Abbott's off-label deal said to be $800M civil, $500M criminal

It's not official yet, but sources are telling Bloomberg that Abbott Laboratories' Depakote settlement will run at least $1.3 billion. About $800 million of that would go to resolve civil claims, while criminal penalties would run $500 million or so. Abbott ($ABT) said last week that it was setting aside $1.5 billion to cover the potential deal with the Justice Department.

The company wouldn't comment for Bloomberg, other than to say that the settlement talks are ongoing. The Justice Department wouldn't comment either. But if the deal does amount to $1.3 billion, it would be the third-largest off-label marketing settlement ever, after Pfizer's $2.3 billion Bextra-and-other-drugs deal and Eli Lilly's $1.4 billion Zyprexa settlement.

In terms of criminal penalties, Pfizer's is far and away the largest: $1.95 billion, a record-setting fine. Lilly paid $515 million in criminal penalties as part of its deal, so Abbott's $500 million-or-so would be within striking distance of second place.

As large as these off-label settlements are, they're still dwarfed by the sales of those improperly marketed drugs. Abbott's case would be no different: As one whistleblower suit claims, Depakote sales grew to more than $1.4 billion a year, partly because the company marketed it for uses not approved by FDA. The settlement could be announced as early as December, Bloomberg's sources say.

- read the Bloomberg story

Suggested Articles

BMS’s Opdivo has plenty of competition in its current bladder cancer indication—so it’s hoping to strike out on its own in a new area of the disease.

The Japanese approval, under the brand name Jyseleca, came a month after an FDA complete response letter that asked Gilead for more data.

The Trump Administration has opened the doors for Florida and other states to import prescription drugs from Canada—despite industry objections.