What Products Have Been Under Investigation And Involved In Injury Lawsuits?
In most of the IVC filter lawsuits, the manufacturers C.R. Bard and Cook Medical are listed. Federally consolidated litigations, formally known as “multi-district litigations” (or MDLs), have been formed against these manufacturers. These are the top five products that are named in most of the IVC filter litigation cases:
- Bard Recovery filter
- Cook Celect filter
- Bard G2 Express filter
- Bard G2 filter
- Cook Gunther Tulip filter
Do I Have A Claim?
Anyone suffering damages as a result of receiving a defective IVC filter is entitled to explore their options. If you or a loved one is suffering a serious health consequence of injury due to a dangerous IVC filter, compensation may be available to cover your lost wages, medical bills, pain and suffering, and other types of damages incurred.
What Are The Benefits Of Having An IVC Filter Put In Your Body?
IVC filters are supposed to prevent blood clots from traveling to your lungs and other parts of your body. IVC filter implantation is often given to patients who have been diagnosed with deep vein thrombosis, which makes blood clots form in the pelvis and legs of the affected individual. While an IVC filter can assist in stopping the clots from traveling elsewhere in the body, it is not a perfected process or product. Unfortunately, many recipients of the IVC filter have suffered extreme physical harm.
What Is The Risk Of Fracture?
Anywhere from 9-25% of IVC filters fracture. However, some IVC filter devices hold a higher fracture risks than others. In a study conducted in 2010, it was found that 12% (or 6 out of 52 patients), of Bard G2 filters fractured, compared with 25% of Bard Recovery filters that broke (or 7 out of 28 patients). Arguably little research has been done on IVC filters, and it is expected that with more research conducted, there will be more evidence of fracture occurrence.
Do Studies Support IVC Filter Safety?
There has only been one randomized and controlled study evaluating IVC filter safety, which was conducted in 1998. Of the 400 patients who participated in the study, 35% of the participants with filters developed DVT. It was also found that the filter implantation did not improve patient survival.
When Did The FDA Warn About IVC Filters?
After receiving 921 reports of adverse events occurring after receiving the IVC filter implantation since 2005, the FDA issued a warning to the public in 2010. The FDA put out a formal recommendation that the retrievable filters should be removed once they were no longer necessary. More recently in 2014, the agency recommended that the filters be removed as soon as the patient’s risk of PE was gone.
How Does The IVC Filter Removal Procedure Work?
IVC filter removal can be more difficult than its placement, especially if the filter has migrated from its initial implantation location.
If the filter hasn’t moved, the physician will retrieve the filter in almost the same way that he/she placed the filter. First, the physician will create a small incision in the neck or groin in order to access the vena cava. Then, the physician will insert a contrast dye and take x-ray images to properly visualize the filter, making sure it can be removed safely. Finally, the physician will use a snare to grab the hook, located at the top of the filter, in order to remove it from the body.
When an IVC filter migrates from its original location, removal becomes riskier. In some migration cases, the IVC filter cannot be removed at all, because the filter migrated to a place in the body that was unsafe to operate around, such as the heart or lungs.
How Long Do Physicians Recommend Leaving The Filter In Place? What Are The Risks Of Keeping The IVC Filter In Place For Longer Than Recommended?
It is currently recommended that retrievable IVC filters be removed four to six weeks after placement or after the risk of pulmonary embolism (“PE”) has subsided. On August 9, 2010, the FDA released a warning regarding leaving IVC filters in place for longer than recommended. The warning alerted physicians that IVC filters should only be implanted as a short-term “fix” to patients who were at high-risk for pulmonary embolisms. The filters are not meant to be left in the body long-term. If they are left in place longer than recommended, the filter has the potential to attach itself to the vena cava wall. This is known as filter embedment. In these cases, it is generally unsafe to remove the filter, which can cause additional complications to arise.
What Are Some Of The Critical Vena Cava Filter Complications Associated With IVC Filters?
