Serzone Lawsuit

A Brief Guide to Filing a Serzone Lawsuit:

What is Serzone?

The antidepressant Serzone was voluntarily recalled from the American market by its manufacturer Bristol-Myers Squibb in 2004. Though the company insisted that this action was not taken in response to reports of serious Serzone side effects, the manuever prompted a mass class action Serzone lawsuit. Since this product has not been available in America for a long period of time, the statute of limitations concerning Serzone lawsuits has likely expired. Therefore, filing a Serzone lawsuit, at this time, is not possible.

Serzone utilized Nefazodone to treat depression. This drug is an antidepressant that worked by increasing the amounts of certain substances in the brain necessary for promoting mental stability.

Serzone Lawsuit: FDA Regulations

In 2001, an FDA-mandated warning concerning potential Serzone side effects was issued in response to over 100 reports of liver damage. From 2002 to 2004, hundreds of patients filed a claim seeking a Serzone settlement; the suit was later condensed to a class action suit.

Further controversy ensued in March 2004 when the public advocacy group Public Citizen filed a Serzone lawsuit against the FDA. In its suit, the group charged that the FDA had failed to respond to cases of serious Serzone side effects, thereby endangering consumers. Shortly thereafter, the company announced that they were removing the product from the market. The FDA's Serzone lawsuit did not make it to court.

In 2005, a $70 million Serzone lawsuit, to be divided among 6,524 plaintiffs was initiated. The Serzone side effects which led to this action primarily concerned the risk of serious liver failure. However, when the results of this Serzone lawsuit were announced, approximately 2,500 patients opted out of the suit. By refraining from the class action legal settlement, plaintiffs can pursue private litigation.

That being said, aside from this class action Serzone lawsuit, there are currently no reports of significant success in obtaining additional compensation for dangerous Serzone side effects. If Serzone lawsuits resulted in a settlement, the figures were affirmed in a private/out-of-court agreement.

Following the removal of Serzone from the market, the United States Food and Drug Administration announced that it was considering filing suit against the former manufacturer, Bristol-Squib Myers. Ultimately, the FDA chose not to proceed with a Serzone lawsuit.


Serzone Side Effects:

Serzone has been studied in numerous clinical trials, whereby a group of individuals taking the drug experiences Serzone side effects and compares them to the control group (individuals who are not administered the drug. The studies revealed the following Serzone side effects:

• Headaches are common Serzone side effects experienced in up to 36 percent of patients

• Dry Mouth is experienced in up to 25 percent of patients

• Drowsiness is experienced up to 25 percent of patients

• Constipation is experienced in up to 14 percent of patients

• Weakness is experienced in up to 11 percent of patients

• Insomnia is experienced in up to 11 percent of patients

• Heartburn is experienced in up to 10 percent of patients

• Diarrhea is experienced in up to 8 percent of patients

Though the trademarked form of the medication is not available, several generic alternatives can be procured via prescription. As stated above, serious generic Serzone side effects are not likely to provide successful grounds for litigation—Serzone lawsuits concerning generic forms of medication also are attached with limited success. Patients who experienced serious Serzone side effects are unlikely to be able to pursue compensation at this point.

Serzone Lawsuits:

At the time of its removal from the U.S. market, Serzone had already been banned in Canada and Europe, due to its link to liver failure—Serzone was responsible for causing at least 20 deaths in these markets.

In addition to the Serzone lawsuits listed above, the drug’s manufacturer (Bristol-Squib Myers) has been sued over allegations that the company knew the significant risks of liver damage, liver failure and even death and proceeded to manufacture and market Serzone.

Sources:

1. http://www.fda.gov/ohrms/dockets/ac/04/briefing/4006B1_11_Serzone-Label.pdf

2. http://www.fda.gov/Safety/MedWatch/SafetyInformation/

SafetyAlertsforHumanMedicalProducts/ucm155496.htm

3. United States National Library of Medicine "Nefazodone" retrieved from:

http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0000956/