In the early 2000s, the manufacturers of permanent IVC filters saw a market opportunity for temporary IVC filters. They changed the design to allow the device to be more easily retrieved. It did not take long for adverse event reports involving device migration to the heart, fractures, and perforation of the vena cava and surrounding organs to become apparent to the FDA. The FDA has issued several warnings including safety communications in 2010 and 2014, and then a warning letter to one of the biggest manufacturers, Bard, in 2015.
IVC filter lawyers have filed cases against Bard for about the past five years. There is extensive discovery going on, but all of the Bard cases have been consolidated and are being pursued in Arizona, which is common when you are dealing with a product failure on a mass scale. That is just a little bit about the litigation. The case itself has been ongoing for several years and it was really brought to the forefront because of the adverse event reports being reported to the FDA.
Root Cause of Defective IVC Filters
The main causes of IVC filter issues include device migration to the heart, device fractures, perforation of the vena cava and surrounding organs, the device becoming embedded, and a piece of the device breaking off.
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Manufacturers
Bard and Cook together have a big portion of the IVC filter market. A multidistrict litigation (MDL) was created for Bard, which is a consolidated litigation where all the cases are being filed. And then another MDL was created for Cook. There are also manufacturers of retrievable IVC filters outside of Bard and Cook who are being looked into. These manufacturers includes Johnson & Johnson and Boston Scientific. Really anyone who has a retrievable IVC filter product, should probably be investigated.
Awareness of Issues
Arguably, when they submitted their paperwork to the FDA to have the devices approved, there was some indication. There are some indications that knowledge was in the documents presented to the FDA. Whenever a drug company is trying to get a new device approved, they submit their own studies and documentation to the FDA showing adverse events, if there were side effects, and things of that nature. Arguably, the company should have known at the time they were seeking the FDA’s approval that this was a dangerous product.
Major Cases in Litigation
The Bard MDL has been going on for the past five years. Lots of discovery has been completed, lots of depositions taken, and what will usually happen is bellwether cases will be selected. Out of many hundreds or thousands of cases that are filed, a handful will be selected to move forward to trial. Oftentimes, the outcomes of those trials is really indicative of what will happen with everyone who has an IVC filter case.
Sometimes manufacturers might settle cases out of court and include a confidentiality provision so that the plaintiff cannot talk about their case. That may not specifically be happening here, but it is a tactic that is sometimes used to keep major cases out of the public knowledge..
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