Here are some of the severe complications that have been reported in association with IVC filter placement:
- Internal bleeding
- Fracturing of the IVC filter
- Perforation, puncture or serious damage to the heart
- Lower limb DVT
- Permanent damage to the lungs, vena cava, or surrounding organs
- Ventricular tachycardia
- Hematoma or nerve injury at the puncture site
- Chronic pain in the chest, stomach, back, legs, or other places in the body
- Infection in the body
Please keep in mind that this list does not necessarily include all problems that an injured patient may suffer as a result of a faulty IVC filter. As every BODY is different, not all patients experience the same associated problems.
What Are The Symptoms Or Side Effects Of Device Migration?
Device migration is one of the severe complications that can arise from an IVC filter implantation. In fact, it was the top complaint reported to the FDA between the years of 2005 and 2010. There are reports of IVC filters migrating from the inferior vena cava to the heart and lungs. The filters also commonly migrate throughout other areas of the body, including the stomach and bowels. Once the filter or fragments of the filter has migrated from its original location, there is a greater risk of the object embedding into veins, arteries, or other organs. If the filter migrates into the lungs or heart, painful and severe effects may present, such as;
- Chest discomfort and pains
- Feelings of shortness of breath
Doctors Believe Natural Flattening And Movement Of Vena Cava May Be Causing The Defects And Fractures Reported In IVC Filter Lawsuits
As the number of IVC filter injury-related lawsuits increases, doctors have taken a deeper look into what exactly may be causing faulty IVC filters to break. Experts believe that the movement and flattening of the vena cava, the location in which the filters are placed in order to prevent blood clots from forming in the lungs, may be the culprit.
Doctors from Baylor Scott & White Health’s Department of Radiology in Dallas reported in a study, published in the Baylor University Medical Center Proceedings Journal, that the “foreshortening and flattening” of the vena cava may be the cause of injuries presented in IVC filter fracture lawsuits.
Doctors came to this conclusion after a complicated removal procedure involving a fractured Bard G2 IVC filter. The Bard G2 filter is one of the filters currently in litigation. During this particular removal procedure, the device fractured, which caused pieces of the filter to puncture the patient’s vena cava.
IVC filters are implanted into the inferior vena cava for patients who are at high-risk of suffering from a pulmonary embolism. According to their manufacturers, these small and spider-shaped filters are designed to “catch” blood clots that may form in the body, and “filter” them by allowing the clots to thin over time. This prevents the clots from migrating into the lungs, which could be fatal.
However, according to a growing number of claims raised in product liability lawsuits filed against C.R. Bard and other manufacturers of these retrievable IVC filters, many devices sold and implanted are prone to failure Reports indicate that many of these devices migrate from their original location, which causes puncturing of veins and organs in the body, often sending pieces of the device into the patient’s blood stream.
In May of 2014, the FDA issued a warning physicians to remove IVC filters within four to six weeks after an individual was no longer at risk of suffering a pulmonary embolism. The FDA discovered that the devices caused more problems for the patient the longer that the filter was left in place. Despite the potential harmful effects of these IVC devices, many of the manufacturers still sell the filters without properly informing doctors about the risks associated with leaving them in place for too long.
Physicians have also realized that while the retrieval of IVC filters has a relatively high success rate when removed within the first year of implantation, the procedure becomes much more complicated the longer that the filter remains in the body.
As mentioned, the large number of lawsuits brought against different IVC filter manufacturers is what prompted doctors to take a closer at the causes of the reported problems with these filters. Currently, there are over 700 pending lawsuits against C.R. Bard. These lawsuits are being presented before one judge for routine pretrial activities, as part of a multidistrict litigation (MDL). Nearly 650 Cook IVC filter lawsuits are also being brought about as part of a separate MDL.
It is expected that several thousand cases will be filed against these manufacturers on behalf of patients from all over the country. For all MDLs, “bellwether” trials are presently being prepared for trial. These trials provide an idea of how subsequent similar trials may resolve. This type of information and assessments may aid the judges and IVC filter manufacturers in determining an overall settlement amount. This allows avoidance of thousands of individual trials against these manufacturers throughout the country, which may take years of negotiations between large corporate firms and smaller plaintiff firms. So injured parties are fairly and adequately compensated, many plaintiff firms hope for success in the MDL and cooperation from the corporate defendants. MDLs do take time, therefore injured parties and their representatives look at bellwether trials as a step closer to potential resolution.
