Cordis IVC Filter Lawsuit | 2025 Latest Updates

Cordis IVC Filter Lawsuit Overview

Legal action has been initiated against Cordis Corporation (a Johnson & Johnson company) for injuries caused by their inferior vena cava (IVC) filters, including the OptEase and TrapEase models.

The primary allegations focus on device defects that cause filter fracture, migration, and organ perforation. A 2012 JAMA Internal Medicine study found that 50% of Cordis TrapEase filters fractured within 50 months of implantation.

The FDA issued safety warnings in 2010 regarding IVC filter complications and announced a Class I recall of approximately 33,000 Cordis OptEase filters in 2013 due to unclear instructions that could lead to backward implantation.

Cordis IVC filter lawsuit claims center on the manufacturer’s alleged failure to warn about serious device complications and design defects.

Latest Cordis IVC Filter Lawsuit Updates

• 2015 – The PRESERVE study launched as the first large-scale, multi-specialty research trial to evaluate IVC filter safety, including Cordis devices. The 5-year study will investigate 2,100 test subjects at 60 centers across the U.S., with at least 300 subjects for each participating filter manufacturer [1].
• August 2013 – FDA announced Class I recall of approximately 33,000 Cordis OptEase IVC filters distributed from May 2010 to April 2013. The recall addressed concerns that unclear instructions could lead healthcare providers to implant the devices backward, accompanied by an “URGENT Medical Device Correction” letter [2].
• January 2012 – JAMA Internal Medicine published study showing 50% fracture rate for Cordis TrapEase IVC filters within 50 months of implantation. Researchers analyzed 20 patients and found the fracture risk increases the longer filters remain implanted [3].
• August 2010 – FDA issued Drug Safety Communication warning about removable IVC filters, including Cordis OptEase, noting devices were not being removed after blood clot risk passed, leading to complications including filter fracture, migration, and vascular perforation [4].

FDA Reports and Statistics

The FDA has documented numerous adverse events related to Cordis IVC filters through safety communications and recall notices.

The 2013 Class I recall affected approximately 33,000 Cordis OptEase filters distributed over a three-year period, representing a significant safety concern for implanted patients.

Clinical studies have identified specific complication rates for Cordis devices, with the TrapEase filter showing a 50% fracture rate within 50 months according to peer-reviewed research.

The FDA’s 2010 safety warning identified multiple serious complications when IVC filters are left implanted beyond their intended duration.

The PRESERVE study, launched in 2015, represents the largest safety investigation of IVC filters, including Cordis devices, with participation from seven manufacturers and evaluation of 2,100 patients across 60 medical centers nationwide.

Cordis IVC Filter Injuries & Side Effects

Cordis IVC filters have been associated with serious complications that can result in life-threatening injuries requiring emergency medical intervention and additional surgical procedures.

• IVC Filter Fracture : Filter components breaking apart and potentially migrating through the vascular system, causing damage to organs and blood vessels.
• Device Migration: Filters moving from their intended placement in the vena cava to the heart, lungs, or other organs where they can become lodged.
• Organ Perforation: Filter components puncturing blood vessels, heart, lungs, or other organs, causing internal bleeding and tissue damage.
• Vascular Complications: Deep vein thrombosis, blood clots clogging the filter, pulmonary embolism, and cardiac tamponade.
• Cardiac or Pericardial Tamponade: Cardiac tamponade occurs when fluid or blood accumulates in the pericardial sac, putting pressure on the heart and impairing its function. This can happen when a filter punctures blood vessels or the heart, leading to internal bleeding.

PRESERVE Study to Investigate Cordis IVC Filter Safety

The first large-scale, multi-specialty research trial to evaluate the safety of IVC filter use kicked off in 2015 with participation from 7 filter manufacturers, including Cordis.

The 5-year study, entitled Predicting the Safety and Effectiveness of Inferior Vena Cava Filters (PRESERVE), will address concerns that retrievable IVC filters can migrate or break apart after being implanted, leading to significant health risks for patients.

The PRESERVE study will benefit patients by helping determine how well filters prevent pulmonary embolism and when retrievable filters should be removed. – Peter Lawrence, Vice President of the Society for Vascular Surgery (SVS).

Manufacturers and devices that will be included in the study are:

• ALN Implants Chirurgicaux (ALN IVC Filters)
• Argon Medical Devices, Inc.
• Cook Incorporated (Cook Günther Tulip IVC Filter)
• Cordis Corporation (Cordis OptEase Retrievable Vena Cava Filter)
• Volcano Corporation (Crux Vena Cava Filter System)

PRESERVE will investigate the safety of IVC filters, including 2,100 test subjects at about 60 centers across the U.S.

There will be at least 300 subjects for each participating filter, and patients will be evaluated every 6 months post-procedure up to 24 months or filter retrieval.

Do You Qualify for a Cordis IVC Filter Lawsuit?

You may qualify for a Cordis IVC filter lawsuit if:

• You received a Cordis OptEase or TrapEase IVC filter between 2010 and present.
• You experienced serious complications including filter fracture, device migration, organ perforation, or vascular injury.
• The injuries required medical treatment, additional surgery, or resulted in permanent disability.
• You can provide medical documentation linking your injuries to the Cordis IVC filter.
• Your filter was not removed within the recommended timeframe despite resolution of blood clot risk.

