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.

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