08 September 2015

Ohio Mother Claims Daughter’s Heart Defect Caused By Zofran

Recent court filings indicate that at least 34 Zofran lawsuits have been filed in Federal Courts. But many of the actual complaints have remained unavailable, leaving many stories of tragedy and perseverance untold, until now.

Monheit Law recently obtained a horde of court documents central to this ongoing litigation, which involves an anti-nausea drug that many families say causes birth defects. We’ll be making their stories public over the coming weeks.

In one of the most recent claims, a mother from South Euclid, Ohio, minutes from downtown Cleveland, says the drug caused her unborn daughter to develop a “large atrial septal defect.” The child, named A.T. in court documents, underwent open heart surgery at the age of three, according to her mother.

A reading copy of the complaint can be found below:

View Complaint: 1:15-cv-01435

Plaintiff brought her lawsuit in the US District Court for the Northern District of Ohio, Eastern Division. Filed on July 20, 2015, her claim was registered as case number 1:15-cv-01435.

At Three Years Old, Daughter Braved Open Heart Surgery, Mother Claims In New Zofran Lawsuit

Like so many American women, Plaintiff says she was prescribed Zofran to treat the symptoms of morning sickness during her first trimester.

Recent estimates suggest that as many as 1 million pregnant women in the US receive “off label” prescriptions for Zofran every year.

GlaxoSmithKline Promoted Zofran In Violation Of Federal Law, Government & Plaintiffs Allege

At the time, the mother was unaware of any potential link between the drug and major birth defects. Her lack of knowledge, she claims, was by GlaxoSmithKline’s own design.

In her complaint, she says “GSK simply chose not to study Zofran in pregnant women [before] market[ing] the drug for treatment during pregnancy.”

Echoing allegations originally leveled by the US Federal Government, Plaintiff claims GlaxoSmithKline mobilized a “nationwide fraudulent marketing campaign,” deceiving physicians across the country into believing Zofran’s safety during pregnancy had been established as safe and effective.

As she notes, the company has never undertaken a single study to investigate Zofran’s effect on fetal development.

Child’s First Nine Days Spent In NICU, Plaintiff Says, But Conclusive Diagnosis Only Comes Two Years Later

A.T., Plaintiff’s daughter, was born on January 20, 1995, after being allegedly exposed to Zofran throughout the most crucial periods of her prenatal development.

Chronic Lung Ailments Lead To Heart Diagnosis

Suffering from “lung-related issues, including pneumonia,” The newborn spent more than a week in the hospital’s Neonatal Intensive Care Unit (NICU). She was eventually discharged into her mother’s care, but would continue to suffer from breathing difficulties for years.

After two years, A.T. would finally be referred to a pediatric cardiologist and diagnosed with a congenital heart defect. A “large atrial septal defect,” or ASD, was found to be the cause of her lung issues.

This “hole in the heart” lies between the organ’s two uppermost chambers, and allows oxygen-rich blood to mix with oxygen-poor blood. Forced to pump harder than normal, the heart can create intense blood pressures that strain and ultimately damage blood vessels running through the lungs.

To learn more about atrial septal defect, visit the Heart Birth Defect Resource Center.

At Three, Child Placed On Cardiac Bypass Machine For Open Heart Procedure, Mother Claims

According to her mother, A.T.’s atrial septal defect was so large that it required almost immediate surgical intervention. The child underwent open heart surgery at the age of three.

She was placed on a cardiac bypass machine “for several hours,” during a procedure in which surgeons also attempted “to repair some of the damage to her lungs.” And while a post-operative diagnostic years later would find that her ASD had been repaired completely, A.T.’s mother claims the child continued to suffer from the effects on her lungs for years to come.

Two Major Studies Link Zofran To Atrial Septal Defect, Other Heart Abnormalities

Plaintiff notes two studies in support of her contention that Zofran caused A.T.’s birth defect.

“Andersen” Points To Specific Atrial Septal Defect Risk

Completed in 2012, the “Andersen” study conducted a systematic review of nearly 1 million Danish birth records. Among 1,368 pregnancies exposed to Zofran during the first trimester, 4.7% resulted in children with congenital abnormalities. Only 3.5% of babies not exposed were born with a birth defect.

Andersen’s authors found an increased risk for several congenital heart defects, including a 2.1 times increase in the risk for atrial septal defect. Elevated risks for ventricular and atrioventricular septal defects were also found.

“Danielsson” Finds Increase In All Cardiac Septal Defects

The “Danielsson” study came one year later. Reviewing over 1 million birth and prescription logs, researchers found a more than doubled risk for cardiac septal defects, including atrial septal defect, among babies exposed to Zofran during early pregnancy.

While the study’s sample size was unprecedented, Danielsson’s authors did not report a specific risk estimate for atrial septal defect.

“Pasternak” Flawed, Plaintiffs Claim, But Supplemental Data Suggest Increased Risks

Plaintiff also references an earlier Danish paper, the “Pasternak” paper. Published almost simultaneously with the Andersen study, Pasternak performed a significantly smaller review, looking at around 600,000 Danish pregnancies between 2004 and 2008. Many Plaintiffs, and some academics, have also criticized Pasternak for including women who began taking Zofran after the first trimester, and fetal organ formation, were complete.

Pasternak’s authors found no association between Zofran exposure and “a significantly increased risk of major adverse fetal outcomes.” But analyzing supplemental materials published along with the study, Plaintiffs in many Zofran lawsuits have said the additional data indicates an unreported increased risk.

In the recent Ohio claim, the mother writes that Pasternak’s data suggests babies exposed to Zofran prenatally are at a:

  • 22% increased risk for all cardiac septal defects
  • 41% increased risk for ventricular septal defects
  • over 400% increased risk for atrioventricular septal defects

Other Parents May Be Able To File Zofran Lawsuits

If these claims are true, any parent who was prescribed Zofran for morning sickness and delivered a child with birth defects may be eligible to file a claim against the drug’s manufacturer.

ZofranLegal.com is sponsored by a multi-state coalition of trial lawyers dedicated to protecting the rights of families and birth defect survivors. Led by Michael Monheit, Esq. of Monheit Law, our experienced attorneys are now investigating potential Zofran lawsuits.

For a free consultation, call 1-877-620-8411 or fill out our contact form.