There have been significant developments in the potential for IVC Filter litigation. The safety of IVC Filters was first highlighted by the FDA in August 2010, with over 900 problem cases being reported. Since then, the FDA has carried out further investigations into the issues of IVC Filters moving, failing entirely or having parts come away. In an October 2013 paper called, ‘Decision analysis of retrievable inferior vena cava filters in patients without pulmonary embolism’, the findings were published.
The significance of this paper for potential or current IVC Filter litigants cannot be underestimated. The paper clearly sets down the basis under which the filters should or should not have been fitted, and also establishes a firm protocol around the ongoing treatment regimens that are appropriate for their use.
This potentially opens up three avenues for lawyers to investigate whether their clients have been harmed by the devices and deserve financial redress.
1) The decision analysis sets down the initial treatment rules. If a patient had an IVC Filter fitted, but did not have a pulmonary embolism or a drug contraindication that may have indicated its use, then there is a clear case to investigate why it was fitted in the first place.
2) If the device then failed in use, broke away from its original target site, or failed to operate in the intended manner then there is a case to litigate against the manufacturers of the specific device. As a medical device it needs to operate within certain parameters and if it fails then there is a potential claim.
3) The paper sets down the ongoing treatment rules for IVC Filters. Prior to 2010 these devices were often left in place, even after the risk of pulmonary embolism had significantly reduced. Largely this was as a result of their perceived safety by doctors. But this new analysis sets down that there are three potential risk profiles.
- The risk of leaving the filter in place.
- The risk of removing the filter.
- The risk of not having a filter at all.
In effect, it establishes guidelines as to when each of those three may be indicated. As the study was first published in October 2013 then the guidelines from that period onwards are now clear. If the risk of pulmonary embolism has passed then the study indicates that IVC Filters that can be retrieved should be. The time period that is recommended in the report is that between 29 and 54 days after they were first implanted, that the risk profile favors removal.
To reach this conclusion the study looked at eight specific adverse effects of IVC Filters. Of these eight, five were indicated by the earlier 921 cases that the FDA had reported on in their safety warning in 2010. Namely:
- Filter migration.
- Filter embolization.
- IVC Filter occlusion.
- IVC penetration.
- Fracture of the filter.
It remains to be seen in the current ongoing litigation into IVC Filters how many of these can be shown to be clearly indicated prior to 2010. But the decision analysis study has created a clearer path as to the treatment and removal regimes that medical professionals should be following post 2010.