Zofran Product Liability Claims Involving Birth Defects Centralized in Massachusetts Federal Court

Numerous plaintiffs from across the country have initiated lawsuits against drug manufacturer GlaxoSmithKline, LLC, alleging that its drug Zofran caused a host of birth defects like cleft palate, club foot, and heart defects. During the early 1990s, the company received approval for the drug from the United States Food and Drug Administration (“FDA”) for the limited purposes of treating vomiting and nausea in patients undergoing surgery and chemotherapy.

During the past few years, doctors have started to prescribe the drug for a so-called “off label” use to help pregnant mothers cope with severe morning sickness, the most common side effect associated with pregnancy. In fact, over 80 percent of pregnant women have reported experiencing severe nausea and vomiting during some stage of their pregnancies. Unfortunately, the American Journal of Obstetrics and Gynecology has reported that over 97 percent of the medications prescribed for pregnancy-related nausea and vomiting are not labeled for this application or classified as safe for pregnant women to use by the FDA.

Today, roughly 25 percent of pregnant women have been exposed to Zofran, or the active ingredient it contains called Ondanestron. In 2013, the FDA issued a warning against the use of Zofran and products containing ondansetran during pregnancy. According to studies published at the time, the FDA found a correlation between the off-label use of Zofran during pregnancy and high rates of birth defects like cardiac malformations and facial clefts. The reports also noted risks for the pregnant mother, including a complex cognitive or behavioral disorder referred to as Serotonin Syndrome.

In July 2015, GlaxoSmithKline filed a motion with the United States Judicial Panel on Multidistrict Litigation (“JPML”), asking that a multidistrict litigation (“MDL”) be formed for any and all lawsuits involving claims that Zofran caused harm to a pregnant mother or birth defects in her child that had been filed within the federal court system.

Last month, the JPML granted the company’s request to form an MDL involving Zofran lawsuits, and it selected the United States District Court of Massachusetts as the location for the consolidated actions. The proceeding is now operating under MDL number 2657 and is assigned to Judge Dennis Saylor.

Next, the presiding judge will begin to organize the MDL proceeding, which involves issuing case management orders and setting other administrative ground rules and processes. Ultimately, a “bellweather” plaintiff will be selected. This plaintiff is someone with a case that the parties use to test their factual and legal arguments with the ultimate goal of moving the litigation toward a global settlement of all the claims contained in the MDL. A bellweather’s claim is typically representative of most of the actions contained in the MDL.

If you or someone you love has suffered injuries as the result of taking Zofran or another dangerous drug, you may be entitled to compensation. At the Law Offices of John S. Moffa, we proudly represent Massachusetts residents in cases against large drug companies. We know just what it takes to investigate a claim, to gather evidence, and to ensure that your rights are asserted along every step of the way. We offer a free consultation to help you figure out the options available to you and your family. Call us now at 1-800-446-4485 or contact us online to set up your appointment now.

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