Depakote, Depakote CP and Depakote ER have recently been linked to an increased risk for birth defects in babies born to mothers who take the drug during pregnancy.
If you or somebody you know has taken Depakote while pregnant and given birth to a child with birth defects, you should contact us immediately. You may be entitled to compensation by filing a lawsuit and our lawyers can help.
Update: Depakote Settlement Talks in Progress; Federal Judge Stays Litigation
January 31, 2018 – Settlement talks are now underway between federal prosecutors and the manufacturer of the epilepsy drug Depakote, Abbott Laboratories. At issue are allegations that the pharmaceutical giant illegally marketed Depakote for the off-label treatment of Alzheimer’s disease and as a chemical restraint for the elderly. In addition to the claims of illegal marketing, Abbott also currently faces scores of lawsuits around the country on behalf of women who claim that Depakote caused their children to be born with birth defects.
In what appears to be the latest chapter in a series of embarrassing mishaps for troubled pharmaceutical manufacturer Abbott Laboratories, the company is now reportedly in settlement talks with federal prosecutors over allegations that it illegally marketed its best-selling antiepileptic drug Depakote.
The Depakote lawsuit was filed by three former Abbott account executives under the qui tam provision of the False Claims Act, which allows whistleblowers who report a false claim against a company to be entitled to receive a portion of any money that the government recovers from offenders. However, a clause in the provision states that the whistleblower must be the first to bring the claim to the government’s attention, and must not publicize the claim until the Department of Justice (DOJ) decides to pursue the case.
The U.S. government has filed a whistleblower lawsuit against Abbott, claiming that the company violated federal law by promoting Depakote for ‘off-label’ purposes including Alzheimer’s disease and as a chemical restraint for elderly patients, which is often considered a form of nursing home abuse. Off-label use is the practice of prescribing drugs for unapproved indications for which they have neither been tested or evaluated for.
What’s the Problem?
Depakote (divalproex sodium and valproic acid) is an anti-seizure medication used to treat a variety of seizure and mood disorders, and to prevent migraines. Unfortunately, Depakote has been linked to a large number of severe, potentially life-threatening birth defects in babies exposed to the drug in the womb, as well as serious side effects in users.
Study Links Depakote to 12X Risk of Spina Bifida
A study published in the New England Journal of Medicine in June 2010 linked Depakote to an increased risk for 16 severe birth defects, including:
- Spina bifida — 12.7-fold increased risk
- Craniosynostosis — 6.8-fold increased risk
- Cleft palate — 5.2-fold increased risk
- Atrial septal defect — 2.5-fold increased risk
- Hypospadia — 4.8-fold increased risk
- Polydactyly — 2.2-fold increased risk
“The use of valproic acid monotherapy in the first trimester was associated with significantly increased risks of several congenital malformations, as compared with no use of antiepileptic drugs or with use of other antiepileptic drugs,” the researchers concluded.
Depakote Birth Defects
Birth defects linked to the use of Depakote during pregnancy include:
- Spina Bifida
- Atrial Septal Defects (ASD)
- Ventricular Septal Defects (VSD)
- Persistent Pulmonary Hypertension of the Newborn (PPHN)
- Respiratory Distress Syndrome (RSD)
- Tricuspid Valve (Ebstein’s Anomaly)
- Mitral Valve Prolapse
- Transposition of the Great Arteries (TGA)
- Transposition of the Great Vessels (TGV)
- Tetralogy of Fallot (TOF)
- Hypoplastic Left Heart Syndrome (HLHS)
- Hypoplastic Right Heart Syndrome (HRHS)
- Tricuspid Atresia
- Aortic Stenosis
- Pulmonary Atresia (PA)
- Patent Forman Ovale (PFO)
- Patent Ductus Arteriosus (PDA)
- Coarctation of the Aorta
- Truncus Arteriosus
- Tricuspid Valve Stenosis
- Vascular Ring
- Heart Murmur
- Enlarged Heart
- Pulmonary Stenosis
- Gastroschisis – abdominal wall defect
- Diaphragmatic Hernia
- Craniosynostosis (aka Clover Leaf Skull)
- Chiari Malformation
- Esophageal Stenosis
- Anal Atresia
- Imperforate Anus
- Cleft Palate
- Missing Limbs
- Cerebral Palsy
- Tethered Spinal Cord
- Cryptorchidism (undescended testicles)
- Vesicoureteral Reflux (VUR)
- Renal Agenesis
- Renal Dysplasia
- Renal Hypodyspasia
- Renal Hypoplasia
- Ectopic Kidney
Depakote and Spina Bifida
Spina Bifida is divided into two subclasses, Spina Bifida Cystica and Spina Bifida Occulta.
