Many prescription drugs are manufactured for specific conditions, but may also be efficacious in others that may not have been intended or studied. Viagra (sildenafil), for instance, was originally formulated as a treatment for hypertension, but is currently more closely associated with erectile dysfunction. Many birth control formulations are also frequently used as a treatment for acne. These are considered “off label” uses and are generally acceptable provided it is done with caution and after some studies have been conducted to investigate the effects of this type of use. In many cases, off label uses have provided unexpected benefits for patients.
But it does not always work out for the best.
One example is Depakote, the anti-seizure medication manufactured by Abbott Labs. It is accepted that prescription medications are likely to have serious side effects, which is why they are not available over-the-counter and patients take it under the supervision of a doctor. But when a drug company in the US encourages the use of a product without the approval of the Food and Drug Administration (FDA) and personal injury results, it renders the company vulnerable to criminal and civil action.
Depakote is primarily intended to provide relief for epileptic patients; even when used for this, allegations of the drug causing birth defects have sparked legal trouble for the manufacturer for failing to provide adequate and timely warning to physicians and patients. Add to that marketing strategies that encourage off label uses of Depakote for treatment of bipolar disorder and migraines, and there is a recipe for disaster. Many civil lawsuits focus on the fact that women who suffer from bipolar disorder or migraine are prescribed with Depakote when they should not be, and the resulting birth defects of their children are due to this off label use.
If you or someone you know has been described with Depakote for epilepsy or other uses and a child is born with a birth defect such as spina bifida, there may be a personal injury case in the making. Consult with a products liability lawyerfamiliar with Depakote litigation in your area to get advice on how to proceed with a claim.Read More