Depakote Birth Defects Lawsuit

July 11, 2014

What is Depakote?

Depakote — also known as divalporex sodium — is an anticonvulsant and psychotropic prescription drug approved by the FDA in 1983 for the treatment of seizures, migraines and mania stemming from bipolar disorder.

The active ingredient in Depakote is valproic acid, which works by balancing naturally occurring neurotransmitters in the brain.

This drug is also packaged and prescribed as Depakote ER (Extended Release tablets) and Depakote Sprinkle Capsules, which is a delivery system used for seizures.

Depakote is manufactured by Abbott Laboratories, an American pharmaceutical company based near Chicago, Illinois.

What are the reported side effects alleged in the lawsuits?

The most common side effects alleged by depakote lawyers are related to depakote and birth defects. Pregnant women who took Depakote claim their children were born with various health problems.

Birth defects claimed include:

    • Cleft palate
    • Neural tube defects
    • Spina bifida
    • Heart defects
    • Anencephaly
    • Hypoplasia(underdevelopment)
    • Learning disabilities
    • Low IQ

Other side effects linked to Depakote include suicidal thoughts, liver damage, liver failure, and inflammation of the pancreas or life-threatening pancreatitis.

What are the civil depakote lawsuits about?

Most of the civil lawsuits are seeking medical expenses, future loss of income, pain and suffering, and depakote lawyer fees related to birth defects. At least one depakote attorney filed a lawsuit in Illinois on behalf of over a dozen claimants. The lawsuit alleges that Abbott Laboratories was negligent in manufacturing and distributing a “defective drug.” The suit also alleges that the pharmaceutical company “misled” doctors as to the “danger of [the drug’s] ingestion.”

A class action lawsuit was filed in Illinois in 2013. The plaintiffs in this case are unions that claim they should be reimbursed for covering off-label Depakote prescriptions in their benefits plan. The lawsuit also accuses Abbott Laboratories of engaging in violations of federal racketeering laws. These lawsuits have followed a series of depakote lawsuit settlements made in 2012.

What are the depakote lawsuit settlements about?

Abbott Laboratories has settled with both state and federal entities. There have been civil, criminal and administrative consequences enforced, mostly related to the promotion of off-label usage. According to a release from the U.S. Department of Justice, Abbott pled guilty to “misbranding” Depakote by actively promoting it as a treatment for agitation and aggression in elderly patients with dementia and as a treatment for schizophrenia, neither of which were FDA approved uses. Abbott also admitted to maintaining a “specialized sales force” that was trained to target nursing homes with these unapproved claims.

The company also pled guilty to entering into long-term contracts in which it paid millions of dollars to pharmacies in return for training consultant pharmacists to encourage and promote off-label usage.

Furthermore, the DOJ found that Abbott funded two studies on the efficacy of the drug for schizophrenia. Although both studies determined that Depakote was not effective in treating schizophrenia, the DOJ charged that Abbott waited two years before informing its sales team of these results.

As part of its guilty plea, Abbott Laboratories was ordered to pay a financial settlement. At the time of the settlement, the Department of Justice announced it as the second largest ever made by a pharmaceutical company.

The settlement paid in 2012 was for $1.6 billion. This money was divided with $800 million going to repay federal and state governments who covered the prescription in Medicaid or Medicare plans. Another $700 million was paid as a criminal penalty. A final $100 million was set aside from consumer protection claims.

Abbott’s settlement with the DOJ also required the institution of a “self-policing” board within the company that monitors marketing to ensure off-label uses are not promoted.

As recently as June 2014, Abbott has made an additional settlement with the State of Louisiana for a total of $9.5 million. This settlement again regarded the marketing of off-label usage.

Why hasn’t Depakote been recalled?

Depakote is still FDA approved for its original purposes for seizures, migraines and mania.

Abbott Laboratories must now include black box warnings on Depakote’s packaging and must cease all off-label marketing.

The FDA mandated a black box warning that notified patients of the risk of birth defects. This mandate was enforced after a study found up to 20 percent of pregnant women who took Depakote had children born with one or more birth defects.

The FDA is also tracking other reported birth defects in a series of Safety Communications. These safety warnings are expected to increase as studies continue to show the heightened risk of birth defects. These studies demonstrate a “significantly increased risk” of congenital defects and malformations, which may help bolster civil lawsuits claiming prescription drug injuries.

What should I do if I took Depakote?

If you are considering taking Depakote or one of the generic versions of these drugs, ask your doctor for more information about the risks and benefits, especially if you are taking it for an off-label purpose or if you are pregnant or planning to become pregnant.

If you believe you or someone you know was injured by Depakote, consult with an attorney for information on filing a lawsuit or to make a claim as part of an existing class action settlement.

Since there may be a statute of limitations, it is important for those interested in making a claim to get the process started. Find a Depakote lawyer as soon as possible.

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