Spina Bifida Cystica -This includes meningocele and myelomeningocele. Meningocele is less severe and is characterized by herniation of the meninges, but not the spinal cord, through the opening in the spinal canal. Myeolomeningocele involves herniation of the meninges as well as the spinal cord through the opening.
Spina Bifida Occulta -In this type of neural tube defect, the meninges do not herniate through the opening in the spinal canal.
Spina bifida (Latin: “split spine”) is a developmental birth defect caused by the incomplete closure of the embryonic neural tube. Somevertebrae overlying the spinal cord are not fully formed and remain unfused and open. If the opening is large enough, this allows a portion of the spinal cord to protrude through the opening in the bones. There may or may not be a fluid-filled sac surrounding the spinal cord. Other neural tube defects include anencephaly, a condition in which the portion of the neural tube which will become the cerebrum does not close, and encephalocele, which results when other parts of the brain remain unfused.
Spina bifida malformations fall into four categories: spina bifida occulta, spina bifida cystica (myelomeningocele), meningocele andlipomeningocele. The most common location of the malformations is the lumbar and sacral areas . Myelomeningocele is the most significant form and it is this that leads to disability in most affected individuals. The terms spina bifida and myelomeningocele are usually used interchangeably.
Spina bifida can be surgically closed after birth, but this does not restore normal function to the affected part of the spinal cord. Intrauterine surgery for spina bifida has also been performed and the safety and efficacy of this procedure is currently being investigated. The incidence of spina bifida can be decreased by up to 75% when daily folic acid supplements are taken prior to conception.
There is no cure for spina bifida, but there are a number of treatments available to help manage the disease and prevent complications. In some cases, babies who are diagnosed before birth can undergo surgery while still in the womb in an effort to repair or minimize the spinal defect.
Post-birth treatments may include ongoing surgery, prescription medications and physical therapy. Children with the mildest form of the disease, spina bifida occulta, may not require treatment.
FDA Warning on Depakote
The following is an overview of each study and the FDA’s black box warning:
American Academy of Neurology and American Epilepsy Society – found that pregnant women should avoid taking the drug Depakote (valproate) due to the risk of birth defects such as Spina Bifida, cleft palates, lower I.Q.s and others.
New England Journal of Medicine (NEJM). A 2009 study published showed that children born to mothers who took Depakote while pregnant had lower I.Q.s.
Hebrew University Study. A 2009 study by Hebrew University’s Hadassah Medical School and the Israeli Ministry of Health reported that exposure to valproic acid in pregnancy resulted in nearly three times as many major birth anomalies such as Spina Bifida.
Neurodevelopmental Effects of Antiepileptic Drugs (NEAD) Study. A study published in the August 2006 issue of Neurology found that approximately 20.3% of pregnant women who took Depakote suffered serious adverse outcomes related to the birth of their children versus only 1% to 10.7% with other, similar drugs.
FDA Black Box Warning. The results of the NEAD study led to a Black Box warning from the FDA in October 2006, including hepatoxicity (chemical driven liver damage), teratogenicity (the capability of producing fetal malformation) and pancreatitis (the inflammation or infection of the pancreas). The FDA is currently investigating the drug’s link to autism and other developmental delays.
This is a rare neural tube defect that results in extreme bending of the head to the spine. The diagnosis can usually be made on antenatal ultrasound scanning but if not will undoubtedly be made immediately after birth because the head is bent backwards and the face looks upwards. Usually the neck is absent. The skin of the face connects directly to the chest and the scalp connect to the upper back. The infant usually will not survive more than a few hours.
Cleft Lip / Cleft Palate
Cleft lip and cleft palate are variations of a type of clefting congenital deformity caused by abnormal facial development during gestation. A cleft is a fissure or opening – a gap. It is the non-fusion of the body’s natural structures that form before birth. Approximately 1 in 700 children born have a cleft lip and / or a cleft palate.
