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IVC Filter Litigation

The Medical Device that launched 1000 Lawsuits
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The Medical Device that launched 1000 Lawsuits:

IVC filter lawsuits allege that the devices cause severe injuries and health complications, including death. To date, plaintiffs have filed thousands of lawsuits against manufacturers Cook Medical and C.R. Bard, claiming IVC filter design faults, failure to warn about potential risks and other defects.

Almost 8,000 lawsuits are still pending against Cook Medical (of the 11,000 filed thus far) as of November 2023.

The claims were filed by patients who suffered injuries and families whose loved ones died due to complications with the device - most lawsuits involved C.R. Bard and Cook Medical. As of November 2023, over 11,000 lawsuits have been filed against Cook Medical alone. However, other IVC filter manufacturers, including Boston Scientific and Cordis, are also implicated in legal claims.

An inferior vena cava (IVC) filter is a medical device made of metal that is implanted by vascular surgeons or interventional radiologists into the inferior vena cava of the heart to prevent a life-threatening pulmonary embolism or venous thromboembolism – both of which can lead to death.

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Thousands Recalled

Federal lawsuits filed against Bard and Cook and other IVC filter manufacturers allege that defects in the design of IVC filters make them more likely to fracture, migrate, tilt or perforate the blood vessel. People who were injured say the companies knew or should have known about the dangers but failed to warn doctors and patients of the risks.

Thousands of IVC filters have been recalled because they were defective, failed to open, tilted or migrated. In fact, device makers issued seven (7) IVC filter recalls between 2005 and 2019. Two of these recalls were the serious Class I recalls (the FDA’s most serious/urgent recall) — the 2013 Cordis recall of 33,000 of its OptEast IVC filters and the 2005 Boston Scientific recall of 18,000 Greenfield filters.

The OptEase recall was to correct labeling and prevent backwards insertion of the devices, and remains the largest recall to date. The last IVC filter recall came in 2019 from Cook, which brought back multiple sets of its Gunter Tulip IVC because of labeling issues.
Bard, Cook and Cordis are manufacturers that have multiple models of IVC filters named in legal claims. Cordis and Cook have two models named. Bard has six, according to available filings.

IVC FILTER MANUFACTURERS

Plaintiffs allege at least one IVC filter model from three other device makers — ALN, Argon and Boston Scientific — was defective. However, neither Cordis nor ALN, Argon and Boston Scientific are part of an IVC filter MDL (multi-district litigation) as of February 2024.

During a 2015 investigation of Bard IVC filters, NBC News reported that Bard executives had been aware of the risks for years, but the company did nothing. NBC obtained a 2004 Bard-commissioned study that found the Bard Recovery IVC filter had a higher failure rate than competing devices. NBC linked Bard IVC filters to 39 deaths.
The inferior vena cava (IVC) is a large retroperitoneal vessel formed by the confluence of the right and left common iliac veins

WHAT IS AN IVC FILTER USED FOR?

Veins are the blood vessels that bring oxygen-poor blood back to the heart where it is re-oxygenated. The inferior vena cava is a large vein in the middle of your body. This small device, an inferior vena cava (IVC) filter, is designed to stop blood clots from going into the lungs. The device is implanted during a short surgery. Typically, it is used in patients at risk for blood clots who are unable to take traditional blood thinners. It is meant to be removed after the threat of a deep vein thrombosis (DVT) has subsided.

The risk for adverse medical events increases the longer the IVC filter stays in a patient’s body. According to the National Institutes of Health, the FDA currently recommends IVC filters be removed within 25-54 days of their implantation.
Retrieval surgery is complex and can cause IVC filters to fracture, or break. Sometimes, retrieval is impossible. Both retrieval and inability to retrieve can pose serious risks.

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