Table of contents
- Latest Atrial Septal Defects Lawsuit Updates
- April 5, 2016: Court Grants Pfizer Summary Judgment in Zoloft MDL
- October 12, 2015: Philadelphia Judge Dismisses Zoloft Birth Defect Case
- April 17, 2012: Zoloft MDL 2342 Created
- September 23, 2009: BMJ Publishes Danish SSRI Study
- What Is an Atrial Septal Defect?
- Who May Be Affected?
- Reported Injuries or Damages
- Evidence to Preserve
- Filing Deadlines
- Frequently Asked Questions
- Is There a Lawsuit for Atrial Septal Defects?
- What Does the Research Say About SSRIs and Heart Defects?
- How Does an Atrial Septal Defect Affect Blood Flow?
- Are Small Atrial Septal Defects Less Likely to Cause Problems?
Children born with an atrial septal defect after prenatal exposure to Zoloft (sertraline) or other SSRIs are the subject of birth defect claims. A 2009 Danish study reported an association between early-pregnancy SSRI use and septal heart defects.
Plaintiffs in the Zoloft MDL, in the Eastern District of Pennsylvania, alleged that Zoloft caused birth defects in children when their mothers took it while pregnant.
No MDL or class action names atrial septal defects (ASD). The Zoloft MDL ended in summary judgment for Pfizer and the other defendants on April 5, 2016, and the court closed the cases except those with claims against other defendants.
Latest Atrial Septal Defects Lawsuit Updates
April 5, 2016: Court Grants Pfizer Summary Judgment in Zoloft MDL
Judge Cynthia M. Rufe of the Eastern District of Pennsylvania granted summary judgment to Pfizer in the Zoloft multidistrict litigation [1].
The court held the plaintiffs had not shown with admissible evidence that Zoloft was capable of causing their injuries. The ruling concerns the evidence in that litigation. It makes no medical finding about all SSRIs.
October 12, 2015: Philadelphia Judge Dismisses Zoloft Birth Defect Case
A Philadelphia state court judge, Mark Bernstein, granted Pfizer summary judgment and dismissed a Zoloft birth defect case, according to pharmafile [2].
Pfizer said the ruling followed two jury verdicts in its favor in recent months. That statement is Pfizer’s own position.
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 [3].
The MDL centralized claims alleging that Zoloft causes birth defects when mothers take it while pregnant. Pfizer, Inc. was 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 [4]. The study associated SSRI prescriptions in early pregnancy with septal heart defects (odds ratio 1.99, 95% confidence interval 1.13 to 3.53).
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 [5].
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?
A child with a septal heart defect whose mother filled an SSRI prescription in early pregnancy matches the circumstance studied. The study named sertraline (Zoloft), citalopram and paroxetine (Paxil) and grouped septal defects together.
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. 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 BMJ study, odds ratios were 3.25 for sertraline, 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
Is There a Lawsuit for Atrial Septal Defects?
Is there a lawsuit for atrial septal defects? Related Zoloft birth defect claims were heard in MDL 2342. On December 2, 2015, the court excluded plaintiffs’ expert Dr. Nicholas Jewell under Federal Rules of Evidence 403 and 702.
What Does the Research Say About SSRIs and Heart Defects?
What the research says about SSRIs and heart defects includes a finding on all malformations. The 2009 BMJ study found no association between SSRI use and major malformations overall, with an odds ratio of 1.21 and a 95% confidence interval of 0.91 to 1.62.
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.