Cleft palate repair is a type of plastic surgery that can be used to restore function and provide a more normal appearance. Most clefts can be repaired through specialized plastic surgery techniques, improving the child’s ability to eat, speak, hear and breathe.
Hydranencephaly is a type of cephalic disorder. This is a rare condition in which the cerebral hemispheres are absent and replaced by sacs filled with cerebrospinal fluid.
Usually the cerebellum and brainstem are formed normally, although in some cases the cerebellum may also be absent. An infant with hydranencephaly may appear normal at birth or may have some distortion of the skull and upper facial features due to fluid pressure inside the skull. The infant’s head size and spontaneous reflexes such as sucking, swallowing, crying, and moving the arms and legs may all seem normal, depending on the severity of the condition. However, after a few weeks the infant usually becomes irritable and has increased muscle tone (hypertonia). After several months of life, seizures and hydrocephalus may develop. Other symptoms may include visual impairment, lack of growth, deafness, blindness, spastic quadriparesis (paralysis), and intellectual deficits.
Some infants may have additional abnormalities at birth including seizures, myoclonus (involuntary sudden, rapid jerks), and respiratory problems.
A baby born with anencephaly is usually blind, deaf, unconscious, and unable to feel pain. Although some individuals with anencephaly may be born with a main brain stem, the lack of a functioning cerebrum permanently rules out the possibility of ever gaining consciousness. Reflex actions such as breathing and responses to sound or touch occur.
Anencephaly is a cephalic disorder that results from a neural tube defect that occurs when the cephalic (head) end of the neural tube fails to close, usually between the 23rd and 26th day of pregnancy, resulting in the absence of a major portion of the brain, skull, and scalp. Children with this disorder are born without a forebrain, the largest part of the brain consisting mainly of the cerebral hemispheres (which include the neocortex, which is responsible for higher-level cognition, i.e., thinking). The remaining brain tissue is often exposed—not covered by bone or skin.
Anti-Seizure Medications Linked to Low IQ Scores
In May 2013, FDA issued a Drug Safety Communication indicating that pregnant women who take valproate medications during pregnancy could have a baby with birth defects and lower IQ. Drugs in the valproate class include:
- Depacon (valproate sodium)
- Depakote, Depakote CP, Depakote ER (dilvalproex sodium)
- Depakene (valproic acid)
- Stavzor (valproic acid)
The agency found that exposure to Depakote or other valproate drugs during fetal development decreases a child’s IQ at age six by 8-12 points compared to children exposed to other anti-epileptic drugs. FDA originally warned about this risk in June 2011.
To learn more about the Depakote birth defects warning, please visit the following page: Valporate Sodium Birth Defects Warning
Depakote and Pregnancy
Do not use Depakote to prevent migraine headaches if you are pregnant. FDA has classified Depakote as a Pregnancy Category X medication, which means that risks to a fetus outweigh any possible benefit for preventing headaches. For pregnant women with epilepsy or bipolar disorder, Depakote is “Pregnancy Category D.” Women of childbearing age should not take Depakote unless it is absolutely essential to the management of a serious medical condition.
Depakote Side Effects
In addition to being linked to birth defects, Depakote may cause the following serious side effects in patients who take the drug:
- Liver Toxicity
- Panic attacks
- And more
Risks of Depakote During Pregnancy Still Unknown to Many, EMA Declares
September 27, 2017 – More than 3 decades after concerns were first raised about the risk of birth defects in children born to women who take Depakote (valproate acid) during pregnancy, many expecting mothers are still unaware of the startling correlation, according to the European Medicines Agency (EMA).
The EMA on Tuesday convened a hearing in London in which the agency invited citizens of the EU to share their experiences with Depakote.
Sanofi, the company that manufactures Depakote, said at the hearing there was clear evidence of a risk of birth defects from Depakote use during pregnancy, and that it had always provided timely information and warnings about this risk.
However, parents of children with defects countered that health authorities and Sanofi were too slow to warn of the risks associated with Depakote, which is also sold under the brand name Epilim.
