Saturday, July 21, 2007

OxyContin Executives Fined For Not Publicizing How to Obtain a Heroin-Like High?


In southwest Virginia, a Judge has made a decision which may cause a few folks to scratch their heads. The order requires Purdue, the maker of OxyContin, and three executives to pay $634.5 million dollars in fines for failing to publicize the painkiller's risk of addiction. At first blush U.S. District Judge James Jones fine on the company and its lawyer (Howard Udell), former president (Michael Friedman) and former chief medical officer (Paul Goldenheim) sounds like a fair civil penalty. But a closer look at what transpired in the three-and-a-half hour hearing, raises some concern.

First this was a criminal sentence not a civil fine. Granted, there was testimony from several witnesses who said their lives were permanently changed by addiction to OxyContin (oxycodone.) If the pill is crushed to poweder its absorption is greatly expedited which magnifies the risks associated with the drug. But the pill was designed to be swallowed whole and digested over 12 hours. (That is how doctors instruct the pill to be taken.) However, if you crush the pill, it can produce a heroin-like high. Testimony reveal that if it is crushed and then swallowed, snorted or injected a heroin like effect occurs.
The number of deaths associated with OxyContin allegedly increased nearly five times from 1996 to 2001. Sounds bad. But the number of OxyContin prescriptions increased nearly 20 times according to the U.S. Drug Enforcement Administration. (Stop! That means that the number of deaths per prescription actually significantly decreased!) The DEA alleges that in 2002, the drug caused 146 deaths and contributed to another 318. (While any death is one too many, from a statistical standpoint, these are not huge numbers when you consider the number of prescriptions for OxyContin being written for severe debilitating pain.The drug comes with warnings and with any drug their are some recognized risks and complications)

In May, the three executives apparently tacitly admitted to informing doctors that OxyContin was less addictive and less subject to abuse than other pain medications. Formally, they each pleaded guilty to a misdemeanor count of misbranding the drug. (That is negligence opening up civil redress if they had knowledge to the contrary. However, negligence in failing to warn is usually left up to the civil trial lawyers and not typically criminally prosecuted unless there was intent to harm others.) The three individuals were fined a total of $34.5 million and each placed on three years probation. Each executive must also perform 400 hours of community service relating to the prevention of drug abuse. (Purdue was placed on 5 years probation.)


Former New York City Mayor Rudolph Giuliani helped the defendants negotiate with federal prosecutors. (Probably should have left the negotiations up to Howard Shapiro.) Several speakers called for jail terms for Friedman, Udell and Goldenheim. Defense attorneys argued that the three executives were given criminal convictions because of their job titles, not because they themselves promoted OxyContin as a drug with little addiction potential. Defense attorney Howard Shapiro said in court, "They are not here today because of any acts of misconduct on their part." (Again, with criminal law, the law usually requires intent to break the law. I doubt these suits had such intent.) Assistant U.S. Attorney Randy Ramseyer argued, "We cannot bring those people back. It's not something this case can do."


Dillie Walker and Joyce Walker of Bay City, Mich., testified that OxyContin has enabled them to function despite chronic pain. The drug continues to be legally prescribed for moderate to severe pain. Purdue has put in place training and monitoring programs to prevent overpromotion of OxyContin.

In sum: Purdue's three executives were personally criminally prosecuted, convicted, and sentence in part for their failure to inform the doctors and the public that if they crushed OxyContin and then swallowed, snorted or smoked it, an addictive heroine like high would result by speeding up its ingestion. (What a great how to instruction for those illegal street using drug users. ) Yes, it is addictive and should only be used for moderate to severe pain. But it is FDA approved and only available by prescription. And, I have yet to see a prescription that instructed that Oxycontin should be crushed and then swallowed, snorted or smoked.

Update 11-9-07: Marianne Skolek, the mother of a young woman who is believed to have died from from heart complications associated with oxycontin use is continuing the attack on Purdue executives. Link here.


Update 9-3-10: Pennsylvania treatment center offered to pay for a link. We didn't charge them since they asked the proper way. Such treatment centers offer a real benefit to those addicted. Please visit http://www.pennsylvaniatreatmentcenters.org/ to learn more about this facility.



52 comments:

blond bombshell said...

Wow, for anyone wanting substance this is a great read.This is a story that I would not have read in a magazine or newspaper because I would think it of no interest. But I read the legal pub and thought wow! This Judge has punished some executives who probably never said anything about the product.

Addiction is serious. I think some famous and not so famous people with chronic pain have become addicted. (Rush?) But the risk of addiction was not unreasonale if you follow your doctors instructions and he monitors your use.

