Judge Kenneth D. Bell granted Merck summary judgment on March 11, 2025, dismissing all failure-to-warn claims in MDL 3036 on implied federal preemption grounds. On a separate appellate track, the Fourth Circuit affirmed Vaccine Act timeliness dismissals of three bellwether cases on September 4, 2025, and the Supreme Court denied certiorari on March 30, 2026. As of April 1, 2026, 129 actions sit in the Western District of North Carolina, with no federal bellwether having reached a jury. The procedural trajectory echoes the Tylenol MDL dismissal and other federal pharmaceutical case-enders.
This article covers MDL formation, bellwether selection, the Albrecht preemption ruling, the Fourth Circuit's Vaccine Act holding, and practice implications for pending Gardasil cases.
How the JPML Centralized Gardasil Cases as MDL 3036
In In re Gardasil Products Liability Litigation (2022), 619 F. Supp. 3d 1356 (J.P.M.L. 2022), JPML Panel Chair Karen K. Caldwell signed the transfer order on August 4, 2022, centralizing actions in the Western District of North Carolina under 28 U.S.C. § 1407. The case was initially assigned to Judge Robert J. Conrad, Jr., then reassigned to Judge Kenneth D. Bell.
Plaintiff theories included:
- Failure to warn about POTS and POI
- Design defect
- Fraud
- Negligence
Bijan Esfandiari of Wisner Baum, Paul J. Pennock, and K. Rachel Lanier of The Lanier Law Firm served as plaintiffs' co-lead counsel. David Calep Wright III of Butler Snow and Allyson M. Julien represented Merck.
What Did Plaintiffs Allege About HPV Vaccine Autoimmune Injury?
The transfer order described the core allegation as injury "through an autoimmune reaction caused by structural similarities between proteins in the vaccine's antigens and within the vaccine recipient's own cells." The bellwether process focused on POTS and POI cases.
Sixteen bellwether candidates were selected by June 2023, with the pool limited to those two injury categories. On March 20, 2024, Judge Bell resolved MDL-wide motions to dismiss. Claims eliminated included:
- Design defect (preempted under Bruesewitz v. Wyeth LLC, 562 U.S. 223 (2011))
- Manufacturing defect
- Patient-directed failure-to-warn claims
Only provider-directed failure-to-warn and fraudulent concealment claims survived.
Merck's position throughout: controlled clinical studies have not established a causal link, and the Gardasil 9 prescribing information contains no POTS or POI warning because the FDA has never required one.
How Did Judge Bell's Preemption Ruling End the Federal Bellwethers?
Judge Bell granted Merck summary judgment in In re Gardasil Prods. Liab. Litig., applying Merck Sharp & Dohme Corp. v. Albrecht, 587 U.S. 299 (2019). The ruling turned on the FDA's "Changes Being Effected" regulation for biologics, 21 C.F.R. § 601.12(f)(2)(i), and the labeling standard at § 201.57(c)(6)(i). Under these provisions, Merck could not unilaterally change Gardasil's label absent "newly acquired information" showing "reasonable evidence of a causal association."
The court found the plaintiffs' evidence fell short. The record showed one published POTS case report, two additional publications, and fewer than 20 unverified reports, including fewer than ten VAERS reports during the relevant period. Plaintiffs also submitted supplemental material identifying 83 POTS cases worldwide among more than 100 million doses. None of this constituted reasonable evidence of causal association under the regulatory standard.
The court also incorporated the FDA's overwarning concern: adding unsubstantiated warnings dilutes genuine safety signals and may discourage beneficial medical use. Plaintiffs appealed to the Fourth Circuit on April 10, 2025, and that appeal remains pending.
What Did the Fourth Circuit and Supreme Court Decide on the Vaccine Act?
The Vaccine Act timeliness question closed at the Supreme Court on March 30, 2026.
Three bellwether plaintiffs, Tessa Needham, Angela M. Walker, and Shanie D. Roman, had their cases dismissed on judgment on the pleadings in June and July 2024 because their Vaccine Court petitions were filed more than 36 months after first symptom onset, violating 42 U.S.C. § 300aa-16(a)(2).
The Fourth Circuit affirmed unanimously on September 4, 2025, in Needham v. Merck & Co., Inc.. The panel held that timely Vaccine Court participation is a prerequisite to bringing a tort suit and that the special master's timeliness ruling is preclusive in subsequent civil litigation. The court also held that HHS's addition of Gardasil to the Vaccine Injury Table was constitutional, rejecting a Presentment Clause challenge.
Petitioners filed for certiorari on February 2, 2026 (No. 25-924), presenting two questions:
- Whether the Vaccine Act's statute of limitations is subject to a discovery rule
- Whether the Table amendment violated the Presentment Clause
Merck waived its right to respond on March 5, 2026. The Supreme Court denied cert on March 30, 2026.
