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.

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