IVC Filters have been in the news recently and for all the wrong reasons. The New Jersey firm of C.R. Bard, Inc. has been put in the NBC Nightly News spotlight after NBC’s investigation linked C.R. Bard’s brand of IVC Filters to 300 injuries and 27 deaths.
The most common reason for using IVC filters is to stop blood clots from reaching key organs, such as the lungs. In effect, these devices are somewhat akin to a trapdoor. They need to be open at the right moment, and not break apart or move because the results of a malfunction can be deadly.
This is what happened with the C.R. Bard device, called The Recovery. Instead of blocking clots, the investigation showed that it was often ineffective at best, and at worst was actually causing blood clots on occasion.
This has raised the specter of suspicion around the whole use of IVC Filters.
The FDA first warned about the devices back in 2010. Since then there have been a plethora of lawsuits involving the devices, with devices from two companies primarily being targeted, Cook Group, Inc. and C.R Bard.
The Cook Group has had over 100 lawsuits filed against it for its IVC Filters. These lawsuits predominantly claim that parts of the device fracture prematurely while in use. The company itself denies these claims and says that failures are rare and not caused by design flaws.
Yet the 2010 report from the FDA highlighted over 900 reports of issues with IVC Filters, around 2/3rds of which fell within four areas:
- The filters breaking free from their intended area of use and migrating somewhere else in the body. (328 reports)
- Parts of the filters breaking free and moving. (146 reports)
- Perforations appearing in the filters. (70 reports)
- The filters fracturing and causing problems through that. (56 reports)
These reports led the FDA to change its advice to doctors about the use of IVC Filters. Previously it had been common practice to maintain their use for longer periods during the treatment process. But the advice from the FDA to Doctors is now twofold:
- As the threat of a blockage in the arteries to the lung recedes (pulmonary embolism), the FDA now advises that temporary IVC Filters should be removed.
- That more care and thought should be applied in general before the devices are used.
Clearly this is a change of language and approach from the FDA and is indicative that they are now approaching the use of IVC Filters much more cautiously. Whereas previously they may have been used even in cases where the patient did not have anti-coagulant contradictions, the FDA now advises both limiting the scope of occasions where they should be used, as well as how long they should be used for.
The number of people who have now come forward with complications and injuries that they attribute to IVC Filters has resulted in an increased number of lawsuits and significant media interest.
A number of attorneys are currently investigating individual claims involving serious injuries and complications caused by IVC Filters.