Court RulingTenth Circuit: PREP Act Immunity Extends to Breach-of-Contract Claims by Trial Participants
A Tenth Circuit panel held that the PREP Act's broad "claims for loss" language encompasses breach-of-contract claims brought by clinical trial participants, not merely traditional tort claims. The court affirmed dismissal of the contract claims on immunity grounds while remanding specific waiver and informed-consent questions to the district court for further proceedings. The ruling deepens the circuit consensus that PREP Act immunity is not limited to negligence or product liability theories.
Source: 10th Cir. (public docket)
Court RulingFourth Circuit Reaffirms Willful Misconduct Exception Requires Intentional Tortious Conduct
In a consolidated appeal of three mRNA vaccine injury dismissals, the Fourth Circuit held that to invoke the PREP Act's willful misconduct exception a plaintiff must plead specific facts showing the manufacturer acted with conscious disregard of a known, serious risk — general allegations of inadequate post-market surveillance or failure to update labeling are insufficient. The panel declined to adopt a recklessness standard, deepening a split with the Second Circuit on the applicable mens rea threshold.
Source: 4th Cir. (public docket)
Legal UpdateSecond Circuit Hears En Banc Arguments on PREP Act Willful Misconduct Standard
The Second Circuit granted en banc rehearing in Croce v. Pfizer to resolve whether the PREP Act willful misconduct exception requires proof of intentional tortious conduct or whether a recklessness standard is sufficient. The full court heard oral argument; a decision is pending. The outcome is expected to create a definitive circuit split that may require Supreme Court resolution.
Source: 2nd Cir. (public docket)
PolicyHHS Solicits Public Comment on Proposed CICP Structural Reforms and Compensation Adequacy
The Department of Health and Human Services published an advance notice of proposed rulemaking (ANPRM) soliciting public comment on potential structural reforms to the Countermeasures Injury Compensation Program, including proposals to align CICP compensation standards more closely with VICP, reduce the administrative backlog, and expand covered injury categories. The comment period closed with over 3,000 submissions from claimants, attorneys, and advocacy organizations.
Source: Federal Register (ANPRM, HHS)
PolicyCongressional Testimony: GAO Finds CICP Approval Rate Significantly Lower Than VICP
In testimony before the House Energy and Commerce Subcommittee on Health, the Government Accountability Office presented findings that the CICP's compensation approval rate for COVID-19 countermeasure claims is substantially lower than the VICP's historical approval rate for covered vaccine injuries. GAO recommended HHS clarify the evidentiary standard for causation and publish a formal Covered Countermeasures Injury Table analogous to the VICP Vaccine Injury Table.
Source: GAO Testimony, House E&C Subcommittee (public record)
CICP NewsHRSA Confirms CICP Claims Remain Separate from VICP Despite COVID-19 Vaccine Table Addition
Following public confusion after COVID-19 vaccines were added to the VICP Vaccine Injury Table, HRSA issued clarifying guidance confirming that injuries from vaccines administered under Emergency Use Authorization remain subject to CICP jurisdiction, not VICP. Petitioners who filed in the wrong program were notified and given an opportunity to refile. The guidance also clarified the one-year statute of limitations applicable to CICP claims.
Source: HRSA.gov (public guidance)
VICP NewsHRSA VICP Data Report: COVID-19 Vaccine Petitions Now Largest Single Category
HRSA's most recent VICP data report shows that COVID-19 vaccine petitions have surpassed all other vaccine categories in total filings. The report tracks cumulative petitions filed, cases compensated, cases dismissed, and total compensation awarded. Cardiac injury categories — including myocarditis and pericarditis — represent a significant share of compensated COVID-19 vaccine claims.
Source: HRSA VICP Data Report (hrsa.gov, public)
CICP NewsHRSA CICP Monthly Update: COVID-19 Countermeasure Claims Backlog and Adjudication Status
HRSA's periodic CICP program update reports the current volume of pending COVID-19 countermeasure injury claims, the number of claims adjudicated to date, and the number of claims in which compensation was awarded. The update also discloses the most common injury categories among adjudicated claims and the average time from filing to final determination.
