Optease IVC Filter Lawsuit | 2025 Latest Updates

Optease IVC Filter Lawsuit Overview

Latest Optease IVC Filter Lawsuit Updates

• December 3, 2024 – Court documents reveal that inadequate FDA oversight and delayed communication contributed to the public’s exposure to defective IVC filters, including Cordis’ Optease model [1].
• March 7, 2019 – A recent lawsuit filed by 12 patients claims the Cordis Optease and TrapEase filters caused serious injuries, including organ damage and filter migration—alleging defective design and lack of proper warnings.

Related Article: IVC Filter Lawsuit (2023) Update

FDA Reports and Statistics

The FDA’s Manufacturer and User Facility Device Experience (MAUDE) database has documented numerous adverse event reports (AERs) for inferior vena cava (IVC) filters, including the Optease filter by Cordis Corporation.

From 2005 to 2010, the FDA recorded 921 AERs across all IVC filters, as noted in a 2010 Safety Communication, with specific complications including:

• 328 device migrations (filters moving from implantation site, e.g., to heart or lungs)
• 146 embolizations (detached components traveling to organs, risking stroke or heart attack)
• 70 perforations of the inferior vena cava (struts puncturing vessel walls, causing bleeding or pain)
• 56 filter fractures (struts breaking, with fragments potentially lodging in organs)

These figures reflect all IVC filters (e.g., Bard, Cook, Cordis, ALN), not Optease alone, as MAUDE lacks brand-specific breakdowns for this period.

From 2010 to 2023, total AERs likely reached 5,000–10,000 for all IVC filters, based on litigation filings (~7,274 Cook MDL cases, ~24,000 Bard cases, April 2025) and reporting trends, though MAUDE’s limitations—unverified submissions, delayed reporting (33% late, 2019–2022), and underreporting—obscure precise counts.

Optease-specific AERs are undocumented publicly but contribute to hundreds of lawsuits alleging migration, fracture, perforation, and embolization [2].

Optease IVC Filter Injuries & Side Effects

Patients implanted with Optease IVC filters have reported a wide range of serious complications that can lead to significant medical issues or even death.

• Filter Fracture: Breakage of the device leading to metal fragments traveling through the bloodstream
• Perforation: Device components puncturing through vein walls and damaging adjacent organs
• Device Migration: Filter moving from its intended location to other areas of the body
• Cardiac Tamponade: Dangerous pressure on the heart when device components migrate
• Pulmonary Embolism: Failure of the device to prevent blood clots from reaching the lungs
• Deep Vein Thrombosis: Formation of blood clots in the deep veins, often in the legs
• Internal Bleeding: Hemorrhaging caused by vein or organ perforation
• Death: Fatal complications resulting from any of the above injuries

Do You Qualify for an Optease IVC Filter Lawsuit?

You may qualify for an Optease IVC filter lawsuit if:

• You received an Optease IVC filter implant after 2010
• You experienced serious complications such as device migration, fracture, perforation, or embolization
• You required medical intervention, additional procedures, or hospitalization due to filter complications
• You can provide medical documentation of both the implantation and resulting complications

Evidence Required for an Optease IVC Filter Lawsuit

• Medical Records: Documentation confirming Optease filter implantation and subsequent complications
• Imaging Studies: CT scans, X-rays, or other imaging showing filter placement, migration, or fracture
• Surgical Records: Documentation of any procedures required to address filter complications
• Physician Statements: Medical opinions linking your injuries to the Optease IVC filter

Damages You Can Recover

Successful Optease IVC filter lawsuits may result in compensation for:

• Medical Expenses: Costs for surgeries, hospitalizations, and ongoing treatment
• Lost Wages: Compensation for time away from work due to complications
• Pain and Suffering: Damages for physical pain and emotional distress
• Permanent Disability: Compensation for long-term or permanent health effects
• Punitive Damages: Additional compensation in cases of manufacturer negligence

Optease IVC Filter Recall Information

In March 2013, the FDA issued a Class 1 recall for approximately 33,000 Optease Retrievable Vena Cava Filters.

The recall was specifically for a labeling correction to minimize the risk of implanting the device backward. Affected filters were distributed in the United States from May 5, 2010, to April 2, 2013.

A Class 1 recall is the FDA’s most serious recall classification, indicating that there is a reasonable probability that the use of the product will cause serious adverse health consequences or death.

The labeling issue could result in the device being placed upside down, significantly increasing the risk of complications.

