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Active litigation category4 eventsPharmaceutical

Oxbryta

Pharmaceutical · drug-safety monitoring around Oxbryta and possible litigation tied to adverse events or market actions

Defendant

Pfizer Inc.

MDL / Track

See litigation status

N.D. Cal.

Judge

Judge Trina L. Thompson

Plaintiffs

ACTIVE

Bellwether / Trial

No verdicts yet

Settlement Status

  • At least one confidential federal settlement filed in N.D. Cal. in 2026
  • wrongful death settlement in principle reached
  • adult VOC plaintiff Maurice Frazier settlement agreement being finalized
  • child plaintiff Z.C. resolved out of court
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← Torts Case overview Litigation status Geographic exposure Key defendants Timeline Statute of limitations Live activity News PubMed openFDA Court filings

Case overview

Pfizer and Global Blood Therapeutics face coordinated product-liability litigation in the Northern District of California after voluntarily withdrawing Oxbryta (voxelotor) from all global markets on September 25, 2024. The withdrawal followed post-marketing studies showing mortality imbalances and increased vaso-occlusive crisis rates versus placebo, with the FDA issuing a safety alert on September 26, 2024, and the EMA recommending suspension. Key pending cases include Allen v. Global Blood Therapeutics, Inc., No. 3:24-cv-07786 (N.D. Cal.), with trial set for June 7, 2027, and Jolly et al. v. Global Blood Therapeutics, Inc., No. 3:24-cv-09345 (N.D. Cal.), where defendants have moved to dismiss on federal preemption grounds. No MDL has been formed.

Causation Theory

Plaintiffs' causation theory rests on four post-marketing studies—HOPE Kids 2, RESOLVE, RETRO, and PROSPECT—that collectively showed increased vaso-occlusive crises and mortality imbalances in voxelotor-treated patients versus controls. HOPE Kids 2 recorded eight deaths in the voxelotor arm against two on placebo; RESOLVE showed fatal event imbalances in Sub-Saharan Africa; preliminary registry data from RETRO and PROSPECT suggested increased acute pain crises post-initiation. The FDA's September 26, 2024 safety communication confirmed higher VOC rates and more deaths in postmarketing trials. The EMA's Article 20 referral review concluded the mechanism for excess VOCs and deaths had not been established. Individual causation is contested because sickle cell disease itself causes baseline VOCs and fatalities, and final registry data showed investigators attributed no deaths to voxelotor treatment.

Litigation status

No MDL exists for Oxbryta litigation; the JPML's September 1, 2026 active-MDL report does not list Oxbryta or voxelotor. Cases proceed as individual federal and state actions with informal coordination in the Northern District of California before Judge Trina L. Thompson. Fact discovery in the bellwether track closes November 6, 2026, with first trial set for June 7, 2027. The N.D. Ill. in Cosey v. Global Blood Therapeutics, Inc., 1:25-cv-09400, dismissed design-defect claims with prejudice and other claims without prejudice on July 27, 2026, granting 30 days to amend.

State Court Activity

California state court filings reported alongside federal docket

Geographic exposure

Oxbryta (voxelotor) approved 2019 for sickle cell disease; U.S. sickle cell disease population approximately 100,000. No MDL protection exists; state statutes of limitation running now. Product-liability and wrongful-death deadlines vary by state and may depend on injury date, reasonable discovery of connection, treatment dates, residence, and prescription location.

  • Northern District of California

    Primary federal coordination hub for Oxbryta litigation. Judge Trina L. Thompson presiding over related cases including Allen v. Global Blood Therapeutics, Inc. et al., No. 3:24-cv-07786 (N.D. Cal. filed Nov. 7, 2024) and Jolly et al. v. Global Blood Therapeutics, Inc. et al., No. 3:24-cv-09345 (N.D. Cal. filed Dec. 23, 2024). At least eight suits filed by April 2025—two federal, six California state court. Settlement activity reported in individual cases, including settlement notice and settlement-in-principle status report. No JPML MDL exists as of September 1, 2026 active-MDL report.

