"There were no data. We wrote in (the article) that here we are observing these high doses, and they're not helping people, so we asked ourselves, 'Why are we doing it?' " Ballantyne said. "We did the most extensive literature search and looked at all of the trials, and there was basically no evidence supporting what we were doing."
When asked why there wasn't more scrutiny on the initial claims that an opioid-based painkiller wouldn't be addictive, Ballantyne said, "Before, back then, I did what I was taught, and I believed it."
BACKLASH
The inevitable lawsuits began to trickle in, slowly at first, claiming the company dishonestly marketed the pain pill by failing to tell doctors, pharmacists, and patients about the drug's addictive qualities. In 2001, West Virginia became the first state to file lawsuit against the pharmaceutical company, charging Oxy's maker with violating the Credit Protection Act by using "highly coercive and inappropriate tactics to attempt to get physicians and pharmacists to prescribe OxyContin and to fill prescriptions for OxyContin, often when it was not called for." The state eventually settled with Purdue for $10 million in 2004.
But it wasn't the end of Purdue's legal woes. Dozens of lawsuits were filed, sometimes by individuals or groups of people.
By 2005, Purdue spokesman Timothy Bannon actually boasted about it: "Over the last four years, Purdue Pharma has never lost an OxyContin personal-injury lawsuit. On the contrary, 365 personal-injury lawsuits involving well over 1000 plaintiffs, including many cases brought by these same personal-injury lawyers, have ended in Purdue's favor. We expect these new cases will be no different."
The "new cases" he was referring to were 1000 separate suits, all filed on the same day in Purdue's home state of Connecticut, after a judge declined to certify a class-action lawsuit.
But the US Attorney's Office was investigating Purdue as well. As early as 2002, there were criminal murder and manslaughter charges brought against physicians in Florida and California for over-prescribing the pill. And the Connecticut Attorney General issued a press release in 2001 urging the company to only allow pain specialists to prescribe the medication.
In the wake of these civil and criminal charges, then–US Attorney John Brownlee launched a four-year investigation that led to the largest settlement with a pharmaceutical company up to that point. The 2007 suit, which was filed on behalf of 26 states, took aim at Purdue's initial claim that Oxy's time-released formula made the drug less likely to be addictive than faster-acting Percocet or Vicodin.
The federal court records demonstrated Purdue's own clinical trials and the studies performed by the FDA did not show that Oxy was any more effective or any less addictive than existing pain medications.
The company pleaded guilty to one felony count of misbranding, and its three top executives — Michael Friedman, the president; Howard Udell, its top lawyer; and Dr. Paul Goldenheim, its former medical director —pleaded guilty to misdemeanor misbranding. The judge ordered the company to pay $600 million in fines and other payments.
Together, the top executives paid $34.5 million. Judge James P. Jones sentenced them to three years of probation and 400 hours each of community service in drug treatment programs. During the sentencing, Jones said he was troubled by his inability to send the executives to prison.
