Monday, February 28, 2011

Chantix Multidistrict Litigation Prepared to Get Underway

Chantix, the smoking-cessation aid manufactured by Pfizer, has recently been at the centre of thousands of lawsuits from patients who have experienced some of the adverse side effects of the drug. Psychological side effects, such as depression, suicide ideation, behavioral changes, aggression, agitation, suicide attempts, and hostility have been reported in patients, especially those with a history of psychological problems. Physical side effects, such as seizure, muscle disorders, diabetes, vision disturbances, and heart rhythm disturbances have also been reported.
The Multidistrict Litigation Judicial Panel recently identified the need to consolidate Chantix cases into a multidistrict case due to the common issues at the centre of the lawsuits. This will help streamline the judicial process and will get plaintiffs a payout from the company much sooner. In a multidistrict lawsuit, which is similar to a class action lawsuit, similar cases are consolidated and pretrial proceedings are all taken care of in one court. In the case of the Chantix lawsuit, the cases will all be dealt with by Judge Inge P. Johnson in the Northern District of Alabama. However, unlike a class action lawsuit, after the pretrial proceedings take place, the cases will likely be sent back to the district courts from which they originated and be processed through the legal system that way.
However, plaintiffs do not necessarily have to wait this long for their settlement. Although it is not yet known how much of a settlement Pfizer will have to pay to each plaintiff, based on similar cases as well as the large number of cases that have been filed against Pfizer a settlement will likely be offered to many patients before trial proceedings even start. In instances where this is not the case and no settlement is offered by the company, the first cases will most likely begin their trials sometime in 2012.

Friday, February 25, 2011

Chantix Suicide Risk Requires Stronger Warning

Two known and potentially deadly side effects of Chantix—Chantix depression and Chantix suicide—are many times not listed among the possible Chantix side effects named in the product’s pamphlet. These particular side effects are specified separately as possible “severe” side effects that mandate professional medical assistance if they are experienced. Yet many feel that this amended warning is still not strong enough to effectively alert users to the dangers these side effects represent. Even among users with no prior history of mental disorder or depression, severe Chantix depression and suicide can develop very quickly.

Chantix Suicide Identified Shortly After Debut

Pfizer, Inc. is the manufacturer of Chantix, a drug commonly prescribed to cigarette smokers to help them in their efforts to quit. The medicine was approved by the Food and Drug Administration in 2006, but soon after there were reports of extremely adverse effects and events that resulted in the discovery of Chantix’s potential psychological side effects. These include serious conditions such as depression, thoughts of suicide, severe mood swings, and acts of aggression.
Yet Pfizer continues to insist that the drug is a boon to society in that it serves as an effective treatment for patients who need help quitting smoking. Chantix functions by blocking the brain’s receptors that are normally stimulated by nicotine consumption. This results in less pleasure derived from the act of smoking.

Chantix Lawsuits Claim Negligence by Drugmaker

The first report of a Chantix suicide came after the widow of a former Chantix user filed a wrongful death lawsuit against Pfizer in July 2008. Her husband, a man with no prior history of any mental illness, committed suicide after taking Chantix for a few short months. Many more Chantix suicide lawsuits were filed soon thereafter, resulting in multidistrict litigation for all such suits filed in a federal court.
These lawsuits make claims that Pfizer seriously misrepresented the true risks linked with Chantix use, and that this misrepresentation constitutes a reckless and criminally negligent act on the manufacturer’s part. The lawsuits further allege that Pfizer put consumer’s lives at risk by failing to conduct sufficient research on the drug, and by omitting adequate warning statements that both doctors and patients are entitled to.

Chantix Drug Trials and Inserts Flawed from Start

When drug trials were first conducted for Chantix, they excluded all individuals who had a past history of psychiatric troubles or a current psychiatric disorder. Therefore people with relatively commonplace problems such as depression, bipolar disorder, and schizophrenia did not factor into the results of the trial. It has been estimated that around two out of every three smokers do in fact have past experience with or are currently suffering from some kind of psychological disorder related to mood, whether the symptoms be mild or severe. Since people with these types of disorders were not included in the trials, yet the intended consumers of the drug are likely to be made up of people with these same disorders, negligence on the part of the manufacturer is apparent.
Originally, the Chantix warning information mentioned several possible side effects ranging from suicidal thoughts to nausea. But the waning label has been altered several times since the drug was originally given the green light by the FDA in 2006. In the end the FDA made it mandatory for Pfizer to change the Chantix black box warning so that it included information specific to the drug’s possibly life threatening side effects. This is the strongest cautionary measure that can be applied to the warning label of any prescription drug.

