Depakote Marketing Settlement Being Negotiated

Abbott Laboratories (ABT) is in talks to settle a U.S. Department of Justice (DOJ) probe into whether or not it illegally marketed <"">Depakote, its anti-seizure medication for nonapproved uses, said the Wall Street Journal, citing a court department.

We recently wrote that the DOJ will be directing lawsuits accusing Abbott Laboratories of illegally promoting Depakote for nonapproved uses; the DOJ previously filed notices in federal court in western Virginia. The DOJ will be involved in three Depakote lawsuits against Abbott; all were confidential under laws meant to protect whistleblowers who bring forth information concerning allegations of health care fraud. 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.

In its May 20 court filing, the DOJ said that “the parties are engaged in active settlement discussions,” quoted the Journal. Meanwhile prosecutors asked a Virginia federal judge to postpone the deadline for some court proceedings to July 8 so that time for a possible “negotiated resolution” can be enabled, said the Journal.

The government intervened claiming that Abbott attempted to promote the anti-seizure medication for the nonapproved treatment of using the medication as a chemical restraint in elderly and Alzheimer’s disease patients. We have long considered this sort of action a type of nursing home abuse.

The Depakote lawsuit was originally filed by Susan Mulcahy, Doreen Merriam, and Sondra Knowles; Mulcahy and Merriam were specialty account executives at Abbott Laboratories and Knowles is a former employee. The details of the complaint were sealed until the DOJ announced it would intervene.

The False Claims Act contains a so-called qui tam provision that allows whistleblowers to be rewarded with a percentage of the money that the government recovers as a result of their lawsuits. This provision helps encourage people to assist the government in reducing Medicare fraud, defense fraud, and other kinds of fraud despite the effect whistleblowing might have on their jobs and personal lives.

Although never involved in a drug recall, Depakote birth defects have been long making news with Depakote (valproic acid) and similar epilepsy drugs being 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 and, 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.

Some Depakote 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. Physicians are free to prescribe medications off-label; drug makers are legally banned from promoting drugs for off-label uses.

Meanwhile, as we have long been reporting, Depakote lawsuits continue to be brought by individuals and in class actions against Abbott for allegations that the drug caused birth defects in their children and 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.

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