pregnancy Archives | Galiher DeRobertis & Waxman LLP

Researchers Perform World’s First Stem Cell Treatment During Fetal Surgery for Spina Bifida

Posted on October 1, 2023November 21, 2024 by Galiher DeRobertis & Waxman

News of a wanted pregnancy can be the most wonderful of tidings an expectant couple can get. In most cases, that joy continues throughout the pregnancy. However, some expectant and new parents get news of birth defects, such as spina bifida, that can dampen their joy.

Doctors and medical researchers continually work to create treatments that can help minimize the effects of these birth defects and help affected children live long, healthy lives. Recently, doctors performed the first in-utero stem cell treatment to help a fetus diagnosed with spina bifida.

What is Spina Bifida?

Spina bifida is a condition in which the spinal tube in a fetus doesn’t close. It affects about 1 in every 2,750 births in the United States. There are three main types, based on the size of the opening and whether a sac containing fluid, nerves, and/or part of the spinal column grows outside the back. Spina bifida is considered a neural tube defect, and it can cause physical and intellectual disabilities. Health issues can be mild or severe, including paralysis, water on the brain, and incontinence.

What Causes Spina Bifida?

The exact causes aren’t known, but nutrition plays a role. People who are pregnant or are trying to become pregnant should take a folic acid supplement containing 400 micrograms of this vitamin, as is contained in most prenatal vitamins. Diabetes in the mother and usage of certain prescription and nonprescription medications may also cause neural tube defects, so it is important that people who want to become pregnant work with their doctor to minimize risks. The formation of the spinal tube happens very early in pregnancy, so spina bifida may occur before a person knows they are pregnant, so prevention before pregnancy is important.

How is Spina Bifida Treated?

Often spina bifida can be diagnosed during pregnancy, but other instances aren’t apparent until birth. Surgery to close the gap and minimize damage to the nerve and the spinal column is the main treatment. Some cases can be treated with surgery in-utero, while others will need to be treated later. The longer the spine remains open, the more damage to the nerves and spine, which is why fetal surgery has been a positive development for expectant parents when it is considered an appropriate treatment method.

Why is this Stem Cell Surgery a Big Development?

Although fetal surgery can help limit spinal damage and improve outcomes, many children born after fetal surgery still require the use of wheelchairs or leg braces. The researchers at the University of California at Davis hoped the use of stem cells would help prevent paralysis. They began with animal studies on English bulldogs, a breed that is prone to spina bifida and resultant paralysis, and lambs. The treatments were successful at repairing and restoring the damaged spinal tissue more than can be done with surgery alone, and the animals treated in this way were able to walk and play almost normally, according to bioengineer and study participant Aijun Wang.

After these initial successes, the researchers at UC-Davis were ready to begin trials on humans. Three fetuses received a stem cell patch as part of their spina bifida surgery. Researchers will follow them for six years to see how well the stem cell transplant helps them. The first baby, Robbie, born in September 2021, was expected to have full leg paralysis if her spina bifida was left untreated. Her mother, Emily, was thrilled when Robbie immediately began kicking her legs and wiggling her toes after birth. As Robbie and the other children grow up, researchers will be looking to see if they are walking and potty training, in particular, because urinary complications and leg paralysis are such common effects of spina bifida.

What Does This Mean for Future Treatments?

Because this is such an early treatment and the children who participated are still being studied, it is too early to say that this will be the gold standard treatment for spina bifida going forward, but it is promising. More research needs to be done, however, on ways to use stem cells to treat this and other neural tube defects. We will be watching for further developments to help affected fetuses and children.

Prenatal Opioid Use May Adversely Impact Children Later in Life

Posted on March 15, 2023November 21, 2024 by Galiher DeRobertis & Waxman

According to a new study, opioid use during pregnancy may have a negative neurological or behavioral impact on children later in life. While previous studies have drawn a link between prenatal opioid use and adverse health outcomes in infants, the University of Missouri study found that exposure to opioids in utero can have damaging long-term effects on children, potentially impacting them into their adult years.

At issue is how opioids impact the various bacteria and microorganisms (known as the gut microbiome) inside the developing fetus. The gut microbiome serves as a measuring stick for the overall health and wellness of humans and animals.

About the Study

The University of Missouri study compared the gut microbiome of adult mice exposed in utero to the opioid oxycodone with the gut microbiome of adult mice who were not exposed to any opioids. The goal of the study was to find out how opioid exposure in gestation impacts offspring in their later years. According to the researchers, the gut microbiome of humans is very similar to the gut microbiome of mice.

