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Birth Defect Lawsuits: Prescription Drugs & Congenital Abnormalities

Birth defects and birth injuries are not the same. Infants suffer birth injuries during labor or delivery, often as the result of mechanical trauma or oxygen deprivation. Birth defects, on the other hand, happen earlier, while a child is still in the womb.

What Are Birth Defects?

Most birth defects begin to develop during the first trimester of pregnancy. That's when a fetus' organs and body tissues are just beginning to take shape, and thus are most vulnerable to the insult of a dangerous chemical.

Researchers divide congenital abnormalities into two rough categories:

Some congenital abnormalities will leave children with permanent disabilities, long-term impairments that impact the way they develop. In tragic cases, birth defects can be fatal. In fact, congenital abnormalities are the leading cause of infant death in the US, according to the Centers for Disease Control and Prevention (CDC).

What Causes Birth Defects?

Doctors often attribute congenital abnormalities, or "birth defects," to random chance. In some cases, this explanation is completely true.

Every year, over 121,000 children will be born with birth defects in the United States. Many of these disorders, whether structural or functional, are caused by random genetic mutations, errors in DNA that can impair the way an unborn child's organs develop in utero. But studies have shown that genetic mutations are not the only cause of birth defects.

Hundreds of thousands of children are born with congenital abnormalities due to chemicals ingested by their mothers. Sometimes, these chemicals are all around us, floating in the air as environmental exposures. Sometimes, they're in the drugs that we are prescribed.

Prescription Drugs & Birth Defects

Well-regarded research has found that some prescription drugs act as teratogens, chemicals that can harm the formation of an unborn child. Thankfully, these drugs, while severely detrimental to the health of a fetus, are not always dangerous. Some can be safely taken outside of pregnancy, with little risk of harm.

Pile Of Pills

The problem, however, is that most prescription drugs are never tested in pregnant women. Researchers agree that it would be unethical to include pregnant women in clinical trials, so they rarely do. As a result, the US Food & Drug Administration almost never approves drugs specifically for use during pregnancy. In the vast majority of cases, we just don't know which drugs would prove harmful to a fetus - until those drugs make their way into the open market.

Off-Label Prescription & Birth Defect Research

Once a drug is approved, doctors can prescribe it for any reason. There's no law, either federal or state, against prescribing drugs "off-label," for unapproved purposes. It should come as no surprise that pharmaceutical drugs often make their way into the medicine cabinets - and bodies - of pregnant women.

In reality, the vast majority of pregnant women take at least one prescription drug. Studies conducted by the CDC have found that 7 out of every 10 pregnant women continue taking or begin to take a pharmaceutical during pregnancy. Nearly 50% of pregnant women take 4 or more medications at some point during the first, second or third trimester.

This is how we learn about the potential effects that prescription drugs can have on a developing fetus, when real women take them.

Birth Defect Lawsuits

Most lawsuits filed in relation to birth defects are based on the legal theory of "failure to warn." Pharmaceutical manufacturers have a duty to warn physicians and patients about the risks of their products. When manufacturers fail to uphold this legal obligation, withholding relevant safety information from the public, they can be held accountable in court.

Birth defect lawsuits are usually filed against pharmaceutical manufacturers, and most claims will allege that the manufacturer failed to adequately warn physicians and parents of a particular drug's risks. Evidence must be presented to demonstrate that the manufacturer knew, or should have known, of the drug's risk, but that the company never notified the public or medical community of that fact.

In some cases, physicians and pharmacists can also be held liable, if there is evidence that these medical professionals should have known that a drug caused birth defects, but negligently prescribed the drug to a pregnant woman anyway.

If you're curious about your family's legal options, you can learn more from our New York birth defect lawyers today in a free consultation.

Drugs That May Cause Birth Defects

Here's an overview of four prescription drugs that have been linked to birth defects. Some of these medications are known to cause congenital abnormalities, while others have been linked to an increased risk of fetal harm by scientific research. This list is far from conclusive, and should not be considered an exhaustive archive of all the prescription drugs that have been linked to birth defects.

Zofran & Ondansetron

Zofran is an anti-nausea drug; it's active ingredient is called ondansetron. It has been approved by the FDA to treat nausea and vomiting in patients receiving cancer treatments and people who get sick after undergoing surgical anesthesia. Over the last two decades, however, Zofran has become the leading prescription treatment for morning sickness, the nausea and vomiting that most women experience during the first trimester.