  • California (state court)

    Six state-court filings by April 2025, including wrongful-death and medical-malpractice actions against Bay Area hospital networks (Sutter-affiliated hospitals) alongside Pfizer and GBT. California two-year personal injury statute of limitation contested; Judge Thompson set separate briefing schedule on fraudulent concealment tolling issue.

  • Illinois

    Cosey v. Global Blood Therapeutics, Inc. (N.D. Ill.)—design-defect claim dismissed with prejudice; remaining claims dismissed without prejudice with 30 days to amend pleading deficiencies. Not a universal ruling. State-court complaints filed November 2024 alleging defective design, failure to warn, negligent marketing. Wrongful-death filing highlighted 2023 internal analyses allegedly showing higher stroke rates on voxelotor.

  • District of South Carolina

    Attorneys anticipated MDL consolidation in either N.D. Illinois or D.S.C. as of early 2025; neither materialized. No active MDL as of September 2026. Specific case details not provided in sources.

  • United Kingdom / European Union

    NICE issued draft guidance July 2023 refusing NHS reimbursement for voxelotor, citing 'weak clinical benefit.' Revised draft February 2024 reaffirmed same conclusion. EMA initiated Article 20 referral review July 2024 over higher-than-anticipated deaths in clinical studies; EMA formally voted November 19, 2024 to follow CHMP recommendation and pull drug's license. Pfizer withdrew all lots from worldwide markets September 25, 2024; FDA safety alert followed September 26, 2024.

  • PROSPECT study sites (U.S., multi-site)

    150 patients enrolled at 17 sites as of September 21, 2023 data cutoff. Mean age 31.5 years; 89.3% Black or African American; 70.0% HbSS genotype. Mean treatment duration 47.5 weeks. Study ongoing with estimated completion 2029. Registry provides real-world safety data on voxelotor-treated sickle cell disease population.

Key defendants

Pfizer Inc.

Role: Manufacturer

Aggressive preemption defense in personal injury and consumer class actions. Motion to dismiss pending in Allen (3:24-cv-07786-TLT) and Jolly (3:24-cv-09345-TLT), both set for hearing July 8, 2025 before Judge Trina L. Thompson. Argues FDA labeling authority bars state law claims; no 'newly acquired information' for CBE label change. Trial date set for June 7, 2027 in lead personal injury case.

Global Blood Therapeutics, Inc.

Role: Manufacturer

Co-defendant with Pfizer in all pending actions. Acquired by Pfizer in 2022; original developer of Oxbryta. Joint defense posture on preemption and standing. No indemnity disputes visible in case management statements.

DefendantRoleIntelligence Note
Pfizer Inc.ManufacturerAggressive preemption defense in personal injury and consumer class actions. Motion to dismiss pending in Allen (3:24-cv-07786-TLT) and Jolly (3:24-cv-09345-TLT), both set for hearing July 8, 2025 before Judge Trina L. Thompson. Argues FDA labeling authority bars state law claims; no 'newly acquired information' for CBE label change. Trial date set for June 7, 2027 in lead personal injury case.
Global Blood Therapeutics, Inc.ManufacturerCo-defendant with Pfizer in all pending actions. Acquired by Pfizer in 2022; original developer of Oxbryta. Joint defense posture on preemption and standing. No indemnity disputes visible in case management statements.

Timeline

  1. 2019-11

    FDA Grants Accelerated Approval

    FDA grants accelerated approval to Oxbryta (voxelotor) for sickle cell disease in patients 12 and older based on hemoglobin improvement in the HOPE trial. Approval requires post-marketing confirmatory studies.

  2. 2021-12

    FDA Expands Approval to Pediatric Patients

    FDA expands Oxbryta approval to children ages 4 to 11 years old.

  3. 2024-09-25

    Pfizer Announces Global Voluntary Withdrawal

    Pfizer voluntarily withdraws all lots of Oxbryta worldwide and discontinues all clinical trials and expanded-access programs after post-marketing data indicates the drug's benefit no longer outweighs its risks.

  4. 2024-09-26

    FDA Issues Drug Safety Communication

    FDA issues public safety alert confirming higher rates of vaso-occlusive crises and deaths in post-marketing trials and real-world studies, advising health care professionals to stop prescribing Oxbryta.

