IVC Filter Lawsuit

• In 2010 and 2014, the FDA issued a warning about the high risk of complications arising from IVC filter use. More than 33,000 devices were recalled – the ones distributed between 2010 and 2013.
• Lawsuits were filed against different manufacturers, mainly Cook Medical and C.R. Brad, for injuries and losses sustained by patients due to the use of IVC filter devices during surgery.
• In 2015, the FDA found that Bard produced a specific IVC filter removal system without marketing its approval or clearance. NBC News investigation connected the IVC filter by Bard to around 39 deaths and more than 300 injuries.
• Up till April 2019, over 11,000 IVC filter lawsuits were still awaiting decisions and trials in the federal court against different IVC filter manufacturers.

An IVC (inferior vena cava) filter is a metal tool designed to prevent blood clots from reaching the heart. Doctors have implanted thousands of patients with it due to several different reasons. While some IVC filter placement has potentially saved the lives of many individuals, others have resulted in complications and even proven deadly in some cases.

In 2010 and 2014, the FDA issued a warning about the high risk of complications arising from IVC filter use. IVC filter placement reportedly had an extremely high rate of failure. Small parts of the filter broke off and punctured the veins of patients, or migrated to their lungs, heart, and other organs, resulting in severe consequences or death.

A high amount of cases have been filed since then against different manufacturers, mainly Cook Medical and C.R. Brad, for injuries and losses sustained by patients due to the use of IVC filter devices during surgery. Recently, Brad’s and Cook’s cases have been consolidated into MDLs (Multidistrict Litigations).

The main devices named in the majority of the lawsuits are Cook Gunther Tulip, Cook Celect, Bard G2 and G2 Express, and Bard Recovery. Many non-fatal complications and death have been connected to the Bard G2 and Recovery filters.

The companies have been blamed for allegedly knowing the potential risks and dangers of IVC filters but selling them anyway, putting the lives of thousands of patients at risk.

An IVC filter is implanted in the Inferior Vena Cava (IVC), which is the body’s largest blood vein, during minor surgery. It is a small metal device that helps hold the IVC vein in place to direct proper blood flow without allowing the formation of blood clots. It prevents blood clots from reaching the lungs or heart, which could otherwise result in severe damage to the body.

Patients require an IVC filter for different reasons that increase the risk of blood clot formation and damaging major internal organs. These reasons may be:

• Smoking
• Obesity
• Prolonged bed rest
• Stroke
• Genetic Predisposition
• Surgery
• Cancer
• Pregnancy

No matter what the reason, implanting an IVC filter must always be a last resort. Most doctors opt for other treatments to prevent the risk of blood clot formation, including asking patients to use medications like blood thinners and making lifestyle changes like a healthy diet and physical activity. An IVC filter may be appropriate for patients who can’t take blood thinners, in emergency cases or when less invasive treatments fail.

IVC filters have a history of migration and fragmentation, which can cause serious issues, including:

• Tilting of the filter, allowing blood clots to pass by
• The entire filter moving in the lung or heart
• Perforation (ripping) of the vein itself

These complications can lead to life-altering problems, which require additional corrective surgery or the need for a pacemaker. Certain IVC filters are removable, but the majority of them aren’t, which makes it highly risky to remove them. Bard filters are permanent, so in case of filter migration or fragmentation, a large number of surgeons refuse to perform surgery due to the high risk involved.

While there are plenty of IVC filter benefits, including non surgical incision and protection of the lungs and heart, there are also numerous associated risks with these devices. IVC filter complications reported in most of the lawsuits include:

• Tilting or migration of the filter
• Fracture or breakage
• Organ damage
• Deep vein thrombosis
• Malposition
• Perforation of the arteries or veins

These complications result in severe injuries and side effects, including:

• Internal bleeding or hemorrhaging
• Shortness of breath
• Neck pain
• Nausea
• Lightheadedness
• Hypotension
• Irregular heart rhythm
• Confusion
• Chest pain
• Death

Numerous published reports and studies have highlighted certain risks linked to the use of IVC filters by Bard, Cook, and other manufacturers. Pain from IVC filter use can also get severe that it could interfere with the normal everyday activities of a patient after surgery. A study found that patients with IVC filters have a higher blood clot rate due to Deep Vein Thrombosis (DVT).

