This fall, NBC News completed a year-long investigation of medical device manufacturer CR Bard’s Recovery IVC filter.
- IVC Filters intended to be temporary, not permanent
- Bard is the subject of many IVC lawsuits
- 250,000 IVC filters are implanted in patients each year
- The number of fatalities and complications are growing
This device is designed to sit in the vena cava and block blood clots from making their way into the heart or lungs. The Recovery device has a very high failure rate; parts of the filter tend to break off and puncture the patients’ veins, or migrate to the heart, lungs and other vital organs, which can be fatal. NBC’s investigation determined that this filter was associated with 27 deaths and several hundred non-fatal problems.
The NBC report also suggests that Bard allegedly forged the signature of a regulatory specialist on an application for FDA approval after their initial application was rejected.
After the problems with the Recovery began, Bard hired a public relations firm and sent a plan to upper level executives warning of damaged stock prices and ruined reputations. The NBC News report found evidence that Bard executives were fully aware of the dangers to patients as far back as 2004. Bard’s own internal research results linked the Recovery device to higher fatality rates than all of their competitors. The author of the internal Bard study wrote that “further investigation…was urgently warranted.” Instead of issuing a recall or advisory, Bard sold over 34,000 more units.
Bard is currently the subject of many lawsuits involving their IVC filters. In fact, Bard recently received yet another warning letter this summer.
While Bard was the subject of NBC’s investigation, there is much controversy regarding IVC filters. A smaller, local NBC news affiliate in Florida released this report just a month ago.
Despite recommendations that they be used only for high-risk cases, approximately 250,000 IVC filters are implanted in patients each year, and as time passes, patients tend to forget that they have had this device implanted. For many, the only reason they remember that they have had the device implanted is because they suffer serious injury from a complication. It is critical to realize that IVC filters are not intended to be permanently implanted. According to the FDA, IVC filters should be removed between 29 and 54 days after implantation in order to avoid these complications, something most manufacturers have failed to warn doctors or patients about.
One might think that the IVC filter that they’ve had implanted was rigorously tested and thoroughly safe, but that is unlikely the case. Manufacturers generally need only file some paperwork and pay a $4,000 fee to the FDA to start selling a product. Only after an implanted medical device causes widespread complications does the FDA act to correct the issue and alert the public, which has happened repeatedly in the instance of IVC filters.
There are likely financial incentives to bring these devices to market, as the United States remains the largest medical device market in the world with a market size of around $110 billion, and it is expected to reach $133 billion by 2016. The IVC filter market alone is worth $190 million and is is projected to reach $435 million globally by 2016.
Vena cava filters have never been rigorously reviewed by the FDA because the first devices were developed prior to the FDA’s premarket approval process and it is unlikely that the manufacturers of the filters will embark on trials that may negatively affect their profits. Fortunately, first large-scale, clinical research trial to evaluate the use of IVC filters was launched this spring with participation from seven manufacturers. This study will last 5 years and is a collaboration between the Society of Interventional Radiology and the Society for Vascular Surgery.
Unless there is an absolutely critical necessity to implant an IVC filter, for now, it might not be likely that the risks outweigh the rewards. “There is little medical evidence that this device does what it is assumed to do, which is prevent PE and save lives,” said Richard White, chief of general medicine at UC Davis, in 2013. “If we cannot administer a blood-thinning anticoagulant, it may seem logical to use one of these filter devices,” said White. “The problem is that there isn’t any solid proof that this option actually benefits patients. There is also distressing evidence that the majority of the devices are left inside patients and never removed. Over months and years, the device can break apart and become harmful.”
It has been concluded that filter fragmentation could be directly related to the length of implantation, so it is imperative to one’s health to take immediate action. If you’ve had an IVC filter implanted and are unsure of the next step, please contact us at 888-586-7041. The Dysart Law Firm is an experienced law firm practicing in the area of product liability for over 25 years. If you have had a blood clot filter implanted into your body, you may have a claim for money damages.