The researchers identified significant disruptions to the natural balance of bacteria in the guts of the mice exposed to oxycodone in utero. The changes were linked with potential long-term impacts on both neurological and behavioral health.

More Pregnant Women Using Opioids

It’s become increasingly common for women to use opioids during pregnancy, either due to dependency or as a result of a medical prescription. According to the Journal of the American Medical Association, from 2010 to 2017, the number of opioid-related diagnoses documented at delivery increased by 131 percent. Meanwhile, the number of babies in the U.S. born with neonatal abstinence syndrome (NAS) increased by 82 percent from 2010 to 2017.

Neonatal abstinence syndrome occurs when a baby is exposed to a drug in utero and experiences withdrawal from the drug after birth. NAS is most often caused when a mother takes opioids while pregnant and can lead to serious problems in a baby. NAS is associated with withdrawal symptoms such as irritability, seizures, vomiting, and poor feeding in newborns. One of the researchers who led the University of Missouri study noted that children exposed to opioids during gestation are at increased risk for developing an addiction to opioids later in life.

According to the Centers for Disease Control and Prevention, there has been a trend toward opioids being prescribed for pain that may not be serious, despite the risks associated with these drugs.

Other Risks of Prenatal Opioid Use

Beyond the potential long-term harm posed to children whose mothers take opioids while pregnant, prenatal opioid use is associated with other risks to infants, including:

Neural tube defects
Congenital heart defects (problems with the structure of a baby’s heart)
Gastroschisis (a birth defect of the baby’s abdomen)
Stunted growth
Preterm delivery (birth before 37 weeks)

When it comes to opioid use during pregnancy, a significant concern is that a woman may be taking opioids without knowing she is pregnant. A baby’s cells multiply rapidly and the baby may have been exposed to the opioid for a long time before the mother knows she is pregnant.

5 Ways to Lower the Risk of Birth Defects

Posted on February 28, 2023November 21, 2024 by Galiher DeRobertis & Waxman

A new pregnancy – or planning for one – can be such an exciting time in a family’s life. And you will want to do whatever you can to ensure your baby will be happy and healthy.

The problem is that so much conflicting information can confuse parents-to-be about what really works to protect your baby’s health. Although it is impossible to guarantee that your child won’t be affected by birth defects, these time-tested tips can improve your chances of having a healthy baby.

See Your Doctor

Prenatal care is one of the most important actions to take. If you’re still in the planning stages, your doctor can help you manage your health to prepare for pregnancy. Then once you are pregnant, your doctor will monitor your baby’s and your health to ensure both are in good health.

If you have any chronic health conditions, such as diabetes or kidney disease, your doctor may recommend more screenings or more frequent visits to help ensure healthy development. Your doctor will also typically screen for any sexually transmitted diseases, as these can also cause birth defects and ongoing health problems.

Your doctor can also prescribe safe medication to help alleviate pregnancy symptoms if they interfere with your life.

Take Your Vitamins

A prenatal vitamin is a crucial part of a healthy diet before and during pregnancy. Folic acid, in particular, is a vital component. It has been proven to prevent birth defects such as spina bifida. These birth defects can happen before a woman even knows she is pregnant, which is why many health officials recommend that women of childbearing age ensure they are consuming 400 micrograms of folic acid each day to prevent brain and spine defects.

Once pregnant, your body will require increased nutrition as it supports you and your growing baby. If you have any questions about your nutrition and vitamin intake, your doctor is the best person to ask.

Get Your Vaccines

Certain diseases can cause severe birth defects during pregnancy, so it is essential to be up to date on vaccinations before becoming pregnant, including vaccinations to prevent human papillomavirus, measles, mumps, rubella, flu, tetanus, diphtheria, pertussis (whooping cough), and COVID-19. If you haven’t gotten all these vaccines, or they aren’t up to date, you may be able to take them during pregnancy. Concerns about your ability to receive these vaccines are best addressed with your doctor.

Maintain Your Health

Pregnancy can be physically taxing. Cravings can lead to unhealthy eating or unnecessary weight gain. The best option is to ensure that you are at a healthy weight and perform regular exercise before you get pregnant. If you are physically active already, you will likely be able to continue to exercise with some modification, which your doctor can advise you about.

In addition to taking your vitamins, make sure you’re eating a healthy and varied diet so you and your growing baby receive enough nutrition from food.

Although your changing body can make it challenging, especially toward the end of pregnancy, try to get adequate sleep to mitigate some of the fatigue that comes with being pregnant.

