Pfizer indicates that it has reached agreements to settle the vast majority of all Chantix lawsuits filed on behalf of former users of their prescription smoking cessation drug, which allege that side effects of the medication caused users to kill themselves, attempt suicide or engage in other unusual behavior.
According to a filing with the U.S. Securities and Exchange Commission (PDF) on March 1, the global pharmaceutical company disclosed that it has reached a settlement or is approaching a settlement with plaintiffs in about 80% of the known Chantix claims in the United States, with costs of nearly $300 million reported.
Pfizer faces more than 2,500 Chantix lawsuits filed on behalf of individuals who committed suicide, attempted suicide or suffered other psychological injuries.
In addition to lawsuits filed in various state courts, the federal Chantix litigation has been consolidated in U.S. District Court for the Northern District of Alabama before Judge Inge Johnson, as part of a multidistrict litigation (MDL).
According to the filing Chantix paid $273 million to settle these lawsuits and expects to pay at least another $15 million this year to resolve all remaining Chantix actions at both the state and federal level. However, the company notes that some will remain unresolved and may go to trial, which could take years and cost the company an unknown amount. The terms of the settlements reached so far have not been disclosed and are reportedly confidential.
Chantix (varenicline) is a prescription medication that was approved in 2006 to help people stop smoking. Shortly after it was introduced, a number of reports surfaced involving individuals who suffered sudden behavior changes, depression, suicidal thoughts and other problems.
In June 2009, the FDA added a “black box” warning about the risk of psychological problems with Chantix, and Pfizer was ordered to conduct additional clinical trials to provide more data on how often neuropsychiatric symptoms and suicide with Chantix occur and what conditions cause them.
Late last year, Pfizer settled at least two Chantix lawsuits that were scheduled to go to court after plaintiff attorneys won the right to call Pfizer Chief Executive Officer Ian Read to testify. Read was involved with the development of Chantix before he became CEO.