Cook Medical IVC Filter Lawsuit
(Fracture, Migration & Perforation)
Federal litigation alleging Cook Medical's Celect and Günther Tulip IVC filters are defectively designed, causing filter fractures, migration, IVC perforation, and organ damage. Over 10 years of litigation with mixed bellwether results.
Key Takeaways
- Over 6,400 cases pending with mixed bellwether results after 10+ years of litigation
- No MDL-wide settlement: cases are resolving inventory by inventory, and a July 2026 motion seeking remand of all Celect cases is pending
- Plaintiff verdicts include a $3M MDL bellwether award and a 2018 Texas state-court verdict ($1.2M)
- Filters allegedly caused fractures, migration, and organ perforation
- A 2012 single-center study of Celect and Günther Tulip filters reported an 86% perforation rate
Key Facts (October 2026)
| Pending Actions | 6,470 cases in federal MDL |
| Total Actions Filed | 11,478+ cases historically |
| Defendant | Cook Medical, Inc. (privately held, Bloomington, IN) |
| Presiding Judge | Hon. Richard L. Young, Senior District Judge (S.D. Indiana) |
| MDL Created | October 2014 (10+ years active) |
| Bellwether Results | Mixed: 1 defense verdict, 1 plaintiff verdict ($3M); a separate 2018 Texas state-court verdict ($1.2M) |
| Settlement Status | Inventory-by-inventory settlements continue; no MDL-wide deal |
| Can You Still File? | Yes, cases continue to be filed |
*86% perforation rate from 2012 Durack et al. study (PMID: 21448771); 100% perforation after 71 days indwelling
Case Resolution Progress
This mature MDL shows steady resolution of cases, with 1,110 cases resolved since January 2025 through settlements and dispositions.
Source: JPML MDL Statistics Reports, January 2025-October 2026
2012 UCSF Study: 86% Perforation Rate
A 2012 study of Cook Günther Tulip and Celect filters found alarming complication rates:
Source: Durack JC, et al. Cardiovasc Intervent Radiol. 2012;35(2):299-308 (PMID: 21448771)
1 What Are IVC Filters?
IVC filters are small, cage-like medical devices inserted into the inferior vena cava (the main vein returning blood from the lower body to the heart). They act as a physical barrier to catch blood clots and prevent them from reaching the lungs, where they could cause a potentially fatal pulmonary embolism (PE).
Up to 900,000 Americans are affected by venous thromboembolism (VTE) each year, with 60,000-100,000 deaths. IVC filters are primarily used for patients who cannot take blood thinners (anticoagulants) due to recent surgery, active bleeding, or other contraindications.
2 Cook Filter Products in Litigation
Cook Celect Filter
Design: 12 legs with anchoring hooks, conical shape
Material: Nitinol (nickel-titanium alloy)
FDA Cleared: April 2007 (K061815)
Type: Retrievable/optional
Cook Günther Tulip Filter
Design: 4 legs, tulip-shaped with hook at apex
Material: Nitinol (nickel-titanium alloy)
FDA Cleared: October 2000 (K000855)
Type: Retrievable/optional
Both filters were cleared through the FDA's 510(k) pathway based on "substantial equivalence" to predicate devices—a process that does not require clinical trials.
3 Alleged Defects & Failure Modes
Filter Fracture
Metal fatigue from millions of stress cycles (cardiac/respiratory motion) causes filter struts to break. Fragments can embolize to the heart, lungs, or other vessels, potentially causing serious injury or death.
IVC Perforation
Filter struts penetrate through the vena cava wall, potentially injuring adjacent structures:
The 2012 study found 100% perforation in filters present >71 days.
Filter Migration & Embolization
The entire filter or portions may move from the original position. Complete migration to the heart or lungs (filter embolization) is a potentially fatal complication requiring emergency intervention.
Filter Tilting
Deviation from optimal vertical orientation reduces clot-catching effectiveness, increases perforation risk, and makes retrieval more difficult. The 2012 study found 40% tilting rate—and all tilted filters also showed perforation.
4 FDA Safety Communications
2010 FDA Safety Communication
FDA received 921 adverse event reports involving IVC filters between 2005-2010:
2014 FDA Safety Communication
FDA recommended filter retrieval within 29-54 days after implantation when PE risk has subsided. This was based on FDA's quantitative decision analysis modeling showing risks increase with longer indwelling times.
5 Litigation Timeline
JPML centralizes cases in Southern District of Indiana before Judge Richard L. Young.
Defense verdict for Cook Medical—Cook's first outright win at trial.
Reported as a Texas state-court verdict, not an MDL-2570 bellwether trial. Failure to warn theory. Filter perforated plaintiff's intestine.
Plaintiff verdict. Note: Verdict was later vacated and new trial ordered; case ongoing.
Significant appellate ruling on statute of limitations favorable to plaintiffs, affecting viability of many pending claims.
Major settlement conference held with parties negotiating resolution terms.
Reports indicate Cook Medical and plaintiffs' counsel reached agreement on major settlement terms for some (but not all) cases. Negotiations ongoing for remaining cases.
On July 6, the Plaintiffs' Steering Committee moved for a suggestion of remand of all Celect cases. Cook opposed on August 5. The motion is pending.
Stipulated dismissals with prejudice covering about 60 cases were filed August 19–20.
On September 28, Magistrate Judge Tim A. Baker held a conference on an inventory settlement. Cases continue to resolve inventory by inventory; there is no MDL-wide deal.
6 Do You Qualify?
Eligibility Requirements
- Received a Cook IVC filter (Celect or Günther Tulip)
- Experienced a complication — filter fracture, migration, perforation, tilting, or difficult/failed retrieval
- Suffered injuries — additional surgeries, organ damage, chronic pain, or other complications
- Within statute of limitations — 2022 Seventh Circuit ruling expanded timeframes for some plaintiffs
7 Frequently Asked Questions
Are Cook IVC filters still being used?
What happened to the Bard IVC filter cases?
Why hasn't Cook settled like Bard?
What are the legal claims?
What are Cook's defenses?
How long has this MDL been going?
Sources & References
8 official sources cited• Judicial Panel on Multidistrict Litigation (JPML) — MDL Statistics Report (October 1, 2026)
• U.S. District Court, S.D. Indiana — MDL-2570 docket filings, July–September 2026 (via CourtListener)
• Durack JC, et al. "Perforation of the IVC: rule rather than exception." Cardiovasc Intervent Radiol. 2012;35(2):299-308 (PMID: 21448771)
• Johnson MS, et al. (PRESERVE Study) J Vasc Surg Venous Lymphat Disord. 2023;11(3):573-585.e6 (PMID: 36872169)
• FDA Safety Communication (August 2010, May 2014) via Archive.org
• FDA 510(k) Premarket Notification Database
• CDC Blood Clots Information (March 2025)
• NHLBI/NIH Venous Thromboembolism Resources
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