“Measures have been taken,” said Karen Keely from the Irish patient support group Fetal Anti-Convulsant Syndrome. “But these have largely been tick-box exercises with little regard for delivering real change.”
Despite its risks, valproate is recognized as an indispensable drug for the treatment of epilepsy and bipolar disorders, and is included in the World Health Organization’s List of Essential Medicines.
Restrictions on valproate have been strengthened across the EU over the past few years following an initial review. However, a recent survey conducted in the UK found that nearly 70% of women who were prescribed the medicine were given incorrect advice.
Abbott Must Pay $38 Million in Depakote Spina Bifida Lawsuit
September 14, 2017 – The Supreme Court of Missouri has sustained a jury’s award of $38 million to a girl born with spina bifida after her mother took Abbott’s epilepsy medication Depakote during pregnancy, ruling there was evidence that Abbott knew the birth defect risk printed on the drug was more severe than the verbiage suggested.
The court voted unanimously to affirm the St. Louis jury’s award to 14-year-old Maddison Schmidt over her allegations that Abbott Laboratories Inc. failed to warn about the risk of birth defects with Depakote, but did split 4-3 on the reasons for doing so.
Judge W. Brent Powell in his opinion rejected Abbott’s argument that Depakote labels adequately warned as a matter of law, stating that it failed its most important test: to be complete and accurate, so as not to mislead the public.
Powell further noted that Depakote labels stated that use of antiepileptics could increase the risk of birth defects, and that the CDC had estimated the risk of spina bifida was 1-2%. However, the prosecution showed that the risk of birth defects was up to 10%, and that the risk of spina bifida was even higher.
“As Depakote’s label did not reflect this relevant information, a reasonable inference could be drawn from this evidence that Abbott’s warning was not complete and accurate and, therefore, did not adequately warn,” the judge wrote.
Abbott and its subsidiary AbbVie Inc., which has owned the rights to Depakote since 2013, are facing thousands of plaintiffs who say the company didn’t do enough to warn expecting mothers about the risk of severe birth defects in their children.
Schmidt was born in 2003 with spina bifida and other birth defects including microcephaly and brain malformations, is paralyzed and lacks bowel and bladder control, and is severely cognitively impaired, according to the lawsuit. She filed the complaint in Missouri state court, joined with similar claims brought by 24 other people, in May 2012.
Illinois Jury Awards $15 Million in Depakote Spina Bifida Lawsuit
July 15, 2017 – An Illinois jury has awarded $15 million to a woman who claimed that her son was born with spina bifida as a result of her use of the antiepileptic drug Depakote during pregnancy.
According to the lawsuit, drugmaker AbbVie Inc. failed to adequately warn of the severe side effects associated with use of Depakote. Plaintiff claims that without adequate warnings she had no idea that the medication she was prescribed during pregnancy would result in life-threatening birth defects.
Plaintiff’s son, referred to as “E.R.G.” in court documents, was born with spina bifida, a catastrophic neural tube defect in which the spinal cord fails to develop properly in the womb. Children with this condition may suffer from problems ranging from little to no feeling in their extremities, bladder or bowel problems, to a curve in their spine (scoliosis).
E.R.G. is now 10-years-old and has been forced to undergo at least a dozen surgeries to treat his condition. Unfortunately, he is permanently confined to a wheelchair, according to the lawsuit.
The Illinois jury deliberated for more than two days, ultimately concluding that AbbVie failed to sufficiently warn about the serious side effects of Depakote. The $15 million judgment is meant to pay for E.R.G.’s past and future medical expenses.
Punitive damages, occasionally awarded to punish defendants for particularly egregious conduct, were not granted in the case.
Crucial evidence came in the form of internal corporate memos, which suggested that AbbVie executives knew that study results conflicted with verbiage printed on the drug’s labeling, according to Bloomberg Technology.
The trial lasted nine days. Around 700 similar Depakote lawsuits are still pending in state and federal courts across the U.S.
Depakote Linked to 4,000+ Birth Defects in France
April 20, 2017 – Up to 4,100 children in France were born with major congenital malformations between 1967 and 2016 after their mothers took the epilepsy medication Depakote (generic: valproic acid) during pregnancy, France’s drug regulator has announced.
