A Massachusetts couple is suing GlaxoSmithKline, alleging that their daughter was born with multiple severe birth defects resulting from the mother’s use of GSK’s anti-nausea medication Zofran.

Plaintiffs Cynthia and Wayne M. are taking legal action on behalf of their daughter, S.M.

Originally approved to treat nausea and vomiting in chemotherapy patients, Zofran has soared in popularity over the years and is now commonly used for the off-label purpose of treating morning sickness.

Cynthia was one of the many pregnant women who sought treatment for constant bouts of pregnancy-induced nausea. After being reassured that Zofran was a safe and effective method for treating morning sickness, Cynthia started her prescription.

The medication worked well for nausea control, but months later Cynthia and Wayne were devastated to discover that their daughter was born with congenital birth defects.

According to medical records, the little girl was born in 2007 with a craniofacial birth defect. S.M. had to receive immediate treatment, and has had to undergo multiple surgeries and invasive procedures since birth. She continues to require constant medical monitoring.

S.M. suffers from birth defects including feeding problems, ear infections, hearing loss, speech and language development delays, and dental problems. These problems will affect S.M. throughout her life.

Overview of Zofran Birth Defects Complications

The plaintiffs allege there have not been any instances of this birth defect in their families’ medical histories. This leads Cynthia, Wayne, and their lawyers to believe that the birth defects could be attributed to an environmental abnormality in the womb, such as exposure to Zofran.

Cynthia and Wayne’s Zofran lawsuit notes that GlaxoSmithKline has recently come under major criticism for falsely advertising Zofran for off-label purposes. Because the FDA has not approved Zofran for use as a morning sickness treatment, GSK can not legally advertise the product for this purpose.

GSK recently settled a lawsuit with the U.S. Department of Justice concerning unethical Zofran marketing tactics. The allegations described the company deliberately concealing Zofran side effects while directly advertising to pregnant mothers.

For being allegedly responsible for manufacturing, selling, distributing, and marketing a dangerous drug, Cynthia and Wayne are suing GlaxoSmithKline. The charges include: negligence, false advertising, concealing information, and misrepresenting a product.

This Zofran Lawsuit is Cynthia M. & Wayne M. v. GlaxoSmithKline, Case 1:15-cv-13207-FDS, in the U.S. District Court for the District of Massachusetts.