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Depakote, a drug used primarily for treating epilepsy, is facing a number of lawsuits related to children’s birth defects. Though the medication has been in use since 1983 and has helped many patients, Depakote’s manufacturer, Abbott Laboratories, has been ordered to pay more than a billion dollars after being accused of illegal marketing of the drug. In addition to treating epileptic seizures, Depakote is also prescribed for migraines and manic bipolar episodes.
Marketing of Depakote
It was alleged and Abbott Laboratories admitted to building a specialized sales force for marketing Depakote to nursing homes to use as a sedative control for controlling agitation and aggression in patients with dementia, which was not an FDA approved use of the medication. Furthermore, Depakote was also marketed as a medication for treating schizophrenia, despite there being no clinical trials supporting its ability to do so effectively.
Because of the mis-marketing of the drug from 2001 to 2006, Abbott Laboratories has agreed to pay $1.6 billion, $800 million of which will go toward civil cases filed against the company by federal and state authorities. $700 million is allotted for criminal penalties and $100 million will be given to states for consumer protection matters.
Depakote and Birth Defects
Complaints against Depakote include alleged birth defects caused by the medication when taken during pregnancy. The FDA acknowledged there was proof of this risk in 2006 when birth defects were noted in 20% of Depakote users who took the medication while pregnant.
The company was ordered to include a black box warning on the product and later followed up in 2009 by releasing a detailed list of Depakote side effects. This list included birth defects that ranged from neural tube defects to heart and craniofacial defects in developing fetuses. Some users also reported experiencing suicidal thoughts while using Depakote.
A year later in 2010, information from a medical study was published in the New England Journal of Medicine. The study revealed there were six specific birth defects associated with Depakote use and that users experienced these defects at a much higher risk, especially when the medicine was taken during the first trimester of pregnancy.
Specifically, the study revealed a significantly higher incidence of spina bifida in children whose mother’s used Depakote. As a result of the study, the FDA issued another warning in 2012 related to spina bifida. The study also revealed evidence that children born to mothers using Depakote had decreased cognitive function and scored lower on IQ tests.
Spina Bifida and Depakote
Spina Bifida is a developmental birth defect that occurs when a fetus’s spinal column does not close all of the way. “Spina bifida” literally translates to “split spine.” About eight babies born in the United States each day have Spina Bifida or a similar defect of the brain and spine. Children born with Spina Bifida need assistance getting around on their own and often use crutches, braces, or wheelchairs. It is possible for a child born with Spina Bifida to lead a fulfilling life well into adulthood, but it requires a great deal of assistance. Of all the children born with Spina Bifida, about 90 percent live to adulthood and about 75 to 80% lead normal lives, with normal cognitive function and the ability to be mobile and even play sports.
Legal Action against Abbot Laboratories
Numerous lawsuits have been filed against Abbott Laboratories in relation to Depakote use and birth defects. The lawsuits allege the drug causes debilitating birth defects and that the company failed to properly warn doctors and patients of this risk.
Some of the suits claim Abbott Laboratories was negligent in its responsibility to protect patients from harm. Twenty-seven woman filed a federal lawsuit in an Illinois court in 2012 alleging her Depakote use during pregnancy was the reason for birth defects in her children. A year later in January 2013, a man in South Carolina filed a lawsuit against Abbott alleging his Spina Bifida was caused by his mother’s use of Depakote before he was born.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.