Prescription drug abuse has killed more than 20,000 Americans a year, filled jails and treatment centers and spawned a resurgence in heroin use. And nowhere is the pill problem more prevalent than in Kentucky's Appalachians, where officials trace its roots to the aggressive marketing of one potent drug: OxyContin.
For seven years, they've forged ahead with a civil lawsuit that seeks to make drugmaker Purdue Pharma pay. As early as next year, it could bring the first-ever jury trial pitting Purdue against an addiction-plagued state over the painkiller, which experts say may lead more communities to file suits. Chicago and two California counties already have.
"This is about holding them accountable," says Kentucky Attorney General Jack Conway. "They played a pre-eminent role in the state's drug problem. This started to explode in the mid-1990s, when Purdue Pharma was marketing OxyContin. The resulting opiate epidemic … is a direct result."
The suit alleges that an aggressive and deceptive marketing campaign misled doctors, consumers and the government about OxyContin's addiction risk, ultimately saddling taxpayers with millions of dollars in social, health care and other costs.
Company lawyers in legal documents say more than a billion dollars is at stake and cite the potential for a "ruinous" verdict. As it's typically difficult to find drug companies liable for harm caused by their products, University of Louisville law professor Timothy Hall says Kentucky's lawsuit frames the issue in a new way, taking a page from the fight against Big Tobacco.
"We disagree on the merits of this lawsuit," says a statement from Richard Silbert, associate general counsel for Connecticut-based Purdue. "Courts in Kentucky and elsewhere have dismissed claims against Purdue because the evidence did not establish that our marketing caused the harm they alleged. We believe that the Commonwealth likewise" won't be able to show it.
No one doubts Kentucky has one of the nation's biggest drug problems. A common refrain in Kentucky's hardscrabble hills is that an entire generation has been lost to pain-pill abuse, with overdoses tearing children from parents and parents from children.
Brad Ellis, 37, of Louisa, Ky., says he was first prescribed OxyContin after a back injury while in the Army. By the time he got home in 2001, he was hooked. He went from doctor to doctor in Appalachia seeking pill scripts and paid people to bring him the drugs from pill mills in Florida. He crushed and snorted them for a quick high.
Addiction wrecked his life, leading to a divorce, broken relationships with children and parents, and jail time. He withered to 118 pounds, "a walking skeleton."
"It was almost a constant addiction for 17 years," said Ellis, who has been sober for 23 months. "Pain pills in this area are huge."
'DROVE THIS REGION CRAZY'
With more than its share of poverty, illness and chronic pain, Appalachia's coal country was vulnerable to pain pill abuse when this drug twice as potent as morphine came along.
Shortly after OxyContin's federal approval in 1995, the lawsuit alleges, Purdue employees promoted the long-acting oxycodone medication as less addictive than immediate-release opioids — telling some health care providers that the drug didn't even cause a buzz.
A 2004 report by the then-U.S. General Accounting Office says Purdue encouraged primary-care doctors to prescribe the drug for a wide range of injuries and conditions — not just severe pain with serious illnesses like cancer. The Drug Enforcement Administration complained that the company promoted this sort of prescribing to doctors who weren't well-trained in pain management, while also giving out OxyContin "starter coupons" for patients and promotional items such as fishing hats and plush seal toys, which are now sold online as collector's items.
OxyContin prescriptions for non-cancer pain shot up tenfold between 1997 and 2002.
In a May 2007 settlement of a Virginia criminal case, Purdue and three executives pleaded guilty to federal charges that they intentionally misled doctors, regulators and patients about OxyContin's addiction risk and potential for misuse. Purdue agreed to pay $600 million in fines; the executives, $34.5 million total. A portion went to reimburse states' Medicaid programs.
But Kentucky refused the $500,000 it was offered, filing its own lawsuit in Pike Circuit Court, with Pike County as a co-defendant. Purdue had it moved to federal court, and it resided in New York for years until being returned to Pike County, where Pike, but not the state, settled its claims.
