Lieff Cabraser Civil Justice Blog
Zofran birth defect lawsuits

Florida Parents File Suit to Hold GlaxoSmithKline Accountable for Injuries Suffered By Their Son and Warn Pregnant Mothers of the Link Between Zofran and Birth Defects

Sarah R. London and Paulina do Amaral of the national plaintiffs’ law firm Lieff Cabraser Heimann & Bernstein, LLP, announce that Robin and Stanley Zgurski, residents of Florida, have filed a personal injury lawsuit against pharmaceutical giant GlaxoSmithKline LLC (“GSK”) for the injuries suffered by their son allegedly as a result of Ms. Zgurski being prescribed GSK’s drug ondansetron (brand name Zofran) while pregnant.

“We are deeply grateful for the excellent medical care our son has received,” stated Robin Zgurski. “But it has been a long struggle to address the injuries to our son that we believe Zofran caused. We hope our lawsuit helps raise the awareness of the dangers of the drug.”

Zofran is a potent drug developed by GSK that was approved by the U.S. Food and Drug Administration to treat only patients afflicted with the most severe nausea imaginable – nausea suffered as a result of chemotherapy or radiation treatment. GSK nevertheless marketed Zofran “off-label” as a safe and effective treatment for the very common side effect of a normal pregnancy – pregnancy-related nausea and vomiting – otherwise known as “morning sickness.”

In 2012, GSK pled guilty to criminal charges filed by the U.S. Department of Justice for its off-label promotion of certain prescription drugs, including Zofran, for uses never approved by the FDA. Zofran, however, continues to be widely prescribed to pregnant women across America to treat morning sickness even though it was never approved for this use.

The Zgurskis’ son was born in 2006 with a bilateral cleft lip and palate and has been through multiple surgeries and countless visits with various physicians and specialists, receiving care in three different states thus far. He underwent his first medical intervention within his first few weeks of life and had his first surgery before he was even one year old. He has had and continues to have difficulty eating, speaking, and hearing. His birth defects have impaired his development in a variety of ways and interfered with his enjoyment of life both at home and at school.

“Despite having received hundreds of reports of birth defects associated with Zofran and continuing strong sales to pregnant women, GSK has not performed any clinical studies on the safety or efficacy of Zofran for treating morning sickness,” stated London, counsel for the Zgurskis. “Moreover, GSK has not updated Zofran’s labeling to warn mothers and physicians that epidemiology studies report an increased risk of birth defects in infants exposed to Zofran during pregnancy. Recent studies report that a mother exposed to Zofran had nearly doubled risk of having a baby with a cleft palate defect as compared to a mother who did not ingest Zofran during pregnancy.”

The lawsuit was filed Friday November 6th in federal court in San Francisco. The lawsuit alleges claims of negligence, strict products liability, intentional misrepresentation, concealment, negligent misrepresentation, breach warranty, and violations of California law. The Zgurskis seek compensatory and punitive damages from GSK.

About Lieff Cabraser

Recognized as “one of the nation’s premier plaintiffs’ firms” by The American Lawyer, Lieff Cabraser Heimann & Bernstein, LLP is a sixty-plus attorney law firm with offices in San Francisco, New York, and Nashville. Our firm has successfully represented thousands of patients across America in individual lawsuits due to the injuries they suffered from defective medical devices. U.S. News and Best Lawyers have named Lieff Cabraser as their 2016 “Law Firm of the Year” for representing plaintiffs in class actions and mass torts.

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Paulina do Amaral
Lieff Cabraser Heimann & Bernstein, LLP