Birth Defect Lawsuits Mount over Zofran

By John Cooper, Virginia Dangerous Drugs Lawyer

It’s always tragic when a drug that’s meant to help treat a medical problem causes a worse one. This is exactly what families say has happened with Zofran, a drug that has been used to alleviate the effects of morning sickness which is now linked to birth defects.

It’s sobering when a drug that’s used to treat a non-life-threatening condition causes caused disfigurement and potentially life-threatening conditions in infants, according to those who are suing the drug company GlaxoSmithKline LLC. Morning sickness can be very unpleasant, but I doubt if many expectant mothers would have used this drug if they realized there was a chance it could harm their child in the womb.


One of the most recent causes against the makers of Zofran was filed in Louisiana, according to the Louisiana Record.

Cicily and Justin Lafleur filed a lawsuit on Feb. 23 in the U.S. District Court for the Western District Court of Louisiana, Lafayette Division, against GlaxoSmithKline LLC, over birth defects they allege Zofran caused to their child. In the claim, the parents cited claims of negligence, misrepresentation, fraud, and breach of implied and express warranty. 

Cicily Lafleur is claiming she was prescribed Zofran from early in her first trimester of pregnancy to alleviate the effects of morning sickness. She claimed the drug was prescribed by her health care provider. Her son was born on Nov. 7, 2012. The parents say he was diagnosed with congenital heart defects, which they claim were a result of his mother taking Zofran. The parents say their child faced immediate surgery after birth and extensive follow-up treatment after that. 

Dozens of lawsuits have been filed against GlaxoSmithKline over Zofran. Although many women reported no problem with taking the drug, which is also called ondansetron, others say it caused significant health problems for their children.

The most common problems associated with this drug are mouth deformities in infants such as cleft palates, potentially deadly heart defects, musculoskeletal anomalies and jaundice in babies.


Shockingly, The FDA never even approved the use of Zofran for morning sickness. The drug was intended for use in cancer patients. GlaxoSmithKline has promoted the use of ondansetron off-label to doctors and expectant mothers, with very little research about its side effects during pregnancy, its critics say. In 2012, the FDA made the link between taking Zofran and abnormal heart rhythms.

The lawsuits claim the British manufacturer knew of this drug’s dangerous side effects decades ago. Court documents suggest GlaxoSmithKline LLC knew of the  “unreasonable risk of harm” to developing babies from Zofran in the early 1990s.

If you or your child has been harmed by Zofran or another dangerous drug, our dangerous drug attorneys would like to hear from you. Call us at (757) 455-0077.

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