IVC Filters | Medical Device Injury
Medical Device Lawyer investigates defective IVC Filters and hospital negligence cases for injured plaintiffs nationwide
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IVC Filter Lawsuits
Investigating ivc filter defects & patient injury cases
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IVC (Interior Vena Cava) filters are designed to trap dangerous blood clots. However, the safety profile and efficacy is not well established. The IVC Filter is associated with a number of serious medical complications.
Initially introduced into the market in April 2003, the Recovery IVC filter was redesigned following several adverse event reports of device fractures. The new design, Bard G2 IVC, was then introduced to the market place in October 2005.
In 2010, the FDA reported that over a five year period it had received over 900 adverse event reports related to defective IVC complications and injuries and released an advisory report.
IVC filters are small, cage-like devices that are intended to capture blood clots and prevent them from reaching the lungs, heart or brain. The device catches the clots in the bloodstream and allows them to break down over time.
The filters are frequently placed in patients at risk for pulmonary embolism (a blood clot in the lungs) when other anticoagulant therapy is ineffective. IVC filters are designed to be permanent implants although some of these devices may have the option to be removed.
Due to safety concerns, in 2012, the American College of Chest Physicians recommended that IVC filters should only be used in high risk patients who have contraindications for anticoagulants. However, many patients who were at a lower risk and did not have a contraindication for anticoagulants have been implanted with the device.
Joe Lyon is an experienced product liability lawyer and medical device plaintiffs attorney reviewing IVC filter injury lawsuits and actively involved in product liability litigation nationwide.
Defective IVC Filter Recalls
The Lyon Firm is dedicated to improving patient safety and engaging large medical device firms in product defect cases and liability IVC Filter lawsuits. Consumer safety advocates and medical experts work together to protect patients and recover rightful compensation for injured plaintiffs nationwide.
Joseph Lyon is a product recall lawyer and actively involved in medical device litigation nationwide. For a no-cost and confidential consultation on the legal aspects of the IVC filter lawsuit, contact the Lyon Firm.
IVC Filter Complications
The IVC (Interior Vena Cava) filter is intended to prevent blood clots from developing or migrating, however over the last ten years the devices have been associated with a number of serious medical complications. The history of the devices is short though fraught with problems.
In April 2003, C.R. Bard introduced the Recovery IVC filter and was quickly redesigned following several reports of device fractures. The device failures can cause severe medical issues, and may even lead to death.
In 2010, the U.S. Food and Drug Administration published a safety alert that recommended physicians “consider removing the filter as soon as protection from pulmonary embolism is no longer needed.”
Due to safety concerns, in 2012, the American College of Chest Physicians recommended that IVC filters should only be used in high risk patients who have contraindications for anticoagulants. Despite these warnings, many lower-risk patients have been implanted with the device.
Unfortunately, IVC Filters have been linked to a number of serious complications. There is a risk of the filters breaking, which may cause metal fragments to move through the blood, potentially causing serious medical issues, including:
• Pulmonary Embolism
• Stroke
• Hemorrhaging or Internal Bleeding
• Death
IVC Filter Injuries
IVC Filters have been associated with a number of serious injuries, including, but not limited to:
- Vessel Perforation
- Organ Perforation
- Filter Embolization
- Vena Cava Thrombosis
- Explant Surgery
- Hemorrhagic Pericardial Effusion
- Arterial Hemorrhage
- Cardiac Tamponade
- Pericardial Pamponade
- Punctured Vena Cava
- Wrongful Death
Defective IVC Filter Injury Lawsuits
The decision to remove an implanted medical device is a serious medical decision and the risks and benefits of such a procedure must be discussed with the treating physician.
Lawyers are not qualified to render advice on the appropriate candidacy for surgery, and it is important to know that the Society of Interventional Radiology (SIR) guidelines for removing an IVC Filter:
• No further medical reason for a permanent IVC Filter
• Patient is at a low risk for pulmonary embolus
• No expectation of the patient being at a high risk in the near future
• Life expectancy of more than six months
• Ability to retrieve the IVC Filter
Bard IVC Filters
C.R. Bard and Cook are the two manufacturers that control the vast majority of the IVC filter market. The products most often associated with the IVC filter failures include:
• Bard Recovery
• Bard G2
• Bard Eclipse
• Bard G2 Express
• Bard Meridian
• Bard Denali
• Cook Gunther Tulip
• Cook Celect
Medical Device Failure & Lawsuits
Plaintiff attorneys have argued in court that the manufacturer C.R. Bard intentionally hid results of its own research which discovered the filters were potentially dangerous. Some cases even allege the company forged an employee’s signature on an FDA application in order to get faster approval.
Records claim that C.R. Bard was concerned about reports of failures for its G2 series filters within four months after the FDA approved the sale of the G2. Instead of recalling the G2 filter, Bard decided to keep them on the market for the next five years, selling more than 160,000 units.
At least 12 deaths are linked to the G2 series filters, according to Bard and FDA records, leading to possible IVC filter lawsuits.
