Feds Join Lawsuit Over Abbott Off-Label Marketing
9 CommentsBy Ed Silverman // February 4th, 2011 // 8:35 am
The US Department of Justice has decided to intervene - or join - a whistleblower lawsuit that was filed in late 2008 by three former Abbott Laboratories sales reps, who accused the drugmaker of concocting an illegal scheme to promote its Depakote seizure med. The charges include paying kickbacks to docs to boost prescriptions and, subsequently, defrauding Medicare and Medicaid.
The fact that the feds are interested is not a surprise. In late 2009, Abbott disclosed in a Securities and Exchange Commission filing that the Justice Department ws investigating Abbott’s sales and marketing activities of the pill, which is used to treat bipolar disorder, seizures and migraines. The probe centers on possible violations of the Federal False Claims Act, the Food and Drug Cosmetic Act and the Anti-Kickback Statute (back story).
By intervening, however, the feds are raising the ante. Although numerous whistleblower, or qui tam, lawsuits are filed every year, the Justice Department only intervenes in a minority of cases. By joining this case against Abbott, the feds are sending a signal that they believe there is merit to the allegations. The feds also recently intervened in a lawsuit against Pfizer’s Wyeth over Rapamune (see this).
In the Abbott lawsuit, the former employees charge Abbott illegally marketed Depakote to treat dementia and behavior seen in Alzheimer’s patients to nursing homes and the US Veterans Administration. How so? Their lawsuit alleges the drugmaker provided sales reps with materials that required them to encourage nursing homes to use Depakote on an off-label basis and designed ‘Selling Skills Workshops’ for instructing reps on off-label marketing tactics.
What else? Abbott allegedly disguised seminars for docs that were actually sessions on off-label usage; offered reps bonuses and incentives for off-label promotion; failed to disclose that favorable articles were written by docs who were paid by Abbott; paid docs to prescribe the med; trained reps to avoid being detected when promoting off-label; and, generally, lied to nursing homes about the drug and its uses (you can read the lawsuit here).
Doc
Hope this is successful, maybe if they can tie in execs to the instructions for off-label promotion, we will finally see someone go to jail and/or be fined personally.
Stephany
Off-label use of Depakote caused my daughter permanent body injury: Polycystic Ovary Syndrome.
The entire drug industry business practices disgusts me!
Elmore
There was funny stuff going on with depakote 25 years ago. Glad it’s finally catching up to them.
Pharma Critic
Go get ‘em feds! Charge, try, convict, and jail! Then throw away the key. This behavior has completely ruined a once-proud industry. Personal fines for the responsible executives are also needed! Make ‘em pay!
Googly
Oh pish posh, this is small peanuts. Allergan has been doing crap like this for years. They finally got their comeupance with their 600 million fine last year, but its continuing even now. Most guilty, and who the Feds should go after, are the Botox docs. Docs literally being paid to prescribe and use only Botox, they practically work for Allergan! some of the top neurologists in the country. Sad how ethics go out the door when cold hard cash rares its head. These docs need to be thrown in jail.
crybabies
Sounds like somebody is mad about something or looking for an easy buck.
No need to go off label. Drug had three indications and those indications have dozens of symptons.
3 ladies all form MA? huh, sounds like a pact!
Becky
The use of this and other drugs for psychiatric diagnoses, has caused so much damage. What is the point of having the FDA, when “doctors” are allowed to use any drug off label—and fraudulently bill Medicaid? Where is the protection that this agency should be providing? Depakote was prescribed to my son off label for an indication the maker says not to use it for, billed to Medicaid–fraud.
David Klein
“disguised seminars for docs that were actually sessions on off-label usage; offered reps bonuses and incentives for off-label promotion” … this stuff is everywhere in pharma. For a dramatic, page-turning look at this issue, read the novel STASH published by Random House. MOre info at http://www.bydavidklein.com.
RxRights Advocate
Big pharmaceutical companies have been behaving badly for too long—at a huge cost to public health. They recently surpassed the defense industry to become the biggest defrauder of the U.S. government: http://www.rxrights.org/your-thoughts/2011/01/19/the-fraud-of-big-pharma. It’s refreshing to see the Department of Justice pursuing this lawsuit. Let’s hope that it means that this Administration is ready to end its role as Big Pharma’s cheerleader.