Heart Birth Defect Associated With Zofran

Two Ohio Mothers File Zofran Lawsuits For Heart Defects

According to recent court motions, as of September 10, 2015, at least 34 Zofran lawsuits have now been filed in Federal Courts. From California to Massachusetts, families across the nation have accused pharmaceutical giant GlaxoSmithKline of promoting a potentially-dangerous nausea drug for use during pregnancy.

At least six claims have been brought in Alabama, the most of any state, but with the recent filing of two new Zofran lawsuits, Ohio has become a center for the litigation as well. At least 5 pending cases are now registered in the state.

In Ohio, Two Women File New Zofran Lawsuits

Like previous claims, the two recent lawsuits were filed by women who say the anti-nausea drug Zofran, a common but unapproved morning sickness treatment, caused their children’s major birth defects.

The parents filed their claims on the same day, July 20, 2015, in the US District Court for the Northern District of Ohio, Eastern Division. Both women are residents of South Euclid, a suburb of Cleveland.

In court documents, both claim they were prescribed Zofran during the first trimester of pregnancy, the most critical period of fetal organ formation. But notably, their exposure to the drug occurred years ago. One plaintiff’s pregnancy began in 1995, while the other became pregnant in 1999.

By Age Three, Girl Faces Open Heart Surgery

In the first of these recent lawsuits, case number 1:15-cv-01435, Plaintiff says her daughter A.T. was born on January 20, 1995. Far from a healthy newborn, the child was kept in the hospital’s neonatal intensive care unit (NICU) for nine days, as she struggled against breathing difficulties including, her mother writes, “pneumonia.” She was discharged eventually, but her lung issues would continue for years to come.

Congenital Heart DefectAlmost exactly two years after her birth, A.T.’s heart defect, the cause of her breathing problems, would finally be diagnosed. Cardiologists told the mother her daughter had a “large atrial septal defect,” a hole between the two uppermost chambers of her heart. The defect proved so large, Plaintiff claims, that open heart surgery became necessary. A.T. was placed on a cardiac bypass machine “for several hours,” as surgeons tried to patch the hole between her atria.

Thankfully, A.T.’s mother says that her atrial septal defect has now “completely mended.” But attempts to repair her damaged lungs have thus far failed. A.T. continues to live with “difficulty breathing, asthma and allergies,” her mother writes.

A copy of the mother’s complaint can be found below:

View Complaint: 1:15-cv-01435

Heart Defect Only Diagnosed After Three Years

For all their similarities, the second lawsuit, filed under case number 1:15-cv-01436, tells a strikingly different story.

Plaintiff’s child A.F. was born on July 3, 1999, by all appearances a perfectly healthy baby girl. It would take 3 to 4 years after A.F.’s birth for a pediatrician to notice the sound of a “heart murmur” signaling the presence of a congenital heart defect.

Heart Birth Defect Associated With ZofranAfter being referred to a cardiologist, the girl would be diagnosed with a ventricular septal defect. Like the atrial septal defect with which A.T. was born, A.F.’s heart chambers were incompletely separated. But the hole sits between her heart’s two lower chambers, the ventricles responsible for pumping blood to the lungs and body.

Unlike A.T., A.F.’s cardiologists decided on a non-surgical approach, hoping the hole would close of its own accord. In the meantime, A.F. was subjected to routine monitoring, placing a significant financial burden on the young family, Plaintiff writes. But the specter of invasive procedures, the mother writes, is never far from their minds: “over the years, Plaintiff and A.F. have faced the prospect A.F. might require open-heart surgery to repair her condition.”

Now 16, A.F.’s heart defect has yet to close, her mother says.

Click the button below to read more from the complaint:

View Complaint: 1:15-cv-01436

Without “A Single Study,” Zofran Became America’s Leading Morning Sickness Drug

Many of the allegations raised by these two women will be familiar to readers who have followed the Zofran litigation closely.

Zofran has been approved since 1991, but its approval only includes patients experiencing nausea and vomiting due to chemotherapy, radiotherapy and surgical anesthesia.

To date, GlaxoSmithKline has made no concerted effort to study Zofran’s effects during pregnancy. Despite this fact, Plaintiffs accuse the company of promoting the drug directly to obstetricians and gynecologists as a “safe and effective” morning sickness treatment.

This is no idle accusation. In 2012, the US Federal Government leveled an identical accusation against GlaxoSmithKline, charging the company for marketing Zofran for pregnancy-related nausea in violation of federal law. The company has always denied this claim, but federal prosecutors maintain their charges are well-founded.

Regardless, Zofran is currently America’s leading pharmaceutical drug for morning sickness, with an estimated 1 million “off label” prescriptions written to pregnant women every year.

Studies Link Zofran To Heart Defects

While the drug’s own manufacturer has never investigated Zofran’s potential effects during fetal development, others have proved more willing.

In 2013 and 2014, two groups of researchers combed through millions of Danish and Swedish birth records, searching for women exposed to Zofran during the first trimester. After rigorous statistical analysis, these women were found to be at an increased risk for delivering babies with congenital heart defects.

A particularly marked risk was identified for cardiac septal defects, “hole in the heart” like those with which A.F. and A.T. were born in the recent complaints.

Learn more about these, and other, studies linking Zofran to birth defects here.

Future Of Lawsuits Uncertain, But Consolidation Seems Likely

With the filing of these two new claims, at least 34 Zofran lawsuits have been filed in 15 different states. State caseloads may become important now, as Plaintiffs and Glaxo continue to debate where the claims should be consolidated.

The benefits of taking this step, which would see current lawsuits transferred to a single court for more efficient evidence-gathering, are not in dispute. But GlaxoSmithKline’s chosen venue, near the company’s Philadelphia headquarters, has become a point of contention. Arguing against giving Glaxo a “home court advantage,” Plaintiffs have suggested Alabama, Massachusetts and Ohio as possible alternatives.

The matter will be argued in October, 2015, at a hearing of the Judicial Panel on Multi-District Litigation.