Medical Device Defect Settlements
There are more personal injury and IVC Filter lawsuit filings every month in the U.S. The overall increase in IVC failure cases may be due to the increased sale of these devices. One estimate reports that the IVC filter market may be over $70 million in 2016.
Defective IVC Filter Lawsuit
The decision to remove an implanted medical device is a serious decision and the risks and benefits of such a procedure must be discussed with the treating physician.
Lawyers are not qualified to render advice on the appropriate candidacy for surgery, and if you are considering this as an option it should be discussed directly with your treating physician.
By way of patient education, it is important to know that the Society of Interventional Radiology published guidelines on removing and IVC Filter provide the following indications for removing an IVC Filter:
- No medical reason for a permanent Filter
- Patient is at a low risk for pulmonary embolus
- No expectation of the patient being at a high risk in the near future
- Life expectancy of more than six months
- Ability to retrieve the filter
- Patient/ Guardian Consents to the procedure understanding the risks
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Why are these cases important?
Filing a medical device injury lawsuit is often necessary to cover the financial burden of treatment, surgeries, or lost work. Beyond compensation, lawsuits also hold negligent manufacturers accountable, preventing future harm. These claims can spark recalls or stricter safety measures, benefiting countless others. By standing up for your rights, you gain both justice and an opportunity to influence positive change within the medical device industry.
Questions about Defective Medical Device Litigation
Defective medical devices are defined by their inability to perform safely for their intended purpose. Legally, this can involve defects in design, errors during manufacturing, or inadequate labeling and instructions. A stent that fractures inside the body or a prosthetic joint that deteriorates prematurely are common examples. Courts often ask: would a reasonable patient or physician have expected this risk? If the answer is no, the device may be considered defective. Regulatory compliance doesn’t guarantee safety, and legal claims may still succeed if harm results. Ultimately, a device is defective when it undermines trust in patient safety.
- Hernia Mesh
- Breast Implants
- Transvaginal Mesh Implants
- Catheters
- Hip Replacements
- Knee Implants
- Shoulder Replacements
- Heater Coolers
- Bone Grafts
- Ventilators
- Defibrillators
- IUD
- IVC Filters
- Da Vinci Robot Surgery System
Medical Device Manufacturers
- Atrium Hernia Mesh
- Bard Hernia Mesh
- Bard IVC Filters
- Covidien Hernia Mesh
- Depuy Hip Implants
- Arthrex knee replacement
- Exactech knee replacement
- CareFusion ventilators
- Essure Birth Control System
- Ethicon hernia mesh
- Infuse Bone Grafts
- LivaNova Heater-Coolers
- Stryker Hip Implants
- Smith & Nephew Hip Systems
- Zimmer Biomet Shoulder Systems
- Wright Medical Hip Implants
Defective design medical device cases arise not because a mistake was made during the manufacturing process, but rather the original design of the product is unreasonably dangerous. A “risk-benefit analysis” is used to determine whether safer/less expensive alternative designs were available to the manufacturer (e.g. the metal on metal design, the porosity and stiffness of transvaginal mesh )
For these claims, the FDA Review process is critical on whether a pre-emption defense exists. For devices that went through the PMA (pre-market approval process), rather than the 510K process, the case must be evaluated very carefully for any parallel claims under state and federal regulations (e.g., failure to warn or failure to disclose adverse events) that can advance the case forward. Without a careful legal analysis, the case may be subject to dismissal even where the medical device design proves to be defective.
All medical device products come with warnings and instructions for use that are provided to the physician. If the company does not provide the physician with all the relevant safety data so that the physician adequately understand the risks and benefits of the product, then the medical device is defective.
The physician must be in a position to pass the appropriate safety data onto the patient, so the patient can make an informed decision on whether they wish to have the medical device implanted. Patient informed consent is critical because many devices are designed to be permanent.
Litigation arises where there is evidence the medical device manufacturer failed to timely update a warning in light of new data or simply ignored the risk and failed to conduct sufficient research to identify and then disclose the risk.
In determining whether a medical device is defective due to inadequate warning or instruction, evidence must be presented to prove:
- The medical device manufacturer knew, or in the exercise of reasonable care, should have known about a risk
- A reasonable medical device manufacturer would have provided a warning of the risk
- The medical device manufacturer failed to provide the warning
- The patient was injured due to a lack of warning. The same elements apply whether the claim is based on a warning present during the marketing or post-sale warnings.
Defenses to Failure to Warn Claims: (1) the risk was open and obvious or a matter of common knowledge; and (2) in cases of a pharmaceutical drug or medical device, the warning was provided to the prescribing physician (“Learned Intermediary Doctrine”).
You should consider hiring The Lyon Firm because we offer a rare combination of national-level litigation experience and personalized client service. Joe Lyon has successfully represented clients in cases involving defective medical devices, environmental toxins, and corporate negligence. Unlike large firms where clients may feel overlooked, The Lyon Firm ensures each case receives individual attention and care. Joe Lyon’s reputation is built on thorough preparation, strong advocacy, and a passion for justice. Whether through negotiation or trial, the firm fights for maximum recovery. Choosing The Lyon Firm means gaining both a skilled litigator and a trusted legal partner.
Medical Devices Lawsuits
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