In the interest of keeping blood clots from causing debilitating and sometimes lethal damage to patients, an enterprising vascular surgeon named Dr. Kazi Mobin-Uddin invented the inferior vena cava (IVC) filter in 1969. Surgically implanted, the small filters function as traps for roving clots, keeping them from reaching the heart, lungs, or brain, where they can be severely damaging--even fatal.
It was a tremendous advance for medical science. However, as with many medical devices, these filters can fail at their purpose. It's hard to pack much structural integrity into a vein-sized device composed almost entirely of little spider-legs. Due to this fragility, those legs can break, sending metal pieces traveling along the passageways of the body. Understandably, this can have serious negative effects.
If you watch afternoon TV or have seen online ads for current lawsuits, you may have learned about these and other damages that can be related to IVC installation. Such instances are not guaranteed, of course, but more documented cases seem to be cropping up all the time. Let's take a closer look at what can go wrong, who might be responsible for it, and how a skilled attorney can help if such an unfortunate event occurs.
What Are IVC/Blood Clot Filters?
Blood has a tough gig; it needs to flow smoothly through a person's body for his or her entire life. No lunch or smoke breaks. No overtime. No vacations.
More than that, blood also has to stop flowing when a person gets cut or otherwise injured, lest far too much of it spill out of the body. In order for it to do that, the body has clotting mechanisms. When you are cut, the body responds with the following:
- Platelets form a plug. Blood cells called platelets get activated by chemical triggers when a blood vessel is damaged. They stick to each other and the walls of the affected vessel, changing shape to plug the broken area. This stops blood from leaking.
When activated, platelets also attract more platelets and other cells, triggering the next step.
- The clot grows. Clotting factors, a type of protein in the blood, begin a rapid chain reaction. It ends with the creation of long strands of another protein, fibrin. The strands get tangled up with the sticky platelets to make a "net" that traps even more cells. The clot becomes more durable with the extra material.
- Reactions prevent overgrowth. Extra clotting factor proteins are deterred from the site so the clot doesn't grow more than is needed.
- The clot slowly breaks down. As the damaged tissue heals, you don't need the clot anymore. The fibrin strands dissolve, and your blood reclaims the cells from the clot.
That's the ideal sequence of events. You clot, you heal, the clot goes away.
It gets more complicated than that, though. Several other things can trigger the formation of clots, like cholesterol deposits on blood vessel walls and pooling or slow-moving blood in the body. Studies have begun to link extended periods of inactivity, such as many hours sitting in front of a computer without any movement, to be probable contributors to clot development as well.
When clots form without their innate purpose of contributing to healing, the chain of normally-triggered events may not occur. At that point clots can travel through the blood without dissolving; if unchecked, they can wreak serious havoc in the body.
That's where IVC filters come in. Their purpose is to function as a net, or trap, for any blood clots traveling in the bloodstream. Blood can travel harmlessly by the device's legs, but clots will be caught and held in place until the body can dissolve them. They are generally installed in the inferior vena cava, a large vein leading from the leg toward the heart and lungs.
To reiterate--the filter's goal is to prevent clots from traveling to the major systems of the body, where it could be severely damaging and is often deadly.
Who Makes IVC Filters?
Several large medical manufacturers make these products. Resembling modern-art sculptures, the filters take a variety of physical shapes to avoid any patent infringement, but they serve essentially the same purpose.
The "blood clot market" is large enough to have room for competition. The Center for Disease Control (CDC) estimates that as many as 900,000 people suffer from deep vein thrombosis (DVT) or pulmonary embolism (PE) annually, with as many as 100,000 of those proving fatal. Of those instances, about 25 thousand experience sudden death as the first indication they even have a blood clot.
Given these numbers, it makes sense that several manufacturers would enter the fray in an attempt to gain some market share.
When a patient suffers a thromboembolism (blood clot), a health care provider's first instinct will be to try anticoagulants, the medical term for blood thinners. These are typically a doctor's go-to option when trying to prevent clots. A course of oral blood-thinner medication is proven over 90% effective at preventing pulmonary emboli and deep vein thromboses, but it's not always as simple as a pill down the hatch.
Recent developments have suggested that several brands of blood thinner, including Pradaxa and Xarelto, come with considerable risks for patients. Moreover, they don't always work, and some patients are simply unable to undergo anticoagulant therapy. In such situations, IVC filters would be implanted with the intent of preventing clots from traveling through the body, at least until such time as blood thinners are viable again for the patient.
