On January 3, David Collins killed himself with a shotgun, three months after he began taking Chantix, Pfizer's controversial smoking-cessation pill. Now, his widow, Linda, has filed what may be the first product-liability lawsuit against the drugmaker over Chantix side effects and an alleged failure to provide sufficient warnings. And her lawyer predicts many more such lawsuits are on the way.
In her lawsuit, which was filed in federal court in Indianapolis, Collins claims Pfizer failed to adequately study Chantix; delayed publication of studies containing Chantix risk info; failed to update Chantix labeling sooner, and denied Chantix is explicity to blame for suicide by instead suggesting such behavior may be the result of nicotine withdrawal. Here is the lawsuit.
"The magnitude of the safety signal associated with the risk is alarming," Kristian Rasmussen, one of Collins' lawyers, tells us. Prior to the suicide, David Collins exhibited aggression and had strange dreams, but had no history of mental illness. Pfizer has been criticized for not including people with mental illness in its clinical trials, because the drug causes neuropsychiatric side effects.
You may recall the FDA, last February, issued a health advisory about Chantix concerning ties to the side effects, shortly after Pfizer upgraded the labeling. At the time, the FDA reported 39 suicides and 491 cases of suicidal behavior or thoughts.
Since then, the Institute for Safe Medication Practices issued a report showing nearly 1,000 serious side effects of various sorts were reported concerning Chantix, prompting federal agencies to ban use of the drug by pilots and truck drivers. Pfizer responded with a publicity campaign.
A Pfizer spokesman send us this statement: "Pfizer is aware that a lawsuit has been filed in federal court in Indianapolis, Indiana, but we have not been served with a copy of the complaint. Pfizer will file a formal response to the lawsuit at the appropriate time.
"Pfizer believes that it has acted responsibly, appropriately and in the best interests of patient safety at all times in connection with its smoking cessation aid Chantix. Approximately 7.5 million people worldwide have taken Chantix since its approval in 2006.
"Pfizer reviews the risks and benefits of all of its products, including Chantix, on a continuing basis. Based on Pfizer’s review of the available safety information, including certain neuropsychiatric adverse event reports received to date, we believe the Chantix label accurately reflects the product’s efficacy and safety profile, thereby facilitating appropriate use by physicians and patients. It’s important to note that a causal relationship between these reports and the use of Chantix has not been established."