As IVC filters continue to be marketed by manufacturers and implanted by unknowing physicians, it is expected that more patients will suffer consequent injuries. As there are more injuries, more research will be conducted regarding filter movement and fracture. As more research is conducted, one can only hope more knowledge about IVC filter failures spreads, so that eventually IVC filters are no longer implanted so frequently.
What Is An IVC Filter And What Is The Primary Purpose?
Surgeons implant retrievable inferior vena cava filters
(IVCs) in the veins of patients who are unable to take anticoagulants (blood thinners) in order to prevent blood clots from moving to the lungs. IVCs catch the clots in the blood stream and, over time, the clots dissipate. They are small, metal devices that resemble a metal cage and are surgically inserted into a patient’s vein. There are two types of IVC filters: permanent and optional/retrievable filters. Retrievable filters provide short-term protection. They’re designed to be removed from a patient’s body when there is no longer a risk for pulmonary embolism (PE). Unfortunately, they are not always able to be retrieved and can cause severe medical complications.
How Common Are IVC Filters Used In The U.S. Population?
The devices are most common with trauma patients, bariatric patients and orthopedic surgeries. The annual implantation of these devices has grown from 49,000 in 2004 to over 260,000 by 2012.
When Were These First Put Into Use?
The device was introduced in 1979 and its use has increased continuously through the years. The devices that are part of the litigation that our firm is working on were implanted in 2002 and later.
Is There A Certain Age Group Or Gender Where Their Use Is More Common?
The device is tailored towards patients with certain medical conditions, so there is not an age or gender that more commonly uses the implant.
What Are The Known Risks Associated With IVC Filters?
IVC filters are associated with potential risks, like damaging veins and failing to stop blood clots from bypassing the device. Any procedure involving the placement of a catheter inside a blood vessel carries certain risks. Those risks include damage to the blood vessel, bruising or bleeding at the puncture site, infection and allergic reaction. The IVC filter could migrate, penetrate through the vein, break loose or become scarred to the vein and cannot be removed.
What Is Contained Within The FDA IVC Filter Warning?
In 2010, the FDA warned the retrievable filters posed risks of filter fracture, device migration and organ perforation and should be removed as soon as the patient’s risk for blood clots subsided. The FDA updated safety communication in 2014, stating most devices should be removed between the 29th and 54th day after implantation. But the warning signs came too late for some.
What Are The Most Serious IVC Filter Complications That You Tend To See Or Hear About In These Cases?
Although the filters were designed to prevent life-threatening pulmonary embolisms (PEs) – blood clots in the lungs –, they can have life-threatening side effects, including but not limited to organ perforations, embolisms and death. In a report released in 2010, the FDA received more than 900 reports of adverse events associated with IVC filters.
When Did Reports Regarding Complications Associated With IVC Filters Began To Surface?
Lisa Davis sued Bard after a G2 filter implanted in 2006 fractured and migrated to her heart in 2008, causing ongoing heart issues. Davis declined to have open heart surgery to remove the fragment and must take blood thinners for the rest of her life. She claims Bard failed to warn her physician of the G2’s risks and misrepresented the device as safe. She sued for physical trauma, anxiety and impaired ability to earn wages.
When Did Actual Litigations Involving IVC Filters Begin?
Plaintiffs filed the first lawsuits against Bard in California and Pennsylvania state courts in 2012. In October 2014, the U.S. Judicial Panel on Multidistrict Litigation (MDL) consolidated lawsuits against Cook from 11 districts to an MDL
in the Southern District of Indiana. The number of lawsuits against cook has increased to more than 100. The U.S. Judicial Panel on MDL consolidated lawsuits against Bard to the U.S. District Court District of Arizona in August 2015. More than 50 lawsuits are pending in the MDL.
Did The Manufacturers Of IVC Filters Know That Their Product Could Be Dangerous After They Were Implanted?
