When drugs are approved by the Food and Drug Administration (FDA), they are approved for specific uses, to treat specific diseases or problems. The complaint for this class action brings suit against Avanir Pharmaceuticals, Inc., which it claims attempted to market a drug called Nuedexta for other than its original uses, including, it claims, by offering kickbacks to doctors to prescribe it for other conditions.
A class and a subclass have been defined for this action:
- The Nationwide Class is all third-party payors in the US and its territories and possessions that paid for Nuedexta, between 2011 and the present, where the Nuedexta was made, distributed, or sold by Avanir.
- The subclass is all third-party payors that paid for Nuedexta prescriptiosn written by Dr. Deepak Raheja, between 2011 and the present, where the Nuedexta was made, distributed, or sold by Avanir.
Nuedexta is a drug that contains dextromethorphan hydrobromide and quinidine sulfate, which the complaint claims was tested and approved to treat a condition called pseudobulbar affect (PBA), a rare condition that affects only 0.5% to 2% of people in the US. People who have this condition may have bouts of uncontrollable laughing or crying that have nothing to do with their actual emotions.
PBA can occur in people who have multiple sclerosis (MS) and amyotrophic lateral sclerosis (ALS). That was the use for which the FDA approved Nuedexta, the complaint claims, but “it did not approve prescribing Nuedexta for patients with other types of emotional liability than can commonly occur in patients with Alzheimer’s disease and other dementias.”
But, presumably, a drug to treat a condition that occurs in only a half a percentage of the population will not be sold in great quantities. The complaint alleges, “Avanir “aggressively marketed and promoted Nuedexta by expanding the drug’s application to include treating PBA-like symptoms.”
Another step Avanir took, the complaint alleges, was paying for a study that associated Nuedexta with a decrease in PBA-like symptoms. The study’s authors were five doctors, but the complaint alleges that one was an employee of Avanir and the other for were paid by the company. Avanir then used the study to help sell the drug.
As if that weren’t enough, the complaint alleges, “Avanir also provided illegal kickbacks and incentives to doctors to prescribe Nuedexta[.]”
Eventually, the US Department of Justice filed a criminal action against the company for this activity, which the complaint claimed resulted in Avanir’s agreeing to a Deferred Prosecution Agreement (DPA). A copy of the DPA was attached to this class action complaint at the time of its filing.
The complaint is brought by plaintiff MSP Recovery Claims Series LLC, for itself and other third-party payors, who ended up providing payment for the drug under Medicare parts C or D.
Article Type: LawsuitTopic: medical
Most Recent Case Event
Avanir Encouraged Nuedexta Use for Off-Label Purposes Complaint
May 20, 2022
When drugs are approved by the Food and Drug Administration (FDA), they are approved for specific uses, to treat specific diseases or problems. The complaint for this class action brings suit against Avanir Pharmaceuticals, Inc., which it claims attempted to market a drug called Nuedexta for other than its original uses, including, it claims, by offering kickbacks to doctors to prescribe it for other conditions.
Avanir Encouraged Nuedexta Use for Off-Label Purposes ComplaintCase Event History
Avanir Encouraged Nuedexta Use for Off-Label Purposes Complaint
May 20, 2022
When drugs are approved by the Food and Drug Administration (FDA), they are approved for specific uses, to treat specific diseases or problems. The complaint for this class action brings suit against Avanir Pharmaceuticals, Inc., which it claims attempted to market a drug called Nuedexta for other than its original uses, including, it claims, by offering kickbacks to doctors to prescribe it for other conditions.
Avanir Encouraged Nuedexta Use for Off-Label Purposes Complaint