Class Action Lawsuit Over Depakote Marketing Permitted to Move Forward
A federal judge has cleared the way for an investor class action lawsuit to move forward against Abbott Laboratories over its marketing of Depakote, an epilepsy drug that has been promoted off-label and linked to potential health concerns.
U.S. District Judge Virginia Kendall approved a Depakote class action lawsuit against the drug maker on behalf of stockholders, who raise similar illegal marketing claims to those brought by state and federal authorities, which resulted in a $1.6 billion settlement by the company last year.
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Judge Kendall agreed to allow the lawsuit to move forward after investors showed that it would have been useless to try to get the company to change its marketing tactics.
Plaintiffs in the lawsuit include a number of retirement and pension funds. Judge Kendall said that the plaintiffs were able to show sufficient evidence that the board members named in the lawsuit knew about the marketing tactics for several years and did nothing.
The illegal marketing claims against the company allege that Abbott specifically marketed Depakote for uses that were not approved by the FDA or determined to be safe and effective. While doctors can prescribe a drug for any purpose they see fit, manufacturers are only legally allowed to promote them for uses approved by the FDA.
In May 2012, the U.S. Department of Justice (DOJ) and Abbott reached an agreement where the drug maker pled guilty to criminal charges of unlawful promotion of Depakote and agreed to pay both criminal and civil fines of about $1.6 billion. It was the second largest settlement a drug company has ever reached with the U.S. government.
From 1998 through 2006, Abbott has admitted that it marketed Depakote off-label for treatment of schizophrenia and tried to convince nursing homes to use Depakote to pacify elderly dementia patients, which is many consider a form of nursing home abuse from chemical restraint.
Abbott Laboratories went as far as maintaining a specially trained sales force whose job it was to push nursing homes to use Depakote to drug their more unruly residents into a stupor. The company also tried to convince doctors to use Depakote in combination with atypical antipsychotic drugs to treat schizophrenia even after the company’s own clinical trials showed that Depakote did not appear to help.
As part of the company’s plea, it will pay $700 million in criminal fines and profit forfeitures, and it will pay another $800 million in civil fines. The company has also agreed to a five year probation period.
Depakote Pregnancy Risks
In recent years, Abbott Laboratories has faced an increasing number of Depakote lawsuits filed over the failure to adequately warn about the risks associated with using the medication during pregnancy, which has been linked to the development of severe birth defects and malformations, including spina bifida, cleft palate, abnormal skull development, malformed limbs, holes in the heart and urinary tract problems; especially when the drug is taken during the first 28 days, 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.
Just last month, the FDA put new restrictions on Depakote pregnancy use, contraindicating it for pregnant women, but only when it was used for the treatment of migraines. The agency did not contraindicate it for pregnant women.
The FDA changed all valproate-based drugs from a class “D” to a class “X” pregnancy drug, but only as they pertain to migraines. In addition to Depakote and Depacon, other drugs that are affected by the warning include Depakene, Stavzor and generic equivalents.
A Class D classification means that a drug’s benefits may be acceptable despite known potential risks to pregnant women. A Class X designation means that the risks of a drug outweigh the benefits for pregnant women. However, the FDA still considers the side effects to be an acceptable risk for the treatment of epilepsy and manic episodes associated with bipolar disorder, but not migraines.
MelanieNovember 5, 2017 at 12:01 am
I was on depakote for 10 1/2 years, I'm 41 now n my kidney's are not functioning correctly any more. I'm wondering if anyone else is having this problem?
MilaNovember 3, 2017 at 3:55 am
Depakote and Lithium made my naturally talented daughter dysfunctional and disoriented and doctors evils in power to damage her brain, muscles system and other organs to help her to die in ongoing pain and suffering. Dangerous power abuse by the system is outrageous and treats patients like slaves. Need a revolution to start to use the Rule of Law and charge authorities for their crimes. Too many [Show More]Depakote and Lithium made my naturally talented daughter dysfunctional and disoriented and doctors evils in power to damage her brain, muscles system and other organs to help her to die in ongoing pain and suffering. Dangerous power abuse by the system is outrageous and treats patients like slaves. Need a revolution to start to use the Rule of Law and charge authorities for their crimes. Too many Hillary's Clinton out of law in power everywhere to establish hers own laws and kill whoever does not intend to serve them silently. Evils everywhere are in power.
JasonJune 2, 2017 at 9:56 pm
My 17 year old Son was put on Depakote for 1 seizure he had when he was 12-He died This Feb 2017 from Leukemia ALL-B, I just found two other kids within a 2-mile radius of me that both are now fighting ALL-B Leukemia, Coincidentally they to were both on Depakote for over 5 years I am looking for more case, ? Please Send out to everyone you know Thank you
KennethMay 21, 2017 at 2:43 pm
Depakote damaged my liver.
kevinMarch 12, 2016 at 10:04 pm
I currently still taking depakote for mental health I take it off and on I do that because I can't go to the bathroom and I am gaining weight like crazy and eating nonstop
ChadJune 16, 2015 at 3:34 am
I have been on depakote for over 10 or so years because of bipolar but I feel tired all the time they have me on 1500 milligrams a day I have a hard time waking up and staying awake.
ceceliaJanuary 20, 2015 at 1:26 am
I. Lost a baby while on this med. I was not warned or informed about a n y again a n y side effects. Now i suffer tremendous headaches 2 the point. That i have to have low lights or sit completely still.
BeverlyJanuary 9, 2015 at 8:37 am
I was placed on Depakote for seizure disorder. I took this medication for approximately 10 years. During this time I developed migraine headaches and suffered a stroke. Whether or not the drug was related to my medical conditions is unknown.
MelissaAugust 4, 2014 at 12:39 pm
I was put on depakote years ago for bipolar. Now I have seizures due to depakote withdrawal and will have to be on depakote the rest of my life.
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