A Depakote lawsuit may be an option for mothers who took the drug and gave birth to a child with severe birth defects, including spina bifida. Lawsuits allege that the drug maker, Abbot Laboratories, failed to disclose risks associated with Depakote and that it promoted the drug “off-label,” or for purposes unapproved by the U.S. Food and Drug Administration (FDA). Affected families may be able to pursue compensation with the help of a dangerous drug attorney.
For more information, contact Attorney Group today. Our consultations are free, confidential and without any obligation on your part. We can help answer your questions, and if you choose to pursue a claim we can connect you with an affiliated Depakote lawsuit attorney who can assist you throughout the legal process.
Have You Seen a Depakote Lawsuit Commercial?
You may have seen a Depakote lawsuit commercial on television and wondered whether you or a loved one have been affected by Depakote and similar drugs and, if so, whether you are eligible to pursue a claim against the drug manufacturer or others. The purpose of this article is to provide you with additional information so that you have a better understanding of your options.
What is Depakote?
Depakote, also known as valproic acid or divalproex sodium, is part of the anticonvulsant class of drugs. Anticonvulsants are often used as treatments for brain-related conditions including epilepsy, migraines, and bipolar disorder. Depakote has also been used as a treatment for attention deficit hyperactivity disorder (ADHD) and chorea, or hyperactive movement disorder. Other brand names of Depakote include Depakene, Depacon, and Stavzor.
How Does It Work?
Depakote works by correcting the imbalance of certain chemicals in the brain called neurotransmitters that help nerves communicate with one another. The drug contains valproate semisodium, an active ingredient that is a type of mood stabilizer. By increasing the brain’s amount of the neurotransmitter GABA, which acts as a nerve calming agent, Depakote can prevent excessive and rapid firing of electrical signals in the brain that are present in patients with bipolar disorder.
Depakote and Pregnancy
Since 2006, the FDA has been warning women and health care professionals about the alleged risks for pregnant women who use Depakote.
Based on the results of a study that examined women who took the drug while pregnant, researchers discovered in 2006 that 20 percent of women involved reported delivering a child with birth defects, including spina bifida.
Following the study, the FDA issued a black-box warning about the potential risk of birth defects from Depakote use during pregnancy.
In December 2009, the FDA issued post-marketing drug safety information reminding health care professionals about the increased risk of neural tube defects and other major birth defects, including craniofacial defects and cardiovascular malformations, in babies exposed to valproate sodium and related products marketed as Depakote (valproic acid and divalproex sodium) during pregnancy.
In 2011, the FDA issued another safety announcement, this time to inform the public that “children born to mothers who take the anti-seizure medication valproate sodium or related products (valproic acid and divalproex sodium) during pregnancy have an increased risk of lower cognitive test scores than children exposed to other anti-seizure medications during pregnancy.” These findings were based on an epidemiological study in which cognitive tests were performed at age three as well as supportive studies performed at ages five to 16.
An additional FDA warning was issued in May 2013 advising health care professionals and women that the anti-seizure medication valproate sodium and related products, including Depakote, should not be taken by pregnant women for the prevention of migraine headaches. According to the FDA, the 2013 warning was issued based on the final results of the Neurodevelopmental Effects of Antiepileptic Drugs (NEAD) study, which showed that these medications can cause decreased IQ scores in children whose mothers took them while pregnant. Long-term effects on cognitive development remains uncertain.
Depakote Fetal Risks
Studies suggest that women who use Depakote while pregnant are at risk for giving birth to a child with serious birth defects. According to the Mayo Clinic, “studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities” associated with the use of valproic acid (Depakote).
Additionally, a report issued by France’s National Agency for the Safety of Medicines indicated that between 2,150 and 4,100 children suffered severe malformations linked to the use of Depakote. According to the BBC, types of birth defects linked to the drug include spina bifida, defects of the heart, and genital defects.
Depakote and Spina Bifida
The use of Depakote during pregnancy has been linked to neural tube defects, including spina bifida. The neural tube is part of the embryo that grows into the brain, spinal cord, and surrounding tissues. Spina bfidia occurs when a portion of the neural tube fails to close, causing defects in the spinal cord and vertebrae. According to the National Institute of Neurological Disorders and Stroke, the condition is America’s most common neural tube defect with approximately 1,500 to 2,000 cases each year.
The severity of spina bifida varies depending on the location and size of the defect, the spinal nerves involved, and whether the defect is closed. Complications from spina bifida range from minor physical impairment to severe mental and physical disabilities.
Other Depakote Birth Defects
Other birth defects linked to the use of Depakote during pregnancy include:
|Cleft palate – A congenital birth defect that occurs when the tissue in the roof of the mouth does not grow together properly between the sixth and ninth weeks of pregnancy, causing a split. In some cases, the palate is open at the front and back. A baby with a cleft palate may have difficulty swallowing or eating, speaking clearly, and can have ear infections more frequently than babies without cleft palate.|
Atrial septal defect – A birth defect that causes a hole in the wall between the heart’s atria. Depending on size, the hole may close in infancy or early childhood. Undetected atrial septal defect that are larger in size can shorten an adult’s lifespan by causing heart failure or pulmonary hypertension, which affects the arteries in the lungs. Surgery is often required to prevent potentially fatal complications resulting from atrial septal defects.