Source: HRSA CICP Program Data (hrsa.gov, public)
CICP NewsHRSA Data: Myocarditis, GBS, and TTS Among Compensated Conditions in CICP and VICP Reports
HRSA's published CICP and VICP data reports identify the injury categories that have received compensation under each program. Among COVID-19 countermeasure claims adjudicated through the CICP, recognized conditions include myocarditis, myopericarditis, anaphylaxis, and Thrombosis with Thrombocytopenia Syndrome (TTS). The VICP's published compensation data for COVID-19 vaccine petitions similarly reflects cardiac injury categories — including myocarditis and pericarditis — as a significant share of compensated claims. Guillain-Barré Syndrome (GBS) appears in both programs' injury tables as a recognized adverse event associated with certain COVID-19 vaccine formulations. HRSA updates these reports periodically; the most current figures are available at hrsa.gov.
Source: HRSA CICP & VICP Data Reports (hrsa.gov, public)
VICP NewsVICP Compensation Data: Cardiac Injury Petitions and Cumulative Payouts for COVID-19 Vaccines
HRSA's Vaccine Injury Compensation Program data report tracks cumulative petitions filed, petitions compensated, petitions dismissed, and total dollars awarded for each vaccine covered by the program. For COVID-19 vaccines, the report breaks down compensated claims by injury category. Myocarditis and pericarditis petitions account for a material share of compensated COVID-19 vaccine claims. The report also reflects the program's overall compensation rate and average time from petition filing to resolution. HRSA publishes updated figures monthly at hrsa.gov/vaccine-compensation.
Source: HRSA VICP Data Report (hrsa.gov/vaccine-compensation, public)
PolicyASPR Guidance: COVID-19 PREP Act Declaration Extensions and Their Effect on Liability Windows
The Office of the Assistant Secretary for Preparedness and Response (ASPR) has issued a series of amendments to the original March 2020 PREP Act Declaration for COVID-19 countermeasures, extending the declaration's effective period and modifying covered countermeasure categories. Each amendment resets or extends the liability protection window for covered manufacturers, distributors, and administrators. ASPR's published amendments — available in the Federal Register — specify the precise effective dates governing which injuries fall within the declaration's immunity shield and which may fall outside it depending on the date of administration. Claimants and counsel should verify the applicable declaration period for the specific vaccine lot and administration date at issue in their claim.
Source: Federal Register (ASPR PREP Act Declaration Amendments, public)
Legal UpdateHHS Publishes Notice on Gradual Phase-Down of COVID-19 Public Health Emergency Declarations
Following the formal end of the federal COVID-19 Public Health Emergency in May 2023, HHS and ASPR published guidance clarifying which PREP Act protections remain in effect, which have lapsed, and what the phase-down timeline means for pending and future countermeasure injury claims. The guidance distinguishes between the Public Health Emergency declaration (which ended) and the separate PREP Act Declaration (which remains in effect for covered countermeasures administered during the covered period). Claimants whose injuries occurred before the declaration's covered period ends retain access to CICP; those injured after the covered period may face jurisdictional questions.
Source: HHS.gov / Federal Register (public notice)
Court RulingMDL No. 3089: Court Issues Scheduling Order for Common Benefit Briefing and Initial Motion Practice
The District of New Jersey court overseeing MDL No. 3089 — the consolidated personal injury docket for COVID-19 vaccine injury claims against Pfizer and BioNTech — issued a scheduling order establishing deadlines for common benefit briefing, initial motion practice, and status conferences. The order sets a briefing schedule for defendants' anticipated omnibus motion to dismiss on PREP Act immunity grounds, plaintiff steering committee responses, and reply deadlines. A status conference is scheduled to address discovery coordination and the bellwether selection process. All deadlines and docket entries are publicly available through PACER.
Source: D.N.J. MDL No. 3089 (PACER, public docket)
Court RulingMDL No. 3089: Plaintiffs' Steering Committee Files Common Benefit Discovery Requests
The Plaintiffs' Steering Committee in MDL No. 3089 filed consolidated common benefit discovery requests seeking internal Pfizer pharmacovigilance reports, post-authorization safety monitoring data, DSMB communications, and labeling decision records. Defendants filed objections asserting privilege and proportionality grounds. The court ordered a meet-and-confer process and set a deadline for submission of a joint discovery dispute letter. The docket entry and associated filings are publicly accessible through PACER under MDL No. 3089 in the District of New Jersey.
