Depakote Lawsuit Considered by Attorneys General Over Marketing

A group of attorneys general are considering whether to file a lawsuit over Depakote, bringing criminal charges against Abbott Laboratories over how it marketed the popular epilepsy drug. 

The committee of attorneys general are from eight states who believe the company may have violated their consumer protection laws by marketing the medication for off-label uses, according to a report disclosed this week by Abbott Laboratories. The company has already set aside $1.5 billion to settle similar claims brought by the U.S. Justice Department (DOJ).

Off-label marketing occurs when a drug manufacturer promotes a drug for uses not approved by the FDA, which is illegal. While doctors may prescribe approved medications for any reason they deem appropriate, companies are barred from marketing or encouraging such use.

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According to allegations raised by the DOJ, Abbott promoted Depakote for use as a nursing home “chemical restraint”, suggesting that it could reduce aggression and agitation among the elderly. The attorneys general who are now considering a claim for payments made by their states come from Florida, Illinois, North Carolina, Ohio, Oregon, Pennsylvania, South Carolina and Texas.

Depakote was approved in the United States in 1978 for treatment of certain forms of epilepsy. However, it has been widely used off-label for other purposes.

Abbott Laboratories also faces a number of Depakote lawsuits filed on behalf of minor children who were born with birth defects and malformations after their mothers were given the medication during pregnancy.

Side effects of Depakote pregnancy use has been linked to a risk of severe health problems for unborn children, especially when the drug is taken during the first 28 days of the pregnancy, when neural tube closure and other critical formations are taking place.

In 2006, the FDA added a “black box” warning about the potential risk of Depakote birth defects after a study found that 20% of pregnant mothers who gave birth while on Depakote had a child with malformations or a birth defect.

One of the more commonly reported problems involves children diagnosed with spina bifidia after Depakote use during pregnancy.  However, other birth defects associated with Depakote include, cleft palate, abnormal skull development, malformed limbs, holes in the heart and urinary tract problems.

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4 Comments

  • LeanneMay 8, 2012 at 3:16 am

    I would like to know how to become a part of this lawsuit my daughter was on this for 4 years from the age of 3 to 7 years old and she was a Zombie on it she has had many problems from being on this. Please help me get into this lawsuit

  • DavidFebruary 27, 2012 at 10:06 pm

    Diana, I was the same way with Depakote. My psychiatrist has prescribed Zonisamide 100 MG 4 @ night 100 MG. This drug was a good substitute for me and it does not put weight on like most of the psych drugs do. Check with your doctor. You may have to go through a period of experimentation to get it right, but there are new drugs on the market now. Some even take weight off, as an added benefit[Show More]Diana, I was the same way with Depakote. My psychiatrist has prescribed Zonisamide 100 MG 4 @ night 100 MG. This drug was a good substitute for me and it does not put weight on like most of the psych drugs do. Check with your doctor. You may have to go through a period of experimentation to get it right, but there are new drugs on the market now. Some even take weight off, as an added benefit.

  • DavidFebruary 27, 2012 at 9:42 pm

    Are there any lawsuits against Depakote for weight gain resulting in Type II Diabetes and possible heart complications? Any State Attorney-Generals and/or at the Federal level working on this?

  • DianaFebruary 23, 2012 at 4:46 am

    I was basically "poisoned" by taking Depakote for over 20 years...causing major health related problems, including edema, heart, diabetes, etc...are there any lawsuits other than in pregnant women against this drug, like side effects in woman that are not pregnant,etc? I am now 55 , and three times my original weight...please help me thank you.

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