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Zofran Lawsuits May Be Centralized in MDL


October 1, 2015 — Federal judges meet today to decide whether to centralize dozens of lawsuits involving birth defects linked to the anti-nausea drug Zofran.

The U.S. Judicial Panel on Multi-District Litigation (JPML) had a hearing in Manhattan to hear oral arguments. The manufacturer of Zofran, GlaxoSmithKline (GSK), has requested that the litigation be centralized in Pennsylvania, near the company’s American headquarters.

At least 33 lawsuits are now pending in federal courts around the nation. Centralizing the litigation could help improve efficiency, reduce costs, and eliminate the risk of conflicting rulings in lower courts.

Meanwhile, the litigation continues to grow at a rapid pace. One recent lawsuit (PDF) was filed by Therese Trivosonno, a woman who used Zofran early during her first trimester of pregnancy and had a baby with a heart defect.

The child was diagnosed with a “hole in the heart” (septal heart defect) at the age of two. She had to have open heart surgery at age three. She continues to suffer from lung damage, chronic lung infections, asthma, bypass side effects, and other complications that affect her health and development.

GSK is accused of downplaying the risk of birth defects while aggressively marketing Zofran for “off-label” (unapproved) uses. According to the complaint:

“Zofran would never have become the most prescribed morning sickness drug in the United States, and Plaintiff Therese Trivisonno would never have taken it, if GSK had not misleadingly marketed the drug as a safe and efficacious treatment for morning sickness.”

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