All the while, Kentucky was drowning in a sea of prescription pills. OxyContin became so ubiquitous it was dubbed "hillbilly heroin." Retail distribution of oxycodone skyrocketed elevenfold between 1997 and 2010, and Kentuckians abused opioids and died of overdoses at some of the nation's highest rates.
"OxyContin changed the face of addiction in this region," says Dan Smoot, president of the eastern Kentucky anti-drug organization Operation UNITE. "It made addicts out of people who otherwise weren't. It drove this region crazy."
When the federal government approved an abuse-deterrent formulation of OxyContin in 2010, many addicts turned to other opioids — mostly pills, but also heroin.
"We've lost nearly an entire generation to prescription drug overdose while Big Pharma has reaped huge profits," said U.S. Rep. Harold "Hal" Rogers, a Republican. "I've been trying to hold (Purdue) accountable for years."
PURDUE HOPES TO PREVAIL
Silbert, the Purdue lawyer, agrees that prescription drug abuse is a serious problem and says that's why the company reformulated the drug to make it harder to snort or inject.
Purdue officials remain confident they will prevail — as they did in a 2001 Kentucky lawsuit brought by addicts. In that case, a U.S. District Court judge wrote that they "failed to produce any evidence showing that the defendants' marketing, promotional, or distribution practices have ever caused even one tablet of OxyContin to be inappropriately prescribed or diverted."
Purdue acknowledges the state's suit will be tougher, especially since their request to move it out of Pike County was denied. In a survey, their expert found that seven in 10 people agreed OxyContin has devastated local residents' lives.
The fight has now turned to the issue of "request for admissions," or what the plaintiff asks the defendant to admit — including allegations that Purdue caused OxyContin to be "excessively overprescribed."
Pike County Circuit Court Judge Steven Combs ruled that Purdue missed a deadline to respond to the state's admissions request, effectively meaning the company is considered to have admitted to the whole list — while he ruled the opposite way for co-defendant Abbott Laboratories. Purdue appealed the decision and lost, then appealed again to the state Supreme Court, which hasn't yet ruled.
If the decision isn't overturned, Purdue lawyers say that will limit them in defending themselves on the case's merits. Combs' orders "confront Purdue with the risk of an immense and ruinous judgment," and damages sought "could produce a record-breaking verdict," lawyers wrote in court documents.
Conway says he's preparing for trial but is open to a fair settlement and would like any money to go toward drug education and treatment.Treatment is what saved Ellis, who now works as a cook at Chad's Hope in Manchester, Ky., the faith-based treatment center where he got clean. Ellis blames only himself for his addiction and says only God could free him from its grip.
"God's what pulled me up," he says. "I don't even crave the drug anymore."
Official figures released by the UK’s Department of Health show that nearly half of the population in England are regularly taking prescription drugs.
According to the new data in a report by the Health and Social Care Information Centre (HSCIC), 50 percent of women and 43 percent of men are commonly on specialized drugs to deal with a range of mental and physical illnesses, state-funded BBC reported Tuesday.
The figures showed that cholesterol-lowering statins and anti-depressants remain among the drugs most often used by the British population.
The statistical report, prepared by the HSCIC’s Health Survey for England (HSE), also showed that UK doctors issued an average of 18.7 prescriptions per person across England during 2013, costing the National Health Service (NHS) more than £15 billion per year.
Moreover, the official figures revealed that over one in 10 women surveyed said they were taking medication to deal with mental health problems, with 17 percent of women from low-income backgrounds taking anti-depressants, compared to seven percent of women in higher-income brackets.
“It’s well known that rates of depression are much higher among women than men, so I am not surprised to see that antidepressant use follows the same pattern in this study,” said Dr Sarah Jackson, of University College London as cited in the report.
Earlier this week, the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) further warned that a record number of Britons were also buying illegal drugs through social media channels, and that the UK had emerged as a ‘phenomenal market’ for promoting such illicit medication.
The MHRA also revealed that thousands of sleeping pills, sexual enhancement chemicals and weight loss medication were marketed through the black market, with the UK remaining among the most lucrative countries for drug distributors.