Recent research has linked ondansetron, and thus Zofran, to an increased risk for congenital heart defects and cleft palate. In two European studies, scientists found that Zofran taken during the first trimester of pregnancy could increase the risk of delivering children with cardiac septal defects by 200% to 400%. An earlier study out of Harvard University found evidence that Zofran increased the risk for cleft palate more than two-fold.

Nearly 300 families have filed lawsuits against GlaxoSmithKline, accusing the company of hiding Zofran's link to increased birth defect risks. As parents note, the study results were never publicized by the Zofran's manufacturer, GlaxoSmithKline. In fact, there is evidence to suggest that GlaxoSmithKline illegally marketed Zofran as a morning sickness treatment, even while the troubling studies were being published.

To learn more about filing a Zofran lawsuit, click here.

Selective Serotonin Reuptake Inhibitors (SSRI)

Selective serotonin reuptake inhibitors, or SSRIs, are antidepressant drugs usually used to treat major depressive disorder and anxiety disorders:

Studies have found that women taking SSRI drugs during pregnancy may be more likely to deliver children with a range of major birth defects, from congenital heart defects to cleft palate. The FDA has repeatedly warned the public that SSRI antidepressants may cause neonatal persistent pulmonary hypertension, a condition that inhibits a baby's ability to breathe outside the womb.

Antidepressants have also been linked to neurological conditions, including autism spectrum disorders. In one study, researchers estimated that around 3% of autism spectrum disorders were caused by selective serotonin reuptake inhibitors alone.

Depakote & Other Anti-Convulsants

Numerous anticonvulsants, or anti-epileptic drugs, have been associated with an increased risk for child birth defects, from minor finger abnormalities to severe and potentially-fatal conditions like spina bifida.

These drugs present a "known" risk for birth defects, according to the United Kingdom's National Health Service. But epilepsy itself, and the risk of having a seizure during pregnancy can severely harm unborn infants as well. In fact, the risks presented by epilepsy may, for some women, be greater than the birth defect risks associated with taking anti-seizure medications. Some women will need to continue taking these drugs during pregnancy, despite their risks. Every decision to take, or stop taking, a drug should be made with the guidance of a trusted medical professional.


Accutane, or isotretinoin, is a drug that no pregnant woman should use. Approved to treat severe cystic acne, isotretinoin causes heart, brain and facial defects in children at staggering rates. Up to 42% of infants exposed to isotretinoin in utero will develop birth defects. The drug is so dangerous that doctors who want to prescribe it have to register with the government. Women are required to take pregnancy tests before using it, and must use two forms of birth control after receiving a prescription.

More than 7,000 lawsuits have been filed against Accutane's manufacturer, over side effects from inflammatory bowel disease to birth defects. As in similar cases, pregnant women claim that the company failed to warn them of the drug's risks until it was too late. Although the name-brand version of isotretinoin, Accutane, was recalled by its manufacturer in 2009, generic versions of the drug are still available.

Medications In Pregnancy: Which Drugs Are Safe?

Not sure if the drug you take is safe during pregnancy? Speak with your doctor and discuss your concerns. You can also check the drug's prescribing information, a packet that comes with each prescription and contains risk data, along with the results of any relevant studies.

In previous years, the FDA ranked each drug on a grade-school letter scale, depending on what researchers had discovered about its pregnancy safety. Drugs that had been found safe for pregnant women received an A, while drugs that pregnant should never take, ones that we know cause birth defects, were given an X. When drugs fell somewhere in the middle, either because of insufficient evidence or because their benefits may still outweigh the risks, they received grades of B, C or D.

The FDA no longer uses this system. As of June 30, 2015, the pregnancy risks of newly-approved drugs are summarized in long-form informational sections, with descriptions of relevant studies, but no letter grade. Drugs approved between June 30, 2015, and June 30, 2001, will be switched over to the more-comprehensive pregnancy information requirements gradually. Medications approved before June 30, 2001, have been exempted from the new provisions, but still have to remove the letter grades by June 29, 2018.

Further Reading

Laurence P. Banville
Date Published: October 19, 2016
Laurence P. Banville is the managing partner of Banville Law. As an experienced personal injury attorney, Mr. Banville helps clients recover compensation from those responsible for his clients' injuries. Our firm is located in New York City, serving clients from the five boroughs: Manhattan, Brooklyn, Queens, The Bronx, and Staten Island.
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