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.