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.

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