Verified snapshot
The facts that anchor this dossier
Cook IVC filters sit at the intersection of lifesaving clot prevention, retrieval decisions, and alleged long-term device complications. This dossier separates the clinical role of a filter from the claims being coordinated in MDL 2570.
- Federal proceeding
- MDL 2570
- Actions pending
- 6,536
- Device function
- Trap emboli in the inferior vena cava
- Core allegations
- Tilt, perforation, fracture, migration
- FDA principle
- Consider removal when risk has passed
Southern District of Indiana before Senior Judge Richard L. Young.
JPML count on July 1, 2026; 11,473 actions are listed historically.
Filters are intended to reduce pulmonary embolism risk in selected patients.
The court has not found that every Cook filter has a defect or caused injury.
For retrievable filters, FDA has advised clinicians to consider removal once protection from pulmonary embolism is no longer needed.
Documented chronology
How the litigation reached this point
FDA cleared the Cook Celect vena cava filter through the 510(k) pathway for specified pulmonary-embolism-prevention indications.
Cook Celect 510(k) K061815 ↗The JPML centralized Cook IVC filter cases in the Southern District of Indiana, citing common allegations involving fracture, migration, tilt, and perforation.
MDL 2570 Initial Transfer Order ↗The PREPIC2 randomized trial reported no reduction in recurrent pulmonary embolism from adding a retrievable filter to anticoagulation in the specific high-risk patients studied.
PREPIC2 Randomized Clinical Trial ↗FDA cleared Cook Celect Platinum filter sets as substantially equivalent under 510(k) K171712.
Cook Celect Platinum 510(k) K171712 ↗A prospective Cook IVC filter study published two-year results for Celect and Günther Tulip filters, reporting high technical effectiveness and retrieval success while also recording adjudicated adverse outcomes.
Two-Year Outcomes from the Cook IVC Filter Study ↗The JPML listed 6,536 pending actions and 11,473 historical actions in MDL 2570.
Pending MDL Dockets by Actions Pending — August 3, 2026 ↗What an IVC filter is supposed to do
The inferior vena cava is the large vein that returns blood from the lower body toward the heart. An IVC filter is a small metal framework placed inside that vein to catch large clots before they reach the lungs. Cook's product family includes the Celect and Günther Tulip designs. FDA-cleared indications for the original Celect included pulmonary thromboembolism when anticoagulation is contraindicated, failure of anticoagulant therapy, selected emergencies after massive pulmonary embolism, and chronic recurrent pulmonary embolism when anticoagulation has failed or cannot be used.
That intended use matters. A filter can be medically important for a patient who cannot safely take anticoagulants, while long dwell time can create a different set of management questions. Some filters are designed to be retrieved. FDA reiterated in a 2021 announcement that its 2014 safety communication advised implanting physicians to consider removal as soon as blood clots are no longer a risk. The decision is individual: an embedded filter, clot burden, continuing PE risk, anatomy, and retrieval risk can all affect the plan.
No one should interpret litigation coverage as instructions to remove a filter. Retrieval is a medical procedure requiring imaging and specialist judgment. The relevant question is whether the treating team has reassessed the continuing need and the risks of removal versus leaving the device in place.
The allegations in MDL 2570
The JPML created MDL 2570 in October 2014. Its transfer order described recurring allegations that defects in Cook filters made them more likely to fracture, migrate, tilt, or perforate the vena cava. The Southern District of Indiana summarizes the cases as alleging defective design, marketing misrepresentations, and failure to warn doctors and patients. Cook has the right to contest those allegations, and a centralized docket is not a liability judgment.
These complication words describe different events. Tilt concerns the filter's alignment. Perforation usually refers to struts extending beyond the caval wall on imaging. Fracture means a component broke; migration means the filter or a fragment moved. Thrombosis can involve clot in or around the device or vena cava. An imaging finding may be asymptomatic, clinically significant, unrelated to current symptoms, or one part of a more complicated history. The label on a radiology report does not, by itself, establish defect, negligence, or damages.
Published research is mixed because it asks different questions. A retrospective comparison of Celect and Option filters reported more strut perforation with Celect. In contrast, the prospective CIVC study followed 473 patients with Celect or Günther Tulip filters and reported a 94.9% successful retrieval rate and results that the authors said supported safety and effectiveness. The studies differ in design, patient selection, follow-up, endpoints, and potential conflicts; neither decides an individual lawsuit.
