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Page 4 of 15 |
What are the major legal issues in a case involving Oxycontin? |
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Purdue Pharma has not done an effective job of warning of the dangers of abusing Oxycontin. When the drug was first approved in 1995, the label contained several warnings. However, by 2001, the FDA had required Purdue Pharma to add a black box warning about the dangers of Oxycontin. This is the highest level of warning that the RDA requires. Also, the FDA compelled Purdue Pharma to send out letters to health care professionals reinforcing the dangers of Oxycontin, the possibility of addiction, and the necessity to taper use to avoid severe withdrawal symptoms. This should have put Purdue Pharma on notice that their marketing of Oxycontin would be under scrutiny; nonetheless, by 2003, the FDA issued a warning letter discussing several ads that had appeared in medical journals which the FDA found to omit or minimize the serious risks to people who had Oxycontin prescribed for them and promoting uses that were unsafe or ineffective. Purdue Pharma was directed to submit a plan of action that would correct future advertisements as well as publicize the dangers of Oxycontin, the potential for and signs of abuse and addiction, and the possibility of severe withdrawal symptoms particularly if withdrawal was not handled appropriately.
A case brought for injuries or death caused by Oxycontin will probably be brought under a theory of product liability – that the product, Oxycontin, was so unreasonably dangerous that it should not have been on the market. The continued need for regulatory oversight and sanctions by the FDA can be used to show that Purdue Pharma was, at best, negligent with respect to the health of the end users of Oxycontin. This can help you prove your case against Purdue Pharma, and your attorney will develop a strategy to maximize the impact of this information for your case.
You may also have a relatively good case for malpractice against the doctor that prescribed the Oxycontin. The drug has always had strong warnings associated with it and the black box warning, in particular, is a strong indicator that the drug should be used with caution and only in particular cases. Furthermore, doctors should have been on the alert for signs of abuse and addiction in their patients who took Oxycontin.
The pharmacist who dispensed the drug and the pharmaceutical sales rep who distributed the drug may have somewhat limited liability. To the extent that the pharmacist failed to warn you about the risks associated with Oxycontin use or ignored signs that you were abusing the drug, there may be a viable cause of action. Information showing that the rep knowingly downplayed the hazards of Oxcontin use and abuse would help pin some liability on him or her. However, it may be difficult or impossible to show that these parties are somehow liable to you. Your attorney can help you decide if the facts of your case make these potential defendants desirable or not. |
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