Even if the company should have been fined, I feel these three executive were used as scape goats.

Thanks for making me think on a Saturday morning.

Shell

Ms. Calabaza said...

Oxycontin is transported up and down Virginia's 1-81. Rt. 1-81 replaced the railroads that traversed the state years ago. I am told, that many truckers subsidize their income by selling oxy. It is called the redneck heroin and has affected countless in the Shenandoah Valley. Next to meth, oxy is the drug of choice for the poor and desparate. This is a HUGE problem and people become addicted very, very quickly. I understand what you are saying, Legal Pub and as someone with fairly civil libertarian tendencies, agree people should share in personal responsibility. However, it seems oxy was dispensed too quickly when it was first introduced into the market. If these execs purposefully hid this fact, they should pay the price. Remember in the 80's when cocaine was touted as non-addictive? What a scam . . .

Legal Pub said...

Ms.C, I agree, if they had personal knowledge then they are "drug pushers." But there apparently was no evidence of actual intent. For that matter there was no evidence (that I am aware of) that these three individuals were involved in the direct marketing of the product.Furthermore the FDA tested and approved the product.

Oxycontin is strong.It is tantamount to oral morphine. In my practice I see many addicted to prescription medication.On the other hand, many can not function a normal life without this pain medicine. Terminally ill patients die everyday in the hospital or at home as "morphine addicts." The manufacture and executives of the morphine are not arrested.

Any drug, chemical or substance that when abused will get someone "high" has a street value. Those truckers you described and users without a legal prescription should be punished. However, the manufacturers and doctors who are operating with in the law, should only be targets if they step outside the law, in my view.

I understand the illegal drug use and trafficking needs to be stopped. If the company was negligent in failing to warn, make them liable in the courts to the victims. But unless individuals in the company intended to break the law, I struggle to find them criminals.

Thanks for your comments on a Saturday!

california surfer dude said...

Hey, another way to get wasted. Did you know that taking an aspirin with any medicine increases the rate of absorption and magnifies the effects.

Dudes working for Bayre and other aspirin companies better hold onto their briefs...


Surfer Dude

Ron said...

On one hand, doctors generally prescribe too many drugs, because Americans expect to get a pill for anything that ails them. It is wrong, and good doctors know this.

On the other hand, people need to be responsible for what they put inside them. I have a hard time believing there were not enough warnings on the labels, because most drugs have so many warnings of side effects, nobody would take the drugs if they took the time to read the label. Have you ever read the warnings that come with prescription medicines these days? They barely stop short of saying "this drug is highly likely to kill you."

iron mike said...

What Ron says.

Iron Mike

Anonymous said...

Poor Howard Udell. How is he suppose to pay this fine?

Anonymous said...

I am just a kid and I get what you are saying, Legal Pub. If I intend to break the law that is usually a crime. If I accidentally break the law, then while I may have to pay in damages for any problems I cause, I usually do not commit a crime.

These guys got made examples of ... I thought that stopped once you get old enough to move out of Mom and Dad's house.

Justin

Legal Pub said...

Justin, you have a sharp mind. Never dreamed this would be a story that a student might read.

Sounds like you are ready for law school!

Anonymous said...

You sure the rug rat wasn't just here reading about how to get high? Just Wondering.


Concerned adult

richard said...

This is the beef I like to read! I think I actually learned something on this one.

Richard

Anonymous said...

Good story L.P. Never would have thought of it like this...

Anonymous said...

Howard Udell was railroaded into a plea in my opinion.

Anonymous said...

Shapiro is a good negotiator. He did not need much help from anyone else!

Anonymous said...

Seems like a lot of personal criminal charges. Guess every corporation needs some "fall guys."

Bob said...

Fall guys indeed. EVery one wants someone to blame.

Sinclair said...

Wonderful well written story!

Sinclair

Anonymous said...

oxycontin is some powerful sh#t.

Anonymous said...

Just don't see how executives should go to jail over this...

Anonymous said...

If Friedman, Udell and Goldenheim did nothing wrong, then they should not have pled guilty. Of course they knew what was going on about the criminal marketing of OxyContin, but they made $9 billion and thought they were untouchable. Now their reputations with the pharmaceutical industry, families, community, etc. are forever etched in stone -- convicted criminals.

Viper said...

Friedman, Udell and Goldenheim took plea agreements to avoid the uncertainty of trial and post trial punishment. They did not illegal make, sell or use drugs! They were executives who did not publish a warning that oxycontin could be addictive. Same thing manufacturers of cigarettes did for many years, but none of them were criminally liable.

