IVC Filter Lawsuit – What You Need To Know
The Most Important Things to Know About the New IVC Filter Lawsuit
IVC blood clot filters may cause serious and fatal health risks. But is an IVC blood clot filter lawsuit the right answer? We’re diving deeper into the issue today.
What Are IVC Filters?
IVC filters are retrievable devices that go into the veins of patients who would not normally be able to take anticoagulants (i.e. blood thinners). The Inferior Vena Cava (IVC) filter prevents blood clots from moving to the lungs.
The device works by catching clots as they travel through the blood stream. Then, the clots dissipate over time. The IVC filter is removed from the body when the patient is observed to have reduced their risk for blood clot-related problems.
Why Are They Potentially Dangerous?
Unfortunately, the FDA has received hundreds of reports about problems related to retrievable filters – including punctured organs, punctured blood vessels, and problems related to the filter migrating to different parts of the body.
The FDA started noticing IVC filter problems around 2010, when they warned the public of the possible risk of the filters fracturing or migrating throughout the body or perforating organs.
As a result, the FDA recommended that the devices be removed as soon as a patient’s risk for blood clots had subsided.
In 2014, the FDA updated its recommendations once again, stating that devices should be removed between the 29th and 54th day after implantation.
Unfortunately, the FDA’s warnings came too late: already, IVC filter users across America have begun filing lawsuits. These lawsuits allege that the filters caused some type of harm or death to the patient.
Who is the Target of the Lawsuit?
IVC filter lawsuits target two medical product manufacturers, including C.R. Bard and Cook Medical. Together, these companies made five different types of IVC filters that have been linked to health problems. Those five products include:
-The Cook Gunther Tulip Filter
-The Cook Celect Filter
-The Bard Recovery Filter
-The Bard G2 Filter
-The Bard G2 Express Filter
The lawsuits all allege similar problems, including that the manufacturers were negligent in selling these devices. The manufactures allegedly failed to warn consumers of problems and failed to protect consumers against manufacturing defects. They also breached implied warranty and negligently misrepresented their products.
The first lawsuits against Bard were filed in California and Pennsylvania state courts in 2012.
By October 2014, the US Judicial Panel on Multidistrict Litigation (MDL – the body that awards certain cases class action status) had consolidated lawsuits against Cook from 11 districts to an MDL in the Southern District of Indiana.
To date, the number of lawsuits filed against Cook has risen to more than 100.
In February 2015, C.R. Bard settled against one plaintiff named Kevin Philips just 10 days after the trial begin. Philips received an IVC filter implantation which later broke inside his body. One of the small metal legs of the filter traveled through his bloodstream to his heart, creating a perforation. The tear in his heart forced him to have open heart surgery followed by a lengthy and painful recovery process.
Bard lawsuits have also reached class action status: the US Judicial Panel on MDL decided to consolidate all lawsuits against Bard to the US District Court of Arizona in August 2015. To date, more than 50 lawsuits are part of that MDL.
Meanwhile, a number of other lawsuits are currently making their way through the court system in other parts of the country.
Damages Caused by IVC Filters
Starting in 2010, the FDA received reports of complications related to IVC filters. It’s expected that the number of complications has risen dramatically since then. However, the initial 2010 report included 900 different cases across America, including:
-70 filter perforations
-328 device migrations
-56 filter fractures
Study Shows Most IVC Filters Cannot Be Safely Removed
In 2013, researchers published a study in the Journal of the American Medical Association (JAMA) that sought to determine the risks associated with IVC filters.
In that study, researchers looked at 680 successful IVC filter implantations. Of those 680 patients, doctors were only able to successfully remove 58 IVC filters. Doctors made 13 unsuccessful removal attempts, 11 of which occurred in patients who had had their IVC filters for more than 85 days.
3 of those patients could not have their filters removed because the filters protruded through a blood vessel.
You can read the full study here.
Bard May Have Known About the Risks
Many of the lawsuits against Bard allege that the company knew about the risks of the IVC filters but still decided to sell the filters to the market.
That information was revealed in the now-infamous Lehmann report. In 2004, Bard hired Dr. John Lehmann, an independent consultant, to examine fracturing and migration problems related to the new version of their IVC Filter. Lehmann completed his report in December 2004 and found that the Bard IVC filter experienced a higher complication rate than its competitors.
You can read the full Lehmann report here.
Did Bard Forge a Signature on an FDA Application?
Another serious allegation against Bard is that they may have forged a signature on their FDA application. That information was revealed in an NBC News investigation.
NBC News claims that the company hired a regulatory specialist named Kay Fuller in 2002. Bard wanted Fuller to help bring the company’s IVC filter to market. Fuller, however, grew concerned about the safety of the device and refused to help Bard gain market clearance for the device.
Nevertheless, Fuller’s name and signature appear on an application for the IVC filter to the FDA. This application was later used to approve Bard’s IVC filter. Fuller later told NBC that she did not sign the form and that the signature was used on the application without her knowledge.
Should You Join an IVC Filter Class Action Lawsuit?
If you or a loved one has experienced medical complications as a result of an IVC filter, then you may be eligible for significant compensation under US law.
As more and more details of this case emerge, lawyers are starting to realize that plaintiffs could be eligible for huge compensation – especially if it was proven that Bard forged signatures on FDA applications.
Ultimately, your best course of action is to schedule a free consultation with a lawyer. Many personal injury lawyers will provide free consultations where you can discuss the details of your case before locking into a contract or paying anything. Many lawyers will also work on a contingency basis, where they won’t charge you upfront but will take a cut of the award once a settlement or verdict has been reached.
If you or someone you love has been hurt as a result of an IVC filter complication, then there’s no better time than now to stand up for your rights.