Craniosynostosis – A birth defect that occurs when one or more of the joints of a baby’s skull close prematurely before the brain fully forms, limiting the brain’s space to grow and develop and causing the baby’s head to be an unnatural shape. Craniosynostosis, in some cases, is linked with a brain abnormality that keeps the brain from proper growth and development. Surgery is typically required to separate the closed joints, and if there is no underlying brain abnormality, the brain will have space to grow properly.
Polydactyly – A condition in which a baby is born with extra fingers or toes. Additional digits are often on the little finger or toe side of the hand or foot and may be underdeveloped. However, sometimes extra fingers or toes are adequately developed and can function. Surgery is typically required to remove larger digits.
Other Depakote Side Effects
According to WebMD, Depakote side effects may include the following:
- Hair loss
- Blurred/double vision
- Change in menstrual periods
- Ringing in the ears
- Weight changes
- Signs of infection including fever, persistent sore throat, and swollen lymph nodes
- Chest pain
- Easy bruising
- Unexplained bleeding
- Irregular heartbeat
- Swelling in hands or feet
- Uncontrolled eye movement
- Rapid breathing
- Loss of consciousness
- Mental/mood problems
- Severe brain disorder (encephalopathy), particularly in patients with certain metabolic disorders
Other side effects related to the use of Depakote include allergic reactions, such as rash, severe dizziness and trouble breathing.
Other Depakote Risks
According to the drug’s prescription information, the use of Depakote has caused potentially fatal liver problems, particularly within the first six months of treatment. This risk of severe liver problems is reportedly higher in children under two years of age, particularly if they take multiple seizure medications, have a severe seizure disorder with mental retardation, an organic brain disease, or if they have an inherited metabolic disorder.
In rare cases, the use of Depakote may also cause pancreatitis, a potentially life-threatening disease that activates digestive enzymes before they enter the small intestine, causing them to attack the pancreas. Cases of pancreatitis have been reported shortly after initial use as well as after several years of use. Serious symptoms of pancreatitis include abdominal pain, nausea, vomiting, and/or anorexia may require prompt medical evaluation.
Lauren A. on May 16, 2016
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Has There Been a Depakote Recall?
Although there has not been a Depakote recall, lawsuits claim that the drug makers failed to disclose known side effects of the drug and that patients suffered damages as a result. Failure to warn of side effects of a drug can be a basis of drug company liability, regardless of whether the drug has been recalled.
Is There a Depakote Class Action?
In 2011, a Depakote class action lawsuit was filed against Abbott Laboratories on behalf of children whose mothers took the medication while pregnant and developed birth defects. However, Depakote lawsuit attorneys are doubtful that an additional class action will be certified for patients who are adversely affected by the drug. Instead, if multiple Depakote lawsuits are filed against the drug makers alleging injuries and other damages caused by Depakote and similar drugs, it is anticipated that these lawsuits will be consolidated for discovery and other pretrial proceedings.
When cases are consolidated in this way in federal court it is called multidistrict litigation (MDL), and on a state level it is known as a state court consolidated proceeding. MDLs are distinct from class actions, and it is generally agreed that consolidating cases instead of proceeding in a class action is a more efficient and effective way of handling claims arising from injuries caused by pharmaceutical products.
Have There Been Depakote Settlements?
Some cases settle early in the claims process, but it is not expected that there will be early Depakote settlements associated with the alleged risks linked to the drug. In most cases that proceed in an MDL or state court consolidated proceedings, after a certain period of time initial trials, also known as bellwether trials, take place. The purpose of these trials is for the parties to get an idea of the types of evidence and arguments that will made, as well as to see how juries will respond to the evidence and arguments. After a certain number of cases have been tried, the parties are in a better position to determine whether a case can be settled.
However, a jury awarded a total of $38 million to a Minnesota girl and her family in 2015 after the girl’s family claimed that the use of Depakote caused the girl to suffer from spina bifida. Although the drug makers claimed that the girl’s mother was aware of the risks associated the medication, the jury awarded $15 million in compensatory damages and an additional $23 million in punitive damages.
Depakote lawsuit attorneys note that the outcome of any case is never guaranteed, and past results are not necessarily predictive of future outcomes.
- April 2017Report issued by France’s National Agency for the Safety of Medicines indicates that between 2,150 and 4,100 children suffered severe malformations linked to the use of Depakote.
- May 2015Jury awards a Minnesota girl and her family a total verdict amount of $38 million after the family alleged that the use of Depakote while the girl’s mother was pregnant caused the girl to suffer from spina bifida.
- May 2013FDA issues warning advising health care professionals and women that the medication should not be taken by pregnant women for the prevention of migraine headaches.
- April 2013According to a study conducted by Danish researchers, findings indicate that pregnant women taking Depakote and other similar medications may be three times as likely to give birth to a child with autism spectrum disorder than women who did not take the drug.
- June 2011FDA issues safety announcement to inform the public that children born to mothers who take Depakote and similar drugs during pregnancy may have an increased risk of lower cognitive test scores than children exposed to other anti-seizure medications during pregnancy.
- December 2009Based on the results of a study that examined women who took the drug while pregnant, the FDA issues a safety alert after researchers discovered that 20 percent of women involved reported delivering a child with birth defects, including spina bifida.