Drug manufacturer sued over Zofran Birth Defects

Published on October 8, 2015, by Matthew Sharp


Drug manufacturer sued over Zofran Birth Defects

Drug manufacturer GlaxoSmithKline has been hit with a glut of lawsuits filed by parents who allege their use of GSK drug Zofran to treat morning sickness has caused birth defects. Children whose mothers took Zofran reportedly suffer from congenital heart defects, cleft lips and cleft palates.Personal injury and product liability lawyers representing the victims claim the company failed to warn doctors of the possible side effects when the drug is taken by women in their first trimester of pregnancy.

The drug – which is approved for use to treat nausea and vomiting stemming from surgery and chemotherapy – is being used “off label.” In other words, doctors are prescribing it to treat conditions outside of the scope of the original conditions for which the U.S. Food and Drug Administration approved the drug. Such usage is legal, and sometimes even encouraged by the drug manufacturer. However, the drug company hasn’t necessarily conducted clinical trials to determine whether such usage is safe. According to the FDA:

“Good medical practice and the best interests of the patient require that physicians use legally available drugs, biologics and devices according to their best knowledge and judgement. If physicians use a product for an indication not in the approved labeling, they have the responsibility to be well informed about the product, to base its use on firm scientific rationale and on sound medical evidence, and to maintain records of the product’s use and effects.”

Zofran Lawsuits

In recent months, countless lawsuits have been filed against GSK alleging that the company failed to provide sufficient warning about the use of Zofran by pregnant women.

When a company faces many similar lawsuits filed in courts around the country, the defendant (GlaxoSmithKline, in this instance) can ask to have the cases’ pre-trial matters handled by a single court. This so-called multi-district litigation (MDL) helps streamline cases, saving money for both plaintiffs and defendants, and helps ensure that all parties are treated fairly and consistently.

GSK has requested that the cases be consolidated in the U.S. District Court for the Eastern District of Pennsylvania, which has jurisdiction over Philadelphia, where GSK is headquartered. While many of the plaintiffs agree with the consolidation, not all are satisfied with the requested venue. The U.S. Judicial Panel on Multidistrict Litigation heard arguments related to the consolidation on Oct. 1, and had not reached a decision at the time this article was written.

Reno Product Liability Lawyer for Zofran Victims

If you or a loved one has been harmed by Zofran, contact Reno product liability lawyer Matthew L. Sharp today. We have experience advocating on behalf of clients who have been injured by defective products. This includes pharmaceutical litigation involving defective drugs. Call us today at (775) 324-1500 to schedule a free initial consultation.