There were numerous studies that came out after the release of these implants that demonstrated failures and did not prove the efficacy of the products. In 2010, the U.S. FDA announced a safety alert regarding retrievable IVC filters. The FDA received 921 reports of adverse events from 2005-2010.
What Types Of Legal Claims May Patients Bring Against IVC Filter Makers For Their Injuries?
Patients may bring product liability (defective device) claims, as well as wrongful death claims, if applicable.
Are These Cases Class Action Lawsuits, Mass Torts Or Individual Personal Injury Claims? Is There Even An Option? And If So, Is One Better Than Another From A Financial Standpoint?
Claimants who received Bard IVC filters filed three class-action lawsuits against Bard in Florida, Pennsylvania and California courts. The lawsuits argue plaintiffs with Bard Recovery, G2 and G2 Express filters that had not fractured or migrated must receive medical monitoring because of Bard’s negligence, misrepresentation and concealment of data. The plaintiffs claim everyone who had one of the devices implanted in them make up a class which should be compensated for medical monitoring expenses. Courts have not approved the formation of a class yet. Plaintiffs filed the first lawsuits against Bard in California and Pennsylvania state courts in 2012. The majority of cases are mass tort claims – individual lawsuits filed in federal MDL courts. In October 2014, the US Judicial Panel on MDL consolidated lawsuits against Cook from 11 districts into an MDL in the Southern District of Indiana. In August 2015, the US Judicial Panel on MDL consolidated lawsuits against C.R. Bard to the US District Court – District of Arizona.
Who Qualifies To Make An IVC Filter Claim Or File An IVC Filter Injury Lawsuit?
Any patient that has a Bard or Cook IVC filter implanted 2002 or later. While there are 11 companies that manufacture IVC filters, Bard & Cook have over 80% of the market so most filters will belong to either company. Patients were supposed to receive an implant card after surgery, but not all patients may have them.
How Do I Know If My Injuries Were Caused By An IVC Filter?
You may not know yet. If your doctor has informed you that your IVC filter or any part of the filter has moved/migrated, please contact us immediately. Our law firm will review records to determine causation and that responsibility is not placed on you.
Who Might Be Held Responsible For Injuries Patients With IVC Filters Have Suffered?
This is strictly a product liability and NOT a medical malpractice claim, so we will not be suing any of the medical providers involved in the implantation or resultant injuries. We will solely be going after the manufacturers of these implants, namely Cook and Bard.
What Damages Might I Expect To Receive In A Claim Against These Companies?
There have not been any bellwether trials as of yet in this litigation, so we cannot give any estimation of valuation for these cases. In addition, each claim will be different based upon the patient, the severity of their injuries and the state in which they live.
What Factors Determine The Compensation Amounts?
A number of factors influence the compensation for these claims, including, but not limited to, type of IVC filter, length of time of implant, severity of injury, age, cardiac health prior to implant and state of residence.
How Much Time Do I Have To File An IVC Filter Lawsuit?
The statute of limitations is different for each claim, based mainly on state of residence, state of implant (if different) and when the injury occurred. Therefore, we urge you to contact us immediately so we can ensure to bring your claim in a timely fashion.
What Makes Up A “Good” IVC Filter Lawsuit Vs. One That Really Won’t Go Anywhere?
The litigation is still in its infancy, so this hasn’t been determined yet. For now, any patient that has a Bard or Cook IVC filter implanted 2002 or later. The better cases are those in which a complication has already occurred (i.e. filter migration, vein/organ perforation, embolism, etc.), especially if it involves a surgery (attempted or successful removal of IVC filter). However, all IVC filter cases will be reviewed, as there is a strong risk to just having the implant.
I Was Injured By An IVC Filter Several Years Ago. Is There Still Time To Bring An IVC Filter Lawsuit?
In most cases, yes. However, we would need to review the specifics of the case to determine its viability.
My IVC Filter Has Not Caused Me Any Injuries. Can I Still Bring A Case?
