Depakote Autism Lawsuit

Depakote (generic name: valproate or divalproex sodium) is a prescription drug initially approved for treating epilepsy, bipolar disorder, and migraine headaches. However, it has also been linked to significant risks when used during pregnancy, particularly concerning developmental disorders such as autism and ADHD in children exposed to the drug prenatally. The Depakote autism lawsuit represents an important avenue for families seeking justice after experiencing severe impacts related to the use of this medication. 

The ongoing lawsuits stem from allegations that the manufacturers, including Abbott Laboratories, failed to adequately warn consumers and healthcare providers of the risks associated with Depakote use during pregnancy. Numerous families have come forward, claiming that prenatal exposure to Depakote has led to life-altering developmental conditions for their children.

These legal actions aim to hold the manufacturers accountable for the alleged negligence and to secure financial compensation for medical expenses, long-term care needs, and emotional distress caused by the drug's harmful effects. This article delves into the latest lawsuit updates, scientific connections between Depakote and autism, and what affected families need to know to take legal action.

By examining the legal and medical issues surrounding Depakote, this comprehensive guide aims to empower families to make informed decisions about their rights and potential claims. Whether you are just learning about the lawsuit or exploring your eligibility, understanding the facts about Depakote is the first step toward seeking justice.

May 4, 2025

Abbott Laboratories and AbbVie continue to face lawsuits from families claiming birth defects caused by Depakote. A few new suits were filed in early 2025, but no major verdicts or settlements have been announced.

April 16, 2025

Three potential interactions or warnings were found for these two drugs:

• Depakote is also known as Divalproex (sodium).
• meclizine

April 10, 2025

Autism Risk after Prenatal Valproate or Lamotrigine Exposure

April 7, 2025

A man's family received $3.3 million for an overdose of fentanyl in the Orange County jail. According to a death report published by the OCDA on November 20,23, during the screening of the prisoner's case in March 2023. Campos stated that he was prescribed several medications, including Albuterol and Depakote. He also claimed to have asthma. He denied using alcohol or illegal drugs such as heroin or opiates.

April 3, 2025

Depakote tablets are taken by mouth. The usual starting dose is 250 mg twice a day. Some individuals may respond better to doses up to 1,000 mg per day. However, clinical trials did not show any added benefit from higher doses.

April 1, 2025

Decades after exposure, families impacted by fetal valproate syndrome are still fighting for compensation. Despite recognition from officials and public inquiries, no redress scheme has been implemented. This reinforces the growing demand for accountability and systemic reform surrounding sodium valproate use during pregnancy. It parallels ongoing scrutiny of pharmaceutical companies and echoes similar themes present in U.S. litigation involving inadequate warning and harm to offspring.

March 27, 2025

Victims of sodium valproate exposure continue to await compensation, decades after the drug was linked to birth defects and developmental issues when taken during pregnancy. Families have voiced frustration over the lack of progress on redress schemes, calling for immediate action to support affected children and their caregivers. Legal and regulatory pressure is building as advocates push for accountability and long-term care solutions.

March 25, 2025

According to the World Health Organization, it's essential that women of childbearing age use effective contraception throughout the entire course of their Depakote use. Women in this age bracket should also regularly meet with a specialist who can work with patients to determine whether Depakote continues to be the best course of treatment for their needs.

March 20, 2025

Ongoing research shows that certain antiseizure medications, including lamotrigine and levetiracetam, are not associated with learning differences in children whose mothers used the drugs during pregnancy. This news holds promise for epileptic women who are interested in having children, as these drugs appear to be more safe to unborn children than Depakote.

March 16, 2025

The FDA added new warnings to Depakote's prescribing information, including warnings about hyperpigmentation (darkening of some areas of the skin).

March 13, 2025

Depakote is associated with a higher risk of neural tubes defects, such as spina bifida. The rate of neural tubes defects in the general public is between 0.1 and 0.2 percent. However, it has been reported that the incidence rate for children exposed to Depakote during the first trimester is as high as five percent.

