MDL Track
MDL 3178
ByHeart infant botulism litigation
Pharmaceutical · claims alleging ByHeart infant formula was contaminated with harmful bacteria or foreign substances, causing illness in infants
Defendant
ByHeart, Inc.
MDL / Track
MDL 3178
S.D.N.Y.
Judge
Judge Denise L. Cote
Plaintiffs
18 pending
Bellwether / Trial
No verdicts yet
Settlement Status
No settlements yet
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Case overview
The JPML will consider consolidating ByHeart infant formula botulism lawsuits in March 2026, as litigation expands following FDA confirmation that ByHeart Whole Nutrition formula is the source of a multistate outbreak. At least 51 infants in 19 states have developed infant botulism, with cases dating back to March 2022, prompting a total product recall and multiple individual and class action filings including Valenzuela v. ByHeart Inc., E.D.N.Y., filed Nov. 13, 2025, and Everett v. ByHeart Inc., E.D. Ky., Case No. 5:25-cv-00422, filed Nov. 12, 2025.
Causation Theory
Infant botulism results from ingestion of Clostridium botulinum spores that germinate in the immature infant gut, producing botulinum neurotoxin that causes flaccid paralysis. FDA testing confirmed C. botulinum Type A toxin in finished product samples, and whole genome sequencing by the New York Wadsworth Laboratory matched the strain to outbreak cases. ByHeart's independent testing found 6 of 36 samples from two batches positive for C. botulinum, and FDA investigators have identified persistent contamination across all production runs since March 2022, suggesting a systemic source likely in raw materials or manufacturing environment rather than isolated lots.
Case Management Orders
Litigation status
Plaintiffs filed a motion to establish MDL on January 15, 2026, seeking consolidation in the Southern District of New York before Judge Denise L. Cote. The JPML scheduled oral argument for March 26, 2026, in Birmingham, Alabama. At least 18 federal cases are pending, including personal injury and economic loss class actions.
MDL Track
MDL 3178
ByHeart infant botulism litigation
State Court Activity
Economic loss class action filed in E.D.N.Y. (Valenzuela v. ByHeart Inc., Nov. 13, 2025); consumer protection class action filed in S.D.N.Y. (Rachwal et al. v. ByHeart Inc., Dec. 2, 2025)
Geographic exposure
51 infants across 19 states with confirmed/suspected infant botulism and ByHeart formula exposure as of December 10, 2025; CDC expanded case definition to March 2022-present. All 51 hospitalized; zero deaths. Nationwide retail distribution through Walmart, Target, Kroger, Acme, Shaw's, and Amazon (including Guam, Puerto Rico, and 21 international markets). FDA cannot rule out contamination across all product lots since March 2022 launch. Source: CDC, FDA, AP News December 10, 2025.
8 confirmed infant botulism cases — highest state count. All 39 outbreak infants hospitalized; Texas represents 20.5% of national cases. Illness onset dates August 9 to November 19, 2025. Source: CDC/FDA outbreak data as of December 3, 2025 (Food Poison Journal, Marler Blog).
5 confirmed cases; California Department of Public Health (CDPH) and Infant Botulism Treatment and Prevention Program (IBTPP) led outbreak identification. CDPH first detected cluster. Source: CDC/FDA joint investigation (Food Poison Journal, Marler Blog).
3 confirmed cases. Source: CDC case count map, December 3, 2025 (Food Poison Journal, Marler Blog).
4 confirmed cases; Blendhouse Portland LLC packaging facility located here. FDA March 2025 inspection classified No Action Indicated (NAI). Source: FDA Establishment Inspection Reports (EIRs) released November 26, 2025 (Food-Safety.com).
Allerton manufacturing site (Blendhouse Allerton, LLC). FDA February 2025 inspection issued Form 483 citing rodent activity, rusty surfaces, C. sakazakii-positive environmental swabs, and release of unapproved ingredient. Classified Voluntary Action Indicated (VAI). Source: FDA Form 483, February 2025 (Food-Safety.com).
1 confirmed case; Reading facility (Blendhouse LLC) shuttered September 2023. FDA January 2024 inspection classified Official Action Indicated (OAI) for moldy water tank, leaking roof, dead insects. Source: FDA EIRs, January 2024 (Food-Safety.com).
2 confirmed cases. Source: CDC case count, December 3, 2025 (Food Poison Journal, Marler Blog).