Thursday, February 24, 2011

Possible Diabetes Link Leads to Chantix Lawsuits

The psychological side effects of smoking cessation drug Chantix – depression, suicidal thoughts, increased aggression, mood swings, and homicidal thoughts – have been publicized widely after hundreds of patients have reported these side effects after being prescribed the drug, and many lawsuits seeking settlements for harm caused by these psychological issues are currently pending. There is another potential side effect, however, caused by Chantix that many people don’t seem to know about – Chantix diabetes.
Chantix, known generically as varenicline, was approved by the FDA in 2006, after it had been reviewed for six months. Normally, drugs must undergo a 10-month review by the Food and Drug Administration before they are approved or disapproved for distribution on the pharmaceuticals market. Chantix’s initial clinical trials seemed promising – the drug helped 23 users quit smoking for a year, which was more than twice as effective as the placebo others were given – and initially seemed safe, with no apparent indication of potential to aggravate or cause psychological or physical problems. However, this idea was very quickly overturned, with the Food and Drug Administration announcing in 2007 – only a year after the release of the drug – that there had been numerous reports of Chantix users experiencing severe psychological side effects as a result of the drug. In 2009, the Food and Drug Administration required that Pfizer place a “black box” warning on Chantix. A “black box” warning is the strongest warning an agency can impose on a drug, and emphasized the risk of causing psychological symptoms. And now, new evidence is showing that Chantix may be linked to physical side effects as well.
Chantix has been associated with loss of glycemic control and increased glucose levels. This link is still being monitored by legal and medical professionals, but Chantix could face liability if it is determined that they have under-reported the drug’s potential to cause diabetes.

Chantix Settlements Draw Nearer

Numerous plaintiffs have filed Chantix lawsuits against Pfizer, a multi-billion dollar pharmaceutical company and maker of the contentious anti-smoking medication. Now these plaintiffs are finally getting closer to a Chantix lawsuit settlement.

Consolidation of Chantix Lawsuits

In January 2011 it was decided that approximately 1,200 Chantix lawsuits are to be consolidated through multidistrict litigation (MDL) that will be under the control of U.S. District Court Judge Inge Johnson in Birmingham, AL. Lawyers monitoring the progress of these proceedings say that the number of Chantix lawsuits that were initiated in federal courts and subject to MDL consolidation may rise to more than 2,000 before the first lawsuits are returned for trial to the courts where they were first filed. Another possible outcome is that a Chantix lawsuit settlement will be reached with the defendant and a specific compensation amount will be announced.
An attorney in Birmingham has been appointed lead counsel for all of the plaintiffs who filed Chantix lawsuits in federal court. The lead counsel predicts that the earliest lawsuits are likely to reach trial sometime in 2012 unless a Chantix settlement is reached first. In such instances of MDL centralization it is common for the defendant to agree to a settlement with the plaintiffs before the cases go to trial, and so a Chantix settlement may be announced before the expected trial time arrives.
Nevertheless, it is equally likely that Judge Johnson will elect to send one or more of the earliest lawsuits to trial where they will function as “bellwether cases.” The results of these first few trials may persuade Pfizer to offer a settlement to the remaining plaintiffs, or the plaintiffs may be influenced to drop or continue pursuing their lawsuit claims. In the case of a settlement for these Chantix lawsuits, the total sum paid out by Pfizer may well total a billion totals or more.

Pfizer Defends Drug

The primary phases of multidistrict litigation are underway, yet there has been no sign from Pfizer that they are considering a Chantix settlement. In fact, in a statement released earlier this month, Pfizer insists that the company did nothing inappropriate while developing and marketing Chantix. The drug has been proven to cause certain psychological side effects that can include depression, suicide, and violently aggressive behavior. In addition, there are also several physical Chantix side effects that can manifest, such as diabetes, Stevens-Johnson syndrome, and possible injuries stemming from a so-called “Chantix blackout.” Any of the aforementioned side effects have the potential to be severe enough to require hospitalization.
As stated by Pfizer: “Chantix is an effective treatment option for many smokers who want to quit, and we intend to defend this important medication.”

Comparing the Risk of Chantix side effects to Cigarette Smoking

Despite the numerous lawsuits, no one is arguing that Chantix doesn’t work as advertised. Multiple clinical trials confirmed that Chantix simulates the effect of nicotine on the human brain and helps people quit smoking. But studies have also determined that Chantix represents a significant psychiatric risk to users, whether they have a history of mental illness or not.
At this time Pfizer continues to fight the lawsuits, but before long it may become obvious that a Chantix lawsuit settlement will offer the best resolution for everyone involved.