March 9, 2025

Spinal health issues aren't the only birth defects associated with the use of Depakote during pregnancy. A research study that explored the behaviors of more than a milion children shows that prenatal exposure to valproic acid, the active ingredient of Depakote, may increase the risk of attentional issues, poor school performance, and autistic traits later in life.

March 5, 2025

Many babies born to mothers who took Depakote for the treatment of seizures and/or bipolar disorder while they were pregnant are born with spina bifida, a congenital spinal condition that can result in disability and lifelong health issues. The Spina Bifida Assocation recently released a statement regarding the Trump Administration's federal budget cuts expressing concern that a lack of federal funding could hinder research that benefits people with the condition.

March 3, 2025

Research on fetal valproate spectrum disorders has determined that prenatal exposure to valproate, the main ingredient in Depakote, causes genetic mutations during fetal development. In addition to intellectual and neurological changes, these mutations also result in distinct facial features, including a short nose, microcephaly (a condition in which a baby's head is much smaller than normal), hypertelorism (a wider-than-normal distance between the eyes), and other abnormalities.

March 1, 2025

Some pregnant women who live with bipolar disorder are turning to a new antipsychotic medication called Lumateperone (brand name Caplyta). Approved by the FDA in 2019, there are no known birth defects associated with lumateperone. Despite the lack of birth defects associated with the drug, pregnant women are advised to use caution during the third trimester, as fetal exposure to lumateperone can cause withdrawal symptoms and extrapyramidal symptoms (motor system issues).

February 24, 2025

Some children born to mothers who used the anti-seizure medication Depakote during pregnancy are diagnosed with spina bifida, a condition in which the spinal tissue doesn't fuse properly during pregnancy, often leading to lifelong complications. During a recent clinical trial, a doctors performed fetal surgery on a baby diagnosed with the condition in utero, Doctors used a surgical stem cell patch to repair the baby's spine, and today, the now two-year-old child is able to walk independently, unlike many children diagnosed with spina bifida.

February 17, 2025

Birth defects aren't the only issue with Depakote, according to the drug's black box warning. Depakote has been found to potentially cause severe liver damage, which can eventually lead to death. This type of liver damage is most common in people who have mitochondrial disorders, including Pearson syndrome and Leigh syndrome.

February 12, 2025

Researchers are have dubbed the neurodevelopmental conditions suffered by babies who were exposed to Depakote in the womb as Fetal Valproate Spectrum Disorder, or FVSD. Research shows that of the children and adults in the study who were diagnosed with FVSD, more than 62% were diagnosed with autism spectrum disorder, over 80% experienced sensory difficulties, and 87% utilized speech therapy services.

February 9, 2025

According to Massachusetts General Hospital and Harvard Medical School, women who typically use anticonvulsants to control bipolar disorder may be able to use lamotrigine (Lamictal), an alternative to Depakote, during pregnancy to lower the risk of harm to the fetus.

February 4, 2025

Spina bifida—the most common neural tube birth defect related to Depakote use during pregnancy—is now being treated with fetal surgery. During the procedure, doctors attach a stem cell patch to the developing baby's spinal cord, giving it a second chance to fuse properly. When successful, this can correct spina bifida.

February 1, 2025

Previously, Abbott Laboratories pleaded guilty to misbranding Depakote and agreed to pay $1.5 billion to resolve criminal and civil investigations related to its promotion of the drug for unapproved uses.

January 29, 2025

It's essential that all pregnant women get plenty of folic acid to support fetal health, and this is especially true for women who are taking Depakote and/or other mood stabilizer and anti-convulsive medications. Folic acid reduces the likelihood of neural tube defects in the general population. Research is ongoing, and many healthcare professionals are hopeful that high levels of folic acid supplementation (4 to 5mg) could help to reduce the likelihood of neural tube defects in babies born to women taking Depakote and similar drugs.

January 26, 2025

According to a study, mothers aren't the only ones who could put their babies at risk by taking Depakote. Children born to fathers who took Depakote up to three months before conception are more likely to develop neurodevelopmental issues. It's possible that men could eventually join the class action lawsuits regarding Depakote and birth defects.