Pregnant women who took Depakote for epilepsy treatment were 4 times more likely to give birth to babies with major congenital defects compared to women who did not take the drug, according to the study, which was conducted by the French National Agency for the Safety of Medicines (ANSM) and the national health insurance administration.
Birth defects linked to Depakote include spina bifida, heart malformations and genital defects.
“The study confirms the highly teratogenic nature of valproate,” said Mahmoud Zureik, scientific director of ANSM and a co-author of the report. “The figure of about 3,000 severe malformations is very high.”
From 1967 to 2016, between 64,100 and 100,000 women took valproate during pregnancy, resulting in 41,200 to 75,300 live births, the study found. Most of the defects occurred in women who were being treated for epilepsy.
However, starting in the late 1970s, valproate started being prescribed in France to treat bipolar disorder. Bipolar women taking the drug were twice as likely to give birth to children with major congenital defects, according to the researchers.
The lower risk compared with women treated for epilepsy likely stems from the fact that doctors stopped prescribing valproate early in pregnancy for the treatment of bipolar.
Valproate, which is manufactured in France by Sanofi as Depakine for epilepsy treatment and Depakote and Depamide for bipolar disorders, is also believed to cause slow neurological development.
ANSM said it would also publish a study on the neurological effects of Depakote later this year.
Special Master Appointed in Depakote Birth Defects Trial
April 11, 2017 – An Illinois judge has tapped retired state judge Daniel J. Stack as special master in an upcoming trial alleging birth defects from the anticonvulsant drug Depakote (generic: valproic acid).
U.S. District Judge Nancy J. Rosenstengel said that Stack’s initial duties would be to organize the parties’ objections to deposition designations and then make recommendations on those issues. Given that the next trial in the multidistrict litigation (MDL) is scheduled to begin on May 23, Stack also reserves the right to expand his role to include additional duties, such as evaluating motions and recommending rulings.
Stack served as a circuit judge in Illinois for 24 years until his retirement in 2010. Since then, he has been a special master in multidistrict litigations involving Yaz, Yasmin and Pradaxa.
He also presided over the first jury trial in the Midwest alleging injuries from the painkiller Vioxx (generic: rofecoxib), which was recalled in September 2004 after being linked to a significantly increased risk of heart attack and stroke.
In the upcoming trial, Plaintiff Michelle Leal claims that her use of Depakote for seizures caused her son J.F.’s spina bifida, a severe birth defect characterized by the failure of the backbone and spinal cord to close before birth.
Abbott claims that in 2006, the year of most of Leal’s pregnancy, Abbott put all-caps warnings about the risk of birth defects on the labeling of Depakote.
The case was originally chosen as a bellwether trial scheduled to begin in June 2016. However, in May Abbott filed a motion seeking to exclude the testimony of physician Olaf Bodamer concerning J.F.’s behavioral problems and mild cognitive impairment, saying it was too speculative.
Judge Upholds $38 Million Depakote Settlement
February 6, 2017 – A judge in St. Louis has affirmed a $38 million settlement to a girl who was born with spina bifida and other severe birth defects after her mother took the anti-seizure medication Depakote during pregnancy.
The lawsuit was filed on behalf of Maddison Schmidt, who was born with spina bifida, microcephaly, ocular coloboma (congenital eye defect), brain malformations, cognitive impairment (IQ between 55 and 61, bottom 1%), and is paralyzed from the waist down and confined to a wheelchair. As a result of these problems, Schmidt has required numerous surgeries including the placement of a shunt in her skull, shunt revisions, and spinal surgery.
In May 2015, a St. Louis jury awarded $15 million in compensatory damages and $23 million in punitive damages to Schmidt after finding that Abbott had failed to warn her mother about the risk of birth defects with Depakote.
The U.S. Food & Drug Administration (FDA) classifies Depakote as a Pregnancy Category X medication, which means that studies have demonstrated evidence of human fetal risk, and the risks involved with use of the drug during pregnancy outweigh any potential benefits.
However, when Maddison’s mother took Depakote in 2002, the label had not been updated for nearly 20 years. It was so outdated that lawyers accused Abbott of intentionally downplaying the risk in order to maximize profits.
