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Formation
Active Litigation
Maturation
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45–55
55–70
70+
Valsartan
ClosedFLATMDL 2875Pharma
1,400+
Total Cases
Causation
NDMA (N-Nitrosodimethylamine), classified by IARC as a probable human carcinogen (Group 2A), was generated as a byproduct during valsartan API synthesis at Zhejiang Huahai after a 2012 process change. Patients ingested NDMA-contaminated medications for up to six years before FDA detection in 2018. NDMA causes liver cancer in animal studies and is linked to gastric, colorectal, and liver cancers in humans. The contamination also affected losartan and irbesartan products from multiple generic manufacturers.
Defendants
| Entity | Role | Note |
|---|---|---|
| Zhejiang Huahai Pharmaceutical | API Manufacturer | Chinese manufacturer whose 2012 process change introduced NDMA contamination |
| Hetero Labs Limited | API Manufacturer | India-based generic API supplier — alternate valsartan source |
| Mylan N.V. | Generic Distributor | Distributed contaminated valsartan tablets in US market |
| Teva Pharmaceutical | Generic Distributor | Distributed contaminated valsartan and losartan products |
| Novartis / Sandoz | Original Manufacturer | Developed Diovan (brand valsartan); Sandoz generic arm also affected |
Litigation Timeline
2012
Zhejiang Huahai changes manufacturing process — introduces NDMA contamination
2018-2019
Recalls expand to losartan and irbesartan — dozens of manufacturers affected
2020-2022
Bellwether discovery and expert depositions
2023-2024
Most claims resolved through settlement programs and dismissals
Intelligence Signals
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Key Facts
- Status
- active
Geographic Exposure
·D.N.J. (MDL 2875, Judge Martinotti)
·Nationwide — millions of patients affected by recalls
·International recalls in EU, Canada, and Asia-Pacific
Eligibility Criteria
- ✓Took valsartan, losartan, or irbesartan from a recalled manufacturer
- ✓Took contaminated medication for 6+ months
- ✓Diagnosed with liver, stomach, intestinal, or other NDMA-associated cancer
- ✓Diagnosis occurred during or after use of recalled ARB medication