This post was originally written in 2008. We do not know of any active Chantix suicide lawsuits that are pending in 2023.
What the Chantix Suicide Lawsuits Were About
Chantix (varenicline) is a prescription medication developed by Pfizer to help people quit smoking. It works by reducing nicotine cravings and blocking the pleasurable effects of smoking. It worked well and Pfizer was printing money from the sales of the drug. However, since its approval by the U.S. Food and Drug Administration (FDA) in 2006, Chantix was been linked to several serious side effects, including suicidal thoughts and behaviors, depression, and other neuropsychiatric issues.
Many individuals who took Chantix and experienced these severe side effects or had loved ones who committed suicide while using the drug have filed lawsuits against Pfizer. These lawsuits claim that the company failed to adequately warn patients and healthcare providers about the risks associated with Chantix.
The Chantix lawsuits primarily focused on the claim that Pfizer failed to provide adequate warnings about the drug’s potential side effects, particularly the increased risk of suicidal thoughts, behaviors, and other neuropsychiatric issues. Plaintiffs in these lawsuits argue that if they or their loved ones had been properly informed of the risks, they might have chosen a different smoking cessation aid or been more closely monitored by healthcare professionals while using Chantix.
Many of the lawsuits filed against Pfizer were consolidated into a multidistrict litigation (MDL) in the U.S. District Court for the Northern District of Alabama. MDL is a legal procedure that allows similar lawsuits filed across the country to be combined for pretrial proceedings, such as discovery and motions, to streamline the litigation process and promote consistency in court rulings.
Black Box Warning Ended Litigation
In 2009, the FDA required Pfizer to add a black box warning, the strongest warning label for prescription drugs, to Chantix packaging to inform consumers about the risk of serious neuropsychiatric symptoms. This ended any new lawsuits because the warning now said what the plaintiffs’ lawyer said all along it should say.
The first Chantix lawsuit went to trial in 2012, but the case was settled before a verdict was reached. After this initial case, Pfizer started negotiating settlements for many other lawsuits. Between 2012 and 2013, Pfizer paid almost $300 million to settle thousands of lawsuits alleging adverse neuropsychiatric effects from Chantix. The average settlement value of the Chantix lawsuits was not high. But some suicide cases were seven-figure settlements.
New Study in 2016
In 2016, there was a study done that was published in Lancet that concluded that Chantix did not cause suicidal ideations or actions. Some defense lawyers have argued this is an example of litigation that should not have settled because the science was unclear. But others have pushed back, arguing that the Lancet study (called the EAGLES study) was scientifically unsound.
This is a complex issue. I suspect Chantix has saved lives. I don’t think there was ever a good argument to take the product off the market. (Cf. I may have suggested the possibility below in 2008.) But if there is a concern about the drug, should the manufacturer provide the facts surrounding that concern so doctors and patients can decide for themselves?
2008 Original Post
When Chantix was introduced into the marketplace to cure nicotine addiction, many saw a panacea that would finally cure our country’s unproductive addiction to nicotine. The problem is that anytime you have a drug that can make a great impact on many people, there is an awful lot of money to be made. As a result, products get rushed onto the market. Did this happen with Chantix? The early returns appear to say yes.
The Food and Drug Administration has received information about numerous serious problems with Chantix, including suicidal thoughts and ideation, homicidal ideations, and hallucinations. The FDA received reports of 37 suicides and 491 cases in which people had suicidal thoughts. If history is any guide, the actual incidences are often over 10 times what the FDA reports. In other words, these numbers are probably just the tip of the iceberg. Still, there is no indication from Pfizer that there will be a recall of Chantix.
Pfizer released the drug without any warning regarding these potential side effects. By January of 2008, the reports of psychological side effects, most notably suicidal actions, and ideations, reached a critical mass and Pfizer added a warning to the label of Chantix about the potential risks of suicidal behavior and depression. This warning followed a November 2007 update to Chantix’s “post-marketing experience” section, which stated that there had been reports of depression, agitation, and suicidal behavior and ideation in patients on Chantix. The FDA now says it is “increasingly likely” that there is an association between Chantix and suicidal thoughts, actual suicide, depression, and other psychiatric symptoms.
No one knows exactly how Chantix works. But doctors do have a theory that certainly makes sense. People get addicted to nicotine because the brain craves it. Chantix does a pretty fascinating thing: it targets receptors in the brain that respond to nicotine. By targeting the brain receptors that respond to nicotine and release dopamine, Chantix prevents nicotine from reaching those brain receptors.
Accordingly, Chantix works in two ways. It blocks nicotine from stimulating these brain receptors, so cigarettes do not give users the dopamine release they crave, and it stimulates the release of lower levels of dopamine to help decrease the craving for nicotine which is what drives people who are trying to quit smoking back to cigarettes. And by all accounts, Chantix works for many people who have tried it. In a study published in the Journal of the American Medical Association, 44% of people taking Chantix could quit smoking compared to 17.7% percent of those taking placebos. No one can argue that Chantix is not an effective drug. But is it safe?
I’m a lawyer, not a pharmacologist. But it does not take a pharmacologist to realize that when you play with the chemicals in the brain that alters mood, like serotonin or dopamine, you are playing with fire. Because no one understands how all of these chemicals work together, altering the brain’s chemical processes should be done with a lot of care and you have to advise patients of the risks associated with doing so. Moreover, everyone’s brain chemistry is different and not every drug will suit every person. This is true with any drug, Chantix is no different. But when the side effects are as serious as these appear to be, particularly the suicide, it raises whether Chantix should be on the market at all.