Stay Away from Harmful Chemicals

Finally, avoiding dangerous substances before and during pregnancy is essential in maintaining fetal health. As mentioned, many birth defects happen in the earliest stages of pregnancy, long before a woman realizes she is pregnant. So, avoiding chemicals that can cause damage is an important step in preparing for a baby. In fact, even if you aren’t planning to become pregnant, any woman of childbearing age is wise to minimize chemical exposure.

Some substances to avoid include alcohol, tobacco, marijuana, chemical solvents, pesticides such as glyphosate (found in Monsanto’s Roundup and other bands), herbicides, and cleaning products. Because these chemicals have been linked to cancers and other diseases in addition to birth defects, avoiding these substances is in the mother’s best interests, too.

Exposure to Pesticides During Pregnancy Linked to Brain Damage in Embryos

Posted on February 7, 2023November 21, 2024 by Galiher DeRobertis & Waxman

Bringing a new child into the world can be the most exciting event for a family. But that excitement is often short-lived once you hear that your child will be born with a severe birth defect. One particularly devastating condition is holoprosencephaly, or HPE, a brain condition that can cause moderate to severe facial deformities, developmental delays, miscarriage, and early death.

Although this birth defect can be genetic, it is often caused by environmental factors, including the use of pesticides before and during pregnancy.

When children are born with serious birth defects, such as holoprosencephaly, it can be devastating and costly to the family and for the health care and educational systems as they provide lifelong support to these children.

Medical researchers are looking at possible causes of this birth defect so we can help prevent it in the future. They study genetic information and other things that might increase risk, such as chemicals pregnant women might be exposed to.

Putting Pregnant Women at Risk

A recent study in the journal Environmental Health looked at how pesticides might be linked with HPE. They chose to study pesticides and this particular birth defect because we already know that pesticides have been linked to other birth defects and they tend to have a greater effect on a developing brain than on an adult brain.

In this study, researchers gathered a group of women who had given birth to a child with holoprosencephaly and a group of women whose child was born with Williams-Beuren Syndrome, a similar birth defect with a known genetic cause. The researchers asked women what types of pesticides they had used or had been exposed to during their pregnancy, if any, including insect repellant, flea and tick medications, and bug sprays. The researchers also asked women whether they had lived near an agricultural field during their pregnancy.

They compared the results of these different groups of women to see if pesticide use seemed to be linked more strongly to cases of HPE than to Williams-Beuren Syndrome. They found a link between all types of pesticide use they asked about and HPE, with especially strong links between the use of flea and tick medications and agricultural pesticides among the women who had lived near an agricultural field while they were pregnant.

The researchers noted that the critical period for holoprosencephaly to develop is the first trimester, often before a woman even knows she is pregnant. HPE affects 1 in 250 embryos, although many of these pregnancies result in miscarriage. It is still relatively common, affecting 1 in 10,000 babies born at full term.

The Long-Term Dangers of Pesticide Exposure

There are many different types of pesticides, some of which are commonly available for household use and some of which are mainly used in industrial and agricultural settings. The researchers in the Environmental Health study found some increased risk of holoprosencephaly with all of them.

One particularly disturbing finding in their study was the increased risk of HPE for women who live near an agricultural field. It could be easy for women to stop using insect repellant, flea and tick medicine, and bug spray when they are pregnant or are planning to get pregnant, but few neighbors can control what pesticides are used by the people nearby producing food, grass seed, Christmas trees, or other agricultural products—and they may have no way of knowing what is used to control pests right next door.

Other researchers are looking deeper into specific components of pesticides and how they might cause HPE. One study at the University of Wisconsin explored the effects of piperonyl butoxide, or PBO, on the brain development of mice. This chemical is used in many household pesticides, including the flea and tick medications associated with HPE in the Environmental Health study.

These university researchers exposed mice to PBO during the period in their pregnancies that matches the early pregnancy period so critical in a baby’s brain development. The mice exposed to PBO showed facial deformities similar to those that accompany HPE in humans. The more PBO the pregnant mouse was exposed to, the more severe the deformities in the fetus.

The Environmental Protection Agency estimates that PBO is found in more than 1,500 commercial products. But there is no requirement to label it as dangerous during pregnancy.

