An Alabama woman filed a lawsuit against GalaxoSmithKline (GSK) alleging that its anti-nausea drug Zofran caused her baby to be born with birth defects.

Plaintiff Cali P. began using Zofran to treat her pregnancy-related nausea under her doctor’s care beginning in the first trimester.

Her child was born with cleft palate, and there was no family history of birth defects nor did genetic testing detect a genetic anomaly to explain the condition, according to the Zofran lawsuit.

The plaintiff further alleges that GSK misrepresented, both to her as a patient and to the medical profession, that Zofran is safe to use during pregnancy, thereby fraudulently concealing facts and information that could have allowed her to avoid injury to her child.

Cali’s lawsuit accuses GSK of negligence, strict products liability, fraudulent misrepresentation, fraudulent concealment, negligent misrepresentation, breaches of express and implied warranty, and loss of consortium (relationship) with her son as a result of the company’s actions.

The plaintiff is seeking general, consequential and compensatory damages, reimbursement for medical and hospital expenses, a refund on her purchase of Zofran, attorney’s fees and costs and pre-judgment and post-judgment interest. She is also seeking punitive damages in order to punish GSK for their conduct as described in the lawsuit.

The Zofran Birth Defects Lawsuit is Case No. 2:15-cv-0191-TMP, in the U.S. District Court for the Northern District of Alabama.

Zofran Use In Pregnancy

Zofran (odansetron) is a drug that was developed to treat the most severe forms of nausea that patients suffer as a result of chemotherapy, radiation and post-surgery. It was approved for that use in 1991.

According to allegations in numerous lawsuits, GalaxoSmithKline began marketing Zofran as a “wonder drug” for pregnant women despite any evidence that the drug was safe to use in pregnant women.

Other drugs were FDA approved to treat nausea in pregnant women, but GSK chose to not seek FDA approval for use in pregnant women but allegedly marketed its drug for the treatment of pregnancy-related morning sickness anyway.

Lawsuits against GSK also allege that the company avoided conducting studies because its marketing of the drug would have been hampered, thereby reducing profits when it was potentially found to cause birth defects in children.

Cali’s lawsuit went so far as to claim, “GSK’s conduct was tantamount to using expectant mothers and their unborn children as human guinea pigs.”

According to court documents, GSK has been aware since the 1980s that Zofran was unsafe for use in women due to the results of research study on other mammals.

GSK’s prenatal promotion of Zofran finally led to the FDA conducting an investigation. In 2012, GSK settled a federal, civil false claim lawsuit alleging GSK had promoted Zofran for the treatment of morning sickness in pregnant women despite being approved only for post-operative nausea, and that GSK had paid doctors kickbacks for prescribing Zofran. In 2012, GSK settled that lawsuit along with three similar lawsuits regarding other GSK products for $1.043 billion.

Filing a Zofran Lawsuit

If you took Zofran for the treatment of morning sickness during pregnancy and had a child born with birth defects, you may be entitled to legal compensation for your child’s injuries. An experienced Zofran attorney is available to review your case at no charge to you to assist you in determining your options for pursuing legal action.