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IVC Blood Clot Filter Lawsuits and Legal Information
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Key Takeaways
IVC blood clot filters have been linked to serious injuries, including organ perforation and device migration. This has prompted thousands of lawsuits against device manufacturers. The FDA has recommended timely filter removal of these devices and has received hundreds of adverse event reports, including fatalities.
Inferior vena cava (IVC) blood clot filters are medical devices used to reduce the likelihood of dangerous blood clots and related medical complications. They look like tiny wire whisks.
IVC blood clot filters have been linked to dozens of deaths and hundreds of injuries. Patients have sued the two main manufacturers of the device, C.R. Bard, Inc. and Cook Medical, for allegedly failing to take adequate action despite awareness of potential dangers.
If you or a loved one has an implanted IVC filter, you should speak with your physician as soon as possible. You may also have a legal claim if you have suffered injuries from a faulty Bard IVC filter or other medical device.
The following is an overview of IVC blood clot filters. You’ll learn about:
- Complications and risks
- FDA actions
- IVC blood clot filter lawsuits
Medical device manufacturers are well-resourced with teams of attorneys who defend against lawsuits. If you decide to pursue legal action against C.R. Bard, Cook Medical, or any pharmaceutical or medical device company, you’ll need legal advocates of your own. Contact a product liability attorney in your area for a case review. Knowing your legal options and can help you move forward with confidence.
How Do IVC Blood Clot Filters Work?
IVC filters are inserted into the inferior vena cava (the main blood vessel carrying blood from the lower half of the body to the heart) to prevent dislodged blood clots from moving into the lungs. This can result in a dangerous, life-threatening condition called pulmonary embolism.
When loose blood clots travel to other parts of the body and become lodged, they can cause a painful condition called deep vein thrombosis (DVT). This is a common occurrence in the veins of the legs. IVC blood clot filters are often implanted in patients who are at risk for pulmonary embolism or deep vein thrombosis but who are unable to take blood thinners.
IVC Filter Complications and Problems
Potential issues with IVC blood clot filters can arise from both product defects and medical errors. Common problems with the filter include:
- Fracturing, breaking, or deteriorating over time
- Migrating from its original position
- Becoming embedded in the vein wall, making removal difficult or impossible
Some complications, like improper placement or issues with removal, may stem from medical malpractice. Others are linked to design flaws or manufacturing defects, such as weak materials or inadequate warnings about known risks.
These failures can result in life-threatening injuries like organ perforation. Some patients have died as a result of the filter migrating and puncturing vital organs.
IVC Filter Alerts and Safety Communications
Between 2005 and 2010, the U.S. Food and Drug Administration (FDA) received 921 claims of adverse effects from individuals with the implanted devices, including several fatalities. According to the reports, claimants experienced IVC perforation, punctured tissues and organs that included the heart, and other complications resulting from filter migration.
Many of the fatalities were attributed to fragments of the device coming loose, traveling to the heart or other organs, and puncturing vital organ tissues. Others were resolved through open heart surgery and other emergency interventions.
The FDA warned that long-term use of IVC filters could lead to serious complications and recommended removing retrievable filters once the risk of pulmonary embolism subsides. They later updated this communication in 2014, suggesting retrieval between 29 and 54 days after implantation.
The FDA continues to track adverse events for medical devices through its Manufacturer and User Facility Device Experience (MAUDE) database.
IVC Filter Recalls
In July 2015, the FDA issued a warning letter to Bard regarding quality system violations regarding their Denali IVC filter. This led to the FDA issuing a warning letter to Bard concerning quality system issues related to the Denali IVC filter. The FDA classified this as a Class II device recall.
IVC filter recalls from other manufacturers include:
- Boston Scientific Greenfield Filters (2005)
- Cordis OptEase Filters (2013)
- B. Braun VenaTech Filters (2007)
Despite being named in thousands of lawsuits and linked to serious injuries and deaths, Bard and Cook Medical did not recall their Recovery, G2, Gunther Tulip, or Celect filters.
You can check for medical device recalls using the FDA’s Medical Device Recall Database. Search by the product name, manufacturer, or product code.
