Spina Bifida - Consumer Justice Foundation

Spina Bifida

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Babies exposed to potentially defective medications in pregnancy may have a higher risk of developing birth defects like spina bifida. If you believe your child has been affected by a dangerous pharmaceutical drug, contact a birth defect attorney today.

Women struggling with severe nausea and vomiting during pregnancy, or medical conditions like epilepsy or major depressive disorder, may be prescribed pharmaceutical drugs like Zofran, Depakote, Topamax or Paxil during pregnancy. However, a growing body of research shows that these medications and others may cause devastating birth defects in babies exposed to the drugs in utero. If you took a prescription drug while pregnant and your child was born with spina bifida or another serious neural tube birth defect, our consumer advocates at the Consumer Justice Foundation can help. We are dedicated to protecting the rights of consumers harmed by dangerous medications, and can help put you in touch with an attorney who has experience handling spina bifida birth defect claims.

What is Spina Bifida?

Spina bifida is a neural tube birth defect occurring when the bones of the spine, or the vertebrae, do not form properly around part of the baby’s spinal cord. If the malformation is minor, it may be called spina bifida occulta, which is often only signaled by a birthmark or small patch of hair at the site of the defect. The more severe form of the malformation is called spina bifida cystica, in which part of the spinal nerves push out of the spinal canal, encased in a fluid-filled cyst on the child’s back. In babies born with spina bifida cystica, the spinal cord nerves are often damaged, resulting in problems with walking, coordination, and bladder or bowel control.

Common Symptoms of Spina Bifida

The symptoms associated with spina bifida vary depending on the severity of the birth defect. The milder form of the malformation, spina bifida occulta, is also the most common, and often causes little to no problems. In fact, some children born with spina bifida occulta may live their entire lives without ever being diagnosed with the birth defect. Spina bifida cystica on the other hand, typically results in easily recognizable symptoms, especially if the spinal nerves are exposed. Children born with spina bifida cystica may suffer from nerve damage that affects daily living. They may have little or no feeling in the arms, legs or feet, and they may not be able to move those parts of the body. Babies with severe spina bifida may also be born with hydrocephalus, or a buildup of fluid in the brain, which can cause seizures, vision problems and cognitive disabilities.

The appropriate method of treatment for spina bifida also depends on how severe the birth defect is. Children born with mild forms of spina bifida may not need treatment, while more severe forms of the malformation typically require surgery. Unfortunately, the complications associated with spina bifida may persist throughout the child’s life even with treatment, making physical therapy and the use of a wheelchair, leg braces, or other aids necessary. Most children born with spina bifida cystica benefit from lifelong medical care to monitor their development and treat any additional neurological, physical or intellectual complications that may arise.

Who May Be at Risk for Spina Bifida?

The exact cause of spina bifida is unknown, although researchers have found a possible connection between maternal use of certain pharmaceutical drugs in pregnancy, particularly anticonvulsant and antidepressant medications, and the development of spina bifida in unborn babies. According to a growing body of research, developing babies exposed to the following prescription medications in utero may face a greater risk of developing spina bifida birth defects:

  • Zofran (ondansetron)
  • Depakote (valproate)
  • Topamax (topiramate)
  • Tegretol (carbamazepine)
  • Effexor (venlafaxine)
  • Lexapro (escitalopram)
  • Celexa (citalopram)
  • Zoloft (sertraline)
  • Paxil (paroxetine)
  • Prozac (fluoxetine)

Lawsuits Filed for Birth Defects from Pharmaceutical Drugs

October 2009 – The first Paxil birth defect lawsuit goes to trial in Pennsylvania, and the jury finds that GlaxoSmithKline “negligently failed to warn” a doctor treating a pregnant woman about the risk of birth defects from Paxil, awarding the plaintiff $2.5 million in damages.
July 2010 – At this time, GlaxoSmithKline has settled approximately 800 Paxil birth defect lawsuits for a total cost of $1.14 billion.
February 2012 – Three women who took Lexapro during pregnancy file lawsuits against Forest Pharmaceuticals and Forest Labs, alleging that the drug makers failed to warn expectant mothers and women of childbearing age about the risk of birth defects from the antidepressant drug.
June 2012 – A Boston woman files a claim against Pfizer after suffering birth defects allegedly caused by her mother’s use of Zoloft during pregnancy.
July 2012 – A product liability lawsuit filed by a couple from Idaho alleges that their daughter’s birth defects were caused by her exposure to Zoloft in utero.
July 2012 – Twenty-seven plaintiffs file suit against Abbott after their children are born with spina bifida and other birth defects allegedly caused by their exposure to Depakote in pregnancy.
August 2012 – A couple from Pennsylvania files a Zoloft lawsuit after their daughter is born with numerous birth defects, alleging that side effects of the antidepressant drug caused her congenital malformations.
August 2012 – Two families file Effexor birth defect claims in a Philadelphia court, alleging that use of the antidepressant drug during pregnancy caused their children to be born with serious congenital birth defects.
October 2012 – An Indiana woman files a Celexa lawsuit against Forest Laboratories, alleging that the antidepressant drug caused her child to be born with numerous birth defects.
October 2012 – Forest Laboratories faces a Celexa lawsuit filed in Texas on behalf of a little girl who was born with several different birth defects after her mother was prescribed the SSRI antidepressant in pregnancy.
January 2013 – A Wisconsin couple files a Zoloft birth defect claim against Pfizer, alleging that exposure to the SSRI antidepressant during pregnancy caused the death of their daughter from numerous birth defects.