The 2002 labeling did warn that 1-2% of babies exposed to Depakote in the womb would develop spina bifida, but actually means that Depakote increases risk of the defect by 2,060% compared to non-users. Depakote is now known to cause birth defects in at least 10% of babies who are exposed to it, according to the lawsuit.
Abbott appealed the verdict and requested a new trial; however, in November 2016 the Missouri Court of Appeals upheld the award. The verdict doesn’t bode well for Abbott, which faces hundreds of other similar lawsuits alleging birth defects from Depakote.
Depakote Linked to Lower IQ, Cognitive Birth Defects
January 24, 2013 – A new study has determined that Abbott Pharmaceuticals’ controversial anti-epileptic drug Depakote (generic: divalproex sodium) can cause lowered IQ’s and other cognitive deficiencies in children born to mothers who take the drug during pregnancy. Specifically, the research found that babies exposed to Depakote in the womb had IQ’s that were seven to 10 points lower than other children at age six, as well as reduced language skills and memory capacity. In addition to cognitive impairment, the maternal use of Depakote during pregnancy has been linked to neural tube defects, craniofacial abnormalities and cardiovascular malformations.
The study, which was conducted by researchers at Emory University in Atlanta and published in the January 22 online edition of The Lancet Neurology, included a cohort of 224 test subjects, and found that children exposed to Depakote in the womb had less verbal and memory abilities than children born to mothers who took other anti-epileptic medications during pregnancy. The research determined that the severity of these deficiencies were dose-specific, meaning that the more Depakote the mother took while pregnant, the lower the child’s I.Q. and other cognitive abilities.
“High doses of valproate were negatively associated with IQ, verbal ability, non-verbal ability, memory, and executive function, but other antiepileptic drugs were not,” the researchers determined.
Precautions When Taking Depakote
Before taking Depakote, tell your doctor or pharmacist if you are allergic to divalproex sodium or if you have any allergies. Depakote may contain inactive ingredients which may cause allergic reactions or other problems.
Depakote should not be used if you have certain medical conditions. Before using this drug, consult your doctor or pharmacist if you have liver disease, pancreatitis, or any metabolic disorders.
Depakote may make you dizzy or drowsy or cause blurred vision. Do not drive, use heavy machinery, or any other activity that requires alertness or clear vision until you are sure you can perform such activities safely. Limit alcoholic beverages.
This medication is not recommended for use during pregnancy due to the possible risk of birth defects and harm to an unborn baby. Do not suddenly stop taking Depakote unless directed by your doctor. Suddenly stopping medication could cause a severe, possibly fatal, seizure.
If you become pregnant or think you may be pregnant, tell your doctor immediately. If you are planning pregnancy, discuss a plan for managing your condition with your doctor before you become pregnant. Your doctor may switch the type of medication you use during pregnancy. Talk to your doctor for more information.
Before using Depakote, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you use, especially of:certain antidepressants (e.g., amitriptyline, nortriptyline, phenelzine), certain benzodiazepines (e.g., clonazepam, diazepam), certain antibiotics (carbapenems such as doripenem, imipenem), mefloquine, other medications for seizure (e.g., carbamazepine, ethosuximide, felbamate, lamotrigine, phenobarbital, phenytoin, rufinamide, topiramate), rifampin, vorinostat, warfarin, zidovudine.
Tell your doctor or pharmacist if you also take drugs that cause drowsiness such as: antihistamines that cause drowsiness (e.g., diphenhydramine), medicine for sleep (e.g., sedatives), muscle relaxants, narcotic pain relievers (e.g., codeine), psychiatric medicines (e.g., phenothiazines such as chlorpromazine), & tranquilizers.
Check the labels on all your medicines because they may contain ingredients that cause drowsiness. Ask your pharmacist about the safe use of these products.
This is not a comprehensive list of possible Depakote interactions. Therefore, before using this drug, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.
Do I Have a Depakote Lawsuit?
The Pharmaceutical Litigation Group at our law firm is an experienced team of trial lawyers that focus exclusively on the representation of plaintiffs in Deapkote lawsuits. We are currently evaluating potential birth defect claims in all 50 states.
Again, if you or somebody you know has taken Depakote during pregnancy and had a child with birth defects, you should contact us immediately. You may be entitled to compensation by filing a lawsuit and we can help.