Defective IVC Blood Filter Claims
IVC blood clot filter lawsuits against IVC filter manufacturers often fall under product liability claims. These include:
- Negligence
- Failure to warn
- Design defects
- Manufacturing defects
- Breach of implied warranty
- Negligent misrepresentation
Let’s take a closer look at some of these.
Design Defects
Some suits accuse manufacturers of creating filters with design flaws that made them prone to fracturing or shifting. Some devices had edges that were too sharp, perforating veins or organs.
Suits allege these defects persist across multiple product generations, including the Bard G2 and Recovery filters, despite the manufacturer’s knowledge of risks.
Manufacturing Defects
Even when designs were sound, some filters were improperly manufactured. Manufacturing defects include weak welds, joints that can fail under pressure, and material inconsistencies that cause deterioration.
These issues can cause the device to migrate within the body. They can also make retrieval procedures more difficult.
Failure To Warn
Some claims allege that manufacturers failed to adequately warn patients and healthcare providers about the risks associated with the implants. Cases state that despite FDA safety alerts and adverse event reports, manufacturers failed to update product labeling and public communications in a timely and sufficient manner.
Some patients also alleged negligent misrepresentation on behalf of the manufacturers. These suits accuse manufacturers of misrepresenting the safety of their devices in promotional materials and communications with healthcare providers.
Notable IVC Filter Litigation
Filters manufactured by Cook Medical and C.R. Bard have been the subject of IVC filter lawsuits. Thousands of these lawsuits have been consolidated into multidistrict litigation (MDL) to streamline the legal process.
MDL is a legal process often used to handle mass tort cases. It consolidates multiple lawsuits that share common facts or issues. These cases are then transferred to one court and handled by one judge. MDL can streamline pretrial proceedings and improve efficiency.
Cook and Bard aren’t the only IVC filter manufacturers facing lawsuits. Other IVC filter companies have been the subject of litigation, including:
- Argon
- Boston Scientific (Greenfield Filter)
- Cordis (OptEase Vena Cava Filter)
- Rex Medical
This list isn’t exhaustive. Let’s examine the legal actions against Bard and Cook.
C.R. Bard MDL
The Recovery was the first device sold by Bard linked to IVC lawsuits. It’s associated with 27 deaths and hundreds of non-fatal complications. Bard discontinued the Recovery filter around 2005 and replaced it with the G2 series, but it was not formally recalled.
According to the FDA, the G2 has been associated with at least 12 deaths and hundreds of other non-fatal complications. Bard allegedly knew the replacement IVC blood clot filter still had problems, but failed to recall the device after reports of injuries and deaths surfaced.
Bard IVC filter lawsuits were consolidated into MDL in the U.S. District Court for the District of Arizona. In addition to the Recovery, G2, and G2 Express, the MDL included other bard filters such as:
- Eclipse
- Meridian
- Denali
Bard settled over 8,000 cases for undisclosed amounts before the MDL officially closed in July 2024.
Cook Medical MDL
Thousands of individual cases were centralized in MDL No. 2570 in the Southern District of Indiana against Cook Medical. Cook Medical manufactured the Gunther Tulip and Celect IVC blood clot filters.
Complications associated with Cook’s devices were similar to those associated with Bard’s filters, but details have not been disclosed.
Many cases in the Cook MDL are still pending or in settlement discussions.
Injured by an IVC Filter Product? Contact an Attorney
If you currently have an implanted IVC blood clot filter, consult with your medical provider to ensure proper care. If you’ve experienced shortness of breath, persistent chest pain, or other unusual symptoms, you should seek emergency medical attention.
Afterwards, consider learning about your legal options. FindLaw’s directory of products liability attorneys can get you started. Select your state or city to review contact and ratings information for local experts. Your search results will also link you to additional details about the attorneys’ experience with IVC filter cases. Take some time to familiarize yourself with their backgrounds.
Don’t let too much time pass before you reach out, though. Plaintiffs who miss their state’s statute of limitations may lose their right to file a lawsuit and recover compensation. Many attorneys offer free case evaluations.
Can I Solve This on My Own or Do I Need an Attorney?
- A lawyer can help seek fair compensation on your behalf
- Accident and injury claims are complex and insurance carriers have lawyers on their side
- An attorney can help gather evidence and documentation to support your claim
An experienced attorney can increase your chances of a favorable verdict. Many attorneys offer free consultations.
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