The study revealed that 35% and more patients with these filters experienced DVT, whereas only 27% of individuals without a filter experienced DVT. The findings further indicated that IVC filters could in fact be causing the condition it was created to prevent.

The first safety announcement by the FDA regarding IVC filters was made in 2010, warning the public of the potential adverse complications of its long-term usage. This announcement came after various studies highlighted the dangers of these filters.

The findings showed that about 40% of Cook Medical’s IVC filters migrated to the body. In other cases, the filters tilted, punctured the vein, or fragmented. Bard’s filters caused similar issues. The research revealed that Bard Recovery filters resulted in fractures in 25% of patients, at least.

A recall was announced in 2013 by the FDA of Cordis IVC retrievable filter, stating an issue in implant instruction and labeling of the device. More than 33,000 devices were recalled – the ones distributed between 2010 and 2013.

The FDA made another safety announcement in 2014, highlighting further complications linked with IVC filters, and problems associated with certain products and manufacturers. The announcement highlighted concerns about how retrievable filters are not usually removed within the right time frame. Many of the complications could be prevented if the filter is taken out after the risk has subsided. The FDA recommended that removable IVC filters be removed between 29 and 54 days after its implementation.

In 2015, the FDA found that Bard produced a specific IVC filter removal system without marketing its approval or clearance. The FDA issued a warning letter to the company stating that they had violated the law and was subject to penalization.

In the same year, an investigation by NBC News connected the IVC filter by Bard to around 39 deaths and more than 300 injuries. The network claimed that the management of Bard was aware of the risk and complications associated with the device for years, but neglected to do anything about it.

During the investigation process, the network attained a 2004 study funded by the company that discovered the Bard Recovery had a higher rate of failure in comparison to its competing devices. The company only made the report available on a “need-to-know” basis and instructed people who read the report to not share its content with anyone.

This report led to further investigation, as well as lawsuits. However, Bard kept selling IVC filters without issuing a warning to patients and doctors, even with the mounting evidence against them. The increasing awareness and research about IVC filters and their complications highlighted specific products and manufacturers.

Cook Medical is one of the largest manufacturers of IVC filters – both non-retrievable and retrievable. Several of the company’s retrievable IVC filter devices were cited in many of the IVC lawsuits, particularly:

• Cook Celect Platinum
• Cook Celect
• Gunther Tulip Mreye
• Gunther Tulip

Presently, Cook filter lawsuits have been consolidated into MDLs (Multi-District Litigation) and are pending before a judge in U.S. District Court, Illinois. Allegations made against Cook is that the company was aware of the defects in their devices, knew about the health complications and dangers, but failed to warn the public and health institutions about the IVC filter placement dangers.

C.R. Bard is another major manufacturer of IVC filters. Several of their IVC filter devices have been cited in many IVC lawsuits, particularly:

• Eclipse
• Meridian
• Denali
• G2 Express
• G2
• Recovery

Bard IVC filter lawsuits have also been consolidated into MDLs and are pending before a judge in U.S. District Court, Arizona. The allegations stated in the Bard IVC filter lawsuits are similar to Cook's allegations, alleging that the company was aware of the defects in their devices and dangers to patients, but failed to warn the public and health institutions.

Additionally, some lawsuits have also been made against other manufacturers of IVC filters, including:

• Rafael
• Crux
• Cordis
• Boston Scientific
• Braun
• ALN

With increasing research revealing the dangers of IVC filters to patients, many lawsuits have been made against these manufacturers. Since 2017, there are 1,600 and more cases pending against Cook Medical and Bard.

