Experts Permitted to Testify About Chantix Suicide Side Effects: MDL Judge

A federal judge has rejected an attempt by Pfizer to bar the testimony of several plaintiffs’ expert witnesses, who are expected to offer opinions in the Chantix litigation about the risk of depression and suicidal thoughts that may occur while taking the controversial stop-smoking drug.

Pfizer currently faces more than 2,600 Chantix lawsuits filed on behalf of individuals who have committed suicide or experienced severe injuries from psychological problems that were allegedly caused side effects of Chantix.

As the parties prepare for the first Chantix trials in the federal MDL later this year and early next year, Pfizer asked U.S. District Judge Inge Johnson to exclude certain general causation and liability opinions that are expected to be offered by six plaintiff experts, including Dr. Richard E. Olmstead, Dr. Curt Furberg, Dr. Shira Kramer, Dr. Antoine Bechara, Dr. Josephe Glenmullen and Dr. Jon Wesley Boyd.

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These experts had been identified by the plaintiffs to provide an opinion about either the reasons Chantix side effects cause suicidal symptoms or depression, the methods by which these psychological problems could occur or that Pfizer knew or should have recognized that the drug had the potential to cause these adverse effects.

In an order (PDF) issued August 21, Judge Johnson denied the drug maker’s motion to exclude the expert testimony, allowing the experts to offer testimony. However, Judge Johnson did indicate that they will not be permitted to testify about what the defendants knew or that they intentionally misled the FDA about the suicide risks of Chantix.

CHANTIX SUICIDE LAWSUITS SET FOR TRIAL IN MDL

Judge Johnson is presiding over pretrial proceedings in all federal lawsuits over Chantix, which have been consolidated as part of an MDL, or multidistrict litigation, in the U.S. District Court for the Northern District of Alabama.

Chantix (varenicline) was approved in the United States in 2006, as a prescription medication to help people quit smoking.  The drug works by reducing the positive feelings that come from cigarettes, blocking the receptors in the brain commonly stimulated by nicotine.

Within months after the medication was introduced, reports began to surface about individuals committing suicide or engaging in other unusual behavior on Chantix, which was allegedly caused by the neuropsychological effects of the medication on the brain.

In July 2009, the FDA added a “black box” label warning to the smoking cessation drug about the risks of psychological side effects, which Judge Johnson already determined last month was adequate as a matter of law to alert people about the potential psychological side effects of Chantix.

The complaints all involve similar allegations that Pfizer failed to adequately research the Chantix suicide side effects or warn users about the increased risk of suicidal thoughts or unusual behavior.

According to a pretrial order issued earlier this year, the first Chantix trial date in the federal MDL is expected to begin on October 22, 2012, with a second trial scheduled to begin on January 22, 2013.

These cases, known as bellwether trials, are designed to help the parties gauge how juries are likely to respond to certain evidence and testimony that is likely to offered throughout many cases in the Chantix litigation. The outcomes of the cases may also help facilitate or promote a Chantix settlement agreement or other resolution for the cases.

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2 Comments

  • helpSeptember 5, 2012 at 7:19 am

    Is there anyone out there that knows if there is ANY treatment for how bad this drug screwed me up??? i've been searching to find other's real life stories of going through the terrible side effects - hostility, agitation, etc- -from both during taking and after stopping the drug, and how or what they are doing to manage it. I took the drug for the first week ok, or so i thought, got to week 2 s[Show More]Is there anyone out there that knows if there is ANY treatment for how bad this drug screwed me up??? i've been searching to find other's real life stories of going through the terrible side effects - hostility, agitation, etc- -from both during taking and after stopping the drug, and how or what they are doing to manage it. I took the drug for the first week ok, or so i thought, got to week 2 stronger dose, and half way through the 2nd day, started crying uncontrollably, literally for 3 days, and my anger and rage developed. Needless to say, I stopped immediately, now here I am 11 months later, and I still am having the worst mood effects I could ever imagine. I have no control over my emotions, I never know how I'm going to react to things, but the slightest irritation may go unnoticed sometimes, and then sometimes my rage is unimaginable. It's obviously affecting my job, I have had to call in more times in the last year I think than I have in the last 10, just because there are days and times that I know that it would not be a good situation at all if I were to encounter other people. And then just how my moods are at work.My job is on the line at work now, 15 years of working for them, and it all counts for nothing with how much this has changed me. I just would like to know if there is anyone out there that has experienced similar, but are now getting any treatment for this. Is it getting any better? Is there any hope at all that I will ever be able to go back to being the person I was before I took the drug??? Or am I stuck like this forever??? I used to be a very happy person, but I can't stand to be around myself most times anymore. Honestly, I think its great that this drug has helped people, but now with going through with what I have, and although they say it is rare, I WOULD NEVER RECOMMEND ANYONE TO TAKE THIS, as in my opinion, the risk is FAR greater than the risks of smoking. There are other options to quit, use absolutely every other possible way before EVER considering this drug even as an option, again, in my opinion!

  • cynthiaAugust 27, 2012 at 6:37 pm

    I think Pfizer would be smart to try and settle these cases beFORE they get to a jury.

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