SEATTLE – Attorney General Rob McKenna today announced a $19.5 million multi-state settlement with Purdue Pharma. Washington will receive $719,500 from the agreement, which resolves allegations the company aggressively marketed its painkiller OxyContin to doctors while downplaying the risk of addiction.
“The states alleged Purdue’s sales representatives promoted OxyContin, a potent painkiller with addictive qualities similar to morphine, to a wide variety of doctors while downplaying known health and safety risks,” McKenna said. “As a condition of this settlement, Purdue agrees to establish a training program for its sales employees and to market OxyContin for federally approved uses.”
The Washington Attorney General’s Office will file a consent judgment Wednesday in Thurston County Superior Court.
Under the agreement, Purdue does not admit any wrongdoing but agrees to maintain a program that includes internal procedures the company established to detect problem prescribing. All Purdue employees and third-party sales staff must undergo training before they can promote OxyContin.
In 1995, the FDA approved the use of OxyContin, an opioid, to treat moderate to severe pain over an extended period of time.
Washington, 25 other states and the District of Columbia launched an investigation into Purdue’s marketing practices in 2004. The states alleged that the company violated consumer protection laws by engaging in extensive “off-label” marketing of OxyContin. Off-label marketing involves the promotion of prescription drugs for purposes that have not been approved by the U.S. Food and Drug Administration.
According to Washington’s complaint, which will be filed with the settlement, Purdue initially marketed OxyContin principally for treatment of chronic pain in cancer patients. But that quickly changed. Starting in 1996, the company expanded its marketing program to focus on primary care physicians and encouraged OxyContin to treat a wider pool of patients and conditions.
The states also alleged that Purdue failed to adequately disclose the risks of OxyContin abuse and addiction. Due in part to its controlled-release feature, OxyContin contains more oxycodone than other oxycodone drugs.
The settlement includes provisions that Purdue must:
- market and promote OxyContin in a manner consistent with its package insert and not in a manner that minimizes the approved uses for the drug;
- ensure that any grant or payment from Purdue for OxyContin research is publicly disclosed by the company and the recipient of those funds; and
- take into account, as part of its employee performance evaluations, whether sales representatives educated prescribers about OxyContin and its potential for abuse and diversion.
In addition, the agreement prohibits Purdue from marketing OxyContin for off-label purposes, sponsoring educational events where Purdue knows that a speaker will recommend OxyContin for off-label use, or basing sales representatives’ bonuses solely on the volume of OxyContin prescribed.
The following states participated in the investigation and will file settlements in their local courts: Arizona, Arkansas, California, Connecticut, Idaho, Illinois, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Montana, Nebraska, Nevada, New Mexico, North Carolina, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Vermont, Virginia, Washington, Wisconsin and the District of Columbia.
Each participating agency will allocate its portion of the $19.5 million as it deems worthwhile. The money may be used for consumer protection education and outreach programs, litigation, attorneys’ fees or other uses determined by each state’s attorney general. The agreements don’t establish a refund program for individual consumers.
Purdue Complaint re: OxyContin
Purdue Consent Judgment re: OxyContin
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Media Contacts: Kristin Alexander, Seattle Media Relations Manager, (206) 464-6432
Mary Lobdell, Assistant Attorney General, (253) 593-2256