Overview
Zoloft birth defect lawsuits — MDL 2342, In re: Zoloft (Sertraline Hydrochloride) Products Liability Litigation, E.D. Pa., Judge Cynthia M. Rufe (per JPML). Plaintiffs allege prenatal sertraline (Zoloft and generics) exposure contributed to their children’s birth defects on failure-to-warn theories (per complaints). The FDA issued a drug safety communication on the reports in 2006 (per FDA). After the court excluded plaintiffs’ general causation experts (2014, per court orders and reports) and granted summary judgment for defendants in 300+ cases (2016, per court orders and reports), new individual claims (e.g., craniosynostosis) continue to be filed (per public dockets). Causation remains contested; we track the public record — we do not promise or predict outcomes.
Status of the science / claims: The FDA issued a drug safety communication on birth-defect reports in 2006 (per FDA). The court excluded plaintiffs’ general causation experts (2014) and granted summary judgment for defendants (2016) (per court orders and reports). Causation remains contested; new individual claims (e.g., craniosynostosis) continue to be filed (per public dockets).
Companies involved
Settlement amounts
No global settlement is on the public record for the consolidated action as of August 2026. The consolidated cases were largely dismissed after summary judgment for defendants (per court orders and reports). No payout amount is available or can be promised.
Key dates
- May 1, 2024New individual claims continue (e.g., craniosynostosis complaint, E.D. Pa., per public docket)
- January 5, 2016Summary judgment for defendants in 300+ cases (per court orders and reports)
- March 11, 2014Plaintiffs’ general causation experts excluded (per court orders and reports)
- April 17, 2012MDL 2342 established in E.D. Pa., Judge Rufe (per JPML)
- July 25, 2006FDA drug safety communication on birth-defect reports in Zoloft users (per FDA)
Updates
- Updated Aug 1, 2026Seeded from research (Aug 31, 2026): MDL 2342 (E.D. Pa., Judge Rufe); consolidated cases largely dismissed after 2014–2016 rulings; new individual claims continue (per public dockets).
Notable filings
No notable filings recorded yet. Docket entries are added from public court records as they appear.
FAQ
What is the Zoloft birth defects lawsuit about?
Plaintiffs allege prenatal sertraline (Zoloft and generics) exposure contributed to their children’s birth defects on failure-to-warn theories (per complaints). The MDL is In re: Zoloft (Sertraline Hydrochloride) Products Liability Litigation, MDL 2342, E.D. Pa., Judge Cynthia M. Rufe (per JPML).
Who is the defendant?
Pfizer, the maker of Zoloft (sertraline), is the principal defendant; some claims also involve generic manufacturers (per complaints and court records).
What did the court decide?
The court excluded plaintiffs’ general causation experts in 2014 and granted summary judgment for defendants in 300+ consolidated cases in 2016 (per court orders and reports).
Is the case over?
The consolidated MDL cases were largely dismissed after summary judgment (per court orders and reports), but new individual Zoloft claims continue to be filed (per public dockets, 2025–2026).
What did the FDA say?
The FDA issued a drug safety communication on the birth-defect reports in 2006 (per FDA). That communication predates the modern litigation.
How much will victims receive?
No global settlement is on the public record for the consolidated action as of August 2026. The consolidated cases were largely dismissed after summary judgment for defendants (per court orders and reports). No payout amount is available or can be promised.
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