Atrial Septal Defect (ASD) Lawsuit

A Danish study reported an association between SSRI antidepressants such as Zoloft (sertraline) or Paxil (paroxetine), taken in early pregnancy, and septal heart defects in children. The authors described the absolute increase in prevalence as low. Plaintiffs in the Zoloft MDL, which sits in the Eastern District of Pennsylvania, allege that Zoloft causes birth defects in children when their mothers take it while pregnant. Zoloft is a prescription medication approved for depression and other ailments. No MDL or class action names atrial septal defects (ASD). Related claims are individual drug-injury claims, and the Zoloft MDL covers children whose mothers took Zoloft during pregnancy.

Latest Atrial Septal Defects Lawsuit Updates

April 17, 2012: Zoloft MDL 2342 Created

The Judicial Panel on Multidistrict Litigation created MDL 2342 in the Eastern District of Pennsylvania before Judge Cynthia M. Rufe [1]. The MDL centralizes claims alleging that Zoloft causes birth defects when mothers take it while pregnant. Pfizer, Inc. is a defendant. Pfizer and the other defendants deny the allegations.

September 23, 2009: BMJ Publishes Danish SSRI Study

Aarhus University researchers published a BMJ cohort study of 493,113 Danish children [2]. The study associated SSRI prescriptions in early pregnancy with septal heart defects. It reported an odds ratio of 1.99, with a 95% confidence interval of 1.13 to 3.53. The authors wrote that the absolute increase was low.

What Is an Atrial Septal Defect?

According to MedlinePlus, an atrial septal defect is a heart defect present at birth. A wall called the septum, which divides the upper heart chambers, does not form correctly [3]. MedlinePlus says atrial septal defects are defined as primum or secundum. Secundum defects can be a single small or large hole, or more than one small hole.

Who May Be Affected?

Children born with a septal heart defect may be affected if their mothers filled an SSRI prescription in early pregnancy. The Aarhus study named sertraline (Zoloft), citalopram and paroxetine (Paxil). The study counted prescriptions redeemed in the first trimester. The largest association was seen where mothers redeemed prescriptions for more than one type of SSRI. The Zoloft MDL involves children whose mothers took Zoloft during pregnancy. Whether a family has a claim depends on an individual legal review.

Reported Injuries or Damages

The injuries at issue are septal heart defects in children exposed to SSRIs before birth. In the Aarhus study, odds ratios for septal heart defects were 3.25 for sertraline and 2.52 for citalopram and 4.70 for more than one SSRI. Septal heart defects affected 0.5% of unexposed children (2,315 of 493,113). The rate was 0.9% with any SSRI (12 of 1,370) and 2.1% with more than one type (4 of 193). Fluoxetine’s ratio was 1.34, with an interval of 0.33 to 5.41. The authors wrote that the odds ratios “represent small absolute differences in prevalence.” These figures show an association. They do not prove that a drug caused any single defect.

Evidence to Preserve

Keep these records together, because they show the drug, the timing and the child’s diagnosis:

• Prescription and pharmacy records that show the drug, the dose and the dates.
• Prenatal and obstetric records from the pregnancy, plus birth and hospital records.
• Cardiology and echocardiogram reports, and any surgery or catheter-closure records.
• Medication labels and packaging from the drug the mother took.
• Medical bills and other costs tied to the child’s heart care.
• A timeline of when the drug was started and when it was stopped.

Filing Deadlines

Filing deadlines come from state law, so the time limit that applies to your family depends on where you live. The deadline can also depend on when the child’s heart defect was diagnosed. Missing a deadline can end a claim even when the facts are strong, so speak with a lawyer promptly about your family’s situation.

Frequently Asked Questions

Can Antidepressants During Pregnancy Cause Atrial Septal Defects?

Whether antidepressants taken during pregnancy cause atrial septal defects is not settled. The Aarhus authors wrote that even if SSRI use is causally related to septal heart defects, those defects might not necessarily require treatment.

What Does the Research Say About SSRIs and Heart Defects?

The research on SSRIs and heart defects includes a 2009 BMJ study. It found no association between SSRI use and major malformations overall, with an odds ratio of 1.21. It did find one for septal heart defects.

How Does an Atrial Septal Defect Affect Blood Flow?

An atrial septal defect affects blood flow because it lets blood move between the two upper heart chambers, which normally stay separate. MedlinePlus says blood most often flows from the left side to the right, and the right side of the heart then enlarges.

Are Small Atrial Septal Defects Less Likely to Cause Problems?

Very small atrial septal defects, less than 5 millimeters, are less likely to cause problems, according to MedlinePlus. It adds that smaller defects are often discovered much later in life than larger ones, and that the defect’s location also affects blood flow.

References

1. https://www.paed.uscourts.gov/mdl/mdl-2342-re-zoloft-sertraline-hydrochloride-products-liability-litigation
2. https://www.bmj.com/content/339/bmj.b3569.full
3. https://medlineplus.gov/ency/article/000157.htm