Zofran Plaintiffs Win Key Early Victory

Publish Date : 02/11/2016

In January, a federal judge ruled that lawsuits against Zofran manufacturer GlaxoSmithKline (GSK) could proceed. These suits allege that that GSK promoted Zofran, an anti-nausea drug, for off-label use during pregnancy. This type of promotion is illegal, and it may have lead to serious birth defects in children whose mothers used Zofran to treat morning sickness.

Off-label use occurs when a doctor prescribes a drug for a purpose that is not approved by the FDA. This practice is not illegal and is in fact quite common. An estimated 20% of all prescription are written for off-label uses. Off-label use can be dangerous, however. In the case of Zofran, plaintiffs allege that when used in pregnant women, the drug can cause serious birth defects. Plaintiffs also allege that GSK promoted Zofran for use in pregnant women despite the fact that off-label promotion is prohibited by federal law.

GSK filed a motion with the court to dismiss all pending Zofran claims. They argued that the claims were constitutionally barred because they were preempted by a Food and Drug Administration decision not to reclassify the drug at GSK’s request. Federal Judge F. Dennis Saylor IV of the District of Massachusetts recognized that this type of decision differed from a citizen’s petition for reclassification. Judge Saylor denied GSK’s motion and, in doing so, allowed the Zofran claims to continue.

This decision is a victory for all families injured by Zofran. The drug has been linked to serious birth defects including congenital heart defects, kidney malformation, cleft palate, and gastrointestinal defects. These types of birth defects can take a serious toll on families and result in thousands of dollars in healthcare costs.

If you or a loved one has been harmed by Zofran, let us know. We would love to help your family get the compensation and closure that you deserve. When Injuries strike / We strike back.

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