  5. 2024-11-07

    First Federal Complaint Filed in N.D. Cal.

    Allen v. Global Blood Therapeutics, Inc. et al., No. 3:24-cv-07786 (N.D. Cal.), filed alleging physical injuries including vaso-occlusive crises, stroke, and death.

  6. 2025-03-01

    First Scheduling Order Sets Bellwether Trial

    Judge Trina L. Thompson enters scheduling order in Allen v. Global Blood Therapeutics, Inc., locking in June 7, 2027, for the first bellwether trial, with fact discovery running approximately 18 months.

  7. 2025-04-11

    N.D. Cal. Accepts Second Coordinated Complaint

    Judge Trina L. Thompson accepts a second federal Oxbryta complaint for coordination with Allen, bringing related cases under single-judge management to prevent duplicate discovery and inconsistent rulings.

  8. 2025-09-09

    Court-Ordered Mediation Begins

    Judge Thompson appoints retired Judge Philip S. Gutierrez to oversee court-ordered mediation in the coordinated Northern District of California docket.

  9. 2026-05

    Pfizer Settles First Child Injury Case

    Pfizer reaches settlement in lawsuit brought by mother on behalf of minor son who suffered severe vaso-occlusive crisis injuries, the first confirmed individual-plaintiff settlement in the litigation.

  10. 2026-07-27

    N.D. Ill. Grants Motion to Dismiss in Cosey

    In Cosey v. Global Blood Therapeutics, Inc., No. 1:25-cv-09400 (N.D. Ill.), court dismisses design-defect claim with prejudice and remaining claims without prejudice, allowing 30 days to amend pleading deficiencies related to newly acquired information and the learned intermediary doctrine.

Statute of limitations

No MDL established as of March 2026; federal cases coordinated in N.D. Cal. under Judge Trina L. Thompson. September 26, 2024 FDA alert and Pfizer global withdrawal is the critical discovery date for most plaintiffs. Intake priority: Tennessee (1-year SOL expiring September 2025 for pre-withdrawal injuries).

⚠ 1 state with critical SOL — act immediately

California

2 years from injury

Rule: Cal. Code Civ. Proc. § 335.1; discovery rule applies per Jolly v. Eli Lilly & Co., 751 P.2d 923 (Cal. 1988)

Discovery: Accrues when plaintiff discovers, or through reasonable diligence should have discovered, the injury and its cause

First trial date set: Allen v. Global Blood Therapeutics, Inc., N.D. Cal., Judge Trina L. Thompson, trial June 7, 2027; Ford v. Global Blood Therapeutics, trial Sept. 13, 2027. Federal cases coordinated May 2025 under single judge in N.D. Cal. No MDL yet. September 2024 withdrawal likely triggers discovery rule for many plaintiffs.

Illinois

2 years from discovery of injury

Rule: 735 ILCS 5/13-202; discovery rule per Witherell v. Weimer, 421 N.E.2d 869 (Ill. 1981)

Discovery: Accrues when plaintiff knows or reasonably should know of injury and its causal connection to defendant's conduct

Active filings reported; Tirrell Allen (Illinois resident) filed November 2024. September 2024 global withdrawal is likely discovery date for most plaintiffs.

⚠Tennessee

1 year from discovery of injury

Rule: Tenn. Code Ann. § 28-3-105; discovery rule per Shadrick v. Coker, 963 S.W.2d 726 (Tenn. 1998)

Discovery: Accrues when injury is discovered or reasonably should have been discovered; narrow construction—mere suspicion insufficient

Shortest SOL in major filing states. September 2024 withdrawal = hard discovery date. Intake must screen for any earlier symptoms that could trigger earlier accrual.

New York

3 years from discovery

Rule: N.Y. C.P.L.R. § 214-c; discovery rule per LaRosa v. Scientific Design Co., 402 N.E.2d 1275 (N.Y. 1980)

Discovery: Accrues when plaintiff discovers, or through reasonable diligence should have discovered, the injury and its cause; 10-year repose cap from act/omission per § 214-c(2)

2019 FDA approval to 2024 withdrawal falls within repose period. September 2024 withdrawal is clear discovery trigger.

Texas

2 years from discovery

Rule: Tex. Civ. Prac. & Rem. Code § 16.003; discovery rule per Neagle v. Nelson, 685 S.W.2d 11 (Tex. 1985)

Discovery: Accrues when plaintiff discovers, or in exercise of reasonable diligence should have discovered, the nature of the injury

Large sickle cell patient population. September 2024 withdrawal is discovery date for most. No MDL means state court filings likely.

