagnosis assigned to the hundreds of thousands of U.S. kids exposed to opioids as a fetus developing in their mother’s womb.

Everything changed for Martinez from the day she brought home her foster son, who’d been born to a 25-year-old local woman struggling with addiction issues and incapable of raising children.

“The first two and a half months are really hard,” says Martinez, recalling her challenges of taking her foster son home after two stressful weeks in the hospital’s neonatal intensive care unit, or NICU. “Most people would have freaked out, because he shook, he cried a lot, and he needed comforting…It took a lot of comfort and love but now he’s doing OK.” Before her first experience as a foster mom, Martinez had worried about many things: The hard work she knew would be needed to care for an infant and toddler, and the emotions that might come if and when the time came to hand that child back to her birth mom.

But in many ways, raising a boy born with NAS has proven to be much more challenging than Martinez could have imagined. The constant crying and shaking in those early weeks were followed by stomach problems. And now that her son, born in 2018, is a toddler, he struggles with his motor skills and requires physical, speech, and occupational therapy. And yet Martinez couldn’t imagine life without him.

She realized her initial dream — bringing the boy’s mom home to live with her and helping her get off opioids to be able to raise her own son — was overly optimistic and perhaps naïve. Within two weeks, the birth mother – who’d been legally prescribed Purdue Pharma’s OxyContin as a teen but then suffered through eight years of addiction – was gone. Martinez is now legal guardian of boy, now 19-months-old, and hopes to permanently adopt him. NAS: A misunderstood American crisis

The story of Martinez and her son are just one of hundreds of thousands of families struggling with the Nation’s opioid public health crisis. You probably know that America has been rocked for more than two decades of opioid overuse and misuse through Big Pharma flooding the market with prescription painkillers, lacking discrimination and in seeming defiance of warnings of a growing addiction crisis.

The impact on America’s adults is both mindboggling and sweeping. Sadly, over 400,000 Americans have reportedly died from opioids during the period of 1999-2017 (from opioids obtained legally in addition to illegal street drugs). This figure is roughly equal to the number of U.S. soldiers killed in World War II, to provide some perspective to the enormity of the current opioid health crisis. Other social consequences and burdens of the Nation’s’ ongoing opioid health crisis is the alarming and unprecedented spike in the number of children who require foster care because of their parents’ addiction to opioids, whether they were prescribed or not. Inexplicably, largely overlooked by society is the impact of the opioid crisis upon children of mothers that had been prescribed opioids during child-bearing age or while pregnant from a doctor that may also been fully unaware of the medical risks to their fetuses.

Opioid Justice is a group of lawyers dedicated to working together in researching and addressing these complex issues, and it estimates that about 250,000 babies are born every year in the United States that, like the baby that went home with Ms. Martinez, will also likely need specialized medical monitoring and treatment. Of the estimated 3.8 million women who gave birth annually, roughly 1.3 million had been prescribed an opioid painkiller, according to one report. Putting that in perspective, that means that every 19 minutes a baby with symptoms of NAS or other problems due to opioid exposure is born somewhere in the United States.

What are the symptoms of NAS?

There is no way to diagnose NAS while the child is still in the womb. When the umbilical cord is cut, the baby’s body and brain receptors begin to experience altered levels of neurotransmitters such as dopamine, norepinephrine, and serotonin <https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4628571/> — the same type of withdrawals that adults experience from the sudden and abrupt cessation of drug use.

Following birth, the distressing symptoms of NAS (i.e. exposure to opioids while in utero), begin to emerge within hours or, sometimes, 2-3 days following birth; the first signs typically involve a combination of uncontrollable irritability, inconsolable crying, tremors, diarrhea, vomiting, sweating, fever and poor sleep and feeding patterns. Studies establish that babies diagnosed with NAS require longer, and more involved, stays in a hospital’s neonatal intensive care unit (NICU) before they can go home. The outcomes for this enormous population of newborns (diagnosed with NAS) is further handicapped by the fact that the federal government has yet to finalize its clinical definition for NAS.

Recommended initial treatments for newborns diagnosed with NAS range from soothing ‘skin-to-skin’ contact with the mother or, when unavailable, another caregiver, to pharmacologic weaning through the use of methadone or morphine; all in an effort to carefully ease the baby off drug dependency with the fewest complications and least suffering. Surprisingly, little is being done to medically monitor newborns diagnosed with NAS once they are sent home from the hospital’s NICU, notwithstanding the mounting medical studies demonstrating that injuries and disorders due to exposure to opioids while in utero can continue throughout childhood.

As opioid-exposed children mature, many will come to exhibit behavioral problems, cognitive delays, mental or motor deficits, as well be diagnosed with attention-deficit disorder (ADD). It is also noteworthy that – as the opioid crisis widens – doctors are also detecting other birth defects that can be attributed to NAS, such as club foot, spina bifida, heart defects, cleft palate, hydrocephalus, esophageal atresia, gastroschisis, anorectal atresia, and diaphragmatic hernia.

A lack of resources for NAS

In New Mexico, Martinez said she struggled at first with a lack of community-funded resources for the ever-rising number of kids diagnosed with NAS or another problem associated with opioid exposure in the womb. Instead, as an adoptive mom Ms. Martinez has needed to improvise and adapt to current gaping holes in the support net. On her own accord, Martinez was able to locate an expert in baby massage whose work, over time, helped her son cope with early stomach problems among other issues.

“He had light sensitivity and sound sensitivity but has overcome that,” Martinez said. In addition to physical therapy her son is also receiving occupational therapy. Martinez, together with a friend who is also a doula(a non-medical companion for major events such as birthing), are looking to see if they can establish a safe haven under New Mexico law where addicted mothers can safely drop off babies they cannot care for.

“We need to work together to come up with things to help these kids,” Martinez said. “It’s better that we address their problems than just hide.” In 2019, Martinez joined numerous other parents and caretakers who signed onto a nationwide legal action against the large pharmaceutical companies, aiming to make them pay for the long-term care of children exposed to opioids in the womb.

The legal fight for NAS babies

Since 2018, class-action lawsuits have been filed by the members of Opioid Justice on behalf of opioid-exposed children and their guardians, in upwards of 40 states. Our legal team has been working hard to get children born to prescription opioid-dependent-and-using mothers to be recognized as their own legal class within the national opioid litigation currently before U.S. District Court Judge Daniel A. Polster, in Cleveland, Ohio.

