Depakote Hit with Class-Action for Off-Label Marketing and Kickbacks

Depakote lawyers at Pintas & Mullins Law Firm report that the manufacturer of popular anti-seizure drug Depakote was recently slammed with a proposed class-action lawsuit by three health benefit plans. The organizations claim the manufacturer fraudulently profited from third-parties through kickbacks for prescriptions and off-label marketing.

Depakote (valproate semisodium, or divalproex sodium) was initially approved by the FDA for treatment of bipolar disorder, seizure disorders, and migraine headaches, which are clearly indicated on its labels. Its manufacturer, Abbott Laboratories, is now accused of misbranding Depakote, resulting in health benefit plans reimbursing Abbott when patients would have better benefited from other medications.

The scheme, plaintiffs allege, was designed to cause health benefit plans to pay for Depakote prescriptions when there were other, cheaper, more effective alternative medications. Despite the clear labels for treatment of only the above-mentioned disorders, Abbott marketed the drug as safe and effective for an array of other uses, such as treatment of schizophrenia, aggression in dementia patients, and narcotics withdrawal.

Plaintiffs say that Abbott had no reliable evidence that Depakote was safe or even useful for treating these maladies, and even knew, or reasonably should have known that it was dangerous for these patients. Indeed, the drug comes with a wide range of side effects, including life-threatening cases of pancreatitis, hepatotoxicity (liver failure), and significant birth defects in children born to women taking Depakote.

The birth defects issue has already resulted in a plethora of lawsuits after studies showed that Depakote use led to ten times the risk of malformations in infants. Such Depakote birth defects include: Spina Bifida, neural tube defects, cardiovascular problems, cleft palate, learning disabilities, and developmental delays, such as autism.

Since its introduction in 1998, the FDA has issued numerous safety alerts modifying Depakote’s warning labels. In 2000, the drug was given a black-box warning, the most serious warning the agency can issue for a medication, after numerous reports of life-threatening pancreatitis. In 2007, the FDA acknowledged the drug’s potential to cause birth defects, and changed its labels accordingly. Finally, in 2009, the agency changed Depakote’s labels a third time to reflect the increased risk of suicidal behavior or thoughts.

Despite its dangers, Abbott continued to aggressively market Depakote for off-label uses, even creating a devoted sales division for this purpose. The manufacturer is also accused to paying doctors to encourage others in the health care field to prescribe the drug, whether as-approved or otherwise. This scheme, as illegal as it was, had lucrative results, and Depakote’s sales dramatically increased. By 2005, the drug was pulling in over $1 billion in sales. In 2007, that number reached $1.5 billion.

Such a scheme could only last so long, however, and in 2012, Abbott pled guilty to misbranding and kickback violations under the False Claims Act. The company was forced to forfeit about $1.6 billion to federal and state governments for the fraud, however, no compensation was allocated for private health plans.

There are several hundred lawsuits currently pending in federal court over Depakote’s birth defects, which were recently consolidated due to similar claims concerning Abbott’s developments, manufacturing, testing, and marketing of the drug. Plaintiffs also allege similarly that Abbott should be held liable for the injuries it caused to infants, and for failing to warn doctors and patients about such risks.

Although it is known Depakote causes significant developmental delays in children, it is largely unknown how exactly it occurs in utero. Lawsuits alleging Depakote birth defects, however, are expected to grow considerably in the coming months. Our Depakote lawyers encourage anyone seriously injured, or with a child who was severely injured by this dangerous drug to contact a qualified attorney as soon as possible. We have extensive knowledge about drug litigation, and are currently representing mothers who took Depakote during pregnancy and experienced devastating effects.

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