Georgia

2 years from discovery

Rule: O.C.G.A. § 9-3-33; discovery rule per Am. Medical Int'l, Inc. v. Giurintano, 596 S.E.2d 604 (Ga. 2004)

Discovery: Accrues when plaintiff discovers, or through reasonable diligence should have discovered, both the injury and its cause; 10-year repose for medical products per § 9-3-71(b)

Significant sickle cell population. 2019 approval to 2024 withdrawal within repose. September 2024 withdrawal = discovery trigger.

North Carolina

3 years from discovery

Rule: N.C. Gen. Stat. § 1-52(16); discovery rule per Sawyer v. Foster, 615 S.E.2d 42 (N.C. 2005)

Discovery: Accrues when plaintiff discovers, or should have discovered through reasonable diligence, the injury and its cause; 10-year repose per § 1-50(a)(5) for products liability

Extended SOL favorable for intake. September 2024 withdrawal is discovery date. Repose period covers 2019-2024 marketing.

StateSOLRuleDiscovery RuleNotes
California2 years from injuryCal. Code Civ. Proc. § 335.1; discovery rule applies per Jolly v. Eli Lilly & Co., 751 P.2d 923 (Cal. 1988)Accrues when plaintiff discovers, or through reasonable diligence should have discovered, the injury and its causeFirst trial date set: Allen v. Global Blood Therapeutics, Inc., N.D. Cal., Judge Trina L. Thompson, trial June 7, 2027; Ford v. Global Blood Therapeutics, trial Sept. 13, 2027. Federal cases coordinated May 2025 under single judge in N.D. Cal. No MDL yet. September 2024 withdrawal likely triggers discovery rule for many plaintiffs.
Illinois2 years from discovery of injury735 ILCS 5/13-202; discovery rule per Witherell v. Weimer, 421 N.E.2d 869 (Ill. 1981)Accrues when plaintiff knows or reasonably should know of injury and its causal connection to defendant's conductActive filings reported; Tirrell Allen (Illinois resident) filed November 2024. September 2024 global withdrawal is likely discovery date for most plaintiffs.
⚠Tennessee1 year from discovery of injuryTenn. Code Ann. § 28-3-105; discovery rule per Shadrick v. Coker, 963 S.W.2d 726 (Tenn. 1998)Accrues when injury is discovered or reasonably should have been discovered; narrow construction—mere suspicion insufficientShortest SOL in major filing states. September 2024 withdrawal = hard discovery date. Intake must screen for any earlier symptoms that could trigger earlier accrual.
New York3 years from discoveryN.Y. C.P.L.R. § 214-c; discovery rule per LaRosa v. Scientific Design Co., 402 N.E.2d 1275 (N.Y. 1980)Accrues when plaintiff discovers, or through reasonable diligence should have discovered, the injury and its cause; 10-year repose cap from act/omission per § 214-c(2)2019 FDA approval to 2024 withdrawal falls within repose period. September 2024 withdrawal is clear discovery trigger.
Texas2 years from discoveryTex. Civ. Prac. & Rem. Code § 16.003; discovery rule per Neagle v. Nelson, 685 S.W.2d 11 (Tex. 1985)Accrues when plaintiff discovers, or in exercise of reasonable diligence should have discovered, the nature of the injuryLarge sickle cell patient population. September 2024 withdrawal is discovery date for most. No MDL means state court filings likely.
Georgia2 years from discoveryO.C.G.A. § 9-3-33; discovery rule per Am. Medical Int'l, Inc. v. Giurintano, 596 S.E.2d 604 (Ga. 2004)Accrues when plaintiff discovers, or through reasonable diligence should have discovered, both the injury and its cause; 10-year repose for medical products per § 9-3-71(b)Significant sickle cell population. 2019 approval to 2024 withdrawal within repose. September 2024 withdrawal = discovery trigger.
North Carolina3 years from discoveryN.C. Gen. Stat. § 1-52(16); discovery rule per Sawyer v. Foster, 615 S.E.2d 42 (N.C. 2005)Accrues when plaintiff discovers, or should have discovered through reasonable diligence, the injury and its cause; 10-year repose per § 1-50(a)(5) for products liabilityExtended SOL favorable for intake. September 2024 withdrawal is discovery date. Repose period covers 2019-2024 marketing.