Our efforts are linked closely to the ongoing complex negotiations – involving big pharmaceutical companies and scores of states and local municipalities hoping to recover their purported costs for dealing with the opioid crisis – aimed at a comprehensive settlement. Importantly, the members of Opioid Justice are fighting every day to make sure that children with NAS or other opioid-related syndromes are represented in the ongoing bankruptcy action filed by the manufacturer at the center of the crisis, Purdue Pharma, the maker of OxyContin, one of the most widely-prescribed painkillers on the market. A tentative settlement of its liability in the range of $10-12 billion has been reported.

A prime motivation and objective of the members of Opioid Justice is avoiding the mistakes that flowed from the historic settlement in the late 1990s with Big Tobacco. There, the major cigarette makers agreed to pay out billions of dollars that largely went to a coalition of states and other localities – similar in many respects to today’s opioid settlement talks. But in the tobacco case, the lawmakers in states and localities reportedly steered this cash to pay off their bills, fill potholes and pave roads, or build ballfields and parks; almost none of the money went towards smoking-cessation programs, or the widespread health problems that are rightly blamed on cigarettes, as intended.

That’s why it’s profoundly important for the public to know there’s still time for new plaintiffs to join our OxyContin birth defects lawsuit, but that window of opportunity is also getting shorter. If your child was exposed to opioid painkillers during pregnancy, we hope you’ll join us in our legal battle for an agreement that will benefit families, like the Martinez family, not lawmakers. We are fighting for justice for children born with NAS as well as all children suffering from NAS, and we would invite you to be part of the solution.

The post What Are Symptoms Of NAS? appeared first on Opioid Justice Team.

from Opioid Justice Team https://opioidjusticeteam.com/what-are-symptoms-nas/

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NAS Baby Lawsuit

NAS baby lawsuit offers hope to families ravaged by America’s opioid crisis

By Donald Creadore

Few women in the United States have seen the effects of the opioid-abuse crisis on the nation’s kids like Kathy Strain. After her children struggled with addiction, the Berks County, Pennsylvania, woman turned her anger and anxiety into activism – especially on behalf of a growing number of grandparents unexpectedly raising babies who are suffering the lasting health impacts of exposure to opioids in the womb.

“It really is a big group of kids, with all of the issues, and nobody knows,” said Strain. She is talking about the estimated 250,000 children born every year in America diagnosed with Neonatal Abstinence Syndrome, or NAS, as well as other health or developmental issues caused by opioid exposure. or NAS – a medical diagnosis assigned to the hundreds of thousands of U.S. kids exposed to opioids as a fetus developing in their mother’s womb.

Strain – who was once a Pennsylvania moderator for a popular internet message board called The Addict’s Mom – talks regularly to family members who worry about physical symptoms like clenched jaws or grinding teeth in their children, or see developmental or psychological difficulties such as attention-deficit problems, autism-like symptoms or memory issues.

It’s because of her work and dedication to families struggling with the ill-effects of in utero opioid exposure Strain is now a leading national advocate for an NAS baby lawsuit – a legal effort launched in late 2019 by a non-profit group that aims to hold responsible the large pharmaceutical companies that caused the opioid crisis, including paying for the massive cost of monitoring these children and making sure they receive proper care.

“We owe it to these kids — and future generations – to develop a tracking system and to study and see why developmental delays and defects may be happening with these children,” said Strain, referring to the lawsuit’s demand for a medical monitoring fund to follow children diagnosed with NAS or other opioid-related injuries.

Strain believes that the Nation’s surge in the number of prescriptions of opioid painkillers, and its ready availability, can be traced back to aggressive marketing tactics by these large pharmaceutical companies which, most alarmingly and egregiously, continued well after the addictive qualities of these drugs and their adverse impacts upon children had become evident to industry. .

NAS injures 250,000 babies every year

It’s been reported that about one-in-three pregnant women in America — or roughly 1.3 million out of the 3.8 million women annually — were given a prescription for opioid painkillers. Our legal team has done the math and determined that a baby with serious problems due to opioid exposure is born somewhere in the United States every 15-20 minutes. That would mean about 250,000 babies requiring specialized treatment are born every year – a number that’s been grossly underestimated by the federal government. The absence of uniform diagnostic and reporting protocols, coupled with underreporting and misdiagnosis by medical workers, unintentional or otherwise, are responsible for gross inaccuracies that unfairly and unjustifiably punish newborn children.

Dr. Brent Bell has analyzed NAS research from around the globe as a retained expert for the Opioid Justice Team and, according to him “the amount of opioid use, the time of exposure in the pregnancy and the length of exposure may show up years later in social, interactive, behavioral, cognitive and educational deficits of the child, even if the born child tests negative.

Despite the pervasiveness of the country’s opioid crisis, there’s been far too little reporting and debate about the medical impacts and sufferings, both short-term and long-term, upon children exposed to opioids in utero as a developing fetus. The most frequent diagnosis is NAS, arising from clinical observation and monitoring, following birth, of its most common conditions manifesting themselves in various forms, including but not limited to body shakes, excessive crying or yawns, feeding problems, diarrhea, sleeping problems, fever, or a runny nose.

Also reported, albeit infrequently, are reports of birth defects (related to opioid exposure in utero), such as club foot, spina bifida, heart defects, cleft palate, hydrocephalus, esophageal atresia, gastroschisis, anorectal atresia, or diaphragmatic hernia. And as these opioid-exposed children mature, many experience behavioral problems, cognitive delays, mental or motor deficits, or attention-deficit disorder (ADD), among other maladies.

Fighting the stigma of opioid addiction

After first learning of her children’s struggle Strain was so distraught and paralyzed by fear, she lost her job and was forced to collect unemployment benefits. Strain decided to become an activist because of this experience and her realization of the lack of resources available to families, like hers. Despite her best efforts to become educated on addiction and best practices, her middle son died from an overdose while he was seeking treatment. But, to her credit, she overcame her fears of public speaking and began her mission to warn other parents about the dangers of opioids. “I didn’t want any family to experience the shame and the stigma that I’d felt,”, says Strain.

