In the pharmaceutical industry, there have been some very bad days for manufacturers, but today was really a bitter pill for Abbott Labs. The company was slapped with the second largest criminal fine for a single drug. Why? Because a Virginia judge found that the company promoted a drug called Depakote for uses that were not approved by the Food and Drug Administration (FDA).
As California defective drug lawyers, we have been involved in many cases involving dangerous drugs, off label uses and other issues that relate to the regulation of medications. In fact, we have been at the forefront of many of the most important medical and drug litigations in the country over the past decades.
In this case, the use that was never allowed by the FDA approvals for Depakote was a use for dementia patients and those with schizophrenia. But because these uses were not approved, their promotion for these off-label uses is not permitted.
The company will pay a large settlement with specific states and the federal government for providing information that amounted to false claims to healthcare programs provided by the government.
Other clean-up programs that the company has agreed to in this matter, include a probationary period that will last five years in which the chief executive officer of the company and the company’s board of directors must certify compliance with relevant laws. Other agreements relate to corporate integrity that is intended to put it on a path that will avoid fraudulent practices in the future.