Legal Pub points out that the typical recourse in such instances are civil liability where they compensate victims with money, not do community service.

I agree with the author, they appear to have been scape goats.

Anonymous said...

Friedman, Udell and Goldenheim are white collar drug traffickers. They are not scape goats -- they pled guilty to charges against them. Wonder why? Because there are tapes of sales meetings where they made incriminating statements -- and they got caught by our fine Justice Department. Do they belong in prison? No they belong in hell.

Viper said...

Seems harsh to call these men drug trafficers. If it were really true how evil they are, I doubt they would be sentenced to community service.

Why did they plead guilty? Because most likely their attorneys told them that they should plead guilty because the possible sentence if convicted would involve actual jail time.

Folks need to listen to their attorneys.

Now, as for the Justice Department, I have nothing but praise for the professionals who work in this department. They do a great job. But if you think this was a typical case and not unusual in how it was prosecuted (as oppose to civil lawsuits involving money damages paid to victims) then we have a difference of views.

J.J. said...

Thanks Viper, but I would add while I may not know all of the facts, only God should judge men and woman when it comes to going to heaven or hell. Everyone who believes deserves foregiveness and chance for salvation.

J.J.

doc said...

Talk of snorting crushed asprin. Funny! Will relieve your headache pretty quick and give you a nose bleed!

What asprin does, when taken orally, it tends to enhance the effects of any other drug.

Get a life, drug users!

Doc

Anonymous said...

http://www.pharmalot.com/2007/11/purdue-exec-please-dont-take-my-law-license/

Anonymous said...

Udell is alive and well...

Anonymous said...

I bet Udell knows all about Red Neck Heroine.

Legal Pub said...

Update 11-9-07: Marianne Skolek, the mother of a young woman who is believed to have died from from heart complications associated with oxycontin use is continuing the attack on Purdue executives.

Anonymous said...

"attack" = "relentless attack!"

Anonymous said...

Whether the execs deserved it or not, great article!

Anonymous said...

Unfortunate consequences of this medication is possible addiction.

Anonymous said...

Marianne Skolek, the mother of a young woman who is believed to have died from from heart complications will never give up or accept a surrender from the Purdue executives!

Lolipop

Anonymous said...

Who knows how much any one person is culpable...

Anonymous said...

Addiction is not a laughing matter, but how this case was handled is...


George

Anonymous said...

Steroids are a better read then oxycontin!

Anonymous said...

Oxycontin abuse must be stopped!

Oxycontin Side Effects said...

My name is Kim Adam and i would like to show you my personal experience with Oxycontin.

I have taken for 3 years. I am 23 years old. I think it is the best pain killer there is. Although it's coming very abused, I think that it is a very powerful reliever and that more doctors should look into it for pain relief.

I have experienced some of these side effects-
mild dependency and constipation

I hope this information will be useful to others,
Kim Adam

Anonymous said...

Supervised use of Oxycontin is fine, Kim. It is the unsupervised abuse that must stop.

Anonymous said...

I miss the scholarly Saturday articles!

Anonymous said...

Being a slave to any drug or substance is no fun!

Anonymous said...

Top site, I hadn't noticed legalpublication.blogspot.com previously in my searches!
Continue the great work!

Legal Pub said...

Update 9-3-10: Pennsylvania treatment center offered to pay for a link. We didn't charge them since they asked the proper way. Such treatment centers offer a real benefit to those addicted. Please visit http://www.pennsylvaniatreatmentcenters.org/ to learn more about this facility.

Legal Eagle 3 said...

Anonymous has left a new comment on your post "OxyContin Executives Fined For Not Publicizing How...":

Thanks for sharing the link, but unfortunately it seems to be offline... Does anybody have a mirror or another source? Please answer to my post if you do!

I would appreciate if a staff member here at legalpublication.blogspot.com could post it.

Thanks,
Thomas


Legal Eagle 3 Response:

The website link at the bottom of the story does work. Try it again or type the site in manually.

Anonymous said...

Wow neat! This is a really great site! I am wondering if anyone else has come across something
exactly the same in the past? Keep up the great work!

Anonymous said...
This comment has been removed by a blog administrator.
Anonymous said...

Hillbilly Heroin is bad stuff. It ruins lives!

Anonymous said...

But oxycontin when used right, eliminates pain.

Anonymous said...

You can quote L.P. as long as we give credit to the site, right?

Anonymous said...

Very informative.

Anonymous said...

The drug, like your article is SO addicting...

Anonymous said...

This article was before its time. the oxycontin problem is even worse now in 2013.