Abbott Laboratories - Depakote

Company: Abbott Laboratories
Settlement amount: $1.6 billion
Drug: Depakote
Year: 2012

Dementia patients were a target market for drugmakers in the late '90s and into the new millennium, if off-label marketing settlements are any indication. Like Eli Lilly ($LLY) and Johnson & Johnson ($JNJ), Abbott ($ABT) promoted a product--the seizure drug Depakote--for off-label use in elderly dementia patients who became agitated or aggressive. A specialized, specially trained Abbott sales force pushed Depakote in nursing homes to help control these patients, even though it had no credible evidence that the drug was safe or effective for that use. In fact, the company had to stop a clinical trial in elderly dementia patients because of adverse events.

Abbott also admitted that it pushed Depakote as a schizophrenia treatment. Though the drug was approved to treat mania in bipolar patients--and sometimes those patients display psychotic symptoms--clinical trials showed that Depakote added to antipsychotics didn't help schizophrenia patients any more than the antipsychotics alone. The company didn't tell Depakote sales reps about that data for two years.

To put the allegations to rest, Abbott agreed to pay a criminal fine of $500 million and plead guilty to a misdemeanor misbranding charge. It also agreed to forfeit $198.5 million in assets, and to 5 years of probation.

The civil side of the settlement--$800 million--wrapped up lawsuits alleging that its marketing tactics triggered false claims to government health programs, including Medicare and Medicaid. Abbott also agreed to pay $100 million to wrap up consumer-protection claims at the state level. And then there's the corporate integrity agreement, a 5-year pledge that Abbott's board and top executives will get involved in the company's compliance efforts.

Abbott Laboratories - Depakote