In May 2000, Purdue’s hope to conquer the arthritis market hit a snag when the FDA criticized an ad for OxyContin in the New England Journal of Medicine. The FDA said the ad, which Purdue Pharma agreed to stop using, overstated the drug’s benefits for treating all types of arthritis without pointing out risks.
News reports of abuse and overdose deaths also were surfacing. Purdue’s 2001 marketing document noted that OxyContin had “experienced significant challenges” the year before because of abuse and unlawful diversion in Maine, Ohio, Virginia, Louisiana and Florida.
OxyContin pills contain oxycodone, an opioid as potent as morphine and maybe more so. Abusers quickly figured out they could crush the pills and snort or inject the dust
In response, Purdue’s 2001 marketing budget included funding to help doctors recognize patients who were in need of “substance abuse counseling” and do more to “prevent abuse and diversion.” It added $1.2 million in spending for what it called “anti-diversion” efforts in 2002, according to the internal records.
Potent Sales Force
In 2002, The Florida attorney general’s office was one of the first law enforcement agencies to investigate Purdue. The state ended its probe after Purdue agreed to pay Florida $2 million to help fund a data system to monitor narcotics prescriptions. It did not admit to any wrongdoing in the settlement.
Yet handwritten notes of a state investigator’s interview with a former Purdue sales manager for West Virginia and western Pennsylvania named Bill Gergely, then 58, suggested otherwise. The notes were part of the documents released by the state.
Gergely, who worked for the company from 1972 until 2000, said Purdue executives told sales staff at a launch meeting that OxyContin “was non-habit forming,” according to the undated investigator’s notes. Gergely said Purdue gave its sales force material — some of which was not approved by the FDA — for “education,” the notes show. He told the investigator that Purdue had a bonus system and paid well; the last year he worked for Purdue, Gergely earned $238,000.
As Purdue charged ahead with OxyContin, prescription pills overtook illegal drugs like heroin and cocaine as killers in Florida, according to medical examiner files. In May 2002, the South Florida Sun-Sentinel documented nearly 400 pill deaths in three South Florida counties the previous two years, based on an examination of autopsy and police records.
Half the deaths involved drugs that contained oxycodone, according to medical examiner records. But it was not always clear in these records that it was OxyContin because oxycodone was an ingredient in many other narcotic pills. In 70 of the deaths, however, police or medical examiner records specifically identified OxyContin as one of the drugs. Though some people who died bought pills on a thriving black market, many were under the care of doctors for what appeared, at least at some point, to be legitimate injuries, according to medical examiner files.
Purdue did not challenge the accuracy of the newspaper’s reporting. It countered that the articles “did a disservice” to the company and patients who take their medicine “according to the directions of their doctors.” While the company said its executives “deeply regret the tragic consequences that have resulted from the misuse and abuse of our pain medicine … advances in the treatment of pain should not be limited or reversed because some people illegally divert, abuse or misuse these drugs.”
To its sales force, the internal Purdue records show, Purdue blamed bad press for cutting into sales. “The media’s attention to abuse and diversion of OxyContin tablets has provided state Medicaid plans and some HMOs, concerned about the effect the product is having on their budget, an excuse to look for ways to limit the prescribing of OxyContin tablets,” the 2002 marketing document said.
But five years after its legal battle with Florida officials, Purdue made a startling admission in federal court in Virginia. The company pleaded guilty in 2007 to felony charges of “misbranding” OxyContin “with the intent to defraud or mislead.” The company paid $600 million in fines and other penalties. Among the deceptions it confessed to was directing its salespeople to tell doctors the drug was less addictive than other opioids.
Three Purdue Pharma executives pleaded guilty to misdemeanor criminal charges for their roles in the marketing scheme. The three men paid a total of $34 million in fines and penalties, court records show. Accepting Purdue’s plea deal, U.S. District Judge James P. Jones noted that federal prosecutors believed the Purdue case of 2007 would send a “strong deterrent message to the pharmaceutical industry.”
A Costly Reckoning?
Ten years on, the 1,500-plus lawsuits, filed mostly on behalf of cities, counties and states, could prove to be a costly reckoning for the opioid industry. The suits are demanding payback from Purdue and other drugmakers for the sky-high costs of treating addiction and other compensation, much as the litigation against Big Tobacco in the late 1990s.
Other drug makers named as defendants in most of the suits include those that Purdue considered to be its top competitors in the pain sector: Janssen Pharmaceuticals, Teva Pharmaceutical Industries, Endo International PLC and Mallinckrodt PLC.
Federal officials estimate the economic cost of opioid abuse topped $500 billion in 2015 alone. Since 1999, at least 200,000 people have died in the U.S. from these overdoses, according to the Centers for Disease Control and Prevention. More than 52,000 of those died in 2015 alone, more than were killed in car crashes and gun homicides combined, the suits contend.
A case filed in April by Baltimore County in Maryland makes an argument common to many of the suits:
“From the mid-’90s to the present, manufacturing defendants aggressively marketed and falsely promoted liberal opioid prescribing as presenting little to no risk of addiction, even when used long term for chronic pain. They infiltrated academic medicine and regulatory agencies to convince doctors that treating chronic pain with long-term opioids was evidence-based medicine when, in fact, it was not.
“Huge profits resulted from these efforts — as did the present addiction and overdose crisis.”
Purdue has not yet filed a response to the allegations in the suit.