Clinical evidence is not one-size-fits-all
PREPIC2 is often cited in discussions of filters, but its scope must be kept intact. Investigators randomized 399 hospitalized patients with acute symptomatic pulmonary embolism, associated lower-limb thrombosis, and severity criteria to anticoagulation plus a retrievable filter or anticoagulation alone. In that population, adding the filter did not reduce recurrent symptomatic PE at three months. That does not answer whether a filter benefits someone who cannot receive anticoagulation—the classic situation described in device indications.
Device performance is also time-dependent. Early Cook Celect experience reported successful retrieval in 93.4% of attempted removals, while noting that hook endothelialization caused some failures and that systematic follow-up for silent complications was lacking. A later comparison found strut perforation more often with Celect than with a competitor. These findings support careful follow-up but do not justify a universal claim that every indwelling filter is failing.
Symptoms such as chest pain, shortness of breath, leg swelling, abdominal or back pain, or a newly dysfunctional filter plan need clinical evaluation, not an online causation conclusion. Some device findings are discovered incidentally. Some symptoms have other urgent causes.
Current docket and useful records
As of July 1, 2026, the JPML lists 6,536 pending actions from 11,473 historical actions. The Southern District of Indiana still identifies the master case as 1:14-ml-2570-RLY-TAB and provides selected substantive orders. The court inventory is federal only. It does not count every state-court case, and it does not disclose a person's procedural status, merits, or any settlement value.
A useful personal record begins with the implant card or operative report: exact filter model, lot information if available, placement date, access route, indication, and planned follow-up. Add imaging reports and images, anticoagulation history, later PE or DVT diagnoses, attempted retrieval notes, and any procedure used to remove an embedded device. The reason a filter remained in place can be as important as the dwell time.
The safe division of labor is straightforward. A vascular or interventional specialist evaluates the device and treatment options. The official court docket establishes what has happened in MDL 2570. A lawyer can assess state law and filing rules after reviewing product and medical proof. A general information page cannot declare that a person qualifies, that a deadline remains open, or that a certain complication was caused by a Cook filter.
Reader questions
Frequently asked questions
Does an IVC filter need to be removed after a set number of days?
There is no single deadline suitable for every patient. FDA has advised considering removal of a retrievable filter once protection from pulmonary embolism is no longer needed, but ongoing clot risk and retrieval risk require individualized medical judgment.
Does perforation on a scan prove injury?
No. It documents an imaging finding. Clinical significance depends on extent, symptoms, nearby structures, other findings, and medical interpretation. Legal causation and defect are additional questions.
Did PREPIC2 show that filters never work?
No. It found no added benefit in a defined group who all received full-dose anticoagulation. Its conclusion should not be extended automatically to patients who cannot take anticoagulants.
Is MDL 2570 a recall or class action?
No. It is coordinated federal pretrial litigation. FDA clearance and recall databases are separate, and individual MDL cases retain case-specific issues.
Does the current count reveal settlement amounts?
No. The JPML statistics provide pending and historical action counts only. They contain no payout schedule, eligibility criteria, or claim deadline.
Primary-source file
Documents used for this dossier
- The JPML report supplies the pending and historical action counts shown on this page.Pending MDL Dockets by Actions Pending — August 3, 2026U.S. Judicial Panel on Multidistrict Litigation · accessed
- The JPML centralized Cook IVC filter actions as MDL 2570.MDL 2570 Initial Transfer OrderU.S. Judicial Panel on Multidistrict Litigation · accessed
- The Southern District of Indiana's case information page is the court record for MDL 2570.MDL 2570 Case InformationU.S. District Court, Southern District of Indiana · accessed
- The Celect 510(k) record defines the device's cleared intended use and regulatory history.Cook Celect 510(k) K061815U.S. Food and Drug Administration · accessed
- The Celect Platinum 510(k) record defines that device's cleared intended use.Cook Celect Platinum 510(k) K171712U.S. Food and Drug Administration · accessed
- FDA granted marketing authorization for a device used to remove IVC filters.FDA Grants Marketing Authorization for IVC Filter Removal DeviceU.S. Food and Drug Administration · accessed
- The PREPIC2 randomized trial examined retrievable filters in patients with pulmonary embolism.PREPIC2 Randomized Clinical TrialPubMed / JAMA · accessed
- A published study compared retrievability between Celect and Option filters.A Comparison of Retrievability: Celect versus Option FilterPubMed / Journal of Vascular and Interventional Radiology · accessed
- A published study reported two-year outcomes from a Cook IVC filter study.Two-Year Outcomes from the Cook IVC Filter StudyPubMed / Journal of Vascular and Interventional Radiology · accessed
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