Zofran, Glaxo, Birth Defect & MDL

The Zofran, Glaxo, Birth Defect & MDL case is about mothers that took Zofran (ondansetron, generic Zofran) during pregnancy and gave birth to a child with a birth defect (e.g., congenital defect, heart defects…).

Zofran, Glaxo, Birth Defect & MDL: A recent case in the United States District Court, D. Massachusetts ruled on the issue of federal preemption.

A brief summary of the Zofran, Glaxo, Birth Defect & MDL case includes:

  1. This multi-district litigation arises out of claims that the use of the drug Zofran (ondansetron) by pregnant women caused birth defects.
  2. Defendant GlaxoSmithKline, LLC has moved to dismiss all complaints on the grounds that any state-law failure-to-warn claims are preempted by federal law under Wyeth v. Levine, 555 U.S. 555 (2009), and that any remaining claims are preempted under Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001).
  3. GSK first contends that plaintiffs’ state law failure-to-warn claims are preempted by federal law under Wyeth v. Levine, 555 U.S. 555.
  4. In Levine, a patient brought a claim under state law alleging that Wyeth, the manufacturer of the brand-name drug Phenergan, failed to provide adequate warnings in its label of the dangers of administering the drug through an “IV-push.”
  5. In response, Wyeth argued that the failure-to-warn claim was preempted because it was impossible to comply with both the duties imposed on it by state law and the labeling requirements imposed by the FDA.
  6. The Supreme Court disagreed, and found that Levine’s failure-to-warn claim was not preempted. In doing so, the Court relied heavily on 21 C.F.R. § 314.70(c)(6)(iii), commonly referred to as the “Changes Being Effected” (“CBE”) regulation.
  7. The Court ruled: Denied
  8. For more on this case, please follow this link: Zofran MDL– January 22, 2016

CASE WATCH℠ is a compilation of a variety of cases, including birth defect and prescription drug (for more news on paxil or zofran related cases, follow this link – birth defect), personal injury, jones act and toxic tort cases nationwide.

We hope that these posts provide an insight into the various situations in which someone has been injured and the various remedies sought. And, we hope that it is both helpful and informative.


At the Gooch Law Firm, we pride ourselves on providing our clients reliable representation for even the most challenging cases.

If you have a child that has a birth injury, birth defect or birth defects (e.g., congenital defect, heart defects, PPHN, lung defect and others) that you believe may have been caused by a defective drug, e.g., paxil, zofran – and need help filing a birth defect lawsuit, please contact our office at 1.844.329.5955.