January 7, 2025

Depakote lawsuits are centered around allegations that the drug caused heart defects. They also claim that Depakote can cause neurological complications, which may lead to autism spectrum disorders or developmental delays. These injuries can be devastating to children and their parents.

January 1, 2025

Alembic Pharma gets USFDA nod for seizure treatment drug. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Depakote Sprinkle Capsules.

The Depakote lawsuits have been making headlines for years, shedding light on the drug's risks and the legal actions surrounding its use. A significant development came in 2012, when Abbott Laboratories, the manufacturer of Depakote, agreed to pay a historic $1.5 billion settlement to resolve criminal and civil investigations into its marketing practices. According to the U.S. Department of Justice, Abbott promoted Depakote for uses not approved by the Food and Drug Administration (FDA), such as treating agitation in elderly dementia patients and schizophrenia.

This record-breaking settlement marked one of the largest penalties for off-label marketing in U.S. history. The case brought attention not only to Abbott's marketing practices but also to the drug's potential dangers when misused or prescribed without adequate warnings. The financial penalties included:

• $700 million in criminal fines.
• $800 million to resolve civil claims, including whistleblower lawsuits filed under the False Claims Act.

The settlement also required Abbott to adhere to a strict corporate integrity agreement to prevent future misconduct. These events set the stage for additional lawsuits, as families and individuals affected by Depakote's risks came forward with claims related to its side effects, particularly its impact on children exposed in utero.

Ongoing Legal Updates

Since the 2012 settlement, numerous lawsuits have focused on Depakote's alleged link to autism and other developmental disorders in children born to mothers who took the drug during pregnancy. Plaintiffs in these cases argue that the manufacturer failed to adequately warn about the risks despite existing evidence linking prenatal exposure to neurological and developmental harm.

While earlier lawsuits primarily revolved around marketing practices, the current wave centers on product liability, emphasizing the devastating effects of prenatal exposure to Depakote. Families across the U.S. are seeking compensation for medical expenses, loss of quality of life, and the long-term care required for children with autism or ADHD linked to Depakote use.

Stay tuned for more updates as these cases progress, potentially shaping the future of pharmaceutical accountability and patient safety.

Autism and ADHD (Attention-Deficit/Hyperactivity Disorder) are neurodevelopmental disorders that affect millions of individuals worldwide. Though distinct in their characteristics, they often coexist and share overlapping symptoms, particularly in children exposed to certain environmental or prenatal risk factors.

What Is Autism?

Autism, or Autism Spectrum Disorder (ASD), is a complex developmental condition characterized by challenges in social communication, behavioral patterns, and sensory processing. Key features of autism include:

• Difficulty with verbal and nonverbal communication
• Repetitive behaviors or restricted interests
• Sensitivity to sensory input, such as sounds or textures

Autism is a spectrum disorder, meaning it varies widely in severity and presentation. While some individuals with autism may have significant developmental delays and require lifelong support, others may excel in specific areas such as mathematics, art, or memory skills.

What is ADHD?

ADHD is a neurodevelopmental disorder that impacts a person’s ability to regulate attention, behavior, and energy levels. Common symptoms include:

• Inattentiveness (difficulty focusing, forgetting tasks)
• Hyperactivity (excessive movement or restlessness)
• Impulsivity (acting without considering consequences)

ADHD is typically diagnosed in childhood and can persist into adulthood, often affecting academic performance, workplace productivity, and interpersonal relationships.

Overlap Between Autism and ADHD

Autism and ADHD often occur together: approximately 30-50% of individuals with autism also meet criteria for ADHD. Shared symptoms, such as difficulties with focus, social interaction, and emotional regulation, can complicate diagnosis and treatment.

Understanding these conditions is crucial when examining the potential impact of external factors, including prenatal exposure to medications like Depakote, which studies have linked to developmental issues like autism and ADHD.

Depakote has been under scrutiny for its potential to cause developmental disorders, including autism, in children exposed to the drug during pregnancy. Scientific studies and legal claims have highlighted the risks associated with prenatal Depakote use, particularly concerning its effects on a developing fetus.

