Zofran Heart Defects Blamed for Death of Newborn: Lawsuit

GlaxoSmithKline faces a wrongful death lawsuit brought by the family a baby girl who died of heart defects allegedly caused by the side effects of Zofran, which was used for treatment of morning sickness while her mother was pregnant. 

The complaint (PDF) was filed in the U.S. District Court for the Northern District of Ohio on June 10, by Patrick and Valerie Reagan, as a result of the 2006 death of their daughter, Molly Reagan.

According to allegations raised in the lawsuit, GlaxoSmithKline illegally promoted their anti-nausea off-label to pregnant women without warning about the potential link between Zofran and heart defects when used during the first trimester of pregnancy.

Zofran (ondansetron) is a prescription medication for treatment of nausea and vomiting, which is only approved for use among cancer and surgery patients. However, it is commonly used among pregnant women for treatment of morning sickness or pregnancy-associated nausea and vomiting.

Valerie Reagan was prescribed Zofran by her physician to combat morning sickness during her pregnancy. Nine days before Molly was born, her heart began to decelerate. When Molly was born, on March 17, 2006, she was immediately diagnosed as having a right ventricle heart defect and was placed in an intensive care unit, where she died three days after her birth.

The Reagans became activists to raise awareness about ventricle heart defects, but indicate that they only recently became of aware of that their daughter’s condition may have been caused by Zofran.

The case joins a growing number Zofran heart defect lawsuits filed in recent months by families throughout the U.S., which allege that GlaxoSmithKline knew or should have known about the risks associated with using their medication during pregnancy, yet failed to adequately warn women or the medical community. The drug maker also faces similar claims brought by families that indicate inadequate information was provided about the risk of cleft lip and cleft palate from Zofran.

Zofran Birth Defect Risks

Although Zofran is not approved by the FDA for treatment of morning sickness, GlaxoSmithKline has allegedly engaged in illegal marketing.

As a result, a false assumption exists within the medical community that the medication is safe during pregnancy, despite a number of studies that have highlighted Zofran pregnancy risks when the drug is used during the first trimester.

As early as 2006, a study published by Hong Kong researchers confirmed that Zofran crosses the placenta in significant amounts when taken by pregnant women. Researchers concluded that the “developmental significance of this drug exposure requires further investigation,” yet millions of women have continued to be prescribed the medication without warnings about the potential Zofran birth defect risks.

In November 2011, a study published in the medical journal Birth Defects Research Part A: Clinical and Molecular Teratology concluded that women may be 2.37 times more likely to give birth to a child with a cleft palate following Zofran use. This may leave children with a severe facial deformity like Jacob’s, which can occur when development of the fetus is impacted during the first trimester.

Additional studies have also identified potential Zofran heart defect risks. An August 2013 study that reviewed data on more than 900,000 pregnancies in the Danish Medical Birth Registry found that children may be two to four times more likely to suffer a septal defect, involving holes in the heart, following Zofran exposure. Heart murmurs following Zofran use during pregnancy may be a sign or symptom of these heart problems.

More recently, a study published by the medical journal Reproductive Toxicology in October 2014 found that there is a statistically significant increased risk for certain heart defects with Zofran use early in pregnancy.

The Reagan lawsuit accuses GlaxoSmithKline of failure to warn, designing a defective drug, gross negligence, negligence, fraudulent promotion, fraud by concealment, fraudulent and negligent misrepresentation, breach of warranty, inflicting emotional distress, and loss of consortium. The couple seeks both compensatory and punitive damages.