What Legal Claims Can Patients Bring Against The IVC Filter Manufacturers?
The claims can be twofold. One would be a traditional tort claim that Bard or Cook or any manufacturer had a duty of reasonable care in the design, manufacture, sale or marketing of any medical device. They would be subject to federal regulations as far as those things were concerned. We feel that the companies did not do enough testing and we do not feel that their warnings were sufficient. We also feel that these products are not safe and efficacious enough to be used in the manner they are being promoted for, or in other words, they do have a use and probably have saved lives through the prevention of a PE, a blood clot in the heart or the lungs, but they are not for everybody whereas that is the way they were selling them, in our opinion, for manners outside of how the FDA had indicated them. The other piece is that patients with the optional retrieval devices should undergo routine medical monitoring and they should have imaging studies done at least annually, maybe quarterly or semi-annually, to make sure the device was still where it needed to be, that it had not fractured, migrated or tilted and that it was still doing its job and also that the patient still needed it. We think this would be important and that quite frankly, the manufacturer should pay for that medical monitoring because they did not do enough on the front end to tell physicians with these optional retrievals that they needed to follow up the patients and set a program in place where they were encouraging follow-up or demanding follow-up to prevent device failure. As time goes on, the chances or risk of device failure would go up, so they would need to be monitored and when it was determined they did not need it anymore, it would need to be pulled out.
Did The Manufacturers Of The IVC Filter Actually Know Their Product Could Be Dangerous?
It is being debated regarding what they knew and when they knew it, whereas the other school of thought is that they should have known and when they should have known it based on the lack of studies they conducted and the post-market data of the adverse events. We think that in regards to the recovery filter, Bard knew as early as 2005 and maybe even before then that this filter was failing at an alarming rate. The data did not really change much when they periodically released a new filter. The recovery was probably by far the worst but they did not really fix any of the problems with later iterations. We have not really seen much data regarding their newer retrievable filters that have not really been on the market for that long.
How Would Someone Confirm They Had An Injury Caused By The IVC Filter Before Moving Forward?
The person would really need to see an X-ray and see where the filter was and what it was doing. Some cases can be very obvious where an appreciable problem had come up with the filter that could be diagnosed relatively easily but in most of these cases, imaging would be able to tell whether the filter was where it should be, if it was working as it should be or if it had failed.
Who Might Be Held Responsible For Injured Patients With The IVC Filters?
We are currently involved in litigation against Cook Manufacturing and then with Bard, with C.R. Bard and their Peripheral Vascular, a wholly owned subsidiary company, which is Bard Peripheral Vascular Inc. Other filters that have failed may end up in litigation, but right now the ones that I am the most interested in are the ones made by Cook and Bard starting in the fall of 2003.
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