A mother from Texas has filed a Zofran birth defect lawsuit, alleging her daughter’s in utero exposure to the popular anti-nausea drug caused her to develop severe congenital heart defects and she will likely need a heart transplant.

Plaintiff Katherine T. was first prescribed Zofran early in her first trimester. Her daughter, known as M.J.T. in court documents, was delivered in 2003, and diagnosed with a complex congenital heart defect known as Ebstein’s anomaly, which was not visible during her 20-week ultrasound.

Katherine’s daughter spent the first month of her life in the neonatal intensive care unit.  Her condition is marked by a displaced and non-functional tricuspid valve, enlargement of the right side of her heart, myopathy in the heart muscle and the left side of her heart too small.

According to the Zofran lawsuit, M.J.T. has been, and continues to be, under the care of a cardiologist since her birth.  Due to the severity of her heart defects, surgery is not recommended because of the low chance of survival.

At some point in the future, Katherine’s daughter will require a heart transplant because her chances of survival without the transplant will be so low that the potential benefit of transplant surgery will outweigh the risks.

Citing several medical research studies that have found an increased risk for congenital heart defects among babies exposed to Zofran in utero, Katherine claims that her daughter’s congenital birth defects were “a direct and proximate result” of her prenatal exposure to the morning sickness drug.

The Zofran birth defect lawsuit states that had Katherine known the truth about Zofran’s unreasonable risk of harm to a developing child, she never would have taken Zofran and her daughter would not have been injured.

She claims GlaxoSmithKline concealed the dangers of Zofran and brings claims for compensatory and punitive damages, as well as equitable relief in an effort to ensure that other pregnant women are fully informed about the risks of Zofran during pregnancy.

What is Zofran?

Zofran is a member of a class of medications that is known as 5-HT3 receptor antagonists. It works by reducing the effects of a substance in the body that is known as serotonin.

Serotonin is known to cause nausea and ultimately vomiting and since many women get morning sickness during pregnancy, Zofran was prescribed. It basically interrupts the messages sent from the brain to the rest of the body that it should feel nauseous and get ready to vomit.

Zofran has been on the market for more than 20 years, and it was originally approved in the United States by the FDA in 1992, mainly used by cancer victims.

Recently GlaxoSmithKline found a new off-label market for this drug – women who were pregnant, and saw a potential new revenue stream that could generate millions of dollars in revenue for GlaxoSmithKline.

However, Zofran is not approved for use during pregnancy, but many women have received the medication as an “off-label” prescriptions.  Doctors may prescribe medication for off-label uses if the benefits of the drug outweigh the risk.  Manufacturers, however are not allowed to market the medication for unapproved uses.

GSK has been accused of improperly marketing Zofran to physicians for use during pregnancy and paying kickbacks to physicians to use the medication. Unfortunately, several studies, including one conducted by the Centers for Disease control, have linked Zofran to a number of birth defects in women who took the medication while pregnant.

Despite these findings, the U.S. Food and Drug Administration recently rejected a petition to change Zofran’s drug category, saying in an October 2015 statement that these studies “do not support a determination that there is an increased risk of fetal adverse outcomes.”

Zofran Birth Defect Lawsuits

Amid allegations that GlaxoSmithKline unlawfully promoted Zofran as an “off label” morning sickness drug (including charges leveled by the US Federal Government) and concealed evidence of the drug’s link to major birth defects, families continue to file new Zofran lawsuits.

If these claims are true, any parent who was prescribed Zofran during pregnancy and delivered a child with birth defects may be entitled to file a Zofran birth defects lawsuit against GlaxoSmithKline.

The Zofran Birth Defects Lawsuit is Case No. 3:15-cv-03846-EMC in the US District Court for the Northern District of California.