What Can Happen if I Have an IVC Implanted?
Filters, while helpful for patients unable to make use of blood thinners, come with their share of complications. It's a very small device implanted via catheter, and the tiny hooks on the ends of each arm hold it in place within the vein. Because it's somewhat fragile by its nature, certain risks are associated with the IVC filter's implantation. An FDA report issued in 2010 listed 921 known incidents of various malfunctions and injuries:
- Migration - Occasionally the filter does not firmly attach where it is installed, at which point the flow of blood can cause it to migrate away from the implant site. In such circumstances, it will usually move in a cephaladad direction, upward towards the heart (more or less "with the current"). There are reported incidents of caudad migration as well, however, in which the filter moves downward in the body from the implant site.
Filter migration incidents accounted for 35% of the reports, totaling 328 known events by 2010.
- Embolization - Some reports were filed that indicate the IVC had the opposite of its intended effect in a patient's body. Instead of trapping or preventing blood clots, the filter actually was pro-thrombotic, meaning that it contributed to the growth and propagation of clots in the vena cava.
Other instances of this phenomenon involve the filter itself breaking, at which time small pieces of metal are embedded in clots and travel to other parts of the body. Reports have come in about these small metal components lodging in a patient's heart, kidney, lung, spine, liver, or nerves.
Embolization cases constituted 15% of the FDA cases, with 146 instances.
- Fracture/Perforation - As noted, stresses to the IVC can occasionally cause it to break, resulting in one or more of the filter's legs traveling away from the implant site. Sometimes the pieces are not trapped in blood clots, and instead simple travel through the bloodstream until they happen to turn at an angle and pierce the soft tissue of the body. This "perforation" could occur in blood vessel walls or organ tissue, and the metal piece may not be removable once the damage is done.
A total of 126 instances of fracture and perforation made up 13.5% of reported cases.
The above statistics only account for 63.5% of reported cases, suggesting that a variety of other issues arise with IVC filters and simply are not as easy to package together. One such difficulty comes from extended placement of a filter. If left in place long enough, a body may develop around the filter, growing tissue that fixes the device in place more or less permanently, since it can no longer be extracted without surgery to cut it free. Another issue is when the filter tilts at its implant site. It doesn't migrate or break, but if it shifts to another position, it becomes significantly less viable for its purpose. A filter that fails to do any filtering is still a malfunctioning product.
Are All the Filters Affected?
I'm not here to imply that IVC filters don't serve a valuable purpose. The statistics listed above are certainly chilling, but please note that they do not take into account the times that the filter worked successfully. As a personal injury firm, we deal with instances of product failure and malfunction that result in injury, but our view will be skewed because we do not receive calls from unaffected people. "You only open an umbrella when it rains," so to speak.
The main focus of the current lawsuit involves so-called "permanent filters," which are designed to be installed with long-term clot intervention in mind. Most filters on the market are considered permanent in that they can theoretically be left in place indefinitely without incident, even after any immediate threat is past.
A separate type of "retrievable" filter is growing in popularity, however; these are installed with the understanding that they will be removed within a short interval. They are meant only to address a temporary clot-related event, if a patient is temporarily unable to make use of blood-thinners.
As we noted, several manufacturers are in the spotlight for possible filter malfunctions. Two of the main contenders are C.R. Bard and Cook Medical; each of them are giants in the fields of medical devices and prostheses. However, many other companies are currently under examination for similar issues.
Among the devices receiving the closest attention are the following permanent IVC filter models from Bard and Cook:
- Bard Recovery
- Bard G2
- Bard G2 Express
- Cook Gunther Tulip
- Cook Celect
To say that "all" filters are affected wouldn't be accurate. Many types of filter are under heavy scrutiny for their capacity to malfunction, but that is not to say they are guaranteed to do so. Filter models continue to undergo refinement by these manufacturers, and there is a notable transition in the medical field from permanent to retrievable filters.
In the meantime, health care providers weigh the risks versus the benefits of using the filters already available on the market. In many cases, IVC filters are the only viable option without subjecting a thromboembolic patient to further risk from anticoagulants.
Can the Injured Sue the Companies if Something Happens?
The short answer is "yes." A skilled attorney will be able to help obtain justice in the form of compensation for people injured by their IVC filters. Various filed lawsuits against these products contain allegations of negligence, design and manufacturing defects, failure to warn of risks, breach of implied warranty, and negligent misrepresentation by both the manufacturers and their subsidiaries.
