Cleft Palate - Consumer Justice Foundation

Cleft Palate Birth Defect Lawsuits

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Victims of cleft palate birth malformations may be entitled to compensation through a product liability lawsuit. Contact a birth defect lawyer today if your child was born with a cleft palate after being exposed to a medication in utero.

Cleft palate is a birth defect that can occur on its own or with cleft lip, another craniofacial malformation that can lead to significant complications for affected babies, including hearing loss, chronic ear infections, feeding difficulties, dental problems, and delays in speech and language development. Cleft palate with or without cleft lip occurs in about one in every 500 to 550 births in the United States, and may be considerably more likely in babies exposed to certain pharmaceutical drugs taken by their mothers during pregnancy. If you took a prescription medication while pregnant, and your child was born with a cleft palate birth defect, you may be entitled to financial compensation for your child’s injuries, medical expenses, and pain and suffering. Contact a reputable cleft palate birth defect attorney today to discuss your options for legal recourse.

What is Cleft Palate?

During normal embryonic development, the lip is typically formed five to six weeks after conception, followed by the palate at ten weeks. However, when this process is interrupted and the palate does not form properly, a cleft occurs. Cleft palate is a craniofacial defect that occurs when there is a lack of tissue in the mouth or lip area, causing a child to be born with a split or opening in the roof of the mouth. Cleft palate can occur on one or both sides of the mouth and can involve the hard palate, which is the bony front portion of the mouth, or the soft palate, which is the soft back portion of the mouth. The severity of this malformation can range from only a small opening at the back of the soft palate to a nearly complete separation of the roof of the mouth. In some cases, cleft palate may occur as an isolated defect, and in others, as part of another birth defect or health condition.

Who May Be at Risk for Cleft Palate?

In many cases, the cause of a cleft palate birth defect is unknown. However, studies have shown that a pregnant woman’s use of certain pharmaceutical drugs, particularly anticonvulsant or antidepressant medications, may increase her unborn baby’s risk of developing a cleft palate. These drugs can have harmful and possibly fatal effects on infants who are exposed to them during pregnancy, especially during the first trimester, when a developing baby is most susceptible to harm. According to a growing body of research, expectant mothers who take the following drugs during pregnancy may have an increased risk of giving birth to babies with cleft palate birth defects:

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

Long-Term Complications of Cleft Palate Birth Defects

Some cases of cleft palate are diagnosed during a prenatal ultrasound while others are detected after birth, during an examination of the mouth, nose and palate. There are several complications associated with cleft palate that may cause more suffering for an affected child than the actual defect itself. An opening in the palate may allow food and liquid to pass back from the mouth through the nose, preventing a child from being able to eat properly. Children with cleft palate are also more likely to develop a buildup of fluid in their ears, causing chronic ear infections and potential hearing loss. Finally, cleft palate may prevent a child from speaking properly and may also result in severe dental problems.

A child suffering from cleft palate will typically require several surgeries from six months of age possibly even through adulthood. During the first year of the child’s life, a functional man-made palate will be created, allowing him to eat and grow properly until surgery can be performed. Around the age of eight, the child will receive several bone grafts intended to fill in the upper gum line so that it can support permanent teeth. Additional surgeries may be required later in life to improve the appearance of the malformation and to stabilize the jaw. According to the National Institute of Dental and Craniofacial Research, the approximate cost of the surgeries necessary to treat the children born each year with cleft palate and cleft lip amounts to $697 million.

Lawsuits for Cleft Palate Birth Defects

July 2012 – Twenty-seven mothers bring Depakote lawsuits against Abbott Laboratories, alleging that side effects of the anticonvulsant drug caused their children to be born with birth defects.
January 2014 – A Depakote lawsuit filed against Abbott Laboratories in Illinois alleges that the drug maker failed to provide adequate warnings to the public about the alleged risk of Depakote birth defects in babies.
April 2014 – Janssen Pharmaceuticals reaches settlement agreements in 76 complaints brought over cleft lip and cleft palate birth defects from Topamax.
July 2014 – Thirteen product liability lawsuits are filed against Pfizer by women who believe their children were harmed by their exposure to Zoloft during pregnancy.
April 2015 – Exposure to Zofran during pregnancy caused a Montana couple’s daughter to be born with cleft lip and cleft palate birth defects, according to a product liability lawsuit.
June 2015 – A Philadelphia jury recommends updating the Zoloft warning label to include information about the potential for Zoloft use in pregnancy to cause birth defects in babies.
September 2015 – An Arkansas mother files a lawsuit against GlaxoSmithKline, claiming that the company’s anti-nausea drug Zofran caused her child to suffer cleft palate and other birth defects due to exposure during pregnancy.