Scientific Evidence Linking Depakote to Autism

Research has shown that valproate exposure during pregnancy increases the risk of autism and other neurodevelopmental disorders. A landmark study published in The American Epilepsy Society found that children whose mothers used valproate during pregnancy were significantly more likely to be diagnosed with autism spectrum disorder compared to children not exposed to the drug.

The exact mechanisms are not fully understood, but experts believe that Depakote may interfere with fetal brain development by altering gene expression or causing neural damage during critical developmental periods.

The timing of Depakote use during pregnancy may also play a role in its risks. Studies suggest that exposure during the first trimester—a critical period for brain and nervous system development—carries the highest risk of autism and related conditions.

Families affected by Depakote-related autism have filed lawsuits against Abbott Laboratories, claiming that the company:

• Failed to adequately warn about the risks of using Depakote during pregnancy.
• Neglected to provide safer alternatives or mitigate harm to the developing fetus.

These lawsuits aim to hold the manufacturer accountable for the lifelong consequences families face due to autism diagnoses.

Advocacy and Support for Affected Families

Parents of children diagnosed with autism following prenatal Depakote exposure often face significant financial and emotional burdens. From early intervention therapies to lifelong care, the costs can be overwhelming. Legal actions not only seek compensation for these expenses but also advocate for greater pharmaceutical transparency and accountability.

As the medical community continues to uncover the long-term effects of Depakote, understanding the link between the drug and autism empowers families to take legal action and seek justice for their loved ones.

Depakote toxicity occurs when the drug's levels in the bloodstream become too high, leading to harmful effects on the body. Toxicity can result from an accidental overdose, improper dosing, or interactions with other medications. Recognizing the signs early is crucial to prevent severe complications.

Common Signs of Depakote Toxicity

• CNS Depression: Reduced alertness or responsiveness, including drowsiness or confusion.
• Lethargy and Potential Encephalopathy: Extreme fatigue or sluggishness, potentially progressing to brain dysfunction marked by confusion or altered mental states.
• Respiratory Depression: Difficulty breathing or slowed respiratory rate.
• Nausea and Vomiting: Persistent gastrointestinal distress, often one of the first signs of toxicity.
• Myoclonus: Involuntary, sudden muscle jerks or twitches.

Severe Outcomes of Depakote Toxicity

• Seizures: Ironically, Depakote toxicity can trigger seizures, even though the drug is prescribed to prevent them.
• Liver damage: Symptoms may include jaundice (yellowing of the skin or eyes), dark urine, and abdominal pain.
• Coma: Extremely high levels of Depakote can result in a loss of consciousness.
• Death: Without prompt treatment, life-threatening complications can arise.

What to Do If Depakote Toxicity is Suspected

If you or someone you know exhibits symptoms of Depakote toxicity, seek medical attention immediately. Doctors can measure valproate levels in the blood and provide treatments such as:

• Activated charcoal to limit absorption in overdose cases
• IV fluids to flush the drug from the system
• Supportive care for symptoms, such as breathing assistance

Depakote is a powerful medication, but it carries a significant risk of side effects. While some are mild and manageable, others can be severe or life-threatening. Understanding these risks is essential for patients and caregivers.

Common Side Effects

• Diarrhea: Frequent, loose bowel movements.
• Dizziness: A feeling of lightheadedness or unsteadiness.
• Drowsiness: Fatigue or difficulty staying alert.
• Hair Loss: Thinning or shedding of hair during treatment.
• Blurred or Double Vision: Visual disturbances affecting clarity and focus.
• Change in Menstrual Periods: Irregular or altered menstrual cycles.
• Ringing in the Ears (Tinnitus): Persistent buzzing or ringing sounds.
• Shakiness (Tremor): Involuntary trembling, often in the hands.
• Unsteadiness: Difficulty maintaining balance or coordination.
• Weight Changes: Significant weight gain or loss.

Serious Side Effects

• Liver damage: Valproate can cause elevated liver enzymes, leading to jaundice, abdominal pain, and fatigue. Regular liver function tests are critical for monitoring.
• Pancreatitis: Inflammation of the pancreas, presenting with severe abdominal pain, nausea, and vomiting.
• Birth defects: Depakote use during pregnancy is strongly associated with neural tube defects, developmental delays, and autism in children.
• Blood disorders: Rarely, Depakote can cause low platelet counts (thrombocytopenia), leading to excessive bleeding or bruising.
• Cognitive impairment: Long-term use may affect memory and cognitive function.