The arguments for each of these causes of action are distinct, but interwoven. All of the case elements must be demonstrably present in order for a claim to proceed. Most of the allegations will break down to include variations on the following ideas:
- The company should have made a safe product, which means designing and fabricating the device so that it would not break or malfunction within a reasonable threshold of likelihood.
- Upon releasing and marketing these devices without first eliminating the above hazards, the same companies should have at minimum issued appropriate warnings to health care providers and end-users about the possible risks of breakage, thrombotic complication, or filter migration. Their failure to warn suggests either that
- They were not aware the the filters could malfunction in these manners, suggesting that they did not adequately test the devices, or
- They were aware of the risks, but determined that the likelihood of malfunction was small enough that they chose to release the product anyway.
- There is a hidden third option: They knew about the possible catastrophic and potentially-fatal malfunctions of the filters, but chose not to mention them or warn anyone because it would affect profits.
Attorneys in many filed claims have already alleged this exact thing. Should it be proven that company executives suppressed research about these risks (it has been known to happen), they could be held responsible for committing acts of gross negligence.
- An attorney will need to prove that the filter's malfunction is the direct cause of the injury. Given the nature of the injuries in question--metal pieces lodging in blood vessels or organs, obviously-dislocated filters viewed by medical imaging, recurrent clots--and their obvious ties to the IVC filters, this element should not be difficult to prove with medical records.
- Plaintiffs must have demonstrable damages due to the malfunctioning product. An attorney will be able to show these damages in the same records I mentioned before. The defense would have trouble alleging that metal shards simply "appeared" in someone's circulatory system, organs, or spine.
Plaintiffs may also allege that their injuries incurred serious medical expenses, damaged their ability to work, and caused extensive pain and suffering. These should also be investigated as areas in which compensation may be awarded.
Given the number of claims already filed against Bard and Cook, and the expanding client pool as other manufacturers are pulled into the fray, it is clear that the legal community feels these elements are abundantly present and highly provable.
How Many People Are Suing for Filter Injuries?
Over time, hundreds of filter claims have been filed against various manufacturers, though Bard and Cook remain firmly in the limelight as the main offenders. As of 2012, roughly 100 individual cases against Cook Medical had been consolidated into the Southern District of Indiana.
One of the earlier recorded lawsuits against C.R. Bard was filed in 2006 when its G2 filter fractured and metal pieces deposited in the plaintiff's heart. It saw similar sporadic filter claims for the next few years until more cases started to enter public view. The company settled a high-profile case in February of 2015, just 10 days after the jury trial had begun. The plaintiff, Kevin Phillips, alleged that some of the legs on his IVC had broken, causing small metal pieces to travel to his heart and lodge in one of its chambers. Removal of the pieces was critical, and Mr. Phillips required open-heart surgery and extensive recovery.
In August of the same year, an estimated 50 claims against Bard came together in the U.S. District Court in Arizona.
To date, over 1,600 cases are filed against both Bard and Cook. These multi-district litgations, or MDL's, are filed specifically for parties who have been injured by some form of filter malfunction. Several class actions also exist for parties who may not specifically have been injured at this point, but still have to receive extensive monitoring care to prevent such issues. More doctor visits means considerable expense, some of which may not be covered by insurance plans. Even with a good play, the deductibles can add up for someone on a budget.
While class actions could be a viable option for people who have not sustained physical injuries, many attorneys believe they may force plaintiffs to accept lower recoveries while paying higher attorney's fees.
What Does All This Mean?
People damaged by filter malfunctions, and the families of people who were fatally injured, most certainly have legal recourse in the event of injury or wrongful death.
A products liability attorney will collect and examine the evidence supporting these allegations, and upon finding confirmation that the filter malfunction is related to the patient's injuries, will zealously represent the patient's interests as a client against their filter's manufacturer.
One of the key points of such litigation is to obtain financial compensation for these injuries. Because corporations aren't people, there's virtually no way for them to express their apologies for causing injury aside from a monetary distribution. Plaintiffs certainly deserve remuneration for the trials they endure from a faulty product.
More important than the money, though, is the message delivered to these big companies: Your profits aren't more important than your clients. It's a lesson that seems too often to be forgotten in the pursuit of the almighty dollar, and people suffer when companies neglect their safety to bolster their sales.
That's where these lawsuits come in; they amplify a plaintiff's voice and add many others to it to make sure those voices are heard.