The U.S. Justice Department (DOJ) will be directing lawsuits accusing Abbott Laboratories of illegally promoting its anti-seizure drug Depakote for nonapproved uses, such as dementia. The Chicago Tribune wrote that the DOJ filed notices in federal court in western Virginia last week.
The DOJ will be involved in three Depakote lawsuits against Abbott; all were confidential under laws meant to protect whistle-blowers who bring forth information concerning allegations of health care fraud, noted The Chicago Tribune. Because of the DOJ involvement, the lawsuits which were filed between 2007 and 2009 by people who were current or prior Abbott sales reps at the time of the filings were made public.
Although never involved in a Drug Recall, Depakote Birth Defects have been long making the news. Depakote (valproic acid) and similar epilepsy drugs have been linked to serious birth defects. In 2009, the US Food & Drug Administration (FDA) warned that women of childbearing potential should only use drugs like Depakote if essential to manage their medical condition. Abbott Laboratories began marketing Depakote in the 1970s in the U.S., but its key element “valproic acid” has allegedly been connected to serious defects when taken by expectant mothers in their first trimester of pregnancy.
In addition to Depakote, valproic acid is marketed under the brand names Depakote ER, Depakene, Depacon, Depakine, and Stavzor. In addition to epilepsy, Depakote and similar drugs are used to treat mania (episodes of frenzied, abnormally excited mood) in people with bipolar disorder (manic-depressive disorder: a disease that causes episodes of depression, episodes of mania, and other abnormal moods). They are also used to prevent migraine headaches.
The lawsuits allege Abbott promoted its Defective Drug to treat conditions not approved by the FDA “off-label uses” such as dementia in the elderly, Alzheimer’s disease, and schizophrenia, said The Chicago Tribune. Physicians are free to prescribe medications off-label; drug makers are legally banned from promoting drugs for off-label uses.
Last June, the New England Journal of Medicine (NEJM) published a study that found that Depakote and similar drugs increased the risk of six different birth defects: Spina bifida, atrial septal defect (a hole in the heart), cleft palate, hypospadias (an abnormality in the opening of the urethra in boys), polydactyly (extra fingers or toes), and craniosynostosis (premature closure of one or more sutures on a baby’s skull). These birth defects were more common in babies born to mothers who had taken valproic acid in their first trimester of pregnancy.
Abbott said federal prosecutors were probing how it markets Depakote and last year, a judge mandated Abbott provide prosecutors with some of Chief Executive Miles White’s emails, said The Chicago Tribune. Abbott has been fighting the request.
We just wrote that Abbott is involved in another Depakote Lawsuit in a class action involving its Defective Drug and over two-dozen parents. The lawsuit alleges that Depakote caused birth defects in their children. The lawsuit also claims that the drug maker, while minimizing Depakote’s risks and avoiding updates to the drug’s label, continued touting the medication to patients and doctors, of developing a defective medication, and of deceptively hiding the drug’s adverse effects.