Babies Born Addicted to Opioids Cost U.S. Over $500 Million per Year

Posted on January 31, 2023November 21, 2024 by Galiher DeRobertis & Waxman

In the year preceding the onset of the coronavirus pandemic of 2020, the opioid epidemic led the headlines. Studies were conducted, opioid lawsuits were filed, and new regulations aimed at holding drug manufacturers and prescribers responsible for the havoc the highly addictive drugs wreaked on millions were passed. Yet the stranglehold of addiction persists, albeit in the shadow of COVID-19.

As millions of Americans come out from under the coronavirus pandemic blanket with mass vaccinations and opening economies, the opioid epidemic is fast coming back to the fore with a focus on its most innocent victims.

The resumed interest has opioid attorneys working overtime filing opioid lawsuits for clients whose exposure to the drugs around and during pregnancy have led to their children being born with neonatal abstinence syndrome (NAS).

What is Neonatal Abstinence Syndrome?

The Journal of the American Medical Association (JAMA) defines NAS as “a withdrawal syndrome primarily occurring in infants with in-utero exposure to opioids.” It is a diagnosis that occurs “6.7 times per 1,000 live hospital births and costs the U.S. $572.7 million each year,” according to the Healthcare Cost and Utilization Project (HCUP) Kids’ Inpatient Database (KID), which studied a nationally representative sample of all pediatric discharges, as reported in JAMA. Medicaid-covered births account for 83.3 percent of the total cost ($477 million). Babies’ stay in the hospital can be 20.4 days or more with an average cost to families of $22,552.

The Project defined in-hospital births as “those with a primary/secondary diagnosis of live birth and no indication of birth outside the hospital or transfer from another hospital.”

While NAS can happen to any baby exposed to opioids in-utero, the highest incidence rates were among “American Indian/Alaska Native individuals (15.0 per 1,000) and non-Hispanic white people (10.5 per 1,000), the lowest income quartile (9.3 per 1,000), rural areas (10.6 per thousand), and the Northeast (9.5 per 1,000).” Medicaid-covered births had the highest NAS rates (12.3 per 1,000) with those without any kind of insurance just behind at 7.0 per 1,000.

What the Research Shows

The U.S. Department of Health and Human Services reports that 10.1 million people misused prescription opioids in the past year. More than 70 thousand died from overdose, and 1.6 million people misused prescription pain relievers for the first time.

Women who experience severe pain before or during their pregnancies are still commonly being treated with opioids, most often with codeine and oxycodone, according to the Centers for Disease Control (CDC). This is a problem, because “opioid use during pregnancy can affect women and their babies.”

The National Birth Defects Prevention Study conducted from 1997 through 2005, which studied just over 19,000 maternal cases, supports that finding as it showed there is an “association between early pregnancy maternal opioid analgesic treatment and certain birth defects.”

These findings lend support to parents with NAS-affected babies who wish to seek claims against opioid manufacturers and prescribers.

Most Common Opioid-Related Birth Defects

The latest Centers for Disease Control (CDC) study, “Maternal Treatment with Opioid Analgesics and Risk for Birth Defects,” published in the American Journal of Obstetrics and Gynecology, reveals “codeine and hydrocodone were the most frequently prescribed medications, representing 69 percent of all reported opioid analgesics used.” The reasons for a prescribed opioid regimen during pregnancy include chronic diseases, infections, injuries, and surgical procedures.

Treatment with opioid analgesic, according to the study, was linked with congenital heart defects such as:

Atrial septal defect
Atrioventricular septal defect
Conoventricular septal defect
Hypoplastic left heart syndrome
Pulmonary valve stenosis
Tetralogy of Fallot

The study says the “findings related to congenital heart defects were consistent with findings of previous studies showing links between the use of codeine during the first trimester and the occurrence of some heart defects.”

Other common birth defects include:

Gastroschisis (a defect of the abdominal wall)
Glaucoma (an eye defect)
Hydrocephaly (build-up of fluid in the brain)
Spina bifida (a type of neural tube defect)

How We Help Opioid Victims Who Suffered Birth Defects

Contact us to seek justice with the help of our experienced opioid attorneys. We’ve battled corporate giants on behalf of individuals like you for 20 years. Our Dallas, Texas, opioid law firm represents families dealing with opioid-related birth defects. If you have a child with birth defects caused by exposure to opioids during the first trimester of pregnancy, we can help.

Prevention and Prenatal Care Can Lower the Risk of Birth Defects

Posted on October 10, 2022November 27, 2024 by Galiher DeRobertis & Waxman

About three percent of babies born in the United States each year are affected by birth defects. Birth defects, also called congenital defects or malformations, may be mild or severe, and can have a profound effect on the child and the family.

