Are there any special considerations in a case involving Oxycontin?

Oxycontin was approved for use as a narcotic pain reliever by the FDA on December 12, 1995. At that time, the FDA required Purdue Pharma to have a boxed warning on the Oxycontin packaging talking about the serious and potentially fatal effects of abusing Oxycontin. By 2001, however, the FDA required Oxycontin to be packaged carrying a black box warning of the dangers of abusing the drug – the highest level of warning required. The warning stated, in part, that Oxycontin has “abuse liability similar to morphine”. At about the same time, Purdue Pharma was required to send out a letter to health care professionals about the dangers of Oxycontin abuse, what medical cases should and should not have Oxycontin prescribed, and the dangers of withdrawal.

Despite this, in 2003, the FDA had to issue a warning letter to Purdue Pharma, pointing out that several advertisements for Oxycontin aimed at the medical profession minimized the serious risks of taking Oxycontin and promoted uses that were not known to be safe or effective. The FDA pointed to two ads in particular, but stated that the rest of Purdue Pharma’s marketing materials would be scrutinized. As a result, Purdue Pharma was required to come up with a plan of action aimed at circulating a more balanced view of Oxycontin.

Oxycontin remains on the market, but has a widespread group of addicts, some of whom are former legitimate users of the drug, and has caused many deaths due to overdose either by a single large dose or by building up tolerance to the drug over time. It can be argued that Purdue Pharma has not done a sufficient job of either warning the market or of controlling the drug, increasing Purdue Pharma’s potential liability. It can also be argued that a doctor who prescribes Oxycontin has full awareness of the dangers of using and abusing the drug, and owes a duty to his or her patients to carefully monitor their use for signs of abuse or addiction.