A California mother who claims Zofran side effects caused her daughter’s birth defects has filed a Zofran lawsuit against GlaxoSmithKline (GSK).

Plaintiff Melisa A. filed the Zofran lawsuit on behalf of her daughter, who was born in 2002. Melisa took Zofran to treat morning sickness during her first trimester of pregnancy. Her daughter was born with several birth defects, including kidney problems.

The Zofran lawsuit further specifies that Melisa’s daughter was exposed to Zofran in utero during the periods when her heart was developing and was susceptible to developmental complications from this exposure to the anti-nausea drug.

According to the Zofran lawsuit, GSK illegally marketed its drug as a morning sickness treatment. GSK also failed to warn pregnant women as well as the medical community about the findings of Zofran studies. These studies linked the use of the medication during the first trimester to a potential risk of harm including heart defects and other serious birth defects.

The Zofran lawsuit states “GSK not only concealed this knowledge from healthcare providers and consumers in the United States, and failed to warn of the risk of birth defects, but GSK also illegally and fraudulently promoted Zofran to physicians and patients specifically for the treatment of morning sickness in pregnant women.”

Melisa’s attorneys claim GSK knew that their anti-nausea medication could cross the placenta based on animal studies from the 1980s.

Melisa is seeking all general, consequential, compensatory, and punitive damages, and medical expenses for GSK’s negligence in the off-label promotion of Zofran for morning sickness.

Zofran During Pregnancy

Zofran, also known by its generic name ondansetron, is approved by the Food and Drug Administration to treat or prevent nausea and vomiting caused by chemotherapy and radiation therapy treatment for cancer and for post-operative nausea.

Ondansetron is not approved for use during pregnancy, but many women have received the medication as an “off-label” prescription for the treatment of morning sickness during pregnancy.

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 May Have Illegally Promoted Zofran

As far back as 1999, GSK was warned by the FDA for illegal marketing practices regarding Zofran.  The manufacturer was accused of failing to adequately disclose potential risks while aggressively promoting the benefits of the drug.

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.

Zofran Lawsuits

Families, mothers and their children who have had birth defects or been injured by Zofran use may be eligible to receive monetary compensation for medical costs, lost wages or pain and suffering.

Lawsuits have already been filed against GSK regarding birth defects and injuries caused by Zofran use and many more are expected.

The Zofran Birth Defect Lawsuit is Case No: 1:15-cv-13743-FDS, in the U.S. District Court for the Central District of California.