Strain is now a local leader with Not One More, a family support group, in addition to acting as a moderator on popular websites for parents and grandparents. To her further credit, Strain now works for a non-profit grant funded program in Pennsylvania on a program aimed at ending substance use in the workplace and educating employers on what issues employees that have a loved one struggling with addiction may be experiencing. The plight of Strain’s family, like many of the families belonging to her friends and co-workers, is not unusual within her community, nor nationwide. To the contrary, the impact on America’s adults is both mindboggling and sweeping. Sadly, over 400,000 Americans have reportedly died from opioids during the period of 1999-2017 (from opioids obtained legally in addition to illegal street drugs). This figure is roughly equal to the number of U.S. soldiers killed in World War II, to provide some perspective to the enormity of the current opioid health crisis.

In addition, the number of children removed from their parents’ custody and placed in foster care or with relatives has spiked- for example, in Vermont, that number grew by 40% from 2013 to 2016. Similarly, nearly 7,000 West Virginia children find themselves in state care today, a 70% increase from a decade ago.

Strain says there’s still a lot of work to be done in educating would-be mothers, as well as the doctors and medical staff who treat them, about the risks of opioid use while pregnant upon their fetus. . “Women of child-bearing age and, especially, those women seeking to conceive or are pregnant, need to be made fully aware of the danger posed by their use of opioids.” she said. “That wasn’t happening, and I don’t know that that’s happening now.”

In March, the lawyers of the Opioid Justice Team filed in federal court a request for a preliminary injunction requiring women of child-bearing age to test negative for pregnancy as a condition to prescribing her an opioid product.

It’s hardly a radical idea. Especially when one considers that doctors in the United States who treat young women of child-bearing age for acne are already being required to administer a urine pregnancy test before prescribing Accutane, a drug that’s been positively linked to birth defects. This protocol is uniform and, as importantly, demonstrates that doctors, patients, pharmacies and the big pharmaceutical companies are all perfectly capable of acting affirmatively and in the public interest towards protecting young mothers, fetal development, and improving outcomes for both the mother and her newborn.

Yet this simple, common-sense idea – which could dramatically reduce the number of babies exposed to opioids in the womb – remains on hold.

NAS baby lawsuit offers a shot at justice

In the federal court case, our team of attorneys is fighting hard to get children born to mothers that has used opioids while pregnant to become recognized as their own legal class within the national opioid litigation, which is currently before U.S. District Court Judge Daniel A. Polster in Cleveland, Ohio. The same team of lawyers has also filed lawsuits in nearly 40 states, each one also seeking recognition for the legal rights of these kids and their families.

The aim of the NAS babies’ lawsuit is a legal settlement, whereby pharmaceutical companies that had manufactured and aggressively marketed these painkillers – including Purdue Pharma, the firm behind Oxycontin – contribute funds necessary to establish and administer a medical monitoring fund for these children, one of the main goals of family-health-activists such as Strain. The same companies would also be required to provide funding for long-term health care, therapies, counseling and tutoring.

Many of the lawyers on our team vividly memories of a similar case that occurred two decades ago – the lawsuit against Big Tobacco companies, seeking justice in the form of compensation for the decades of harm caused by cigarette smoking, and the failure to warn the public about those health risks. The chief plaintiffs in that case were state and local governments, and the settlement (in the late 1990s) resulted a multi-billion-dollar windfall that only led to government entities spending the money to plug holes in their budgets rather than assisting the victims of smoking, as intended. North Carolina, most brazenly, spent 75 percent of its settlement money to bolster tobacco production

In fighting for justice on behalf of opioid-exposed children, our goal is to make sure that history doesn’t repeat itself in the current case against Big Pharma, even as many of the same states and localities are back again at the bargaining table. That’s why we sought meaningful representation concerning the ongoing settlement talks occurring in Cleveland, as well as in the ongoing bankruptcy case involving Purdue Pharma, to ensure these NAS-affected children have a voice.

There is still an opportunity for new plaintiffs to join other families and our team of attorneys in the lawsuits filed behalf on behalf of children exposed to opioids in utero and their guardians. I hope you’ll join us and help us make sure that any national financial settlement over the opioid crisis goes to the families and the communities that need help as this generation of kids grows up.

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Can I Take Oxycontin When Pregnant?

When Purdue Pharma launched its new painkilling drug Oxycontin in 1996, company officials were sure they had a winner. At a launch party for the opioid-based drug, Dr. Richard Sackler, a Purdue executive from the family that founded the firm and still mostly owns it, declared that the introduction of Oxycontin “will be followed by a blizzard of prescriptions that will bury the competition.”

Sackler was right. Over the next two decades, Purdue’s Oxycontin dominated the rapidly growing market for prescription painkillers. The firm, aided by its aggressive marketing tactics, eventually captured 16 percent of the national market for such drugs, trailing only the generic manufacturers of similar opioids – and the drug’s popularity with both doctors and patients stayed strong even after news stories and lawsuits linked Oxycontin to addiction.

Not surprisingly, with so much Oxycontin on the market, a lot of doses were ultimately prescribed to women who were pregnant. The most extensive study found that between 2008-2012, or near the height of the surge in painkiller use, an astonishing one-in-three American women of childbearing age (defined as age 15-44) were prescribed some opioid painkiller. Meanwhile opioid use disorder – the medical term for addiction – also took off during this period for women who showed up at hospitals in labor, with such cases quadrupling from 1999-2014.

It seems remarkable now, but there was little discussion within the medical community during those years about whether it was safe for these women, or, even more importantly, for their babies to prescribe Oxycontin during pregnancy. In fact, many doctors continued to prescribe Purdue’s profitable painkiller even after studies emerged in the early 2010s linking opioids like Oxycontin to birth defects and a disorder called Neonatal Abstinence Syndrome, or NAS.

Oxycontin, NAS and your baby

Indeed, it’s long past time to put procedures into place to ensure that women who are actually pregnant aren’t prescribed opioid painkillers. Our legal team, which has pushed to include the families of children who were exposed to these medications in the womb in settlement talks with Big Pharma over the industry’s gross negligence and its deceptive marketing practices, is also pushing for a medical monitoring fund that would gather new evidence while providing for the long-term care of kids harmed by these drugs.

The most common health hazard for babies exposed to Oxycontin in the womb is NAS, which is a form of opioid withdrawal that can keep newborns in the hospital for weeks while they’re treated for shaking, vomiting, frequent crying, and an array of other symptoms. Our team of experts carefully analyzed all available data and concluded that government methods have undercounted the number of kids exposed to opioids. (Indeed, even the diagnosis code for NAS or Opioid Use Disorder (OUD) was only developed recently.) We estimated that approximately 42,000 NAS babies are born in the United States every year, meaning the total number of kids dealing with the after-effects of opioid exposure number in the hundreds of thousands. This is a national epidemic that rarely gets mentioned in the news media.