How the Gardasil Rulings Are Reshaping Vaccine and Drug Tort Strategy
The Gardasil MDL's procedural outcome is generating ripple effects across pharmaceutical mass tort practice. Three effects merit tracking:
- Preemption holds only when the FDA position holds. The Depo-Provera MDL (MDL 3140, N.D. Fla.) illustrates the limits of an Albrecht defense when regulatory facts shift. Pfizer initially moved for summary judgment on preemption after the FDA rejected a proposed meningioma warning, but in December 2025, the FDA approved that warning, prompting Judge M. Casey Rodgers to order supplemental briefing. The motion remains pending as of May 2026. The contrast with MDL 3036 sharpens the Gardasil lesson: preemption succeeded because the FDA's labeling position never moved, and plaintiffs could not produce the post-licensure causation evidence that would have unlocked a CBE label change. Defense counsel in other pending pharmaceutical MDLs, including the Ozempic MDL analysis, are watching the same dynamic.
- The Fourth Circuit's strict Vaccine Act timeliness reading forecloses equitable tolling for slow-onset injuries. For conditions like POTS, POI, and lupus, where early symptoms may not prompt a diagnosis for years, the 36-month clock runs from first symptom onset rather than diagnosis. Statute-of-limitations analysis must now precede causation analysis at intake.
- State court litigation continues separately. In California, Robi v. Merck (No. BC628589, L.A. Super. Ct.) began trial on January 28, 2025, then was adjourned after Robert F. Kennedy Jr. was sworn in as HHS Secretary, with the parties citing juror-bias concerns. The retrial reconvened with a new jury in September 2025.
Merck's Q1 2025 10-Q filing reports approximately 245 Gardasil cases pending in federal or state court as of March 31, 2025, and states the company is unable to reasonably estimate possible loss under ASC 450 given pending dispositive motion practice and appeals.
Key Takeaways: What Plaintiff and Defense Counsel Should Take From MDL 3036
MDL 3036 produced two binding procedural frameworks that reshape intake and defense strategy for vaccine tort cases. The implications differ for plaintiff and defense counsel.
For plaintiff counsel
VICP filing must precede any federal tort suit, and the 36-month clock starts at first symptom onset, not diagnosis. Needham confirms that the special master's timeliness finding is preclusive in civil court.
Causation evidence for FDA-regulated product MDLs requires more than case reports and VAERS data to defeat Albrecht preemption. For biologics and vaccines, the CBE regulation under § 601.12(f)(2)(i) incorporates the "reasonable evidence of a causal association" standard from § 201.57(c)(6) as the operative gate. The Paraquat MDL trajectory and other active pharmaceutical MDLs illustrate what an epidemiologic record needs to look like; MDL 3036 demonstrates what an inadequate record produces at summary judgment.
MDL 3036 demonstrates courts will grant summary judgment when that standard is not met. Expert selection must account for amended Rule 702 scrutiny.
For defense counsel
Early dispositive motions on Vaccine Act timeliness can resolve large case populations before merits. The CBE regulation provides a defensible record for preemption when a manufacturer can document its post-market surveillance review, and the FDA's stated regulatory position on causation serves a dual function: preemption predicate and Daubert reliability factor.
Coordinated MDL strategy paid off in MDL 3036. Merck consolidated the federal docket, then dispatched it procedurally while state court cases proceed on a slower timeline.
What Comes Next for MDL 3036 and Vaccine Tort Practice
The Fourth Circuit's ruling on the preemption appeal is the next dispositive event for the federal docket. An affirmance functionally ends federal litigation; a reversal reopens the bellwether process and resets any trial calendar into 2027.
California state court proceedings will set the first jury benchmarks for causation evidence. Judge Bell's preemption ruling carries no binding authority in state court, and no California ruling adopting or rejecting that analysis has been reported. The Third Circuit's restrictive application of Albrecht in In re Fosamax Prods. Liab. Litig., which gives stronger weight to a presumption against preemption, remains the principal circuit-level counterweight; the Supreme Court denied cert on the most recent Fosamax appeal in June 2025.
Why MDL 3036 Remains a Reference Point
MDL 3036 closes early 2026 with the federal docket procedurally dismantled and the preemption appeal still pending at the Fourth Circuit, while California state court proceedings continue toward the first jury benchmarks for Gardasil causation.
For practitioners, the federal preemption analysis here will shape pleading strategy and intake screening across FDA-regulated drug and vaccine cases, even as state court proceedings test causation evidence outside the MDL's procedural boundaries.
For a contrasting MDL resolution, see the Philips CPAP MDL case analysis.
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