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 Attorneys 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 haveat 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 beenknown 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.