SAN FRANCISCO–(BUSINESS WIRE)–Sarah R. London and Paulina do Amaral of the national plaintiffs’ law firm Lieff Cabraser Heimann & Bernstein, LLP, announce that Paul Ramirez and Dulce A. Morga, residents of Los Angeles County, California, have filed a personal injury lawsuit against pharmaceutical giant GlaxoSmithKline LLC (“GSK”) for injuries leading to the death of their infant daughter, Baby Sarah Ramirez Morga, allegedly as a result of Ms. Morga being prescribed GSK’s drug ondansetron (brand name Zofran) while pregnant.
“But the loss of Sarah will be a pain we carry with us for the rest of our days. We hope our lawsuit helps to alert other women to the issues with this drug.”
“We are deeply grateful for the excellent medical care our daughter received,” stated Dulce Morga. “But the loss of Sarah will be a pain we carry with us for the rest of our days. We hope our lawsuit helps to alert other women to the issues with this 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.
Ms. Morga and Mr. Ramirez’ daughter was born in late 2014 with congenital heart defects, including severe Epstein’s anomaly of the tricuspid valve. Per her doctor’s notes, she was born with an enormous heart with a very large atrialized right ventricle that was not functioning. She underwent open heart surgery when she was just five days old, and did not survive the trauma and passed away in her mother’s arms five days later.
“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 Mr. Ramirez and Ms. Morga. “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 greater than doubled risk of having a baby with a heart defect as compared to a mother who did not ingest Zofran during pregnancy.”
The lawsuit was filed November 13, 2015 in federal court in the Central District of California. The lawsuit alleges claims of negligence, strict products liability, intentional misrepresentation, concealment, negligent misrepresentation, breach warranty, and violations of California law. Mr. Ramirez and Ms. Morga seek compensatory and punitive damages from GSK.