Were Patients Wrongly Prescribed Depakote?

Boston, MAWhen it comes to taking medication such as Depakote that can have serious side effects, patients trust they have been given the medication for a good reason. After all, people who take Depakote might be risking Depakote side effects. When they take medication, patients believe the drug has been properly marketed and prescribed. A lawsuit against Abbott Laboratories and Abbott Pharmaceuticals, however, alleges that may not be the case with Depakote. Although the off-label marketing likely is not linked to Depakote birth defects, there is still concern that patients could have been needlessly exposed to Depakote side effects.

The lawsuit was filed in 2007 by three Abbott whistleblowers, who allege Abbott engaged in off-label marketing of Depakote. Off-label use means that a drug is prescribed in circumstances that have not been approved by the US Food and Drug Administration (FDA). It is not illegal to prescribe a drug for off-label use. Pharmaceutical companies, however, are prohibited from marketing the drug for off-label use.

This means, for example, that if a drug such as Depakote (known generically as valproic acid) is approved to treat seizures, migraines and bipolar disorder, the drug company cannot promote the drug as a treatment for dementia linked to Alzheimer's. Pharmaceutical companies are only allowed to promote a drug for approved uses.

According to the lawsuit, Abbott was involved in the off-label promotion of Depakote, Depakote ER and Depakote Sprinkles for Alzheimer's-related dementia. All three plaintiffs are either current or former Abbott employees. They allege that Abbott encouraged nursing facilities to use Depakote drugs off-label, provided incentives to their sales representatives to increase off-label use of Depakote drugs, conducted workshops devoted to marketing Depakote drugs for off-label use, gave false information to health care providers about the safety and efficacy of off-label Depakote use, and paid kickbacks to physicians for prescribing Depakote off-label.

"As part of their illegal off-label promotions of the Depakote Drugs, Defendants have instructed and caused their sales personnel and their medical employees to make false statements to physicians, deliberately omit material information to physicians, and to brief physicians based upon written materials containing false statements and omissions, concerning the safety and efficacy of the Depakote Drugs for off-label uses," the lawsuit argues.

Now, the US Department of Justice is intervening in the lawsuits because many of the patients who received Depakote off-label were on federal health programs, meaning the government may have paid a lot of money for medications prescribed because of Abbott's alleged off-label marketing. Abbott also faces lawsuits alleging babies suffered from Depakote birth defects after being exposed to the medication prior to birth.