Live intelligence

AI litigation brief

Oxbryta remains active litigation category with 4 current signals in the accepted feed.

Overview

No MDL exists for Oxbryta litigation; the JPML's September 1, 2026 active-MDL report does not list Oxbryta or voxelotor. Cases proceed as individual federal and state actions with informal coordination in the Northern District of California before Judge Trina L. Thompson. Fact discovery in the bellwether track closes November 6, 2026, with first trial set for June 7, 2027. The N.D. Ill. in Cosey v. Global Blood Therapeutics, Inc., 1:25-cv-09400, dismissed design-defect claims with prejudice and other claims without prejudice on July 27, 2026, granting 30 days to amend.

Key developments

  • Docwire News news on Feb 26: Voxelotor Shows Improved Hemoglobin With Expected Safety in SCD After Removal From Global Markets - Docwire News

Trajectory

Press coverage is active for Oxbryta. Court-side confirmation through drug-safety proceedings and any emerging federal product-liability claims is the next escalation check.

Editorial intelligence

Editorial coverage should stay tied to source-backed developments and avoid placeholder status copy for Oxbryta.

Generated Jun 26, 2026, 12:00 AM UTC

4 events detected

Google News (4)

  • Voxelotor Shows Improved Hemoglobin With Expected Safety in SCD After Removal From Global Markets - Docwire News

    Docwire NewsFeb 26, 2026, 8:00 AM UTC
  • EU agency confirms continued suspension of SCD therapy Oxbryta - Sickle Cell Disease News

    Sickle Cell Disease NewsOct 21, 2025, 7:00 AM UTC
  • Sickle Cell Drug Suspension Confirmed by EMA - Medscape

    MedscapeOct 17, 2025, 7:00 AM UTC
  • LaRuby May and team of attorneys file suit against Pfizer, claim negligence in premature release of sickle cell drug therapy - AFRO American Newspapers

    AFRO American NewspapersOct 11, 2025, 7:00 AM UTC

No recent PubMed signals. Monitoring is active — this section updates automatically.

No recent FDA signals. Monitoring is active — this section updates automatically.

No recent court filing signals. Monitoring is active — this section updates automatically.

Workbench

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LexGenius Ranking

42Score

Fresh items are present but not yet surging

Evidence10 / 20
Momentum8 / 20
Exposure10 / 20
Regulatory8 / 20
Legal10 / 20

Monitoring

Live

monitoring

Last: Jun 26, 2026, 12:00 AM UTC

Next: —

Source Monitoring

PACER

2m 07s

PACER

Pending

Google News

2m 07s

FAERS

2m 07s

PubMed

17m 07s

Event feed

4

events detected

Google News

AI Brief

Oxbryta remains active litigation category with 4 current signals in the accepted feed.

Overview

No MDL exists for Oxbryta litigation; the JPML's September 1, 2026 active-MDL report does not list Oxbryta or voxelotor. Cases proceed as individual federal and state actions with informal coordination in the Northern District of California before Judge Trina L. Thompson. Fact discovery in the bellwether track closes November 6, 2026, with first trial set for June 7, 2027. The N.D. Ill. in Cosey v. Global Blood Therapeutics, Inc., 1:25-cv-09400, dismissed design-defect claims with prejudice and other claims without prejudice on July 27, 2026, granting 30 days to amend.

Key developments

Docwire News news on Feb 26: Voxelotor Shows Improved Hemoglobin With Expected Safety in SCD After Removal From Global Markets - Docwire News.

Generated Jun 26, 2026, 12:00 AM UTC

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