GlaxoSmithKline eventually could face more than 1,000 Zofran lawsuits because the company allegedly conducted illegal marketing methods to promote the anti-nausea drug for morning sickness to unsuspecting pregnant women.

Zofran is only FDA-approved as a prescription medicine to treat nausea and vomiting in chemotherapy and surgical patients.

In recent years, GlaxoSmithKline encouraged its use for pregnant women suffering from the nausea and vomiting commonly known as morning sickness.

As a result of these heavy marketing efforts, even the medical community has been lulled into a false sense of security that the drug is safe.

Studies Show Zofran Allegedly Causes Cleft Palate

In 2006, Hong Kong researchers determined that Zofran crosses the placenta in measurable amounts.

Researchers warned that the “developmental significance of this drug exposure requires further investigation,” but since then, millions of women have had Zofran prescriptions written for them for morning sickness without knowing of the potential for birth defects.

A study in November 2011 stated that women who take Zofran for morning sickness could be 2.37 times more apt to give birth to a child with a cleft palate.

In this study from the medical journal Birth Defects Research Part A: Clinical and Molecular Teratology, researchers warn the facial deformity can occur when the fetus is adversely affected in the first trimester.

Zofran Lawsuits Identify Heart Defect Risks

Several different heart defects have been reportedly linked to Zofran for morning sickness.

In a study of more than 900,000 pregnancies in the Danish Medical Birth Registry, researchers found that infants could be two to four times more apt to be born with a septal defect that involves holes in the heart after the mother ingested Zofran during pregnancy.

Heart murmurs might be a first symptom of such a heart defect.

Medical Journal Reproductive Toxicology reported in October 2014 that there is a “statistically significant increased risk for certain heart defects” with Zofran ingestion early in a pregnancy.

Judge Creates New Procedure for Zofran Lawsuits

The U.S. District Judge presiding over litigation of Zofran lawsuits has created a Master and Short-Form Complaint to outline the common allegations that make up the claims.

More than 260 Zofran lawsuits are pending against GlaxoSmithKline regarding birth defects allegedly caused by Zofran use during pregnancy.

U.S. District Judge Dennis Saylor in the District of Massachusetts issued a federal MDL (multidistrict litigation) order on May 18th that provides a Master Complaint to be filed on behalf of all plaintiffs by May 31.

As a result, GlaxoSmithKline will need to file a Master Answer responding to the allegations by June 21.

Plaintiffs wishing to file Zofran lawsuits can bring a case in the MDL by filing an abbreviated Short Form Complaint that allows them to outline their specific claims and allegations.

Children born with birth defects as a result of their mothers taking Zofran for morning sickness deserve to have their day in court. GlaxoSmithKline allegedly failed to warn women and physicians about the potential risks of taking Zofran during pregnancy.