Not all trauma patients at risk for thrombotic events respond to anticoagulant medications. When a patient either can't take blood-thinning drugs or the drugs don't produce the desired results, doctors often turn to an ingenious medical device known as an IVC filter. Made up of a number of metal wires and shaped like a small cone, IVC filters are inserted laparoscopically into the neck or groin, and guided into the body's longest vein: the inferior vena cava.
This is one of two major veins tasked with carrying deoxygenated blood from the body into the heart.
Once the IVC filter is placed into the interior vena cava, blood clots that would otherwise flow right by get caught on the filter's wiry “legs,” which hold the clots until they dissipate. IVC filters are literally life-saving for some patients, preventing dangerous thrombotic events, such as stroke, pulmonary embolism (blood clots in the lungs), or deep vein thrombosis (blood clots in the legs).
Unfortunately, while IVC filters can be life-saving for some patients, others experience life-threatening complications. The “legs” of the filter can snap off and migrate to other parts of the body—or the entire filter can dislodge and migrate—damaging tissue and organs all along the way. IVC filters can also become infected or even cause the hazardous blood clots they're designed to prevent.
There are two main types of IVC filters on the market today: permanent IVC filters, which feature rigid “legs” and retrievable IVC filters, which have flexible “legs.” Permanent IVC filters were approved by the U.S. Food and Drug Administration (FDA) in the 1970s and, nearly 20 years later, the agency approved the first retrievable IVC filters. One might be tempted to assume that it's the old-fashioned, permanent type of IVC filter that's causing all the problems, but the opposite is true: most IVC filter adverse events are associated with the newer, retrievable filters.
If your doctor recommended an IVC filter, or you received an IVC filter after being in a serious accident, here's what you need to know.
IVC Filter Issues and Litigation Timeline
- 1970s: The FDA approves permanent IVC filters.
- 1990s: The FDA begins approving retrievable IVC filters.
- 2001: The first retrievable IVC filter becomes available in the United States.
- 2002: The FDA approves the retrievable C.R. Bard Recovery® IVC filter.
- 2003: The FDA approves the Cook Gunther Tulip® IVC filter.
- 2004: Bard begins receiving reports of adverse events related to the Recovery IVC filter.
- 2005: Bard discontinues, but does not recall, the Recovery IVC filter.
- 2005: Bard introduces the G2® IVC filter.
- 2008: Bard introduces the G2 Express® IVC filter.
- 2008: The FDA approves the Cook Select® IVC filter.
- 2010: The FDA issues a warning urging doctors to remove IVC filters as soon as the danger of thrombotic events has passed.
- 2011: Bard introduces the Bard Meridian® IVC filter.
- 2012: Three class-action lawsuits are filed against Bard; patients also begin filing lawsuits against Cook Medical, due to complications with the Gunther Tulip and Select IVC filters.
- 2013: The FDA approves the Bard Denali® IVC filter.
- 2014: The FDA approves the Bard Eclipse® IVC filter.
- 2014: The FDA updates their IVC filter safety warning, citing data that shows the devices should be removed between 29 and 54 days after implantation.
- 2014: U.S. Judicial Panel on Multidistrict Litigation consolidates Cook Medical lawsuits into an MDL in Indiana's southern district.
- 2015: U.S. Judicial Panel on Multidistrict Litigation consolidates Bard lawsuits into an MDL in Arizona district court.
- 2016: Bard IVC filter patients file a class-action lawsuit on behalf of anyone implanted with a Bard blood clot filter.
Do You Need a Personal Injury Attorney?
IVC filters are supposed to save lives but, when left in place too long, the risks begin to outweigh the benefits. Hundreds of IVC filter patients have filed lawsuits against IVC filter manufacturers, alleging that they marketed and sold dangerous products, even after they were aware of the risk associated with use of the devices.
If you were injured by a defective IVC filter, McGartland Law can help you pursue compensation from the manufacturer. Contact McGartland Law today to schedule a no-cost, no-obligation initial case consultation.