If you or a loved one has a blood clot filter or an IVC filter implanted for preventing blood clots or decreasing the risk of pulmonary embolism or other health issues, it is highly recommended that you consult your physician immediately for a consultation. There might be potential complications, and it is recommended to get them treated before they get worse. Moreover, if you have experienced filter failure or are experiencing other complications, including:

• Injury or related issues due to filter malfunction
• Migrated or broken filter
• Tearing or perforating of the vein
• Tilting or moving of the filter

Then, you should contact an injury lawyer for guidance and to help you with the case. The lawyer will try to help you seek the compensation you rightfully deserve, which may include:

• Loss of enjoyment of life
• Lost wages
• Loss of your ability to earn money
• Pain and suffering, both mental and physical
• Cost of recovery and other treatments needed due to the IVC filter
• Medical expenses you endured
• Future medical expenses
• Punitive damages

Our experienced injury attorneys can help file the case on your behalf, and pursue compensation damages or based on the unique circumstances of your case.

Determining the IVC filter lawsuit deadline can be complex. The Statute of Limitations on defective medical devices, product liability, or manufacturer negligence varies in different states. Be sure to contact an injury attorney for legal guidance on the Statute of Limitations for your claim.

Certain states also have a “statute of repose,” which means the statute of limitations begins the day of the incident – when the IVC filter was implanted.

If they are unfortunate to realize the IVC filter complications and injury after the statute of repose deadline, then they will be barred from bringing a lawsuit against the manufacturer.

Therefore, it is important to consult a lawyer to help you determine whether you have a case or not. If you are or have experienced injuries from IVC filters, then you may have the right to bring a claim against the manufacturers, like Cook Medical or Bard. Contact a dedicated injury attorney for guidance on how to pursue your claim.

Up till April 2019, over 11,000 IVC filter lawsuits were still awaiting decisions and trials in the federal court against different IVC filter manufacturers. Before that, various IVC filter settlements were made in favor of the victims.

The first verdict for IVC filter lawsuits came in April 2018 when an Arizona jury found that the negligence of Bard resulted in the G2 IVC to migrate and fracture. The patient was awarded $3.6 million for their pain and suffering.

This case was the first-ever victory in a jury trial for a victim in IVC lawsuits. Many victims and their lawyers had lost against manufacturers before this case. The verdict came as a relief to other victims and re energized lawyers to fight for their clients.

Another reason this case was highly significant to several IVC filter cases was that $2 million punitive damages were also awarded to punish the company for its negligence. It indicated that the jury was furious about the negligence caused by the company, and the settlement showed that they certainly didn’t believe it was merely an honest mistake made on the company’s part. This particular case proved beneficial for other cases and increased the settlement award of IVC lawsuits.

Another verdict came down in May 2018 against Cook Medical in which a firefighter was awarded $1.2 million since Cook Medical failed to warn the surgeon of the patient about the potential risk of their IVC filter device. However, another victim lost their case in October 2018. In February 2019, $3 million were awarded to another victim who experienced a cardiac injury because of the use of a defective IVC filter by Cook Medical.

The defense lawyers of the manufacturers were using FDA approval as their defense to dismiss as many cases as they could, but eventually, IVC victims started winning the fight. There are still many pending cases in the court, which is why you should consult a lawyer sooner than later if you or your loved one has been affected by an IVC filter.

If you are wondering how to file an IVC filter lawsuit against IVC manufacturers, contact a dedicated attorney for advice on how to pursue legal action. At Frankl Kominsky, our attorneys have recovered more than $200 million in accident and injury settlements.

If you or a loved one has experienced complications or wrongful death due to an IVC filter, our lawyers can try to help you recover compensation for your previous and future medical bills, lost wages, and special damages. Our lawyers will evaluate your case and try to help determine if you can join the IVC filter lawsuit to recover damages.

Frankl Kominsky Injury Attorneys have a contingency fee agreement. It means you won’t have to pay us unless our lawyers have successfully recovered damages for your case. We aim to help victims who are already under immense financial stress and suffering from health issues on account of someone else’s negligence.

Call us today at 855-955-1428 for a free consultation on your case.