In addition to the symptoms described earlier, the U.S. Centers for Disease Control and Prevention has asserted that babies born with NAS can experience a range of problems that include trembling, Irritability, including excessive or high-pitched crying, sleep problems, hyperactive reflexes, seizures, yawning, stuffy nose, or sneezing, poor feeding and sucking, loose stools and dehydration, and increased sweating.

Other potential health hazards

Most babies born with NAS are kept in intensive care for several weeks and then sent home from the hospital. However, medical experts are just beginning to learn – first through anecdotal evidence but increasingly through research – that many of the children exposed to opioids during pregnancy develop other problems as they grow. These include behavioral problems, cognitive delays, mental or motor deficits, or attention-deficit disorder (ADD). That’s why our goal in seeking damages from Purdue Pharma and other drug companies is a fund that will track these children — to better understand the medical consequences.

But it’s important to note that while NAS and developmental difficulties may be the most common consequences of taking Oxycontin while pregnant, there are other serious concerns, especially birth defects. In fact, some specialists say that birth defects can happen when an expectant mother takes opioid painkillers in the 4th to 10th week of a pregnancy, which is often before a woman knows she is pregnant or given good guidance on pre-natal care.

As far back as 2011, a CDC study found links between opioid use during pregnancy and common birth defects such as heart defects or cleft palate. The greatest increase in risk involved spina bifida, the condition in which the spinal column doesn’t close properly in the womb. The CDC paper found that women whose babies had been born with spina bifida where twice as likely to have taken opioids during their pregnancy than mothers whose children had no birth defects. Another increased risk from taking Oxycontin or similar painkillers during pregnancy is gastroschisis, in which a baby is born with its intestines hanging outside the stomach, due to a hole in the abdominal wall. There are about 1,800 American cases of this rare illness every year. The CDC research found that rates of gastroschisis are about 60 percent higher in the counties that had the highest rates of prescription opioid use.

In addition to spina bifida, another neural tube defects — which often take place during the first month of pregnancy — that showed increased risk in the 2011 CDC study was anencephaly, where most of the brain and skull don’t fully develop. Heart defects posted the highest gain in the CDC’s study, including hypoplastic left heart syndrome, in which the left side of the heart doesn’t develop properly. It’s fatal if not treated with surgery.

A need for testing – and justice

None of these heartbreaking conditions need to occur. In our legal challenge to Big Pharma, our attorneys have demanded a medical protocol similar to the one that has been widely used since researchers established a link between the drug Accutane — which is taken for skin conditions such as acne — and birth defects. Doctors now require pregnancy tests for women of child-bearing age before Accutane is prescribed, and there’s no reason this can’t be done for Oxycontin or other popular brands of painkillers as well.

But our chief focus is justice for the literally hundreds of thousands of families that weren’t warned about Oxycontin, weren’t tested, and now are raising children with the consequences of a powerful industry’s gross negligence.

Our lawyers have gone into federal court to get children born to prescription opioid-dependent-and-using mothers recognized as their own legal class within the national opioid litigation, which is currently before U.S. District Court Judge Daniel A. Polster in Cleveland. We’ve already filed lawsuits in a number of states seeking recognition for the legal rights of these kids and their families.

Our team of highly experienced lawyers is heavily focused on ensuring that any settlement dollars in these cases go directly to the aid of those in the greatest need: The children. Too many of us were around in the late 1990s when the settlement with Big Tobacco over that industry’s decades of deceit was directed by states and other localities that then typically spent this vast windfall on plugging holes in their budgets rather than directing dollars to the health needs of the people who’d been harmed – or who could be – by smoking cigarettes.

If you took Oxycontin while pregnant and now have concerns about your child’s health and long-term needs, we hope you’ll join us in the fight for justice involving Purdue Pharma and the other big pharmaceutical companies. Time may be limited; potential claimants in the current Purdue Pharma bankruptcy proceedings have until the end of June to file. By signing up, you can help us ensure that any national financial settlement over the opioid crisis goes to the families and the communities that need the money the most.

The post Can I Take Oxycontin When Pregnant? appeared first on Opioid Justice Team.

from Opioid Justice Team https://opioidjusticeteam.com/oxycontin-when-pregnant/

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Oxycontin Birth Defects Lawsuit

Oxycontin birth defects lawsuit offers hope to mothers of NAS babies

An Oxycontin birth defects lawsuit has offered mothers like Colorado’s Shelly Whittaker something that’s been hard to find over a dozen years of struggling with the ups and downs of raising three sons born with the condition caused by opioid exposure in the womb known as NAS: Hope.

Her doctors never told Whittaker – who began taking OxyContin, the Purdue Pharma-manufactured opioid painkiller, for lupus and rheumatoid arthritis in 2007, after her daughter was born and before she became pregnant with her first son – about the increased risk of birth defects.

And no one mentioned Neonatal Abstinence Syndrome, or NAS, when the boy was born with symptoms such as high-pitched crying, tremors and convulsions, diarrhea, vomiting, and difficulty swallowing. “We took him to the doctor, and I said, ‘I don’t know what’s wrong,’” Whittaker recalled. “They said, ‘He’s fine – we don’t know what it is.’”

But things weren’t fine. Her second son experienced many of the same difficulties at birth, and so did a third son – even though by then there was growing awareness of the addictive nature of Oxycontin and Whittaker had been placed on a different medication, Subutex. As Whittaker, now 38, watches her three sons grow, the boys continue to experience developmental and behavioral problems, and have trouble keeping up in school.

Last year, Whittaker read on social media about an Oxycontin birth defects lawsuit, and she decided to sign on as a plaintiff. She sees legal action against the maker of OxyContin, Purdue Pharma, and other leading drugmakers and distributors as a way to get help for struggling families — as well as some manner of justice.

Like other mothers of children with NAS, Whittaker said there’s a whole array of unmet needs for these kids. “I would love for them to have some help with their schooling,” she said. “There’s no school in my community that helps children who’ve been falling behind.”