Rare but Severe Side Effects

• Suicidal thoughts or behavior: Like many antiepileptic drugs, Depakote carries a warning about increased risk of suicidal ideation.
• Encephalopathy: High levels of ammonia in the blood can lead to confusion, lethargy, or altered mental states.
• Allergic reactions: Symptoms like rash, itching, swelling, or difficulty breathing should be treated as medical emergencies.

Minimizing Risks

Patients on Depakote should have regular checkups, including blood tests, to monitor liver function and drug levels. Discuss any new symptoms with your doctor, as they may indicate a need for dosage adjustments or alternative treatments.

By staying informed and vigilant, patients and caregivers can better navigate the risks associated with Depakote, ensuring its benefits outweigh its potential harms.

Depakote, known generically as valproate or divalproex sodium, received approval from the U.S. Food and Drug Administration (FDA) in 1983 for the treatment of epilepsy. Over the years, its indications have expanded to include:

• Epilepsy: Used to control seizures, particularly complex partial seizures and absence seizures.
• Bipolar Disorder: Approved for managing manic episodes associated with bipolar disorder.
• Migraine Prevention: Prescribed to reduce the frequency and severity of migraines.

The approval of Depakote was based on clinical trials demonstrating its effectiveness in managing these conditions. Its ability to stabilize electrical activity in the brain and prevent abnormal signaling made it a critical option for patients with neurological and psychiatric disorders.

While Depakote has been a cornerstone medication for many, its approval came with important caveats. Over time, the FDA issued additional warnings regarding its use:

• 2009 Black Box Warning: The FDA added a black box warning highlighting the risks of hepatotoxicity, pancreatitis, and teratogenic effects (harmful effects on a developing fetus).
• Pregnancy Category D/X: The drug was classified as Category D for epilepsy and bipolar disorder (indicating fetal risk but potential benefit) and Category X for migraine prevention (indicating risks outweigh any potential benefit).

These warnings have made it essential for healthcare providers to carefully weigh the benefits and risks before prescribing Depakote, particularly for women of childbearing age.

While there has never been a mandatory recall for the brand-name drug Depakote, a related product containing the same active ingredient was voluntarily recalled. On December 26, 2023, Amneal Pharmaceuticals initiated a Class II recall for its Divalproex Sodium Extended-Release Tablets (250 mg). This formulation uses the same active ingredient as Depakote—valproate—and was found to fall short of dissolution specifications.

Dissolution issues can impact how the medication is absorbed in the body, potentially reducing its effectiveness or altering its safety profile. Amneal's recall, which remains ongoing, underscores the importance of strict quality control measures for medications containing valproate.

If you are taking Divalproex Sodium or Depakote, consult your healthcare provider to ensure your medication is not affected by this recall. Regular monitoring and open communication with your doctor can help address any concerns about medication quality or effectiveness.

Why Depakote Has Not Faced a Full FDA Recall

Despite its significant risks, the FDA has not issued a complete recall of Depakote. This is primarily because:

1. Therapeutic Necessity: Depakote remains a critical medication for patients with severe epilepsy, bipolar disorder, or chronic migraines who may not respond to other treatments.
2. Risk Management Strategies: The FDA has implemented strict guidelines and warnings, such as requiring prescribers to educate patients about the drug’s risks, particularly for pregnant women.

Calls for Greater Oversight

Advocacy groups and patient safety organizations have called for stricter regulation of Depakote, citing the devastating impact of its prenatal risks and the legal consequences faced by Abbott Laboratories. These efforts aim to improve safety standards and ensure that patients are fully informed about potential side effects.

If you are concerned about the safety of Depakote or believe you’ve been impacted by its use, consult with your healthcare provider and consider seeking legal advice to explore your options.

Over the years, lawsuits related to Depakote have resulted in significant settlements. These lawsuits generally focus on the drug's risks and the alleged failure of Abbott Laboratories, the original manufacturer, to adequately warn about its dangers.