2 confirmed cases. Source: CDC case count, December 3, 2025 (Food Poison Journal, Marler Blog).
2 confirmed cases. Source: CDC case count, December 3, 2025 (Food Poison Journal, Marler Blog).
2 confirmed cases. Source: CDC case count, December 3, 2025 (Food Poison Journal, Marler Blog).
Key defendants
ByHeart, Inc.
Role: Manufacturer
Core defendant in infant botulism outbreak with 51 cases across 19 states. Third Amended Complaint filed Feb. 2026 in W.D. Wash. (Wescott et al.) adds supply chain defendants. Prior 2022 Cronobacter recall and August 2023 FDA Warning Letter create pattern-of-conduct exposure.
Target Corporation
Role: Retailer
Named in Wescott et al. Third Amended Complaint. Strict liability and warranty claims for retail distribution. Standard indemnity posture—likely to tender defense upstream.
Organic West, Inc.
Role: Ingredient Supplier
Added Feb. 2026 in Wescott Third Amended Complaint. Supplied whole milk powder with genetically matched C. botulinum per FDA WGS analysis. Halted pediatric milk powder sales post-recall.
Dairy Farmers of America, Inc.
Role: Processor
Added Feb. 2026 in Wescott Third Amended Complaint. Processed whole milk into contaminated powder for Organic West. Genetic sequencing links processing to finished ByHeart product.
| Defendant | Role | Intelligence Note |
|---|---|---|
| ByHeart, Inc. | Manufacturer | Core defendant in infant botulism outbreak with 51 cases across 19 states. Third Amended Complaint filed Feb. 2026 in W.D. Wash. (Wescott et al.) adds supply chain defendants. Prior 2022 Cronobacter recall and August 2023 FDA Warning Letter create pattern-of-conduct exposure. |
| Target Corporation | Retailer | Named in Wescott et al. Third Amended Complaint. Strict liability and warranty claims for retail distribution. Standard indemnity posture—likely to tender defense upstream. |
| Organic West, Inc. | Ingredient Supplier | Added Feb. 2026 in Wescott Third Amended Complaint. Supplied whole milk powder with genetically matched C. botulinum per FDA WGS analysis. Halted pediatric milk powder sales post-recall. |
| Dairy Farmers of America, Inc. | Processor | Added Feb. 2026 in Wescott Third Amended Complaint. Processed whole milk into contaminated powder for Organic West. Genetic sequencing links processing to finished ByHeart product. |
Timeline
ByHeart Recalls Five Batches for Cronobacter
ByHeart voluntarily recalls five batches of infant formula after sample tests positive for Cronobacter sakazakii at packaging plant. FDA subsequently issues Warning Letter citing inadequate process controls.
FDA Shuts Down Pennsylvania Plant
FDA shuts down ByHeart's Reading, Pennsylvania facility after inspectors find mold in clean water tank, thousands of dead insects, roof leaks, and unreported temperature variations affecting kill steps for microbiological contaminants.
CDC Alerts Public to Botulism Outbreak
CDC and FDA alert public to multistate infant botulism outbreak after California officials identify cluster of cases linked to ByHeart formula. California Department of Public Health detects botulinum toxin in open can of ByHeart formula.
ByHeart Expands Recall to All Products
ByHeart recalls all unexpired powdered infant formula products nationwide. Company later confirms Clostridium botulinum Type A found in five of 36 samples across three lots.
First Lawsuit Filed in E.D. Kentucky
Everett v. ByHeart Inc. filed in U.S. District Court for the Eastern District of Kentucky, Case No. 5:25-cv-00422, on behalf of infant hospitalized with botulism after consuming ByHeart formula. Plaintiffs allege defective product and negligence.
CDC Expands Outbreak to 51 Cases, 19 States
CDC and FDA expand outbreak case definition to include all ByHeart formula produced since March 2022. Outbreak now encompasses at least 51 infants in 19 states, with officials stating contamination may have affected all production runs.
Plaintiffs File MDL Petition
Families affected by ByHeart infant botulism outbreak petition U.S. Judicial Panel on Multidistrict Litigation to consolidate federal lawsuits into single MDL for coordinated pretrial proceedings.
JPML To Consider MDL Consolidation
U.S. Judicial Panel on Multidistrict Litigation scheduled to hear argument on plaintiffs' petition to centralize ByHeart infant botulism litigation. No MDL number yet assigned.
