Purdue General Counsel Fights For His Career
6 CommentsBy Ed Silverman // December 23rd, 2009 // 8:53 am
Mike Friedman, Purdue’s chief executive, and Howard Udell, the drugmaker’s chief counsel, are fighting a decision by the US Human and Health Services department that prevents them from working at companies that do business with federal agencies for 12 years. And as Corporate Counsel notes, Udell is the first general counsel to face this situation.
The case stems from the May 2007 settlement between the US Attorney for Western Virginia and three top execs at Purdue Frederick - including Udell and Friedman - over the misbranding of the OxyContin painkiller. The government claimed Purdue Frederick misled patients, regulators and doctors about the drug’s addictive risks. All totaled, Purdue and the three execs paid $634 million in fines (background here).
The Purdue Frederick subsidiary pled guilty to felony misbranding as part of the settlement and was automatically debarred from winning new government contracts, the paper notes. The parent company, which avoided criminal charges by striking a nonprosecution agreement and paying the fines, can receive contracts. The three execs pled guilty and, in exchange for no jail time, also paid fines.
The HHS, however, took the additional step of debarring the execs. As the paper notes, this appears to be the first time the federal government has imposed such an exclusion based on a “responsible corporate officer” misdemeanor. The move also affects science chief Paul Goldenheim. All three appealed and this is the lawsuit Udell and Friedman filed against the HHS.
Udell’s attorney, Andrew Ceresney, tells Corporate Counsel that “the decision to exclude Udell and two others based on strict liability, no intent misdemeanors, resulting solely from their status as officers of Purdue at a time when others engaged in conduct of which they were unaware, was arbitrary, unfair, and exceeded the inspector general’s statutory powers.” What do you think?
Should Purdue Execs Be Allowed To Do Business With the Government?
- No (82%, 70 Votes)
- Yes (18%, 15 Votes)
Total Voters: 85
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Marianne Skolek
http://salem-news.com/articles/december202009/udell_ms.php
shytown
The post above puts a face on what can happen when Big Pharma puts profits over people.
I remember those sales reps a while back. When my state stopped the triplicate forms that were required for SCHEDULE II Drugs, I remember the Purdue reps dancing in the offices.
You would have thought it was Christmas.
If you don’t punish these criminals, you tell the rest, Hey, it’s ok, if you get caught, at most you will have to pay a small percentage (and I mean small percentage) of the huge amounts that you reaped from the illegal activity.
I applaud this lady’s efforts, and the efforts of the AG to make sure these criminals get what they deserve.
pharmavet
In order to be permanently debarred by HHS, an investigator or drug company executive must have committed a felony. This is setting the bar way too high in my opinion. This was not a bad policy in the 1990’s, when HHS was actively debarring bad actors. However, this activity has slowed to a tricke in the past decade. As clinical researchers we used to be able to rely on the debarrment “black list” to exclusde potential clinical investigators. These days, that list is insufficient and we have to use additional investigatory tools. A cagey investigator can conceal a lot until they are caught. My most embarrassing experience was doing a prestudy visit to Drs. Borison and Diamond while they were committing their frauds, and actually giving them the thumbs up.
Dragonslayer
In my opinion it is about time individuals are punished in big pharma. Look at all the pharma settlements in the past 5 years and it is so easy to tell this is simply the cost of doing business. You make $10billion and pay the government a small percentage back. But, hey when someone with a name gets his hand whacked for having his hand in the til they scream to high heaven claiming they didn’t know and how unfair life is and the big bad government is overstepping. There should have been jail time for these three and few sales reps should have been taken down as well.
terry
The gall. No jail time, and they still want to argue?
2Big2Jail
Friends,
Just a word to say why it would be a disaster for all of us for me to serve time. Trust me, I am only concerned with doing the right thing for all of us.
First, the research and development on which my legal genius depends would grind to a halt. That means that all the life-saving medicines on which you rely would no longer be available to you. All of you would experience slow, agonizing deaths. The plague would spread around the world. Not just people. Also animals. Then plants. Almost certainly, the rocks would eventually crumble as well. And the dust would blow away.
So that’s why jailing me is a really bad idea.
Happy holidays.