Serzone Lawsuits

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What is Serzone?

Serzone® (nefazodone hydrochloride) is a prescription medication used to treat depression combined with anxiety. Its manufacturer, the Bristol-Myers Squibb Company, decided to withdraw the antidepressant from the American market on May 20, 2004. At the time, the drug had already been banned in Europe and Canada because of its link to liver failure, sometimes leading to liver transplants, and at least 20 deaths.

Why was Serzone Taken off the Market?

In December 2001, after receiving more than 100 reports of Serzone®-related liver damage, the U.S. Food and Drug Administration (FDA) required Bristol-Myers Squibb to add a "black box" warning to Serzone's® packaging, advising patients of the risk of potentially fatal liver damage. A black box warning on a drug label is the most serious warning issued by the FDA.

However, the warning had no effect in reducing the frequency of side effects associated with Serzone®. So in March 2004, Public Citizen, a public advocacy group, sued the FDA, citing the agency's "gross negligence" for not issuing a Serzone® ban despite the drug's removal in other countries and its reported connection to 55 cases of liver failure, including 20 deaths, and 39 cases of severe liver injury.

Two months after Public Citizen filed its lawsuit, Bristol-Myers Squibb decided to stop manufacturing the drug. At the time, the company insisted that Serzone® was being recalled because of declining sales, and not because of any concerns about the drug's safety.

What Risks are Associated with Taking Serzone?

The most serious risk associated with taking Serzone® is the risk of developing serious liver problems. Even though it's unlikely that an individual patient taking Serzone® will suffer liver failure, there's no way to predict which patients can take the drug safely and which ones can't.

Symptoms of developing liver problems include:

• Yellowing of the skin or whites of the eyes
• Unusually dark urine
• Loss of appetite that lasts several days or longer
• Nausea
• Lower stomach pain
• Malaise

Other side effects associated with Serzone® include:

• Rash or hives
• Seizures
• Dizziness, fainting
• Erection that lasts too long
• Constipation
• Fever
• Headache

Why are Bristol-Myers Squibb and the FDA Being Sued?

Although Bristol-Myers Squibb no longer manufactures Serzone®, the drug remains available as a generic medication in various strengths, under the names Nefazodone Hydrochloride and Nefazodone HCL. The generic forms are manufactured by several different pharmaceutical companies, but not Bristol-Myers Squibb. Lawsuits against the FDA are aimed at having these generic forms of nefazodone hydrochloride banned.

As for Bristol-Myers Squibb, although the company knew in 1994 that that Serzone® carried a serious risk of causing liver damage, liver failure, and even death, it continued to manufacture and market the drug. Family members of patients who used Serzone® and died have filed lawsuits against the company. This includes the family of Cassie Jo Geisenhof, a Minnesota teenager who died from long-term complications related to a liver transplant, following liver failure caused by Serzone®. Cassie's story was featured on the CBS Evening News in April 2004.

For its part, Bristol-Myers Squibb continues to insist that the drug was safe.

Who Can File a Serzone Lawsuit?

If you have taken Serzone® and suffered a Serzone®-related injury, or if you are a close family member of someone who died as a result of a Serzone®-related injury, you may be able to file a Serzone® lawsuit. If you want to file a lawsuit, you should find a lawyer as soon as possible. Each state has a time limit, called a statute of limitations, restricting how long you have to file your Serzone® claim. The time limit varies from state to state. But if you wait too long, you will be barred from taking legal action.

When choosing a lawyer, you should look for someone who has experience dealing with Serzone® lawsuits. You should look for a lawyer with proven experience in the field, someone who has the resources and contacts to deal with your case quickly and efficiently.

An experienced lawyer will be able to advise you about your options, including whether you should file an individual lawsuit or opt for a class action. Your lawyer may be able to advise you about your chances of success and give you an idea of how much compensation you can reasonably hope to recover.

Once you have selected a lawyer, you will need to provide information regarding:

• When and how long you took Serzone®, as well as the dosage
• What type of Serzone®-related injury you suffered, when the injury occurred, and whether you were taking Serzone® at the time

The more information you provide your lawyer, the better chance he or she will have of preparing a solid Serzone® case for you. As your case develops, your lawyer will be able to advise you about accepting an out-of-court settlement, if one is offered, or if you should go to trial.

How Can I Report a Serious Side Effect With Serzone to the FDA?

If you're aware of a serious adverse reaction to Serzone®, the FDA encourages you to make a MedWatch report (click on "How to Report") or call 1-800-FDA-1088

Related Resources on lawyers.com

- Drugs and Medical Devices
- Products Liability
- Class Actions
- Selecting a Lawyer
- Drug and Medical Devices Lawyers
- Class Action or Products Liability message boards for more help

Web Links

- Information from the FDA regarding Serzone®, generic forms of nefazodone hydrochloride and their manufacturers and antidepressant medications
- DEA "Consumer Alert!" concerning buying drugs online