Two new Zofran lawsuits have joined the dozens of birth defect lawsuits filed against GlaxoSmithKline, alleging that its drug can cause severe birth defects.

Both of these Zofran birth defect lawsuits allege that the drug caused facial deformities that required medical intervention.

Zofran is an anti-nausea medication, approved for treating the nausea that accompanies grueling cancer therapies like chemotherapy and radiation therapy. However, in the United States, physicians may legally prescribe drugs beyond their FDA approval.

This is called “off label” usage. However, drug makers are expressly forbidden from marketing drugs for off-label usage. Although Zofran was never officially tested or approved to treat morning sickness, and despite concerns about alleged Zofran birth defects, it has become the leading drug for mothers experiencing severe morning sickness.

The first of these lawsuits was filed by Plaintiff Vanessa B., on behalf of herself and her minor child J.S. Her Zofran lawsuit alleges that GlaxoSmithKline never specifically tested Zofran for safety in pregnant women, though animal studies in the 1980s indicate that the active ingredient in Zofran can cause birth defects in mammals.

Additionally, the Zofran lawsuit alleges that GSK received reports of Zofran birth defects in humans as early as 1992.

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.

In the case of J.S., Vanessa B. was prescribed the drug in 2009, during her pregnancy. According to her Zofran lawsuit, she has no family history of severe birth defects. When the child was born in September of 2009, he had a severe cleft palate, or a split running down the middle of the roof of his mouth and upper lip.

In other countries, this can prove fatal, as infants with cleft lips and cleft palates often cannot feed. Even in the U.S., a cleft palate requires quick and drastic surgical intervention to repair the damage.

The next case involved very similar circumstances and echoes many of the allegations that GSK knew about the risk of Zofran birth defects, but marketed the drug illegally for morning sickness. This Zofran lawsuit cites the same research and medical reports.

In this Zofran lawsuit, two parents, Plaintiffs Sierra E. and Antoine E. allege that the drug caused their child, Z.E. to suffer from serious birth defects. This included a constellation of facial and cranial bone defects.

Their Zofran lawsuit alleges that the child underwent genetic testing and no genetic anomalies that could cause the birth defects were detected, strongly suggesting that the birth defects were the result of Zofran.

The Zofran birth defect lawsuit states that the child required a bone graft at nine months to fix the problems, and still faces bullying and teasing from other children due to skull defects. Their Zofran lawsuit also states that further corrective surgeries are expected for the child, as well as speech therapy.

The growing number of Zofran lawsuits allege that GSK was aware of the risks of severe Zofran birth defects, but continued to push Zofran for off-label usage, leading to serious birth defects. Zofran lawsuits seek to recoup the cost of medical care and other costs allegedly linked to Zofran birth defects.

These Zofran Lawsuits are Case No. 1522, filed in the U.S. District Court for the Central District of California and Case No. 0319, filed in the U.S. District Court for the District of Idaho, Southern Division.