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Risperdal
ClosedFLATMDL 2767Pharma
900+
Total Cases
Causation
Risperdal (risperidone) elevates prolactin levels far more than other antipsychotics, stimulating breast tissue growth. Boys and young men prescribed Risperdal developed gynecomastia requiring surgical mastectomy in severe cases. Internal J&J documents revealed the company knew Risperdal caused prolactin elevation at rates significantly higher than reported in labeling. J&J was found to have illegally marketed Risperdal to children and elderly dementia patients, resulting in a $2.2 billion DOJ settlement in 2013. Philadelphia jury verdicts of $2.5M (2015) and $70M (2016) confirmed corporate knowledge and concealment.
Defendants
| Entity | Role | Note |
|---|---|---|
| Janssen Pharmaceuticals | Manufacturer | J&J subsidiary — marketed and sold Risperdal in the US |
| Johnson & Johnson | Parent Company | Corporate parent — oversaw Risperdal marketing strategy |
| Janssen Research & Development | Drug Developer | Conducted clinical trials and managed regulatory submissions |
Litigation Timeline
1993
FDA approves Risperdal for schizophrenia in adults
2006
FDA approves Risperdal for pediatric use (autism irritability, bipolar)
2015-2019
Philadelphia bellwether trials — verdicts up to $70M
2020-2023
Settlement programs resolve majority of 900+ cases
2025-2026
Residual cases pending — MDL largely resolved
Intelligence Signals
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Key Facts
- Status
- active
Geographic Exposure
·E.D. Pa. (MDL 2767, Judge Rufe)
·Philadelphia Court of Common Pleas (major verdict jurisdiction)
·Nationwide — most cases resolved
·California state court proceedings
Eligibility Criteria
- ✓Male who took Risperdal (risperidone) as a minor or young adult
- ✓Diagnosed with gynecomastia (abnormal breast tissue growth)
- ✓Gynecomastia developed during or after Risperdal use
- ✓Required surgical intervention (mastectomy) for breast tissue removal