Washington, DCAbbott Laboratories has agreed to settle a Depakote lawsuit alleging the company illegally marketed its drug for off-label use. The Depakote settlement will see Abbott pay approximately $1.6 billion, including a $500 million criminal fine, according to The Washington Post (5/7/12).
An investigation into Abbott's marketing of Depakote began four years ago, when the company was accused of marketing the drug to doctors for the treatment of schizophrenia and dementia. Depakote is approved by the FDA to treat epilepsy, migraines and manic episodes associated with bipolar disorder. It is not illegal for doctors to prescribe medications off-label, but it is illegal for drug companies to market the drugs for off-label use.
According to an article at Reuters (5/9/12), Abbott reportedly trained salespeople to market Depakote as a way to calm elderly patients with dementia. Furthermore, Abbott reportedly gave doctors illegal kickbacks for prescribing the medication.
As part of the settlement, Abbott will plead guilty to violating a federal drug law. Patients who were affected by the illegal marketing of Depakote are not part of this settlement. The $1.6 billion settlement is reportedly the second largest settlement involving illegal drug marketing. In 2009, Pfizer paid $2.3 million to settle allegations about the marketing of Bextra.
The Washington Post (5/7/12) notes that in 1999, Abbott had to stop clinical testing of Depakote on elderly patients with dementia when studies showed that such use of the drug was linked to an increased risk of drowsiness, dehydration and anorexia in elderly patients. Despite discontinuing the study, Abbott's sales team continued to market the drug for such use until 2006.
A whistleblower—one of four whose complaints about Abbott started the investigation—further alleged Abbott's sales force was told to market Depakote as a way for nursing homes to make up for inadequate staffing. The whistleblowers will now split $84 million of the settlement.
Meanwhile, concerns have been raised that Depakote is linked to a variety of birth defects, including spina bifida, hypospadias and oral clefts. According to Courthouse News Service (4/19/12), Keona Clay filed a lawsuit alleging her son was born with a penile birth defect because she took Depakote while pregnant. The lawsuit alleges that Depakote was defectively designed and inadequately tested. Finally, it alleges that the drug's warnings were not adequate.
If you or a loved one have suffered losses in this case, please click the link below and your complaint will be sent to a drugs & medical lawyer who may evaluate your Depakote Birth Defect claim at no cost or obligation.