The FDA has been drawn into a deeper analysis of the medical impact of the failings that have been highlighted in several brands of IVC Filters. These devices are intended to treat blood clots, but have been found to fail more often then would be considered normal, let alone acceptable. In 2010 the FDA issued a safety alert highlighting the problem. But since then the FDA has worked on further understanding the scope of the problem starting with establishing a framework of scientific analysis.
This work was published in October 2013 in the Journal of Vascular Surgery Venous and Lymphatic Disorders. It is primarily a decision analysis study and so is intended to not only investigate the treatment regimens under which IVC Filters have previously been used, but also to reach conclusions as to the ways that the devices should be used in the future.
The research by the FDA clearly establishes a number of parameters. In addition to the two primary motivations highlighted above, it also establishes some important groundwork for potential litigants against C.R. Bard, Inc. and Cook Group, Inc., who are the two makers of IVC Filters which currently have the greatest number of legal cases outstanding.
The first of these findings is with regards to the use of IVC Filters to treat patients who don’t have a previous history of pulmonary embolism (PE).
The study clearly marks these down as ‘off-label’ uses, which has significant implications for some potential litigants. In the real-world this means that the FDA does not recommend use of these devices where there was not a previous PE history. This does not tend to arise so much as an issue in the current climate of suspicion around IVC Filters, because the media spotlight that has been put on them, through reports by NBC Nightly News and others means that doctors are now naturally more careful about using them.
It is important to realize however that this is a relatively recent phenomenon and that up until the safety warning issued by the FDA in August 2010, it was considerably more common for doctors to prescribe the use of the devices, even when not naturally indicated. They were often seen by doctors as a simple, effective and relatively quick solution to the problem of potential blood clotting, without the need for drugs, and so were often used more freely then they are today.
The second of these findings is to set down a framework under which IVC Filters may be used.
The decision analysis report itself sets down four:
- For emergency treatment if there has been a ‘massive pulmonary embolism’ and it is thought that conventional treatment offers reduced benefits.
- For thromboembolic diseases where anticoagulant therapy has failed.
- For recurrent or chronic PE if anticoagulant therapy has failed.
- For PE when anticoagulant therapy is contraindicated.
It is interesting to note that the scope under which IVC Filters can be used has now become much more limited. Essentially IVC Filters are indicated when anticoagulant drugs don’t work or can’t be used because of some specific medical issue.
This means that for patients pursuing legal redress for the use of IVC Filters that there is now a much clearer framework to examine both potential medical negligence and the failings of the devices themselves.