In Feds' Probe of Abbott, a Mystery Defendant Twists in the Wind

Last Updated Jun 6, 2011 12:35 PM EDT

No one knows how big the settlement between Abbott Labs (ABT) and the Department of Justice will be in the whistleblower litigation over Depakote, an anti-seizure drug. But we do know from court papers that it could be huge -- Medicaid alone has paid Abbott $5.5 billion that the case alleges resulted from illegal unapproved, or "off-label," promotion (click to enlarge graphic) -- and we know that Abbott is not alone in the case. The other shoe, it would appear, has yet to drop.

A redacted version of the complaint -- by former Abbott sales rep Thomas J. Spetter -- shows there are at least two other unnamed defendants. That's unusual because the entire case centers on whether Abbott promoted Depakote for a range of dubious uses, such as aggression in dementia, schizophrenia, post-traumatic stress disorder in veterans of Iraq and Afghanistan, and explosive temper in children. The redactions -- which are extensive throughout the complaint -- suggest there are other companies involved. It's not clear who those companies might be, but by an unfortunate coincidence the unredacted portions of the papers suggest Omnicare (OCR), the massive pharmacy provider for nursing homes, may have some involvement in the case.

Abbott and the DOJ entered settlement talks in part because the case alleges that Abbott paid a doctor employed by the federal Veterans Administration $1,000 each time he gave a speech advocating the off-label use of Depakote on injured veterans. Paying federal employees to increase sales of your product is, of course, illegal.

Dr. Randy Mervis, chief of geropsychiatry consultation services at the Sepulveda, Calif., VA Medical Center, was a "key opinion leader" for Depakote on Abbott's payroll, the case alleges. The complaint is detailed -- it's 210 pages long -- and names dozens of doctors paid by Abbott to say illegal things about Depakote. Mervis allegedly wrote "standing orders" for the use of Depakote at the institution he served, the suit claims. Such orders would be placed in the chart of any patient admitted with dementia and aggression, and would require the patient to be given Depakote without the need for an exam by a doctor.

Abbott pushed standing orders at any long-term care facility where it had doctors employed as experts, speakers or consultants, the suit claims. In addition to cash, doctors were given opening day tickets for the San Diego Padres vs. San Francisco Giants game in 2001, the suit claims, as long as they attended a presentation on the off-label uses of Depakote beforehand. KOLS were offered other sports tickets, dinners and golf outings for cooperating with Abbott, the suit claims.

Spiffy performance
Internally, Abbott rewarded its pharmaceutical sales reps with a bonus scheme that encouraged off-label sales, the suit claims. One such scheme was named "SPIFFS," for Special Performance Incentives for Field Sales, and had a top prize of $10,000. Another was called "Over the Edge." That program allegedly urged reps to go "into uncharted territories regions of sales success in your territory."

The push for "standing orders" at long-term care facilities is what suggests Omnicare's involvement. Omnicare is a dominant provider of pharmacy services for nursing homes and long-term care facilities. It has previously been accused of taking money from drug companies -- including Abbott -- to push their drugs at its facilities.

Specifically, page 48 of the Spetter complaint alleges that Abbott funded a "ReView" program with the intention of pushing Depakote in long-term care facilities. Surely Abbott's "ReView" program has nothing to do with Omnicare's similarly named "ReView" program, which was allegedly referred to within Omnicare as the "one extra script per patient program"?

Time will tell.

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Image by Flickr user quaziefoto, CC.