Depakote Settlement Talks Underway Over Illegal Promotion

Abbott Laboratories is reportedly in settlement talks with federal prosecutors over allegations that it illegally marketed Depakote, an epilepsy drug that has been the subject of a growing number of lawsuits and legal claims. 

On May 20, the U.S. Department of Justice (DOJ) told a federal judge that it was discussing settlement of Depakote claims with the pharmaceutical company and asked to postpone upcoming court deadlines so that the discussions could continue.

The government has intervened in a whistleblower lawsuit against the company, claiming it tried to promote Depakote for the off-label treatment of Alzheimer’s disease and for use as a chemical restraint for elderly patients who become agitated or aggressive, which is often considered a form of nursing home abuse.

Did You Know?

AT&T Data Breach Impacts Millions of Customers

More than 73 million customers of AT&T may have had their names, addresses, phone numbers, Social Security numbers and other information released on the dark web due to a massive AT&T data breach. Lawsuits are being pursued to obtain financial compensation.

Learn More

Depakote (valproic acid) is an anti-seizure drug approved by FDA in 1983 for the treatment of epilepsy. It belongs to a class of drugs based on valproate; which includes Depacon, Stavzor, and the first drug in the class, Depakene, which was first approved in 1978. It is also often used to treat bipolar disorder and depression, but has also been widely used off-label.

While doctors are allowed to prescribe approved medications for non-approved uses, it is illegal for drug companies to promote or encourage such uses. Depakote is not approved for treatment of dementia or Alzheimer’s disease.

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

Under the qui tam provision of the False Claims Act, whistleblowers who report a false claim against the government may be entitled to receive a portion of any money that the government recovers from the offenders. In return, the whistleblower must be the first to bring the case to the government’s attention, and must not publicize the claim until the DOJ decides to prosecute the claim.

In recent months, Abbott Laboratories has also faced a growing number of lawsuits over Depakote filed by families of children born with spina bifida or other birth defects after the mother was given the medication while pregnant.

Side effects of Depakote during pregnancy have been linked to an increased risk that the child will be born with severe birth defects or malformations when the medication is taken during the first trimester, especially 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. Birth defects associated with Depakote include spina bifida, cleft palate, abnormal skull development, malformed limbs, holes in the heart and urinary tract problems.

In May 2010, researchers found that Depakote problems for infants could occur after using the drug as early as the first trimester, which means that by the time many women discover they are pregnant, it could be too late to get off the drug and avoid birth defects for their unborn child.

Image Credit: |


Share Your Comments

I authorize the above comments be posted on this page*

Want your comments reviewed by a lawyer?

To have an attorney review your comments and contact you about a potential case, provide your contact information below. This will not be published.

NOTE: Providing information for review by an attorney does not form an attorney-client relationship.

This field is for validation purposes and should be left unchanged.

More Top Stories

Gardasil Vaccine Lawsuits Being Prepared For Early Test Trials in Federal MDL
Gardasil Vaccine Lawsuits Being Prepared For Early Test Trials in Federal MDL (Posted yesterday)

In advance of a a conference this week, lawyers report that progress is being made to prepare a group of federal Gardasil vaccine lawsuits for early test trials, to help gauge how juries may respond to certain evidence and testimony that will be repeated throughout the litigation.

Enfamil Lawsuit Claims Preemie Developed NEC After Being Fed Cow's Milk-Based Infant Formula
Enfamil Lawsuit Claims Preemie Developed NEC After Being Fed Cow's Milk-Based Infant Formula (Posted 2 days ago)

Cow's milk-based infant formula products are dangerous for premature infants, according to a mother's recent Enfamil lawsuit, filed after her newborn developed necrotizing enterocolitis and suffered through surgery and continuing negative health effects.

Ozempic MDL Lawsuits Reassigned To New Judge For Further Pretrial Proceedings
Ozempic MDL Lawsuits Reassigned To New Judge For Further Pretrial Proceedings (Posted 5 days ago)

All lawsuits over Ozempic, Mounjaro, Wegovy and other GLP-1 RA drugs to U.S. District Judge Karen S. Marston, following the death last month of the judge originally appointed to preside over all claims involving stomach paralysis and other gastrointestinal injuries.