Care Providers Can Bridge the Gap

Access to prenatal care has been shown to have a sizable impact on fetal health. Health care providers can perform tests during pregnancy to assess the health of the fetus and screen for potential birth defects. They can also ask questions to help see if the pregnant person has been exposed through work or location factors to harmful chemicals or pesticides that could cause birth defects. For example, farm workers and workers in semiconductor factories have been found to have higher rates of birth defects because of exposure to chemicals before or during pregnancy.

Health care providers will also help plan adequate nutrition and connect women who can’t afford high-quality food and prenatal vitamins with services. Health care providers can perform diagnostic tests to assess the risks for and diagnose some birth defects to help potential parents make informed decisions and plans for their children.

But many prospective parents don’t have adequate access to prenatal care to help prevent birth defects. They also may not have received the vaccinations necessary to prevent pregnancy complications. These factors can create a disparity in birth outcomes between socioeconomic and ethnic groups and lead to higher rates of birth defects in groups who are less likely to receive conscientious health care and to be able to afford high-cost procedures and devices.

Causes and Types of Birth Defects

Although some birth defects are genetic and may not be easily prevented, other birth defects are caused by exposure to dangerous chemicals, lack of adequate nutrition, and exposure to infectious diseases before and during pregnancy. Some birth defects may be caused by a combination of factors, such as a genetic factor that increases sensitivity to an environmental hazard. Still other defects can be caused by lifestyle choices, such as drug use or smoking, and parental medical conditions, including diabetes or obesity. About 30% of the causes of birth defects are known, but the remaining 70% are of unknown or indistinct origin.

Birth defects may be visible or invisible. For example, limb abnormalities, Down syndrome, neural tube defects, and cleft palates are usually visible at birth or soon after. However, defects in internal organs or visual or hearing deficits may not be easily determined at birth. Many birth defects may lead to higher risk of death. In fact, worldwide, nearly 240,000 Infants die each year within 28 days of birth. Birth defects contribute to another 170,000 deaths of children ages 1-5 each year. In the United States, birth defects are estimated to be the cause of 20% of infant deaths.

Birth defects may also lead to lifelong disability, causing emotional distress and financial hardship for their families. Surgeries and medications may be able to cure some birth defects or provide relief from the symptoms, but other birth defects victims may need medical aides and expensive devices to ensure they can lead a full life.

Opioids Prescribed to Pregnant Women Tied to Birth Defects

Posted on August 20, 2022November 27, 2024 by Galiher DeRobertis & Waxman

With over 27 million Americans using an illicit or prescription opioid on a routine basis, it’s quite clear that opioid use impacts many facets of our society. The epidemic kills an average of 70,000 people per year – and the ongoing global COVID-19 pandemic, in fact, worsens widespread drug use. But many of those it doesn’t kill live out their lives with complications. Recently, sales of opioid pain relievers in the United States have surged. The populations most affected by this are pregnant women and their infants.

Impact on Children Exposed to Opioids During Pregnancy

While the impact of opioid use during pregnancy continues to be a subject of ongoing debate, solid evidence suggests that perinatal opioid exposure can cause adverse behavioral, cognitive, or developmental outcomes. In a recent study published in Pediatrics, the official journal of the American Academy of Pediatrics, Dr. Stephen Patrick and his co-authors easily conclude that prescribing opioids to pregnant women is quite common. They also found this practice strongly associated with neonatal complications or possible birth defects. With opioid use during pregnancy typically resulting from prescriptions for pain management, it’s often the case that doctors or medical professions fail to consider all options before prescribing such a drug. Many around the country, including states, cities, counties and even hospitals question the manufacturers of such drugs. Because of the numerous distressing legacies left by the opioid epidemic, many of the ongoing lawsuits filed against drug companies reference infants born with complications.

Birth Defects Caused by Opioid Use During Pregnancy

Ever since this issue came into public discourse over a decade ago, several scientific reports have found that maternal opioid treatment early in pregnancy is associated with certain types of birth defects in infants, including:

Congenital heart defects
Hydrocephaly
Spina Bifida
Glaucoma

Additionally, cognitive and developmental delays are also closely associated with opioids like codeine, hydrocodone, and oxycodone taken either before becoming pregnant and during the early trimester of pregnancy. Researchers like Cheryl S. Broussard urge that women and their physicians consider these risks before making treatment decisions during pregnancy. It’s possible that strengthening existing lax prescription rules and regulations could help decrease the risks that pregnant women prescribed opioids face.