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By: Irvin Jackson | Published: June 27th, 2013
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.
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.