Statute of limitations
MDL consolidation petition pending before JPML, with hearing scheduled March 2026. Outbreak period: December 2023 to December 1, 2025 per CDC. 51 infants hospitalized across 19 states. FDA confirmed C. botulinum Type A toxin in finished product and organic whole milk powder ingredient. Kentucky's 1-year SOL creates urgent screening priority for earliest-exposure cases.
⚠Kentucky
1 year from injury
Rule: Ky. Rev. Stat. § 413.140(1)(a) — products liability actions subject to 1-year SOL; discovery rule applies
Discovery: Accrues when injury is discovered or should have been discovered through reasonable diligence
First-filed ByHeart botulism case: Everett v. ByHeart, Inc., E.D. Ky. Case No. 25-cv-00422 (Nov. 12, 2025). JPML consolidation hearing scheduled March 2026.
New York
3 years from injury
Rule: N.Y. C.P.L.R. § 214(2) — strict products liability; 3-year SOL with discovery rule
Discovery: Accrues when injury and its causal link to product are discovered or reasonably discoverable
Class action filed E.D.N.Y. Nov. 13, 2025. No revival statute applicable.
California
2 years from injury
Rule: Cal. Code Civ. Proc. § 335.1 — strict liability for product defect; discovery rule codified
Discovery: Accrues when plaintiff discovers or should discover injury and its cause
12 confirmed cases, highest state count. CDPH/IBTPP leading outbreak investigation.
Texas
2 years from injury
Rule: Tex. Civ. Prac. & Rem. Code § 16.003 — products liability; discovery rule applies per Jolly v. Eli Lilly & Co.
Discovery: Accrues when injury becomes inherently undiscoverable and objectively verifiable
8 confirmed cases.
Illinois
2 years from injury
Rule: 735 Ill. Comp. Stat. 5/13-202 — strict products liability; discovery rule applies
Discovery: Accrues when plaintiff knows or reasonably should know of injury and causal connection
2 confirmed cases.
Arizona
2 years from injury
Rule: Ariz. Rev. Stat. § 12-542 — products liability; discovery rule applies
Discovery: Accrues when plaintiff discovers or reasonably should discover cause of action
5 confirmed cases.
Oregon
2 years from injury
Rule: Or. Rev. Stat. § 12.110 — products liability; discovery rule applies
Discovery: Accrues when injury and its causal connection are discovered or reasonably should be discovered
4 confirmed cases.
| State | SOL | Rule | Discovery Rule | Notes |
|---|---|---|---|---|
| ⚠Kentucky | 1 year from injury | Ky. Rev. Stat. § 413.140(1)(a) — products liability actions subject to 1-year SOL; discovery rule applies | Accrues when injury is discovered or should have been discovered through reasonable diligence | First-filed ByHeart botulism case: Everett v. ByHeart, Inc., E.D. Ky. Case No. 25-cv-00422 (Nov. 12, 2025). JPML consolidation hearing scheduled March 2026. |
| New York | 3 years from injury | N.Y. C.P.L.R. § 214(2) — strict products liability; 3-year SOL with discovery rule | Accrues when injury and its causal link to product are discovered or reasonably discoverable | Class action filed E.D.N.Y. Nov. 13, 2025. No revival statute applicable. |
| California | 2 years from injury | Cal. Code Civ. Proc. § 335.1 — strict liability for product defect; discovery rule codified | Accrues when plaintiff discovers or should discover injury and its cause | 12 confirmed cases, highest state count. CDPH/IBTPP leading outbreak investigation. |
| Texas | 2 years from injury | Tex. Civ. Prac. & Rem. Code § 16.003 — products liability; discovery rule applies per Jolly v. Eli Lilly & Co. | Accrues when injury becomes inherently undiscoverable and objectively verifiable | 8 confirmed cases. |
| Illinois | 2 years from injury | 735 Ill. Comp. Stat. 5/13-202 — strict products liability; discovery rule applies | Accrues when plaintiff knows or reasonably should know of injury and causal connection | 2 confirmed cases. |
| Arizona | 2 years from injury | Ariz. Rev. Stat. § 12-542 — products liability; discovery rule applies | Accrues when plaintiff discovers or reasonably should discover cause of action | 5 confirmed cases. |
| Oregon | 2 years from injury | Or. Rev. Stat. § 12.110 — products liability; discovery rule applies | Accrues when injury and its causal connection are discovered or reasonably should be discovered | 4 confirmed cases. |
Live intelligence
AI litigation brief
ByHeart Infant Formula remains early-stage / recently consolidated with 22 current signals in the accepted feed.
