Patients who are at risk of developing blood clots, but who are not candidates for blood thinner medication, often have IVC (inferior vena cava) filters implanted, especially after major surgery. These small, cage-like or spider-like devices are implanted in the inferior vena cava—the main vessel moving blood from the lower body to the heart. However, IVC filters manufactured by C.R. Bard and Cook Medical may cause serious injuries, including Bard’s Recovery®, G2®, G2® Express (G2®X), Eclipse®, Meridian®, and Denali® Vena Cava Filters.
Motley Rice Attorney Appointed to MDL
Nov. 2, 2015
Motley Rice medical attorney Don Migliori was appointed to the Plaintiffs’ Steering Committee for the multidistrict litigation (MDL) In re Bard IVC Filter Products Liability Litigation MDL No. 2641 in the District of Arizona under Judge David G. Campbell.
Potential IVC Filter side effects
According to reports made to the FDA, long-term use of retrievable IVC filters may cause serious side effects, including:
- Deep vein thrombosis (DVT)
- Detached device components
- Difficulty removing the filter/irretrievable device
- Embolization (movement of the entire filter or filter fragments to the heart or lungs)
- Fracture of the filter
- Migration of the filter to another area of the body
- Perforation of the inferior vena cava
- Tilting of the filter
An analysis supported by the FDA and published in the October 2013 edition of the Journal of Vascular Surgery: Venous and Lymphatic Disorders determined IVC filters are typically best removed between 29 and 54 days after implantation to avoid potential adverse health risks. Some other physicians encourage patients to tell their doctor right away if they’ve had an IVC filter for more than three months and have not been evaluated. A study published May 2017 in the Journal of Thrombosis and Thrombolysis found that IVC filters may be overused in managed care populations, leading to higher rates of hospital readmission.
Side effects may occur in as little as a week or after years of implantation. If you or a loved one have an IVC filter and are concerned about side effects, you may have a potential claim. Contact medical attorneys Fred Thompson and John Duane by email or call 1.800.768.4026 to learn if you have a case.
Motley Rice attorneys have experience in medical device litigation, including leadership roles in cases against C.R. Bard for allegedly defective transvaginal mesh and Composix® Kugel® Mesh patches.
NBC Nightly News Investigates
Watch the special report about the potential deadly risks of IVC filters and how filter manufacturer C.R. Bard allegedly forged a letter to receive FDA clearance for its Recovery blood clot filter – after the FDA previously declined to clear the filter.
Risks involved with long-term use of IVC Filters
In 2014, the FDA updated its initial findings and recommended that IVC filters be removed between 29 and 54 days after implantation. This news followed the results of a 2013 study, which found that “the risks of complications start to outweigh the protective benefits of the filter at day 35 post-implantation.”
Another study, published in JAMA Internal Medicine in April 2013, found that while most of the IVC filters it reviewed were designed for retrieval, only 8.5% were successfully removed. “Therefore, approximately 91.5% of retrievable filters placed in patients at risk for VTE became permanent filters,” even though “recent data show that increasing complications occur when the filters are left in place for longer periods.
The FDA remarked on this issue as well, noting that it “is concerned that retrievable IVC filters, when placed for a short-term risk of pulmonary embolism, are not always removed once the risk subsides.”
Complications with Cook Celect® and Gunther Tulip® IVC filters
A study published by the Cardiovascular and Interventional Radiology Journal in April 2012 found that all Cook Medical Celect and Gunther Tulip IVC filters included in the study showed at least some degree of blood vessel wall perforation after 71 days, and 40 percent of the filters tilted out of place.
FDA Warns C.R. Bard
On July 13, 2015, the FDA issued a warning letter to medical device manufacturer C.R. Bard for eight violations of federal law regarding its IVC filters, including but not limited to the Denali Filter®, the Simon Nitinol Filter® and the Recovery Cone Removal Kit®. Among the violations cited were:
- Filing of serious injury and death complaints as “malfunctions,” including detached filter arms, broken filter, IVC perforation and aneurysm and filter leg fragment embedment in IVC wall
- Failure to fully explain why at least 10 scheduled IVC filter retrieval surgeries resulted in failed attempts at removal
- Failure to rule out that the malfunction of one of the firm’s long-term IVC filter implants “would not be likely to cause or contribute to a death or serious injury, if it were to recur.”
In 2010, the FDA issued a safety communication, stating that close to 1,000 adverse events had been reported since 2005 and that the delayed removal of IVC filters intended for short-term use could cause serious side effects.
Lawsuits against both Cook Medical and C.R. Bard regarding IVC filters have been consolidated into multidistrict litigations : In re Cook Medical, Inc, IVC Filters Marketing, Sales Practices and Products Liability Litigation (MDL No. 2570) in the Southern District of Indiana and In re Bard IVC Filter Products Liability Litigation (MDL No. 2641) in the District of Arizona.
Motley Rice medical attorney Don Migliori is a member of the Plaintiffs’ Steering Committee for the multidistrict litigation (MDL) In re Bard IVC Filter Products Liability Litigation
Reuters (Nov. 2, 2015): Cook can't split discovery, trial on punitive damages in filter MDL