NAS babies are a hidden crisis in America

Shelly Whittaker is hardly alone. Our team of lawyers is representing hundreds of mothers like her in the OxyContin birth defects lawsuit that is currently pending. In researching the case, we’ve come to discover that there are literally hundreds of thousands of NAS babies growing up in America – far more than the government has acknowledged. These children and their families need medical help, other assistance, and better information.

Here’s the background: OxyContin and other opioid painkillers were introduced into the U.S. market in the 1990s by big pharmaceutical companies and aggressively marketed to doctors as a cure-all for the pain caused by numerous ailments. Unbeknownst to the American public, these large drugmakers learned fairly quickly that their new medications were highly addictive – warnings that were ignored in the face of billions of dollars in profits.

The result has been the largest drug-addiction crisis in the history of this country. Much of the opioid-abuse epidemic began with medications that were legally prescribed such as OxyContin, Percocet, and Vicodin, although over time many users moved into illegal street drugs such as heroin and fentanyl (which is also sometimes prescribed). Although opioid use peaked around 2012, the latest government statistics still find 58 opioid prescriptions for every 100 citizens. The toll has been enormous. According to the U.S. Centers for Disease Control and Prevention, there were 47,600 overdose deaths related to opioids in America during 2017, the last year for which records were available. That’s nearly as many Americans who died in the entirety of the Vietnam War.

The opioid crisis has become front-page news in many American cities, but information about mothers who used opioids during their pregnancies and their babies has lagged. Unfortunately, America’s doctors were slow to make what today seems like a strong connection between opioid exposure in the womb and birth defects such as club foot, spina bifida, heart defects, cleft palate, hydrocephalus, esophageal atresia, gastroschisis, anorectal atresia, or diaphragmatic hernia.

That’s in addition to the most common adverse outcome: NAS, which causes symptoms such as body shakes, excessive crying or yawns, feeding problems, diarrhea, sleeping problems, fever, or runny noses. As these children grow, many experience behavioral problems, cognitive delays, mental or motor deficits, or attention-deficit disorder (ADD).

The number of American children – and families – affected had been grossly undercounted. The current working government number of about 29,500 NAS births in 2018 falls far short of the real total. Based on information that about one-in-three pregnant women in America — or roughly 1.3 million out of the 3.8 million women who gave birth — were given a prescription for opioid painkillers, our team has estimated that a baby with serious problems related to opioid exposure is born somewhere in the United States every 19 minutes.

A conservative estimate is that this results in roughly 250,000 births every year of children with some level of NAS that will require the type of specialized treatment that we are seeking. That’s more than eight times the government’s figure.

‘None of this is my fault’

One of the hundreds of thousands of American parents who knows the trauma of raising a child exposed to opioids in the womb is Jennifer Scully, a 42-year-old career nurse who lives in upstate New York.

Scully says she’s gotten used to the phone calls from the school attended by her 5-year-old daughter from teachers and staff who don’t understand the seizures occasionally experienced by her child, in which she would stare blankly into space for a minute or two, unresponsive to adults. To Scully, the seizures are one more problem – on top of her small size, limited vocabulary, and delayed potty training – that she connects with opioid exposure.

“Because I’m a nurse, I pay a lot more attention to things,” she says. But the career health-care professional trusted her doctors in 2014 when she unexpectedly became pregnant while under treatment for both the aftermath of a broken back and breast cancer, which is why she was on a drug regimen that included OxyContin.

“They said, ‘We’re not taking you off and besides, it won’t affect the baby,” Scully recalls. Instead, her newborn daughter spent five days in the hospital coping with the symptoms of NAS, including tremors and high-pitched crying. When they finally left the hospital, doctors insisted the worst that Scully would have to deal with would be an occasionally cranky baby – a gross underestimation of the developmental problems her daughter has faced.

Like Whittaker, Scully joined the OxyContin birth defects lawsuit shortly after she read about it on social media. She said she agree with the ambitious goals of the legal action: Long-term health care and a medical monitoring fund for children exposed to opioids in the womb. She says the big pharmaceutical firms “need to be held responsible for what they’ve done. I expected a healthy child. None of this is my fault.”

The legal fight for opioid justice

Over the course of 2019, a series of class-action lawsuits were filed on behalf of opioid-exposed children in a number of states. Our legal team has been working hard to get children born to prescription opioid-dependent-and-using mothers recognized as their own legal class within the national opioid litigation, which is currently before U.S. District Court Judge Daniel A. Polster in Cleveland.

Our efforts are linked closely to the ongoing complex negotiations – involving big pharmaceutical companies and a number of states and localities hoping to recover their costs for dealing with the opioid crisis – aimed at a comprehensive settlement. Late in 2019, the OxyContin manufacturer at the center of the crisis, Purdue Pharma, filed for bankruptcy and floated a tentative settlement of its liability in the range of $10-12 billion.

Our lawyers have argued that the proposed Purdue Pharma deal doesn’t go far enough, and that it allows the founders and largest owners of the firm, the Sackler family, to keep too much of their wealth. But our biggest concern about both the Purdue Pharma deal and the related, more universal settlement talks is that those most in need – hundreds of thousands of kids whose childhood has been disrupted – will get shut out.

Most of our attorneys are very familiar with the landmark settlement in the late 1990s with Big Tobacco, in which the major cigarette makers coughed up millions of dollars that were largely paid out to a coalition of states and other localities �� similar to today’s opioid talks. Most of these cash-strapped government entities merely absorbed the money into their general budgets. Very few dollars went toward smoking-cessation programs, or toward the massive health problems that have been caused by smoking.

On behalf of Shelly Whittaker, Jennifer Scully and the thousands of other families stung by the opioid crisis, we desperately want things to be different this time around. The money we are seeking on behalf of the kids, as part of any comprehensive settlement with Big Pharma, would go toward meeting their extensive long-term needs. That includes the medical monitoring fund and collecting data helping doctors understand the scope of the problem and best practices.

The good news is that there is still time for new plaintiffs to join our OxyContin birth defects lawsuit, but that time is also growing short. If your child was exposed to opioid painkillers during pregnancy, join us and our fight for a settlement that will actually benefit families and the communities where they live. Too many parents have suffered in silence for too long. We are fighting for justice and a better future, and we would like you to be part of it.

The post Oxycontin Birth Defects Lawsuit appeared first on Opioid Justice Team.

from Opioid Justice Team https://opioidjusticeteam.com/oxycontin-birth-defects-lawsuit/

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What Birth Defects Does Oxycontin Cause?