Yes. There is a strong risk of future complication with the implant, especially as the FDA recommends its removal and that is not always possible. If you are not sure the status or location of your IVC filter, a CT scan or MRI can show if your IVC filter is in any location that it should not be.
Now That I Have Decided To File A Lawsuit, What Is The First Step?
You will need to hire a product liability law firm to represent you in this matter. As this is federal litigation, you do not need a law firm in the same state as which you live. Time is of the essence, so you will need to contact them to sign the necessary paperwork. They will need the information for your implant, as well as any associated complications or procedures you may have had. If you have any of your medical records, it will expedite the process. However, the law firm can order any necessary records on your behalf.
What Are The Biggest Challenges Your Clients Will Face In These Cases?
This litigation is in the early stages, so we do not know yet all the challenges that we will face. However, although the defendants have not yet done so, we anticipate that the manufacturers will attempt to place blame on the implanting surgeon.
Can I Even Afford To Go Through This Process?
We would recommend that you would only use a firm that works on a contingency basis, as we do. That means that the firm only gets paid if you receive an award/settlement and would be paid out of that award. The law firm would front any of the litigation costs and fees.
Will Pursuing This Case Take Up A Great Amount Of Time, And Will It Be Stressful?
It will take up a great amount of time on the law firm’s part, but not of yours. In general, most of what is required of you for the litigation claim is filling out some paperwork and telephone conferences. We will walk you through the process and advise what is needed of you.
Will My Case Most Likely Go To Trial, Or Will It Settle Out Of Court?
Most MDL cases will settle out of court. There are generally some bellwether trials to determine liability and let both plaintiffs & defendants see how a trial would progress, but they often lead to settlements out of court. There is sometimes a formal claims office formed.
Do I Have Any Say In Whether Or Not I Want To Agree To A Settlement?
With our firm, no decision is made without your participation. If a settlement is offered, we will advise you on how that settlement was determined and any pros or cons to accepting the offer.
What Is An Approximate Estimate On How Long These Cases Take To Be Resolved?
The timeline for this type of litigation varies greatly. Some cases can resolve in a year, while others can last for over ten years. In general, these cases usually take about two to three years to resolve.
What Is A Wrongful Death Claim And How Might It Apply In Some Of These Cases?
If a patient died as a result of a complication from an IVC filter, there might be a wrongful death claim. Each state has a different statute of limitations for wrongful death, but most must occur within two years of the patient’s death. Generally the case is brought by the next of kin, usually the spouse or children. If there was no probate done, we can work with the family to do the necessary paperwork. We would need to review the medical records and specifics of the case to determine if we could bring a wrongful death claim.
What If I Die Before My Case Is Resolved? Is My Spouse Entitled To Any Restitution?
If you should die before your claim is resolved, we can assist your next of kin (spouse/children) to open probate on your estate. The estate can continue with the claim and receive any award, if such is determined. To make the process easier, we recommend that you have a will to determine who should be the executor of the estate and how your estate should be divided.
Why Do I Need A Lawyer In This Type Of Case? If I Have Received The IVC Filter Can’t I Just Show My Medical Records And Receive Compensation?
No, there is no formal claims office for IVC filters. The manufacturers are not admitting liability as of now and we will have to sue them for defective devices. An attorney is needed to file a lawsuit and prove causation between your IVC filter and any injuries you may have incurred.
What Are Some Of The Things To Look For When Finding An Attorney With Experience In These Cases?
Primarily, you want a law firm that will work on a contingency basis, has experience with product liability claims and has worked on federal MDL mass tort litigation cases.
How Does Your Firm Differ From Other Law Firms That Also Handle IVC Filter Lawsuits?
We fit all the necessary requirements for the type of law firm that you want handling your claim. In addition, we are particular about the types of litigation that we handle and only take on cases that we believe have a strong foundation. We do not treat our clients like they are just a number and limit the amount of clients that we take so we can retain a personal one-on-one relationship with each one. We value our clients and aim to always make sure to walk them through the process and hold their hands every step of the way. In addition, we have had years of experience with federal MDL mass tort litigation, with a number of large, successful verdicts.
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