FDA, Spina Bifida and Drugs During Pregnancy

December 2005 – The FDA issues a press release warning patients and healthcare professionals that early results of new Paxil studies suggest that the antidepressant drug may increase the risk of birth defects when taken during the first three months of pregnancy.

July 2006 – A safety alert issued by the FDA indicates cites a case-control study finding that “infants born to mothers who took SSRIs after the 20th week of pregnancy were 6 times more likely to have persistent pulmonary hypertension (PPHN) than infants born to mothers who did not take antidepressants during pregnancy.”

October 2006 – The FDA adds a black box warning to the Depakote label, indicating that the drug may increase the risk of birth defects in babies.

December 2009 – The FDA warns about the potential risk of neural tube birth defects, heart malformations and craniofacial birth defects associated with Depakote use in pregnancy.

July 2011 – A warning from the FDA indicates that a child’s exposure to Depakote in utero may be linked to decreased cognitive functioning, including lower IQ scores.

March 2011 – The FDA issues a drug safety communication warning that Topamax may increase the risk of oral cleft birth defects in babies. The FDA also reclassifies Topamax as a pregnancy Category D medication.

Spina Bifida Birth Defect Studies

Guidelines from the American Academy of Neurology and the American Epilepsy Society indicate that pregnant women should avoid taking Depakote due to the risk of birth defects like spina bifida.

August 2006 – The journal Neurology publishes research finding that about 20.3% of women who took Depakote while pregnant experienced adverse pregnancy outcomes, compared to only 1% to 10.7% of women who took other, similar medications.

July 2008 – A study published in the medical journal Neurology indicates that babies born to mothers who took Topamax while pregnant experienced birth defects at 16 times the normal rate.

July 2009 – The Hebrew University’s Hadassah Medical School and the Israeli Ministry of Health report that exposure to Depakote in pregnancy may result in nearly three times as many birth defects in babies, including spina bifida.

June 2010 – Research published in the New England Journal of Medicine finds an increased risk of six different birth defects associated with Depakote use during the first trimester of pregnancy, including a 12-times increased risk of spina bifida.

August 2011 – The American Journal of Medical Genetics Part C publishes a special issue focusing on the study of birth defects and their causes, indicating that: about 40 infants with spina bifida could be born without the birth defect every year if Depakote wasn’t used during pregnancy, and about five infants with spina bifida could be born without the birth defect every year if Tegretol wasn’t used during pregnancy.

December 2014 – A study published in the American Journal of Obstetrics and Gynecology indicates that Zofran use during pregnancy may be linked to a 30% increased risk of major congenital malformations.

Why We Think Drug Manufacturers Should Be Held Liable for Spina Bifida Malformations

Spina bifida is a severe neural tube malformation that can have life-long consequences for children, and families with children who suffered spina bifida birth defects allegedly caused by exposure to a pharmaceutical drug are now filing lawsuits against the drug manufacturers, alleging that the companies:

  • Developed, marketed and sold a defective medication
  • Failed to conduct post-marketing studies regarding the risk of birth defects associated with their drugs
  • Failed to warn the public, the FDA and the medical community about the alleged risk of birth defects from their medications
  • Failed to disclose the results of important medical studies
  • Misrepresented the safety of their drugs, while downplaying the side effects
  • Failed to act responsibly and in the best interest of the public

What should you do? If your child has been diagnosed with spina bifida, you should contact a lawyer as soon as possible to discuss filing a birth defect lawsuit.

Spina bifida is a devastating birth defect, and the complications associated with spina bifida and other neural tube birth defects can persist throughout the child’s life. If you or a loved one has suffered from spina bifida and you believe a pharmaceutical drug to be the cause, consult an experienced product liability lawyer as soon as possible. You may have grounds to file a birth defect lawsuit against the drug manufacturing company, in order to pursue the financial compensation you deserve for your child’s injuries, past and future medical bills, and emotional trauma. With a qualified drug injury attorney on your side, you can also ensure that your rights are protected throughout the sometimes complicated legal process.

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