Statute of Limitations for Optease IVC Filter Lawsuits

The statute of limitations for filing an Optease IVC filter lawsuit varies by state but typically ranges from one to three years from the date of diagnosis or discovery of harm.

In some states, the timeline may begin from the date of implantation, while in others, it starts when you discover or should have reasonably discovered your injury.

Because these timeframes vary significantly and exceptions may apply in certain circumstances, it’s crucial to consult with an experienced attorney as soon as possible to ensure your legal rights are protected.

Related Article:

• Cordis IVC Filter Lawsuit
• B. Braun IVC Filter Attorney
• Injuries from IVC Filters

FAQs

1. What is the Optease IVC Filter used for?

The Optease Retrievable Vena Cava Filter is a small, cage-like device implanted in the inferior vena cava just below the kidneys. It’s designed to capture blood clots that have broken loose from the lower body before they can travel to the heart and lungs, which can cause pulmonary embolism.

2. How was the Optease IVC Filter approved by the FDA?

The Optease IVC Filter was cleared for sale on the U.S. market through the FDA’s 510(k) approval process. This process requires limited safety information and only some efficacy data as long as the device is deemed “substantially equivalent” to a product already on the market.

3. What makes Optease IVC Filter lawsuits different from other IVC filter cases?

Optease IVC Filter lawsuits specifically involve a Class 1 recall issued in 2013 for labeling issues that could lead to backward implantation. This unique issue, alongside the typical complications associated with IVC filters, strengthens many plaintiffs’ claims against manufacturer Cordis Corporation.

4. How long do Optease IVC Filter lawsuits typically take to resolve?

The timeline for resolving Optease IVC Filter lawsuits varies greatly. Some cases may settle within 1-2 years, while others might take 3-5 years if they proceed to trial. Factors affecting timeline include case complexity, evidence strength, and court backlogs.

5. What is the average settlement for Optease IVC Filter lawsuits?

Settlement amounts vary widely based on injury severity, medical expenses, and other factors. While some cases have resulted in settlements ranging from $100,000 to over $1 million, each case is unique and past results don’t guarantee future outcomes.

6. Can I file a lawsuit if my Optease IVC Filter hasn’t caused problems yet?

Generally, you need to have experienced complications to file a lawsuit. However, you should consult an attorney if you have an Optease filter that was part of the recalled batch, as medical monitoring claims may be possible in some jurisdictions.

7. What should I do if I have an Optease IVC Filter implanted?

Consult with your healthcare provider about the risks and benefits of your specific situation. If your filter was designed to be retrievable and is no longer needed, discuss removal options. Also, maintain regular follow-up appointments to monitor the device.

8. How can an attorney help with my Optease IVC Filter case?

An experienced attorney can help gather medical evidence, identify applicable legal theories, navigate complex procedural requirements, negotiate with defendants, and represent your interests in court if necessary.

9. Are there any class action lawsuits for Optease IVC Filters?

Rather than class actions, most IVC filter cases have been consolidated into multidistrict litigation (MDL) in federal courts. This allows cases to share pre-trial proceedings while maintaining their individual status for potential settlements or verdicts.

10. What if a loved one died due to Optease IVC Filter complications?

If a family member died due to complications from an Optease IVC Filter, qualifying family members may be able to file a wrongful death lawsuit. These claims can seek compensation for medical expenses, funeral costs, lost financial support, and loss of companionship.

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

Get A Free Optease IVC Filter Lawsuit Evaluation With Our Lawyers

Time is limited to pursue legal action for Optease IVC Filter complications. Most states allow only 1-3 years from the date of injury or discovery to file a claim, and this window closes permanently once passed.

At Schmidt & Clark, LLP, we offer:

• Free, confidential case evaluations
• No upfront costs or attorney fees
• Payment only if we win your case
• Nationwide representation for Optease IVC Filter victims
• Dedicated attorneys with experience in medical device litigation

Don’t wait until it’s too late to seek the compensation you deserve. Contact us today to protect your legal rights.

References:

[1] https://www.tctmd.com/news/ivc-filter-lawsuits-expose-holes-fda-oversight-and-public-communication#:~:text=Unsealed%20court%20documents%20from%20lawsuits,need%20to%20make%20informed%20decisions 

[2] https://www.fda.gov/news-events/press-announcements/fda-grants-marketing-authorization-inferior-vena-cava-filter-removal-device