The US Food and Drug Administration (FDA) first approved Depakote, a product of Abbott Labs, for treatment of epileptic seizures, bipolar mania, and migraine prevention, in 1978. However, thanks to marketing pushes from the manufacturer, the drug was being widely used for the off-label treatment of a wide variety of psychiatric conditions, including aggression in dementia patients and schizophrenia, despite the fact that there was no evidence for these claims. In 2012, Abbott Labs was forced to pay $1.5 billion in criminal fines and civil suits.
At Buttafuoco & Associates, we believe that medication safety and transparency is paramount, so in this article, we’ll define off-label medication use and explain why Abbott Laboratories faced legal charges for promoting off-label use of Depakote.
What is Off-Label Medication Use?
Off-label use is the practice of prescribing pharmaceuticals for an unapproved condition or in an unapproved age group, unapproved dose, or unapproved form of administration.
In the United States, before a new drug can be approved for a specific condition, the Food and Drug Administration Center for Drug Evaluation and Research (CDER) reviews a company’s New Drug Application (NDA) for data from clinical trials to see if the results support the drug for that specific indication. Medical trials are rigorous tests of medications for specific conditions, at certain dosages, for particular age groups. In order to be scientifically valid, these trials need to be very specifically targeted; they aren’t “fishing expeditions” just to see what works.
Off-label use happens when clinicians or researchers find that a drug effectively treats another condition. Often an off-label prescription will be for a similar condition as the approved use, such as a chemotherapy being used for another type of cancer. Other off-label uses are more divergent; for example, beta blockers, while intended to treat high blood pressure and other coronary diseases, have been shown to effectively treat anxiety.
Northern New Jersey medication error lawyers advise that while taking off-label medication isn’t necessarily illegal or even a negligent medical practice, the FDA advises caution when taking off-label medications, weighing the research of the drug’s effectiveness for off-label use, its original intended use, and whether your insurance will cover off-label use.
Abbott Laboratories and the Criminal Promotion of Depakote
While Depakote was approved for migraines, bipolar disorder, and epileptic seizures, Abbott Laboratories actively promoted off-label uses, even as their research lacked support for these claims. In 1999, Abbot discontinued their clinical trials of Depakote for behavioral disturbances in dementia patients because of increased side-effects, including anorexia, severe drowsiness, and dehydration. However, Abbott promoted the drug as a legal work-around for certain budget regulations for unnecessary medication and used their sales teams to promote off-label uses to medical staff. Abbot even paid millions in rebate incentives for pharmacies that prescribed the drug. Regarding the treatment of schizophrenia, Abbot funded two studies, but neither study established evidence that Depakote was an effective treatment. Despite these failures of the research, however, Abbott marketed Depakote as a treatment for schizophrenia from 2001 to 2006.
In other words, Abbott Laboratories knew that Depakote was ineffective and even harmful for these psychiatric conditions, but they pushed it anyway for their bottom line.
Do I Have a Medical Malpractice Case for Off-Label Prescriptions?
As we mentioned above, our medication error attorneys in Northern New Jersey note that off-label use of medication is not always negligent, and even may be common and effective practice. However, there are situations when a drug company pushes for unapproved use, or physicians may prescribe drugs off-label in ways that breach the common standard of care.
If you have suffered severe side effects or other issues due to off-label prescription, getting in touch with an attorney may be in your best interest.
Profiteering drug companies seem to do everything they can to sell their products, even if it falls outside sound science and the law; at Buttafuoco & Associates, we’re here to defend you.
Call 1-800-NOW-HURT to consult with a seasoned Northern New Jersey medication error attorney today.
