Zofran Lawsuit Seeks Compensation for Child’s Atrial Septal Defect

Published on December 7, 2015 by Sandy Liebhard

A Zofran lawsuit recently filed by Alabama parents seeks compensation for damage related to their son’s atrial septal defect. According to court documents, the complaint pending in the U.S. District Court, District of Alabama, claims that the child sustained the serious heart birth defect due to his mother’s use of the anti-nausea drug in the first trimester of pregnancy.

Like other birth claims filed over Zofran, the complaint points out that the drug was never approved to treat pregnancy-related nausea and vomiting. However, the plaintiffs charge that GlaxoSmithKline has a long history of marketing the medication for this very purpose.

“GSK chose not to study Zofran in pregnant women or seek FDA approval to market the drug for treatment during pregnancy,” the lawsuit states. “GSK avoided conducting these studies and buried any internal analyses of Zofran’s teratogenic potential because they would have hampered its marketing of Zofran and decreased profits by linking the drug to serious birth defects.

The filing also cites a number of studies that suggest exposure to Zofran in early pregnancy might increase the chances that a baby will be born with serious congenital defects, including heart malformations. These studies include one conducted by Danish researchers which found that children exposed to Zofran in-utero during the first trimester may be two to four times more likely to suffer a septal defect, including an atrial septal defect.

Federal Zofran Litigation

Court records indicate that this case is just one of hundreds of similar Zofran claims currently pending in U.S. courts. In October, federal lawsuits involving the drug’s alleged association with birth defects were consolidated in a multidistrict litigation that is currently underway in the U.S. District Court, District of Massachusetts. In addition to cardiac septal defects, abnormalities most often cited by claimants include transposition of the greater vessels, tetralogy of fallot, clubfoot, kidney defects, and cleft lip and palate.

To date, the Court overseeing the federal Zofran litigation has issued five Case Management Orders, including orders that establish a master file and master docket for the multidistrict litigation. The proceeding’s next Status Conference is scheduled for December 15th.

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