Related Article: IVC Filter Lawsuit Update

Evidence Required for a Cordis IVC Filter Lawsuit

• Medical Documentation: Hospital records, surgical reports, imaging studies showing filter complications, and documentation of device-related injuries.
• Device Evidence: Product identification, implantation records, model numbers (OptEase or TrapEase), and documentation of filter placement procedures.
• Treatment Records: Records of complications, additional surgeries, emergency interventions, and ongoing medical care related to filter problems.
• Expert Medical Testimony: Radiological evidence of filter fracture or migration, vascular specialist assessments, and medical expert opinions on causation.

Damages You Can Recover

• Medical Expenses: Emergency treatment, additional surgeries, filter removal procedures, ongoing medical care, and prescription medications.
• Lost Wages: Income lost due to complications, disability, extended recovery periods, or inability to work.
• Pain and Suffering: Compensation for physical pain, emotional trauma, and reduced quality of life from filter-related complications.
• Punitive Damages: Additional compensation to punish Cordis for releasing allegedly defective medical devices and failing to warn about known risks.

Cordis IVC Filter Recall Information

• Recall Date: August 2013
• Recall Classification: Class I (most serious type of recall)
• Devices Affected: Cordis OptEase IVC filters
• Units Recalled: Approximately 33,000 devices
• Distribution Period: May 2010 to April 2013
• Manufacturer: Cordis Corporation (Johnson & Johnson subsidiary)
• Recall Reason: Unclear instructions that could lead healthcare providers to implant the filter backward
• FDA Action: “URGENT Medical Device Correction” letter issued to healthcare providers with additional implantation guidance

Statute of Limitations for Cordis IVC Filter Lawsuits

The statute of limitations for medical device lawsuits varies by state, typically ranging from 1-6 years from the date of injury discovery.

In Cordis IVC filter cases, the limitations period generally begins when filter complications are diagnosed and linked to device defects.

• Most States: 2-3 years from date of injury discovery
• Discovery Rule: May extend deadlines when device complications are not immediately apparent
• Product Liability Claims: May have different limitation periods based on when device defects became known
• Wrongful Death Cases: Separate statutes apply, typically 2-3 years from date of death

Given the complex nature of IVC filter complications and the time required to establish causation, consultation with legal counsel is essential to determine specific filing deadlines.

FAQs

1. What makes Cordis IVC filters more dangerous than other brands?

Studies show Cordis TrapEase filters have a 50% fracture rate within 50 months, and the OptEase model was subject to a Class I FDA recall due to backward implantation risks. These specific design and instruction defects distinguish Cordis filters from other manufacturers.

2. How many Cordis IVC filters were recalled by the FDA?

The FDA announced a Class I recall of approximately 33,000 Cordis OptEase IVC filters in August 2013 due to unclear instructions that could lead to backward implantation by healthcare providers.

3. What complications are most common with Cordis IVC filters?

The most serious complications include filter fracture (50% rate for TrapEase models), device migration to the heart or lungs, organ perforation, and deep vein thrombosis when filters are not removed timely.

4. Can I file a lawsuit even if my Cordis filter hasn’t caused problems yet?

Our attorneys are evaluating all Cordis IVC filter cases regardless of whether complications have occurred. Contact us for a free evaluation even if you haven’t experienced obvious problems, as some complications may not be immediately apparent.

5. What compensation is available for Cordis IVC filter injuries?

Compensation may include medical expenses for complications and additional surgeries, lost wages, pain and suffering, and punitive damages. The amount depends on the severity of complications and their impact on your health and life.

6. How do I prove that my Cordis IVC filter caused my injuries?

Medical records, imaging studies showing filter complications, expert medical testimony, and documentation of the filter model can establish causation. Hospital records of implantation and subsequent complications are particularly important evidence.

7. What is the PRESERVE study and how does it affect my case?

PRESERVE is a large-scale safety study launched in 2015 to investigate IVC filter complications, including Cordis devices. The study may provide additional evidence of device risks but does not affect individual legal claims.

8. Are both OptEase and TrapEase filters included in lawsuits?

Yes, lawsuits involve both Cordis OptEase and TrapEase IVC filter models. The OptEase was subject to FDA recall, while the TrapEase showed high fracture rates in clinical studies.

9. How long do Cordis IVC filter lawsuits typically take?

Medical device lawsuits typically take 1-3 years to resolve, depending on case complexity and the number of plaintiffs. Some cases may settle earlier while others requiring extensive medical testimony may take longer.

10. What should I do if I have a Cordis IVC filter but no symptoms?

Contact our attorneys for a free evaluation and discuss filter removal with your healthcare provider. Many complications may not cause immediate symptoms, and early evaluation can protect your legal rights and health.

See all related medical device litigations our attorneys covered so far.

Get a Free Cordis IVC Filter Lawsuit Evaluation With Our Lawyers

Time is limited to pursue legal action for Cordis IVC filter injuries. Most states allow only 2-3 years from the date of injury discovery to file medical device lawsuits.

At Schmidt & Clark, we provide:

• Free, confidential consultations to evaluate your case
• No upfront costs or fees for legal representation
• Payment only if we win your case through settlement or trial verdict
• Experienced legal team with IVC filter litigation experience

Our attorneys understand the complex medical and legal issues involved in Cordis IVC filter litigation.

We work with vascular specialists and medical experts to establish causation and fight for maximum compensation for our clients.

Contact our law firm immediately for your free case evaluation. Do not delay – legal deadlines are strict and evidence preservation is critical for building a strong case.

References

1. https://pubmed.ncbi.nlm.nih.gov/31636051/
2. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=119066
3. https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/1108659
4. https://evtoday.com/news/fda-issues-statement-on-treatment-and-follow-up-regarding-ivc-filter-complications