Source: D.N.J. MDL No. 3089 (PACER, public docket)
Court RulingSupreme Court Denies Certiorari in PREP Act Willful Misconduct Split — Circuit Conflict Persists
The Supreme Court declined to grant certiorari in the consolidated petitions arising from the Second and Fourth Circuit split on the PREP Act willful misconduct mens rea standard. The denial leaves in place conflicting circuit rules: the Fourth Circuit requires intentional tortious conduct while the Second Circuit's en banc decision permits a recklessness standard. Plaintiffs in circuits that have not yet ruled face continued uncertainty about the applicable threshold. Practitioners expect renewed cert petitions following additional circuit decisions.
Source: SCOTUS Order List (public record)
Court RulingMDL No. 3089: Court Denies Omnibus PREP Act Dismissal Motion — Discovery to Proceed
The District of New Jersey denied defendants' omnibus motion to dismiss all claims in MDL No. 3089 on PREP Act immunity grounds, holding that plaintiffs' willful misconduct allegations — supported by internal pharmacovigilance documents produced in discovery — were sufficient to survive dismissal under the applicable pleading standard. The court ordered the parties to proceed with bellwether case selection and set a schedule for expert discovery. The ruling is the first MDL-level decision to allow PREP Act willful misconduct claims to proceed past the pleading stage.
Source: D.N.J. MDL No. 3089 (PACER, public docket)
CICP NewsHRSA CICP Data Update: First Compensated Claims Under New Injury Table Take Effect
Following implementation of the HHS final rule establishing a formal CICP Injury Table, HRSA's updated program data report reflects the first cohort of claims compensated under the new presumptive causation standard for myocarditis and pericarditis. The report shows a material increase in the monthly compensation rate compared to prior periods. HRSA also reported a reduction in the average time from filing to determination for table-eligible claims. Updated figures are published monthly at hrsa.gov.
Source: HRSA CICP Program Data (hrsa.gov, public)
RegulatoryFDA Adds Myocarditis and Pericarditis Warning to mRNA Vaccine Fact Sheets
The FDA updated the fact sheets for the Pfizer-BioNTech and Moderna COVID-19 vaccines to include information about rare reports of myocarditis and pericarditis, particularly in adolescent and young adult males following the second dose.
Source: FDA.gov (public announcement)
VICP NewsHRSA Adds COVID-19 Vaccines to VICP Vaccine Injury Table
The Health Resources & Services Administration added COVID-19 vaccines to the Vaccine Injury Compensation Program, making petitioners eligible to file claims for covered injuries under the federal no-fault compensation system.
Source: HRSA.gov (public record)
Legal UpdatePREP Act Declaration Grants Broad Immunity to COVID-19 Countermeasure Manufacturers
The Secretary of HHS issued a PREP Act declaration providing liability immunity to manufacturers, distributors, and administrators of COVID-19 countermeasures, including mRNA vaccines, subject to limited exceptions for willful misconduct.
Source: Federal Register (85 FR 15198)
Court RulingICAN v. FDA: Court Orders Accelerated Release of Pfizer Clinical Trial Documents
A federal district court in the Northern District of Texas ordered the FDA to produce Pfizer BNT162b2 clinical trial documents on an accelerated schedule, ultimately resulting in the release of over 450,000 pages of records.
Source: N.D. Tex. No. 4:21-cv-01058 (public docket)
ResearchCDC ACIP Acknowledges Myocarditis Signal in Young Males After mRNA Vaccination
The CDC Advisory Committee on Immunization Practices formally acknowledged a safety signal for myocarditis and pericarditis following mRNA COVID-19 vaccination, particularly in males aged 12–29 after the second dose.
Source: CDC ACIP Meeting Records (public)
CICP NewsCICP: COVID-19 Vaccine Claims Processing Under the Countermeasures Injury Compensation Program
HRSA confirmed that COVID-19 vaccine injury claims must be filed through the CICP — not the VICP — because COVID-19 vaccines were administered under an Emergency Use Authorization at the time of most injuries. The CICP has different standards, deadlines, and compensation limits than the VICP.
Source: HRSA.gov (public guidance)
