Medical Device MDL-2570 • Southern District of Indiana •
Open - Limited

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.

Last Updated: May 1, 2026
16 min read
JPML Data Verified
7 sources cited

Key Takeaways

  • Over 6,750 cases pending with mixed bellwether results after 10+ years of litigation
  • October 2025: Settlement terms agreed for some cases; negotiations ongoing
  • Plaintiff verdicts include $1.2M and $3M awards against Cook Medical
  • Filters allegedly caused fractures, migration, and organ perforation
  • FDA data shows 86% perforation rate for retrievable IVC filters
6,562
Pending Actions
11,472
Total Filed
$3M
Largest Verdict
86%
Perforation Rate*

Key Facts (May 2026)

Pending Actions 6,562 cases in federal MDL
Total Actions Filed 11,472+ cases historically
Defendant Cook Medical, Inc. (privately held, Bloomington, IN)
Presiding Judge Hon. Richard L. Young (S.D. Indiana)
MDL Created October 2014 (10+ years active)
Bellwether Results Mixed: 1 defense verdict, 2 plaintiff verdicts ($1.2M, $3M)
Settlement Status October 2025: Terms agreed for some cases; negotiations ongoing
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 1,018 cases resolved since January 2025 through settlements and dispositions.

Jan 25
7,580
Feb 25
7,278
Mar 25
7,274
Apr 25
7,202
May 25
6,978
Jun 25
6,984
Jul 25
6,978
Aug 25
6,980
Sep 25
6,979
Oct 25
6,968
Nov 25
6,969
Dec 25
6,901
Jan 26
6,896
Feb 26
6,873
Mar 26
6,750
Apr 26
6,569
May 26
6,562

Source: JPML MDL Statistics Reports, January 2025-May 2026

2012 UCSF Study: 86% Perforation Rate

A 2012 study of Cook Günther Tulip and Celect filters found alarming complication rates:

86%
Perforation rate (43/50 filters)
100%
Perforation after 71 days
40%
Filter tilting rate

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.

FDA Safety Communication (2014): FDA recommended retrieval within 29-54 days after implantation when PE risk has subsided. Yet the PRESERVE study found mean retrieval time was 101.5 days.

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:

• Aorta
• Duodenum (intestine)
• Ureter
• Spine

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:

328
Migration
146
Embolization
70
Perforation
56
Fracture

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

Oct 2014
MDL-2570 Created

JPML centralizes cases in Southern District of Indiana before Judge Richard L. Young.

Nov 2017
First Bellwether Trial

Defense verdict for Cook Medical—Cook's first outright win at trial.

May 2018
Pavlock Verdict: $1.2 Million

First plaintiff verdict in Cook IVC filter MDL. Failure to warn theory. Filter perforated plaintiff's intestine.

Feb 2019
Brand Verdict: $3 Million

Plaintiff verdict. Note: Verdict was later vacated and new trial ordered; case ongoing.

Dec 2022
Seventh Circuit Ruling

Significant appellate ruling on statute of limitations favorable to plaintiffs, affecting viability of many pending claims.

Apr 2025
Settlement Conference

Major settlement conference held with parties negotiating resolution terms.

Oct 2025
Settlement Terms Agreed (Partial)

Reports indicate Cook Medical and plaintiffs' counsel reached agreement on major settlement terms for some (but not all) cases. Negotiations ongoing for remaining cases.

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
Still Have Your Filter? If you have an IVC filter that hasn't been retrieved, consult with your physician about whether removal is appropriate. FDA recommends retrieval within 29-54 days when PE risk subsides.

7 Frequently Asked Questions

Are Cook IVC filters still being used?
Yes. Cook IVC filters remain FDA-cleared and commercially available. They continue to be used in clinical practice, particularly for patients who cannot receive anticoagulation therapy. Cook has received multiple subsequent 510(k) clearances for updated versions.
What happened to the Bard IVC filter cases?
The Bard IVC filter MDL (MDL-2641) has closed after reaching confidential settlements. This leaves the Cook MDL as the primary ongoing IVC filter MDL in federal court.
Why hasn't Cook settled like Bard?
Several factors may be involved: Cook is privately held (unlike Bard, which was acquired by Becton Dickinson), the bellwether results have been mixed (1 defense win, 2 plaintiff wins), and Cook may have different corporate strategies. Reports indicate settlement terms have been reached for some cases as of October 2025.
What are the legal claims?
Plaintiffs allege: design defect (filters prone to fracture and perforate), manufacturing defect, failure to warn (inadequate warnings about complication rates and importance of timely retrieval), negligence, breach of warranty, and in some cases fraud/misrepresentation.
What are Cook's defenses?
Cook argues: the learned intermediary doctrine (warnings provided to physicians), adequate warnings in Instructions for Use, benefits outweigh risks for appropriate patients, FDA compliance, and that implanting physicians make independent decisions. Cook also raises statute of limitations defenses in many cases.
How long has this MDL been going?
MDL-2570 was created in October 2014, making it over 10 years old. It remains one of the larger active product liability MDLs in the federal court system with over 6,750 pending cases.

Sources & References

7 official sources cited

• Judicial Panel on Multidistrict Litigation (JPML) — MDL Statistics Report (December 2, 2025)

• 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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