Felecia Coleman is still angry at her doctors. That’s not because they prescribed her opioid painkillers when she underwent three surgeries for a herniated disc a few years ago. It’s because none of her physicians warned her that her medication, OxyContin, could cause birth defects.

“I’m very bitter inside – I can’t help it,” says Coleman, now 35 and living in upstate New York. Like millions of Americans, Coleman became addicted to opioid painkillers after her doctors legally prescribed OxyContin to address her back pain. And like hundreds of thousands of women, Coleman also became pregnant and gave birth to a son, who was born with neonatal abstinence syndrome, or NAS.

At birth, Coleman’s baby spent two months in the hospital before doctors could send him home. Today, her son is 3, and childhood has been a struggle. He’s still smaller than the other kids his age, and he’s very shy around them. Sometimes it’s a challenge for the boy to communicate.

For Coleman herself, it took medical assisted therapy to end her addiction to painkillers such as Oxycontin, and it also took time to lose her sense of shame and to realize that so many moms are in the exact same boat. When she learned online about a lawsuit targeting Oxycontin birth defects, Coleman was eager to join and to endorse one of the main goals of the legal action – to raise awareness for other would-be parents.

What we know about Oxycontin and birth defects

The frustrating part is that many doctors and leading research centers had begun piecing together the information about Oxycontin and other opioid painkillers and their links to birth defects as early as the early 2010s, long before Coleman and thousands of other moms would expose their children to opioids in the womb.

In March 2011, the federal Centers for Disease Control and Prevention issued a warning that pregnant women taking opioid pain killers such as codeine, oxycodone or hydrocodone faced an elevated risk of birth defects, including congenital heart defects — then the most common type in the United States. Other birth conditions shown with an increased risk by the CDC included spina bifida, hydrocephaly, congenital glaucoma and gastroschisis.

Nonetheless, the medical community failed to implement procedures that could reduce or end prescriptions of Oxycontin and other opioid painkillers to women who were pregnant or could become pregnant – even though such protocols have been implemented for other drugs such as the acne medicine Accutane after an elevated risk for birth defects was established.

Other the course of the 2010s, as prescriptions for opioid painkillers rose and a national addiction crisis took root, hospitals began seeing a huge spike in a condition called Neonatal Abstinence Syndrome, or NAS. These NAS babies had been exposed to opioids in the womb and were now showing classic symptoms of drug withdrawal.

In the early weeks of a child’s life, NAS causes symptoms such as body shakes, excessive crying or yawns, feeding problems, diarrhea, sleeping problems, fever, or runny noses. But mothers say that coming home from the hospital is often just the beginning of their problems. Like Felecia Coleman, the mother in upstate New York, they report their children continue to experience behavioral problems, cognitive delays, mental or motor deficits, or attention-deficit disorder (ADD) as they grow.

The government has underestimated the number of cases

And the numbers of children coping with the aftereffects of NAS are much larger than either the public realizes or than the government cares to admit. In our efforts to seek justice on behalf of NAS kids and families, our experts came to discover that actually about one-in-three pregnant women in America — or roughly 1.3 million out of the 3.8 million women who gave birth — were given a prescription for opioid painkillers. We estimated that a baby with serious problems related to opioid exposure is born somewhere in the United States every 19 minutes, which amounts to as much as 250,000 children every year.

Dr. Neil S. Seligman, assistant professor of obstetrics and gynecology at the University of Rochester Medical Center, told NBC News that birth defects can occur when an expectant mother takes opioid painkillers in the 4th to 10th week of a pregnancy, which is often before a women knows she is pregnant or given guidance on pre-natal care.

As America’s opioid crisis enters a new decade, doctors are gathering even more damning information about links between opioid use and birth defects. Another study funded by the CDC found that using painkillers such as Oxycontin, Vicodin and Percocet during pregnancy doubles the risk of having babies with devastating neural tube defects such as spina bifida.

Neural tube defects, which often take place during the first month of pregnancy, include conditions such as spina bifida, where the spinal column doesn’t close completely, and anencephaly, where most of the brain and skull don’t fully develop.

In 2019, doctors became alarmed by a rise in U.S. cases of gastroschisis, in which a baby is born with its intestines hanging outside the stomach, due to a hole in the abdominal wall. There are about 1,800 American cases of this rare illness every year. The CDC research found that rates of gastroschisis are about 60 percent higher in the counties that had the highest rates of prescription opioid use. At the same time, the CDC’s director wrote in an op-ed that the new reports are “an early alarm for the need to increase our public health surveillance on the full range of fetal, infant, and childhood outcomes potentially related to these exposures.”

New hope from the legal system

There is new hope that the mothers of children who were exposed to opioids in the womb can get help through the American legal system. Our team of attorneys has gone into federal court to get children born to prescription opioid-dependent-and-using mothers recognized as their own legal class within the national opioid litigation, which is currently before U.S. District Court Judge Daniel A. Polster in Cleveland. We’ve already filed lawsuits in a number of states seeking recognition for the legal rights of these kids and their families.

We are seeking a number of changes, including a requirement that doctors conduct pregnancy testing for women of child-bearing age before prescribing opioids, similar to the protocol now in place for Accutane. More importantly, we are looking for a legal settlement in which the pharmaceutical companies that manufactured and aggressively marketed these painkillers – including Purdue Pharma, the firm behind Oxycontin – pay to create a medical marketing fund for these kids. This would allow public health experts to collect data that will help doctors understand the scope of the problem and share best practices.

One of our motivations is that many of us, as attorneys, remember the Big Tobacco settlement of the 1990s, in which the billions of dollars that were paid out by America’s cigarette makers for decades of lying about the health hazards of smoking were absorbed by cash-poor states and cities — with little or any money going toward public health. We are determined not to let that happen to the kids and parents who were harmed by Big Pharma.

One mother who is completely on board with the goals of the lawsuit is Felecia Coleman, who said that now that her son has turned 3-years-old, she wants testing to better understand if he’s experiencing developmental difficulties or needs early intervention. She said she agrees with the goal of the class-action suits to make that kind of testing routine.

“I feel like there should be studies or more research,” she said, adding, of her son: “Yes, he’s three, but how will this affect him later on? We need more research from more kids, so that people will know more in the future.”

