Novartis Pays $185M Fine For Off-Label Marketing
14 CommentsBy Ed Silverman // January 26th, 2010 // 9:07 pm
The drugmaker is pleading guilty to a misdemeanor to resolve criminal allegations for improperly promoting its Trileptal epilepsy med. Since 2005, the US Attorney in Phildelphia has pursued civil and criminal investigations into off-label marketing and eyed “payments made to healthcare providers,” according to the Novartis earnings statement issued today (see page 30). Novartis is also trying “to resolve civil claims,” and increased its reserves relating to the Trileptal investigations by $318 million to $397 million, although whether that includes the fine isn’t clear.
Meanwhile, the US Attorney in Philadelphia is also probing potential off-label marketing and payments to health-care providers for five other Novartis drugs - Diovan, Exforge, Sandostatin, Tekturna and Zelnorm. This follows a $72.5 million fine Novartis paid in September 2009 to resolve federal civil claims and state Medicaid claims after a probe by the US Attorney in San Francisco into off-label marketing of TOBI, a cystic fibrosis treatment.
Justice in MI
Does anyone know why a misdemeanor (besides plea-bargaining)? It sounds like the original charges were felonious if they involved kick-backs to docs.
JaT
Hi JiM,
What little I know about the court process goes like this. Busted first on a misdemeanor. The judge adds felony charges that are horrifying. Now the accused probably has a decision to make:
a) Plead guilty to the lessor charges & you can usually be certain to avoid jail time.
b) Or plead innocent and make the court work to convict you on the felony- which you may pay for with both time & fines.
It appears to be the usual way to clear a court docket. No idea if that is how this went down.
I know a defense attorney who would tell you to NEVER take the lessor charges out of fear of being incarcerated. The felony conviction requires a big investment and the courts might drop ALL charges to avoid that time/cost investment if they can. If the fear of jail time doesn’t make you take the lessor charges then they think you might have good reason. You have basically called the courts bluff- placing the onus on the prosecutor.
(Of course it isn’t the defense attorney’s butt on the line and he may just be drumming up business, lol.)
Novartis’ lawyers had to believe that it wouldn’t be wise to gamble. Their plea speaks volumes.
JaT
No I have never been arrested.
:P
Lisa Van Syckel
A NJ facility was prescribing this drug like candy to individuals with depression in 2005, and the cost was being picked up by the taxpayer.
harpy
felony = automatic debarrment from CMS = end of company.
Conviction of a misdemeanor means DoJ gets some discretion. In part, this is why the Purdue guys were so up in arms after being debarred when they pleaded to a misdemeanor. they are now suing for reinstatement.
Former BP
Once again they let Big Pharma off with a tiny slap on the wrist and a pittance fine. Novartis is laughing all the way to the banks and the commercial execs have already received their huge bonus checks for doing such a good job. And everybody gets off without serving any jail time. Until there is true accountabbility for these shady actions, it will never change. The public is sick of it and hates the drug companies.
harpy
and, actually, it’s a fairly new and big deal to get the misdemeanor plea. if you look back you’ll see before the last couple of years all settlements were “deny any wrongdoing.”
harpy
whew - no need to worry about that fine. Novartis reported a net profit of $2.32 billion in the fourth quarter based on strong sales.
Doc
If you don’t jail those identified in the documents from discovery, this practice will never end - it is too profitable.
Betsy
My son is now taking trileptal, and I’d like to know if anyone can personally report terrible or dangerous side effects.
Miranda
I used to take Trileptal (brand) as a mood stabilizer (off-label)to enhance my MAOI antidepressant, but it really did nothing. Interesting that prominent medical literature included the drug as an adjunct therapy to treat major depression.
What makes me even more curious is this: if Novartis was promoting it on an off-label basis, and this was known at least five years ago, why wasn’t more discretion taken in the approval of the generic Trileptal (oxcarbamazepine)? Does the manufacturer of the generic have any responsibility in this?
Anonymous Patient
Jail the bums… They are doing the same thing with their cancer drugs Gleevec and Tasigna…
Don’t trust the swiss….
Codes R not us.
I found out of this on CP, where someone posted “Rome is finally burning” reffering to Novartis finally getting busted. This Co though it was untouchable for decades, especially since their merger in .96. Then they implemented a new culture of doing biz that boils down to use of equal parts of legal and illegal means of doing their biz. That means that their breaking laws all over the world is deliberate, planned and approved by the very top of the Co. That includes Dr. Vasella.Except that the very top is protected by “buffers” as it is done with real mafia.The top will never be exposed as crooked although the very orders originate there. Finally they are exposed to bigger degree in USA and more is to come. Diovan was promoted out of label all over the world from the very begining. Also bribery, fake postmarketing trials,and other illegal stuff was used on huge scale. That is most likely why Diovan has become #1ARB in the world.In Canada for instance they did even worse things. They have defrauded drug plans of every province to the tune of 150.000.000.00 Can $$ by use of fake PMST.Unlike in US there are no good laws to fight this (no False claim Act) so they do this with complete impunity. Maybe now that US has caught them they may get in trouble even in Canada. Few of us are working hard on this and have irrefutable evidence that the crime has been done, big time.Prediction; by the time it is over, Novartis will have paid a least 1 billion maybe even over 2 billions in fines. They owe it to your people that they as other bigpharma have robbed from you over long time.
JP
I use to work for Novartis (field sales)for four years. Novartis’ leadership are a bunch of crooked clowns who claim that the company is all about its patients and the customers? It’s all about the money and they know it!
Field sales reps earn less than $30,000 in compensation anually and a very modest yearly salary (think less than 85k in total compensation.) $250k-500k Christmas bonuses are a common payout for Novartis executives who have nothing to do with sales, while executives who leave the company are payed in the millions. What a scam!