Subpoena's

Why are you comparing to Vioxx, it helped people with pain, something still in need today? So many people taking Vioxx would still give their left one to be taking Vioxx and Merck pulled it voluntarily, not forced to as was the case with Zelnorm! Vioxx was not sold outside of indication and reps never suggested that physicians use doses outside the circular, it just was not necessary with that product. With Vioxx even the 50mg for acute pain over short course was discouraged if the drug worked at 25mg, don't think that's the case here. Maybe the CV events were patients concommitantly given Diovan with the Zelnorm, cause diovan did cause excess events in VALUE!!
 






Why are you comparing to Vioxx, it helped people with pain, something still in need today? So many people taking Vioxx would still give their left one to be taking Vioxx and Merck pulled it voluntarily, not forced to as was the case with Zelnorm! Vioxx was not sold outside of indication and reps never suggested that physicians use doses outside the circular, it just was not necessary with that product. With Vioxx even the 50mg for acute pain over short course was discouraged if the drug worked at 25mg, don't think that's the case here. Maybe the CV events were patients concommitantly given Diovan with the Zelnorm, cause diovan did cause excess events in VALUE!!

Give the whole story or shut yer yap! Diovan did NOT cause "excess events" in VALUE trial. Read the fuckin study. Diovan failed to prevent CV events in those specific patients. It was a very ambitious trial and the outcomes were not surprising to anyone.
 






Now how in the world would Novartis be able to identify which reps sold Zelnorm off label? A script is a script - right?

It is not Novartis you need to worry about!! It is the physician who prescribed the drug for an off-label use, that you promoted, is sued by a patient. You, personally, along with Novartis will be named in the lawsuit.

The FDA is bad enough in regards to off-label promotion, but if the drug was paid for by Medicare or Medicaid and the OIG gets involved, it can become very painful. The OIG can view off-label promotion, where the drug used in such manner, was paid for by the goverment, as a violation of the False Claim Act, which can carry civil (personal) and monentary penalties.
 






It is not Novartis you need to worry about!! It is the physician who prescribed the drug for an off-label use, that you promoted, is sued by a patient. You, personally, along with Novartis will be named in the lawsuit.

The FDA is bad enough in regards to off-label promotion, but if the drug was paid for by Medicare or Medicaid and the OIG gets involved, it can become very painful. The OIG can view off-label promotion, where the drug used in such manner, was paid for by the goverment, as a violation of the False Claim Act, which can carry civil (personal) and monentary penalties.

This is where the gov't has the most power to prosecute. I'd be pretty worried if I had "detailed" call notes. The OIG will show no mercy because its a federal offense to defraud Medicare/Medcaid and jail time usually is an option along with BIG fines!
 


















It is not Novartis you need to worry about!! It is the physician who prescribed the drug for an off-label use, that you promoted, is sued by a patient. You, personally, along with Novartis will be named in the lawsuit.

The FDA is bad enough in regards to off-label promotion, but if the drug was paid for by Medicare or Medicaid and the OIG gets involved, it can become very painful. The OIG can view off-label promotion, where the drug used in such manner, was paid for by the goverment, as a violation of the False Claim Act, which can carry civil (personal) and monentary penalties.

YOU DON'T KNOW WHAT YOU ARE TALKING ABOUT! The bottom-dwelling plaintiff's attorneys couldn't give a shit about the reps. They don't have enough money to chase, Nofartis damn sure does. The reps will have to show up at a lawyers office, hook-up their computers and the lame-assed call notes will be compiled in to a data base and these assholes will go over them with a fine comb. I personally saw this happen in Little Rock in the two Prempro trials. DO YOURSELVES AND YOUR COMPANY A FAVOR: FORGET CALL NOTES!

The only off label case in recent history was the Parke-Davis Neurontin debacle and NO reps had any problems here. Only Fizzer!
 






Yes they can. Just ask some of the reps who sold for Purdue or the reps who sold for TAP. They all had their computers taken by feds and with a subpoena
the gov't can take it off the hard drives at corporate if need be.

If you put down too much info to kiss ass with your boss then you will be the "fall-guy" when the shit hits the fan.

Don't think that Big Pharma will bail your ass out as threy are only looking at saving their ass from the gov't.

BEWARE OF WOLVES IN SHEEPS CLOTHING!

Cover your own ass. If you feel like its been compromised speak to an attorney!!!!!!!!!!!!

This was posted in 2007, how ironic that the whistleblower lawsuit was settled 3 years later which is not a long time. No matter how much bs is posted on Cafepharma there seems to be plenty of pearls of wisdom. Managers and Hr should be aware reps are not idiots. Are alot of Zelnorm reps still employed? Good for you for surviving and hopefully thriving.