Whistleblowers have succeeded in a $1.5 billion off-label marketing case against Abbott Laboratories Inc., the Department of Justice announced today. Combined, the $700 million criminal fines and $800 million civil fines are the second largest government recovery from a drug company in history.
The Department of Justice intervened after four whistleblowers filed suit against the company. These plaintiffs provided original information to prove that Abbott marketed a drug called Depakote for controlling agitation and aggression in elderly dementia patients and to treat schizophrenia. However, the FDA had never approved Depakote for either use, and Abbott-sponsored studies showed that the drug was both ineffective in these areas and also potentially dangerous.
“Not only did Abbott engage in off-label promotion, but it targeted elderly dementia patients and downplayed the risks apparent from its own clinical studies,” said Acting Associate Attorney General Tony West. “As this criminal and civil resolution demonstrates, those who put profits ahead of patients will pay a hefty price.”
The fines from these suits are hefty, indeed. Government recoveries are three times the amount of the fraud. Since many crimes are never discovered, though, companies still see an incentive to commit fraud. The Department of Justice’s visible and successful cooperation with whistleblowers will force companies to reevaluate their cost-benefit analyses. It is clear, then, that this $1.5 billion settlement is a win for accountability and a win for American health and safety.