ABINGDON, Va. — Purdue Pharma LP, the maker of OxyContin, and three of its executives were ordered yesterday to pay a $634.5 million fine for misleading the public about the painkiller’s risk of addiction.
U.S. District Judge James Jones levied the fine on Purdue Pharma, its top lawyer and former president and former chief medical officer after a hearing that lasted about 4½ hours. The hearing included statements by numerous people who said their lives were changed permanently by addiction to OxyContin, a trade name for a long-acting form of the painkiller oxycodone.
Designed to be swallowed whole and digested over 12 hours, the pills can produce a heroinlike high if crushed and then swallowed, snorted or injected.
From 1996 to 2001, the number of oxycodone-related deaths nationwide increased fivefold while the annual number of OxyContin prescriptions increased nearly twentyfold, according to a report by the Drug Enforcement Administration. In 2002, the DEA said the drug caused 146 deaths and contributed to another 318.
Purdue Pharma LP, its top lawyer and former president and former chief medical officer pleaded guilty in May to claiming to doctors that OxyContin was less addictive and less subject to abuse than other pain medications. Yesterday’s sentencing ends the national case.
Michael Friedman, who retired in June as the company’s president, general counsel Howard Udell and former chief medical officer Paul Goldenheim each pleaded guilty to a misdemeanor count of misbranding the drug. Of the total fine, $34.5 million was levied on them.
Judge Jones placed the company on probation for five years and each of the executives on probation for three years. He also ordered the three to perform 400 hours of community service related to prevention of prescription drug abuse.
Former New York City Mayor Rudolph W. Giuliani played a central role in negotiating on behalf of Purdue with federal prosecutors, but the judge said “I completely reject” suggestions that political influence resulted in a lesser punishment for Purdue.
Many of the nearly 20 speakers called for jail terms for Mr. Friedman, Mr. Udell and Mr. Goldenheim, saying the fines were a small price for the devastation to lives from OxyContin addiction.
“Money can’t buy all the lives that are lost,” said Robert Palmisano, 23, who said he was addicted to OxyContin for four years but has been off the drug for 17 months.
Lawyers for the three executives said giving them criminal convictions was punishment enough, and noted they were charged because of their job titles, not because they themselves promoted OxyContin as a drug with little addiction potential.
“They are not here today because of any acts of misconduct on their part,” defense attorney Howard Shapiro said. “They are good men.”
The speakers, many of whose children died after trying the drug only once, disagreed.
“I feel you are legal drug users, nothing more than a large corporate drug cartel,” Lee Nuss of Palm Coast, Fla., said as she addressed the Purdue Pharma contingent.
She held up a stone urn slightly larger than a pill bottle that she said contained her 18-year-old son’s ashes.
Attorneys for both sides acknowledged the pain of those who had lost loved ones, but urged Judge Jones to accept the plea agreement.
“By pleading guilty they acknowledged that doing nothing was not good enough,” Assistant U.S. Attorney Randy Ramseyer said. “We cannot bring those people back. It’s not something this case can do.”
Dillie Walker and his wife, Joyce, of Bay City, Mich., testified on behalf of Purdue that OxyContin has enabled them to function again despite chronic pain.
“I don’t get high from it. It goes straight to my pain,” Mr. Walker said.
But Kenny Keith of Roanoke said it took little time for him to get addicted after he was prescribed OxyContin.
“The withdrawals were worse than the pain I was having,” he said.
Judge Jones said he would have preferred to have the plea agreements call for spending money on education of those at risk of drug abuse and treatment of those who are addicted to OxyContin. But he said he would not reject the agreement.
“Many young people mistakenly believe today that prescription drugs are safer than other drugs,” the judge said.
The fines are to be distributed to state and federal law-enforcement agencies, the federal government, federal and state Medicaid programs, a Virginia prescription-monitoring program and individuals who had sued the company. About $5 million will go toward a six-year company program to monitor compliance with the agreement.
Survivors of the victims want the Food and Drug Administration to reclassify OxyContin for use only for severe pain. The drug currently can be prescribed for moderate pain.
Purdue Pharma, based in Stamford, Conn., has said it accepted responsibility for its employees’ actions and has put in place training and monitoring programs to ensure overpromotion of OxyContin doesn’t happen again. But officials objected to any ties between the plea agreement and abuse of the drug.
The coal-mining region of Southwest Virginia where the sentencing took place has had a number of oxycodone-related deaths — 119 from 2003 through 2005, according to the Virginia Medical Examiner’s Office.
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