FDA, Cleft Palate and Drugs During Pregnancy

December 2005 – A public health advisory issued by the FDA includes warnings about the potential for Paxil use in pregnancy to cause birth defects in babies.

July 2006 – The FDA adds a black box warning to the Depakote label after a study finds that 20% of women who become pregnant while taking Depakote give birth to babies with congenital malformations.

December 2009 – The FDA issues a drug safety communication indicating that women who become pregnant while taking Depakote may be more likely to give birth to babies with craniofacial defects and other congenital malformations.

March 2011 – A safety communication issued by the FDA warns consumers and medical professionals about the potential for Topamax use in pregnancy to cause cleft lip and cleft palate birth defects in babies.

Cleft Palate Birth Defect Studies

Data from the North American Antiepileptic Drug Pregnancy Registry (NAAED) shows that babies born to women with epilepsy who take Depakote while pregnant are four times more likely to develop birth defects like craniofacial malformations, compared to babies born to women with epilepsy taking another anticonvulsant drug.

August 2006 – A study published in the journal Neurology finds that approximately 20.3% of women who take Depakote during pregnancy experience adverse outcomes related to the birth of their children, compared to only 1% to 10.7% of women who take similar drugs during pregnancy.

June 2007 – The New England Journal of Medicine publishes research linking use of the antidepressant Zoloft in pregnancy to an increased risk of birth defects in babies, including cleft lip and cleft palate.

July 2009 – The journal Reproductive Toxicology publishes a study linking maternal use of Depakote in pregnancy to a nearly three-fold increased risk of major birth defects, including craniofacial abnormalities.

June 2010 – Research published in the New England Journal of Medicine finds that women who take Depakote while pregnant may have a significantly increased risk of giving birth to babies with six major malformations, including cleft palate birth defects.

July 2010 – The UK Epilepsy and Pregnancy Register and the European and International Registry of Antiepileptic Drugs in Pregnancy report that women who take Depakote and other valproate-based anticonvulsant drugs are more than twice as likely to give birth to babies with major malformations.

November 2011 – A study of 9,000 expectant mothers conducted by the Sloan Epidemiology Center and the U.S. Centers for Disease Control and Prevention (CDC) finds that women who take Zofran during the first trimester of pregnancy face more than double the risk of giving birth to a child with a cleft palate.

January 2012 – Research published in the medical journal Birth Defects Research Part A: Clinical and Molecular Teratology finds that women who take Zofran during pregnancy are 2.37 times more likely to give birth to a baby with cleft palate.

July 2012 – The American Journal of Obstetrics & Gynecology publishes a study indicating that use of the anticonvulsant Topamax during the first trimester of pregnancy may increase a baby’s risk of being born with oral cleft birth defects, including cleft lip with or without cleft palate.

August 2012 – Data from the American Headache Society finds a greater risk of oral clefts and other major birth defects among babies whose mothers take Topamax while pregnant, compared to babies whose mothers take other anticonvulsant drugs while pregnant.

December 2013 – A study published in BioMed Research International involving more than 96,000 births in Western Australia finds a 20% higher risk of major birth defects in babies exposed to Zofran during the first trimester of pregnancy.

June 2014 – The Toronto Star publishes a report detailing 20 cases where babies exposed to Zofran during pregnancy were born with mouth deformities and other birth defects.

Why We Think Drug Manufacturers Should Be Held Liable for Cleft Palate Birth Defects

Cleft palate is one of the most difficult superficial malformations for children to deal with, as it is a clearly visible facial deformity. Besides the appearance of the defect, the accompanying complications, including hearing loss and speech problems, will only aggravate the child’s discomfort. Other problems associated with cleft palate include failure to gain weight, feeding problems, poor growth and misaligned teeth. The parents of children born with cleft palate birth defects after being exposed to certain medications during pregnancy are pursuing compensation from drug manufacturing companies, alleging that they:

  • Failed to research the possible pregnancy risks of their drugs
  • Designed and sold dangerous medications to pregnant women
  • Overstated the benefits of their drugs, while downplaying their risks
  • Concealed information about the risk of birth defects from their medications
  • Failed to adequately warn consumers and the medical community about the potential for their products to cause birth defects in babies

What should you do? If your child was diagnosed with cleft palate, you should contact an attorney as soon as possible to discuss filing a birth defect lawsuit.

In most cases, cleft palate can be corrected at an early age so that the child can continue to grow and his proper speech can develop normally. However, in more severe cases, the necessary treatment may be more complicated, and the child may continue to suffer from long-term complications of the congenital malformation. If you or a loved one has suffered from a cleft palate birth defect, and use of a pharmaceutical drug like Zofran, Paxil or Depakote during pregnancy is believed to be the cause, contact an experienced product liability attorney immediately. You may be entitled to reimbursement for your injuries and a knowledgeable birth defect lawyer can help you collect the compensation you deserve.

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