Overview
Plaintiffs filed a motion to establish MDL on January 15, 2026, seeking consolidation in the Southern District of New York before Judge Denise L. Cote. The JPML scheduled oral argument for March 26, 2026, in Birmingham, Alabama. At least 18 federal cases are pending, including personal injury and economic loss class actions.
Key developments
Trajectory
Court filings and press coverage are both active in MDL 3178, pointing to sustained litigation pressure rather than a one-off headline cycle. 4 live sources are contributing current context.
Editorial intelligence
MDL 3178 should stay on the lead docket watch because it is the primary consolidation vehicle for ByHeart Formula.
Generated Apr 5, 2026, 3:00 PM UTC
22 events detected
Google News (11)
19 ByHeart Infant Formula Botulism Suits Centralized In NY - Law360
ByHeart Botulism Infant Formula Cases consolidated in New York Federal Court - Marler Blog
SAFETY ALERT: Recalled infant formula still found for sale, SCDA warns - WRDW
Recalled baby formula still on shelves in SC, parents urged to toss it immediately - WMBF
We Tested 41 Baby Formulas for Lead and Arsenic - Consumer Reports
Outbreak Investigation of Infant Botulism: Infant Formula (November 2025) - fda.gov
Outbreak Investigation of Infant Botulism: Infant Formula (November 2025) - fda.gov
Outbreak Investigation of Infant Botulism: Infant Formula (November 2025) - fda.gov
Public Health Alerts: Multistate infant botulism outbreak associated with powdered infant formula - CIDRAP
Multistate Infant Botulism Outbreak Associated with Powdered Infant Formula - NEJM Evidence
Two companies supplied dried milk powder linked to botulism in ByHeart baby formula - PBS
Journal of agricultural and food chemistry • Lu F • PMID 41927106 • Journal Article.
Journal of microbiology and biotechnology • Kong M • PMID 41889029 • Journal Article.
Microorganisms • Forsythe S • PMID 41900353 • Journal Article.
Microorganisms • Fang L • PMID 41900332 • Journal Article.
Nature communications • Liu B • PMID 41776158 • Journal Article.
No recent FDA signals. Monitoring is active — this section updates automatically.
Hilmar Cheese Company, Inc. v. ByHeart, Inc.
caed
Federal court result for ByHeart Infant Formula: Complaint • District Court, E.D. California • 1:26-cv-02470 • Jennifer L. Thurston
Hilmar Cheese Company, Inc. v. ByHeart, Inc.
caed
Federal court result for ByHeart Infant Formula: COMPLAINT against Hilmar Cheese Company, Inc. by Hilmar Cheese Company, Inc.. Attorney Thomas, John B. added. (Attachments: # 1 Civil Cover Sheet)(Thomas, John) (Entered: 03/31/2026) • District Court, E.D. California • 1:26-at-01656
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LexGenius Ranking
78Score
Court, news, and regulatory activity are elevated
Monitoring
Live
monitoring
Last: Apr 5, 2026, 3:00 PM UTC
Next: 19:10
Source Monitoring
PACER
PACER
Google News
FDA
PubMed
Event feed
22
events detected
AI Brief
ByHeart Infant Formula remains early-stage / recently consolidated with 22 current signals in the accepted feed.
Overview
Plaintiffs filed a motion to establish MDL on January 15, 2026, seeking consolidation in the Southern District of New York before Judge Denise L. Cote. The JPML scheduled oral argument for March 26, 2026, in Birmingham, Alabama. At least 18 federal cases are pending, including personal injury and economic loss class actions.
Key developments
PACER court filing on Mar 30: Hilmar Cheese Company, Inc. v. ByHeart, Inc.. ‖ Law360 news on Apr 3: 19 ByHeart Infant Formula Botulism Suits Centralized In NY - Law360. ‖ PubMed research on Apr 2: A Signature Peptide Strategy for Concurrent Detection of Multiple Pathogens and Toxins in Infant Formula..
Generated Apr 5, 2026, 3:00 PM UTC
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