There is limited time for new plaintiffs to join Coleman and our team of attorneys in our legal fight. Please join us, and help us make sure that any national financial settlement over the opioid crisis goes to the families and the communities that need the money the most.

The post What Birth Defects Does Oxycontin Cause? appeared first on Opioid Justice Team.

from Opioid Justice Team https://opioidjusticeteam.com/birth-defects-oxycontin-cause/

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Jeremay Martinez | NAS Client

Jeremay Martinez, foster mom of boy with NAS

Three years ago, Jeremay Martinez – now a 30-year-old single parent in her native Espanola, New Mexico – underwent the training required to someday become a foster mom. At the time, she didn’t know if she could handle the hard work of an additional child, or the emotions of someday handing that kid back to a birth parent.

Then in the summer of 2018, she learned through a connection with her dad about a 25-year-old local woman dealing with an addiction to opioids who desperately needed foster care for her fourth child. Martinez didn’t hesitate to say ‘yes” but quickly learned that no class could prepare her for the ups and downs of raising a boy with Neonatal Abstinence Syndrome (NAS).

“The first two and a half months are really hard,” Martinez recalled of taking the boy home after two stressful weeks in the hospital’s Neonatal Intensive Care Unit, or NICU. “Most people would have freaked out, because he shook, he cried a lot, and he needed comforting…It took a lot of comfort and love but now he’s doing OK.”

But “doing OK” for a baby born with an opioid dependency still means some difficulty with motor skills and other deficiencies. Martinez says the child still receives a form of occupational therapy twice a week and may continue doing so for some time.

In hindsight, Martinez realized she had a lot to learn about raising an NAS baby, even in a county with a serious opioid problem. She realized her initial dream of bringing the boy’s mom home to live with her and helping her get off opioids to be able to raise her own son was overly optimistic and perhaps naïve. Within two weeks, the birth mother – who’d been legally prescribed Purdue Pharma’s OxyContin as a teen but then suffered through eight years of addiction – was gone. Martinez, now legal guardian of the 15-month-old boy, hopes to permanently adopt him.

Meanwhile, she discovered the Espanola community lacked resources for an ever-rising number of kids born with NAS or other problems that resulted from opioid exposure in the womb. Instead, Martinez has improvised – finding an expert in baby massage whose work helped the boy cope with early stomach problems and other issues.

“He had light sensitivity and sound sensitivity but has overcome that,” Martinez said. The child was also helped with physical therapy as well as the ongoing occupational therapy. Now, Martinez and a friend who is also a doula – a non-medical companion for major events such as birthing – are looking to see if they can establish a safe haven under New Mexico law where addicted mothers can safely drop off babies they cannot care for.

But now that Martinez knows that babies born with an opioid dependency require so many resources, she hopes that legal action against Big Pharma can help families meet those needs. “We need to work together to come up with things to help these kids,” she said. “It’s better that we address their problems than just hide.”

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Jennifer Scully | NAS Client

Jennifer Scully, mother of girl with NAS

Not long ago, Jennifer Scully started getting phone calls from teachers about something unusual going on with her 5-year-old daughter. The girl would occasionally stare blankly off into space for two or more minutes, unresponsive to adults or anyone else.

What Scully’s daughter was experiencing was a rare type of seizure – just one of the many unusual symptoms that the child has coped with since she was born with neonatal abstinence syndrome, or NAS, after her mother – a 42-year-old upstate New York woman – was prescribed opioid medication for pain from back surgery and breast cancer.

Scully said that in addition to the unusual seizures, her daughter is undersized, with a thin vocabulary of only about 50 words, and was in diapers until she turned 4. She says the girl – who has been diagnosed with attention-deficit disorder and OCD (obsessive-compulsive disorder) – is generally about two years behind other kids.

“Because I’m a nurse” – Scully’s profession before all of this happened – “I pay a lot more attention to things,” she said. That means she won’t leave her daughter with a babysitter who might not watch the child closely enough or understand the things that might abruptly upset her.

When Scully unexpectedly became pregnant in 2014, her prescription-drug regimen wasn’t the primary focus of her doctors. She’d broken her back the year before, and had been prescribed Purdue Pharma’s OxyContin and other medications to deal with the severe pain. Then, Scully’s physicians learned she had breast cancer – requiring chemotherapy – and that she was having a baby. They thought it best she remain on painkillers.

“They said, ‘We’re not taking you off and besides, it won’t affect the baby,” recalled Scully, saying her back, cancer and pregnancy doctors all agreed. When her daughter was born in September 2014, the child was diagnosed with NAS and spent five days in the hospital dealing with tremors, high-pitched crying and other symptoms.

Now, her physicians told Scully that “it isn’t like it used to be” for a child born with drug dependency, that her five days in neonatal intensive care would be the end of a brief ordeal. “They said that at the most I’ll have a cranky baby,” she recalled – a gross underestimation of a child’s struggles that were just beginning.

Only now does Scully – who is still facing treatment for the addiction that she developed to opioid painkillers – fully understand what it means to be the mother to one of an estimated 750,000 children in the United States over the past two decades facing often serious issues because of exposure to opioids in the womb.

Many of their moms are like Scully: Women who were legally prescribed drugs like OxyContin for legitimate pain issues, with little or no warning of what could happen during a pregnancy. The New Yorker is currently seeking justice in a class action lawsuit seeking long-term health care and a medical monitoring fund for these kids.

“They” – the big pharmaceutical firms – “need to be held responsible for what they’ve done,” Scully said, adding: “I expected a healthy child. None of this is my fault.”

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Felecia Coleman | NAS Client

Felecia Coleman, mother of boy with NAS

Felecia Coleman knows that her son – who just turned 3 – isn’t much like other kids his age. He’s smaller than the other toddlers, and he’s very timid around them as well. The boy continues to find it difficult to communicate.

“He struggles with his speech,” Coleman said, adding that “I know what he’s saying.”

None of Coleman’s doctors had warned the 35-year-old upstate New York woman that her child might face any problems because of the opioid painkillers that she’d become dependent upon after three back surgeries for a herniated disc the year before. In fact, when Coleman was seriously burned late into her pregnancy and hospitalized for two weeks, physicians treating her actually upped her dosage of Purdue Pharma’s OxyContin.

Today, Coleman is one of hundreds of thousands of mothers across America wondering why her doctors continued to prescribe opioid medication to a pregnant woman – and why they failed to warn about the high risk of neonatal abstinence syndrome, or NAS, as well as birth defects and long-term developmental problems.