Landmark Settlement: $1.5 Billion in 2012

One of the largest settlements occurred in 2012, when Abbott Laboratories agreed to pay $1.6 billion to resolve claims related to off-label marketing and misrepresentation of Depakote. This settlement addressed criminal and civil allegations, including:

• Promoting Depakote for unapproved uses, such as treating dementia and schizophrenia.
• Violations of the False Claims Act, with claims of Medicare and Medicaid fraud.
• Failure to disclose risks, particularly regarding its teratogenic effects when taken during pregnancy.

This historic settlement remains one of the largest in the pharmaceutical industry and underscored the need for stricter regulations and transparency in drug marketing practices.

Settlements for Developmental Disorders

Families affected by Depakote's link to autism and other developmental disorders have also filed lawsuits, leading to individual settlements. These cases focus on product liability and Abbott’s alleged failure to provide adequate warnings about the risks of prenatal exposure.

Settlements often aim to compensate families for:

• Medical expenses for therapy, treatment, and care
• Emotional distress caused by lifelong developmental conditions
• Loss of income due to caregiving responsibilities

Although these settlements vary by case, they represent an important step in holding manufacturers accountable for the harm caused by Depakote.

What Is Depakote?

Depakote, also known as valproate or divalproex sodium, is a prescription medication primarily used to treat epilepsy, bipolar disorder, and migraines. It stabilizes electrical activity in the brain to prevent seizures and mood swings.

What Is Depakote Used For?

The FDA has approved Depakote for the following conditions:

• Epilepsy: Managing seizures, including absence and complex partial seizures
• Bipolar Disorder: Treating manic episodes
• Migraine Prevention: Reducing the frequency of migraines

Who Makes Depakote?

Depakote was originally manufactured by Abbott Laboratories. In 2013, Abbott spun off its pharmaceutical division into a new company, AbbVie, which now oversees the production of Depakote.

What Are the Side Effects of Depakote?

Depakote’s side effects range from mild to severe and include:

• Nausea, weight gain, and fatigue
• Liver damage, pancreatitis, and cognitive issues
• Birth defects and developmental disorders when used during pregnancy

How Often Should Depakote Levels Be Monitored?

Patients taking Depakote should have their blood levels monitored regularly, typically every 6-12 months, or more frequently if symptoms of toxicity or side effects appear. Monitoring helps ensure the dosage is therapeutic without becoming toxic.

Can Depakote Cause Aggression?

Yes, Depakote has been associated with behavioral changes, including aggression, particularly in pediatric and adolescent patients.

Can Depakote Cause Tardive Dyskinesia?

While not commonly linked to Depakote, tardive dyskinesia—a movement disorder—has been reported in rare cases, especially when used alongside other medications that affect the nervous system.

Can Depakote Cause Tremors?

Yes, tremors are a known side effect of Depakote and may occur even at therapeutic doses.

Can Depakote Cause Autism?

Studies have linked prenatal exposure to Depakote to an increased risk of autism spectrum disorder in children. The drug is known to interfere with fetal brain development during pregnancy.

Is Depakote a Class Action Lawsuit?

Most Depakote lawsuits are individual claims rather than a class action. Families file lawsuits tailored to their specific circumstances, focusing on the harm caused to their child due to prenatal exposure.

You may be eligible to file a Depakote lawsuit if you or a loved one meet the following criteria:

1. Prenatal Exposure: The child was exposed to Depakote (valproate) in utero
2. Autism Diagnosis: The child has been diagnosed with autism spectrum disorder or another developmental condition
3. Timing of Use: The mother used Depakote during pregnancy, particularly between week 19 and delivery, when the developing fetus is most vulnerable

If you believe you have a case, consulting a legal professional is the first step toward pursuing compensation for the medical, emotional, and financial challenges associated with Depakote-related injuries.

Medical Disclaimer
This article is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare provider regarding your health, medications, or any medical conditions. Do not stop, start, or change your prescribed medications without professional guidance. If you believe you or a loved one has experienced side effects or harm from Depakote, seek immediate medical and legal assistance.