The Judicial Panel on Multidistrict Litigation will hear oral arguments concerning the consolidation of Chantix lawsuits into a multidistrict litigation on December 1. The anti-smoking drug Chantix, created by Pfizer, has been the subject of debate concerning the drug’s neurological, cardiovascular, and cancerous effects. After a previous MDL focusing on Chantix’s psychiatric complications, the smoking cessation treatment may soon be at the center of yet another MDL.
Anti-Smoking Pill Chantix Linked to Severe Health Consequences
The biotechnology corporation Pfizer received FDA approval for Chantix in 2006. Pfizer designed Chantix as an alternative to nicotine replacement therapy that helps adults quit smoking. Chantix does not contain any nicotine but instead weans adults off cigarettes by blocking specific receptors in the brain responsible for receiving and interpreting the pleasurable effects of nicotine.
Although Chantix has proven effective in assisting smokers, individuals have reported several unintended health hazards related to the medication. The FDA instituted a black box warning for Chantix in 2009 after increasing reports of psychiatric effects, including suicide, suicide ideation, erratic behavior, hostility, and depression. While the FDA removed this warning in 2016, the JPML consolidated dozens of federal lawsuits against Pfizer regarding the neurological effects of Chantix in 2009. By 2013, Pfizer had settled a majority of these Chantix lawsuits through a $273 million settlement.
Yet, psychiatric issues are not the only concern for Chantix patients. In 2011, the FDA issued safety warnings over the cardiovascular effects of Chantix after a study suggested that people taking Chantix were more likely to suffer dangerous cardiovascular events compared to those not on the drug. Furthermore, more recently, Pfizer recalled all lots of its Chantix tablets after the company discovered unacceptable levels of N-nitroso-varenicline, also referred to as nitrosamine. N-nitroso-varenicline is a chemical compound that, if ingested above the acceptable intake over time, can increase the risk of cancer in individuals.
JPML to Review Arguments for Chantix MDL
In August, the county of Monmouth, New Jersey, filed a motion before the JPML to centralize lawsuits concerning whether Pfizer’s Chantix drug products were adulterated or defective due to the presence of n-nitrosol varenicline, a human carcinogen. The motion indicated that eight lawsuits raise similar common questions of fact and law against Pfizer. These common questions include whether Pfizer’s Chantix drug contained nitrosamines and if the company violated good manufacturing practices with Chantix. Plaintiffs seek to transfer Pfizer Chantix cases to the District of New Jersey to avoid duplicative discovery, inconsistent rulings, conserve legal resources, and foster efficient litigation.
Pfizer filed a response to the county of Monmouth’s motion to transfer in September 2022. The company argued that given the small number of cases, the JPML should deny the plaintiff’s request. While Pfizer does not believe that centralization is justified at this time, the company recommended the Southern District of New York should the JPML disagree. On October 13, 2022, the JPML announced a hearing session for December 1 to determine the transfer of cases in RE: Chantix (Varenicline) Marketing, Sales Practices, and Products Liability Litigation.