An inferior vena cava (IVC) filter is an implanted medical device meant to catch a dangerous blood clot, or deep vein thrombosis (DVT), and prevent it from moving to the arteries in a patient's lungs, where a potentially fatal blockage known as a "pulmonary embolism" could occur. But these medical devices haven't always worked as intended, and thousands of IVC filter lawsuits have been filed nationwide.
IVC filters are generally made up of small, metal wires that create a cone-shaped filter (picture a partially-closed umbrella). An IVC filter can fail in a number of ways. Portions of the filter can break off and move to other parts of the body ("migrate"), causing organ damage and increasing risk of DVT. The filter can also shift unexpectedly, puncturing vein walls and increasing the risk of further complications. Attempts at removing a failed IVC filter can also lead to injuries. (Learn why a medical diagnosis is essential to an IVC filter case.)
In August 2010, the U.S. Food and Drug Administration (FDA) issued an Initial Communication and a Safety Communication outlining the agency's awareness of various reports of problems with IVC filters. Specifically, the FDA reported the receipt of more than 900 "adverse events" related to the device, from 2005 to 2010.
The FDA recommended that medical professionals remove IVC filters as soon as the risk of PE was low enough that the benefits of the IVC filter no longer outweighed the risks of keeping the device implanted.
Faced with mounting problems and increased scrutiny, a number of IVC filter manufacturers have initiated recalls:
It's worth noting that two manufacturers (Cook Medical and Bard)—two companies now facing significant IVC filter litigation—took no recall steps. (Get details on how a recall affects a product liability case.)
There are thousands of IVC filter lawsuits across the United States, with most involving Bard or Cook Medical as the defendants. Many of these cases are being handled as multi-district litigation (MDL), special cases where one judge in a single federal district handles similar lawsuits from different federal districts around the country. This improves efficiency, as a single decision from the judge will apply to all cases in the MDL.
The MDL system also facilitates settlements, through use of "bellwether" trials, which offer something of a preview of what the parties can expect in other cases. If a plaintiff (an injured patient) wins a bellwether trial, a defendant (a product manufacturer) knows they’re potentially in for a long fight, so they might choose to settle other cases rather than fight them. If a product manufacturer wins, they might make lower settlement offers or litigate more aggressively.
Many of the IVC filter cases are in one of two MDLs. The Arizona group (MDL No. 15-02641-PHX-DGC) has Bard as the defendant. At one point, it consisted of more than 8,000 cases. But as of May 31, 2019, the group is longer accepting new cases. Plaintiffs can still file new lawsuits against Bard, but they won’t join the Arizona MDL. The existing cases in the group will eventually settle or go back to their home districts for trial. The other MDL is in Indiana (MDL No. 1:14-ml-02570-RLY-TAB) and involves Cook Medical as the defendant. At one time, it had more than 6,000 cases. This MDL is still ongoing.
Aside from these two MDLs, faulty IVC filters are the subject of hundreds of other lawsuits (including a number of class actions) nationwide.
Both the Arizona and Indiana MDLs have had several bellwether cases. There are also lawsuits in other courts, involving other manufacturers. Here are some notable results:
March 2013: Plaintiff alleged an IVC filter broke apart and moved into her heart. Bard and the plaintiff settled the case.
January 2015: Plaintiff’s IVC filter broke down, causing damage to her lungs and heart. Bard settled the case.
February 2015: Plaintiff's Bard IVC filter broke apart, with a piece getting stuck in his heart. Plaintiff underwent open-heart surgery to remove it and fix the damage. The sides reached a settlement.
March 2017: Plaintiff’s family sued Boston Scientific after an IVC filter caused a perforated vena cava and severe internal bleeding. The parties settled the case.
November 2017 (Indiana MDL): Cook Medical prevailed against a plaintiff who claimed her IVC filter perforated her small intestine.
March 2018 (Indiana MDL): The judge threw out a plaintiff’s case on procedural grounds, concluding the plaintiff missed the statute-of-limitations lawsuit-filing deadline.
March 2018 (Arizona MDL): Plaintiff won $3.6 million in compensatory and punitive damages against Bard. The plaintiff’s IVC filter fractured, with bits and pieces spread around her heart and spine.
May 2018: A Texas jury awarded a plaintiff $1.2 million for damage caused to his aorta and intestine by an IVC filter made by Cook Medical.
June 2018 (Arizona MDL): Bard prevailed when a jury decided it wasn't liable for the plaintiff's alleged injuries.
October 2018 (Arizona MDL): Plaintiff’s IVC filter shifted and broke apart, but a jury concluded that Bard was not liable for plaintiff’s claimed arrhythmia damages.
February 2019 (Indiana MDL): Plaintiff won $3 million against Cook Medical, but during post-trial proceedings in January 2020, the judge ordered a new trial due to an error in the admission of evidence during trial.
May 2019 (Arizona MDL): Plaintiff and Bard settled just before jury selection began for trial.
October 2019 (Philadelphia’s IVC filter mass tort program): More than $33 million in compensatory and punitive damages went to the plaintiff in her lawsuit against Rex Medical.
The above-mentioned cases resulted in settlements and a mix of plaintiff and defendant victories, so it's not easy to read the tea leaves, especially in terms of the MDL over IVC filters. There are thousands of IVC filter cases pending in the court system, with more expected, and it's safe to assume that a good number will reach settlement over the next few years. If you’re considering filing an IVC lawsuit, you should consult an attorney as soon as reasonably possible to discuss your options and plan your best course of action.