Depakote, the generic drug divalproex sodium or valproic acid, is a drug made by pharmaceutical company Abbott Laboratories. The drug is an anti-seizure medication, but can also be used to treat certain other conditions like bipolar disorder or migraines. Although Depakote has been effective for many patients, especially those with devastating seizure conditions, there have been some controversies surrounding the medication.
These include the fact that Depakote may be responsible for increasing the risk of birth defects, liver damage, and suicidal thoughts. These serious possible complications have been the reason for a number of Depakote lawsuits filed against Abbott. Another reason for lawsuits against the company is possible illegal marketing of the drug.
How Depakote Is Used
Depakote was first approved by the U.S. Food and Drug Administration in 1983 to treat epilepsy in patients aged ten and older. The drug continues to be a top treatment for epilepsy and other seizure disorders. In the mid-1990s the FDA also approved Depakote to be used as a treatment for migraine headaches, and bipolar disorder, a psychiatric condition. Some doctors prescribe the drug off-label for other uses like bipolar disorder in children and impulse control disorders.
It is thought that Depakote works on such a variety of conditions by increasing the amount of a neurotransmitter in the brain, called GABA. GABA is known to relax nerves, which is why it helps to reduce seizures and headaches. It may also be related to mood and is thought to act as a mood stabilizer in people with bipolar disorder.
Side Effects and Complications
Depakote is effective for many patients and is an important treatment for seizure disorders, but there are possible side effects too. Most commonly it causes drowsiness and dizziness, weight gain, nausea, and diarrhea. Rarely, it may cause excessive bruising, hair loss, liver damage, disorientation, confusion, and other cognitive difficulties.
Also rare, but very serious is the possibility that Depakote may increase suicidal thoughts and actions. Depakote and other anticonvulsants used to treat seizure disorders carry this risk and reports state that it is seen in about one in 550 patients taking one of these medications.
FDA Black Box Warnings
The FDA requires that medications with serious and life-threatening possible side effects, regardless of how common they are, carry a special black box warning. Depakote has one of these warnings and the serious issues warned against are why there have been lawsuits filed against Abbott for this medication.
One of these warnings concerns birth defects. Some women who have taken the drug while pregnant have given birth to children with spina bifida, malformed limbs, face and skull defects, heart defects, and other types of birth defects. Research has shown that women taking Depakote during pregnancy have a four times greater risk of giving birth to a child with one or more defects. Cognitive defects are also possible, including a child with a lower than average IQ.
Another black box warning for Depakote is pancreatitis. This is a serious inflammation of the pancreas, which has occurred in both children and adults taking the drug. In some cases, patients experienced a sudden onset of pancreatitis, which can be deadly if not treated immediately. The instances of pancreatitis have included cases that began soon after starting the drug, but also after years of taking it.
Finally, Depakote carries a black box warning for liver damage. Liver failure, which can be fatal, has been reported in patients taking the medication for six months or more. Young children are especially at risk, and although the drug is not indicated for this age group, some doctors may prescribe it off-label for pediatric patients.
Lawsuits against drug companies that adequately warned patients about risks don’t have much to stand on, but when companies aggressively and unethically market their risky products, these lawsuits have a good chance of ending in settlements for the plaintiffs. Such is the case with Abbott and Depakote. The state of Arkansas won a $3 million settlement, for instance when the company was found guilty of illegal marketing practices.
Abbott had been marketing Depakote for unapproved, or off-label, treatments. While doctors are allowed to use their discretion to prescribe drugs off-label, drug companies may not market their products for these unapproved uses. Abbott did this for Depakote, marketing it for the treatment of autism and schizophrenia, and also for elderly patients with dementia. In addition to the Arkansas suit the company had to pay $1.5 billion in a federal case brought by the U.S. Department of Justice.
Lawsuits and Settlements
It hasn’t only been the state and federal governments filing lawsuits against Abbott and Depakote. Individuals who were harmed by the drug and felt that Abbott did not warn them about the possible risks have also filed suits seeking compensation. That the company was caught out illegally marketing the drug can only help these cases land in favor of the plaintiffs. Failing to warn patients of risks and misleading the public with marketing drugs are major reasons for settlements to be awarded to the injured parties.
In one such case a young girl born with spina bifida won $23 million in her suit in 2015 against Abbott. The court awarded the amount to serve as punitive damages against Abbott, which was found to be negligent in the case of this particular verdict. The Minnesota girl was also awarded $15 million in compensation thanks to the jury’s decision. The young girl and her mother claimed that that the risks of birth defects with Depakote were not labeled clearly.
Cases like this one are ongoing against Abbott, and now its spinoff responsible for Depakote, AbbVie. If you took the anti-seizure drug for any reason and were harmed by it or had a child with birth defects you may have a valid case to make that you did not know about the risks before taking it. Talk with a lawyer about your options and find out how you can seek compensation for the suffering you have experienced thanks to Abbott’s illegal practices.