“I’m very bitter inside – I can’t help it,” Coleman says now. Although she’s now sober from opioids with the help of medically assisted therapy, she admits feeling a sense of shame until she started to meet many other moms who are in the same boat.

Coleman recently joined one of 34 class action suits filed across the United States aiming to require Big Pharma companies, including Purdue, to pay for children’s health care and the establishment of a medical monitoring fund to help better determine their long-term needs.

In her case, her son’s problems were evident from the day he was born in November 2016 and experienced breathing problems – Coleman recalls that “he was purple” — that sent him immediately to the neonatal intensive care unit, or NICU. There, doctors discovered a bowel blockage that required immediate surgery and the removal of several centimeters of intestine.

The boy spent his first two months in the hospital, and there were new problems as soon he was allowed to go home. “His bowels were uncontrollable,” Coleman remembered, and he was soon switched to cloth diapers because of frequent rashes. This was on top of other symptoms consistent with NAS: birth: frequent diarrhea and vomiting; high-pitched crying; irritability; difficulty sleeping, swallowing and eating; heavy sweating, tremors and signs of pain.

Coleman said she decided to wait until her son’s third birthday – which just occurred – before she brings him in for a round of testing to better understand if he’s experiencing developmental difficulties or needs early intervention. She said she agrees with the goal of the class-action suits to make that kind of testing routine.

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Shelly Grann | NAS Client

Shelly Grann, mother of NAS children, tells her story in this video:

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Shelly Whittaker | NAS Client

Shelly Whittaker, mom of boy with NAS

Shelly Whittaker kept going back to the doctors. They kept telling her there was nothing wrong with her son. But she knew better.

In 2007, when the boy was born, the Fort Collins, Colorado, woman was already raising a daughter who would grow up to be a straight-A student. But she became pregnant with her first son, her doctors decided to treat her two serious medical conditions – lupus, and rheumatoid arthritis – with Purdue Pharma’s widely used painkiller, OxyContin. When her first son was born in June 2007, he yawned constantly, and his body shook.

“We took him to the doctor, and I said, ‘I don’t know what’s wrong,’” Whittaker recalled. “They said, ‘He’s fine – we don’t know what it is.’”

She continued to experience problems with the child, including vomiting and other symptoms of withdrawal after she stopped breast-feeding a year later. But her doctors never suggested she stop taking OxyContin or other prescription painkillers, even when she became pregnant with her second son who was born in March 2010.

What happened next followed a familiar pattern. Whittaker’s second son — who spent a week in the neonatal intensive care unit, or NICU, and received morphine to withdraw from opioid dependency – exhibited many of the symptoms of neonatal abstinence syndrome, or NAS: High-pitched crying, tremors and convulsions, diarrhea and vomiting, and difficulty swallowing. When Whittaker became pregnant with her third son in 2013, her doctors switched her to a different medication, Subutex – which didn’t prevent the boy from developing all the same signs of NAS.

A dozen years later, as Whittaker works tirelessly to raise three boys with ongoing behavioral and developmental difficulties, the 38-year-old Colorado woman minces no words when it comes to either the drugmakers who so aggressively marketed their products or the doctors who seemed clueless about the risks.

“I am frustrated with the doctors who kept shoving these pills down my throat and telling me that everything would be fine,” Whittaker says today. But she’s also come to learn that the pharmaceutical giants who made and marketed those pills knew more about the addictive risks than they let on to the public. “It makes me sick to my stomach,” she adds.

Whittaker is hardly alone. Lawyers advocating for children like hers believe that as many as 750,000 children have been born in the United States with NAS or with birth defects, lingering developmental difficulties or other problems caused by in-utero exposure to opioids. Whittaker recently became a plaintiff in one of the more than 34 class action lawsuits filed across the nation on behalf of NAS babies, with the goal of ensuring that medical care, damages and the creation of a medical monitoring fund are paid by the firms that created the crisis.

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Kathy Strain | NAS Client

Kathy Strain, leading opioid abuse activist

There probably aren’t many women in America with a better sense of how many moms are struggling to raise children who were exposed to opioids in the womb – and how little is known about the medical and developmental effects their kids face – than Kathy Strain.

A leading activist in the fight against opioid abuse, the Pennsylvania woman regularly talks with worried moms or family members as a statewide moderator for a popular internet message board called The Addict’s Mom. What she’s learned is that once hospitals send babies home after a few weeks in intensive care to wean them off drug dependency, mothers often remain unaware their children may face long-term difficulties.

“It really is a big group of kids,” said Strain, referring as many as 250,000 children born every year in America with problems related to opioid exposure, “with all of the issues, and nobody knows.” She talks regular to family members who worry about physical symptoms like clenched jaws or grinding teeth, or who face developmental or psychological difficulties such as attention-deficit problems, autism-like symptoms or memory issues.

She sees the current legal actions against America’s biggest pharmaceutical companies, which aggressively marketed these addictive painkillers, as a way to get what these children are lacking: Long-term medical monitoring that will both help doctors learn more about the lingering effects of opioid exposure and aid kids in getting better treatment.

“We owe it to these kids — and future generations – to develop a tracking system and to study and see why developmental delays and defects may be happening with these children,” said Strain. Strain has been asking the hard questions about the opioid crisis in America ever since early in the 2010s, when two of her children became dependent upon the drugs, including her son who eventually died from an overdose while seeking treatment. At first, she said she struggled to focus at work – losing her job and going on unemployment for a time. But eventually she learned to channel some of the pain she experienced into helping others.

Strain, who lives in Berks County about an hour west of Philadelphia, overcame her fears of public speaking when the county asked her to give a talk about the opioid crisis. “I didn’t want any family to experience the shame and the stigma that I’d felt,” she said.

After signing up as a volunteer coach with the Partnership for Drug-Free Kids, she became a moderator with The Addict’s Mom – which maintains highly active websites in all 50 states – and a local leader with Not One More, a family support group. She also now works for the state of Pennsylvania in a program aimed at ending drug abuse in the workplace, and recently appeared in an ad for the Stop Opioid Silence campaign.

Today, Strain says there is still so much work to be done to educate both would-be mothers and their doctors about the risks.

“Women in that age group where they could conceive need to be made aware of the danger,” she said. “That wasn’t happening, and I don’t know that that’s happening now.”

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