Friday, February 18, 2011

Chantix Causes Violent Death for Musician

Carter Albrecht, keyboardist for the pop group Edie Brickell and the New Bohemians, began taking the smoking cessation aid Chantix in the summer of 2007 along with his girlfriend, Ryann Rathbone. After only a few days on the product, he became violent towards her – something that had never occurred before in their relationship. Rathbone eventually locked the violent Albrecht out of her house, when a neighbor saw him screaming and ranting on her back porch. Frightened, the neighbor fired a gun at Albrecht – intending for it to be a warning shot – but Albrecht was shot in the head and died.
Albrecht is not the only victim of the side effect of increased aggression associated with Chantix. Although it is one of the most effective smoking-cessation aids on the market today, it is also one of the most dangerous drugs on the market. A study by the scientific journal PloS ONE showed that varenicline, the active ingredient in Chantix, is more than twice as likely to be involved in a violent event than any other drug on the market – a startling statistic considering that over three million Americans have been prescribed the drug, and exact numbers are not known regarding the number who have experienced these aggressive Chantix side effects.
This side effect is unique because it does not only directly affect the person who is taking the medication but also the people around them. Chantix users have been known to show increased aggression towards strangers and loved ones alike, leading many users and family members of those affected by Chantix aggression to come forward with lawsuits in order to claim compensation for their struggles. Luckily, for 90 percent of Chantix users who experience aggressive behavior, the behavior stops when the drug is no longer being taken. However, as in the case of Carter Albrecht, it may be too late.

Friday, February 11, 2011

Pfizer Employee Files Lawsuit Against Pfizer over Chantix Side Effects

More than 1,200 people have filed Chantix lawsuits against pharmaceutical manufacturer Pfizer over its side effects that can be severe. Randall Sloan, one of these side effect victims, filed suit in an Alabama court in March of 2010 after he was prescribed Chantix in December 2007. A year and a half later, the Food and Drug Administration began to require that Chantix carry a “black box” warning, which is the highest warning it can administer, to warn the consumers about the potential side effects of the drug. The lawsuit claimed that Sloan suffered from “anxiety, depression, aggression, mania, psychosis, erratic behavior, and hospitalization on or about March 2008.”
Hundreds of other Chantix users have made similar claims in their lawsuits, which have been consolidated through multidistrict litigation, a process that combines similar lawsuits into one that is more streamlined and passes through the judicial system more efficiently. It is similar to a class action lawsuit. US District Judge Inge Prytz Johnson is overseeing this lawsuit in the Northern District of Alabama.
Although the first lawsuit will not take place until 2012, many lawsuits have already been filed. Most claim that Pfizer neglected to test the drug on people with a history of people with psychological problems. This is especially an issue because there is a high rate of people with issues such as depression and anxiety who are also smokers. Sloan, who is a former Pfizer employee, says that Dr. Daniel Seidman, who is the director of Smoking Cessation Services at Columbia University, has said that “two out of three” smokers that he sees have a psychiatric or mood problem. Pfizer admits that they did not test people with symptoms of major psychological problems, but people with these problems were prescribed the drug anyway. Now, many of them are filing Chantix-related lawsuits.

Thursday, February 10, 2011

Violence and Suicide? There’s a Chantix for That

Chantix is the popular drug that has been used by thousands of people to quit smoking. These same thousands of people have since found out that Chantix comes loaded with some seriously potent side effects. The most serious of these are the violent, aggressive, and suicidal actions that this drug brings out from its users.
The Food and Drug Administration has maintained that all drugs have side effects, and that they are allowed to stay available to the public as long as the benefits of the drugs outweigh the risks involved in taking them. Interestingly enough, for Chantix, the scales might have finally tipped.

Chantix Brings Out the Worst in People

In a new study titled “Prescription Drugs Associated with Reports of Violence Towards Others,” the Institute for Safe Medication Practices outlined a large list of dangerous drugs that have been shown to cause violent behavior.
Coming in at the number one spot was Chantix. This drug has been linked to aggression and suicide since the day it was released. By blocking the reward system of the body, and keeping dopamine from being released in the brain, Chantix helped people to quit smoking by keeping nicotine from being pleasurable. Unfortunately, blocking dopamine production also leads to suicidal thoughts and aggressive behavior.

Chantix Gets a Black Box Warning

In June of 2009, Chantix was outfitted with a black box warning detailing most of its more serious side effects. The warning stated that some users of the drug have experienced aggression, depression, and suicidal thoughts. Pfizer was also told to conduct clinical trials to show how often using Chantix would lead to abnormal behavior.
The research that was done found that Chantix violence was unprovoked and unexplainable. They also found that there are no precursors to Chantix violence. The aggressive and suicidal behavior usually came on quickly. The good news is that when the subjects stopped taking Chantix, they returned to normal.

The Relationship Between Chantix and Suicide

One shocking case involving Chantix is that of a 47 year old woman who assaulted and yelled at her daughters before taking her own life with a handgun. She had been on Chantix for a month. Another case is that of a man who choked his wife in a frenzied rage, and then hung himself. He was only on Chantix for 8 days.

Chantix Violence is Serious

Researchers who have been following the drug for a while say that Chantix violence needs more attention in the media. Patients should be warned of the risk of having violent thoughts on Chantix. Any abnormal behavior while on the drug should be reported to your doctor right away.