IVC Filter Lawsuits
Designed to stop blood clots, IVC filters – specifically retrievable filters – can cause serious health problems when left implanted in patients for too long. Thousands of lawsuits have been filed against manufacturers for not communicating about the dangerous side effects of these devices.
Why File an IVC Filter Lawsuit?
Every year, approximately 250,000 people in the U.S. are implanted with an IVC filter. The filters are promoted as being able to catch blood clots in the body’s largest veins before they make their way to the heart and lungs. However, the filters often break. A broken device may cause fragments to move throughout the body, potentially causing irreversible damage to vital organs.
Other severe side effects linked to IVC filters include:
- Pain in the heart and chest
- Hemorrhage
- Perforation of tissue, vessels and organs
- Damage to heart, lungs or veins
- Disruption of heart rate
You may be able to file a lawsuit against IVC manufacturers for failing to give appropriate warning of the increased risks of the filters breaking.
Who Is Responsible for IVC Filter Complications?
People adversely affected by an implanted IVC filter are holding the manufacturer responsible for falsely promoting their device as safe and effective. All medical devices are required to undergo comprehensive testing and inform patients of any potential dangerous side effects. Unfortunately, some IVC filter manufacturers – like C.R. Bard and Cook Medical – failed to disclose the long-term harm associated with their retrievable filters.
Common manufacturers of IVC filters include:
- ALN Implants Chirurgicaux
- B Braun Medical
- Boston Scientific
- Cook Medical
- Cordis
- C.R. Bard
- Rafael Medical Technologies
- Rex Medical
Why Are They Being Sued?
Lawsuits against C.R. Bard and Cook Medical state that the companies knew about the defective devices and withheld crucial information from consumers. Other cases point to problems with:
- Lack of testing by the manufacturer to determine how the devices functioned in the body once implanted.
- Complications such as fracture, device migration, organ penetration and increased risk for blood clots in the leg.
- Devices must often be surgically removed; otherwise, patients risk possible long-term severe health complications.
- Misrepresented information in advertising which did not provide data on serious side effects.
IVC Filter Litigation
In 2010, the organization expressed concern that retrievable IVC filters were only intended for short-term placement; however, the devices were too often left in a patient until the risk for pulmonary embolism subsided. Due to these findings, the FDA recommended surgeons remove retrievable IVC filters as soon as possible. They echoed this same safety message again in 2014.
As new information about the danger of IVC filters emerges, many lawsuits are being filed against the manufacturers. Since the cases make similar claims, they have been combined under multidistrict litigation (MDL) to streamline the process in hopes of a quicker resolution for all parties involved.
After a series of bellwether trials, the manufacturers may choose to make a large settlement offer or proceed with individual trials.
C.R. Bard Lawsuits
One of the largest IVC filter manufacturers, C.R. Bard is facing hundreds of lawsuits alleging that the company neglected to advise patients of the risk of fractures in the device. If a filter breaks, metal fragments will be released into a patient’s vascular system, potentially causing lifelong damage.
Research has indicated that C.R. Bard IVC filters have over a 50 percent failure rate and there may be more than 100,000 individuals who have the Recovery® filter implanted in them. The device’s high failure rate could lead to harmful, sometimes life-threatening, injuries. In fact, the IVC filters have been linked to more than 300 injuries and as many as 30 deaths.
In addition, the FDA has issued a warning letter for eight violations of federal law relating to the safety of C.R. Bard’s IVC filters. Of the violations, one faults the company for illegally selling tainted and mislabeled IVC filters, as well as failing to report complications and adverse effects. It further remarks that the company withheld critical information from the FDA and the public.
Cook Medical Lawsuits
A study published in CardioVascular and Interventional Radiology found that Cook Medical’s Celect and Gunther Tulip filters displayed varying degrees of perforation in large veins within just 71 days after implantation. Notably, in 86 percent of the cases, at least one component of the device was found fully punctured. The rates of perforations with Cook Medical IVC filters are much higher than other brands.
The FDA has since called for the removal of IVC filters as early as possible. Doctors have also been advised to look closely at the devices during follow-up imaging appointments.
Due to the significant amount of lawsuits against the manufacturer, all Cook Medical IVC filter cases are part of an MDL. The cases are compiled under Judge Richard L. Young under MDL 2570 in the U.S. District Court for the Southern District of Indiana for pretrial proceedings.
After receiving hundreds of reports about IVC filter migration, device detachments, inferior vena cava perforations and filter fractures, the FDA issued a safety communication to patients and doctors.Getting an Attorney who knows IVC Filters
Manufacturers like C.R. Bard and Cook Medical should be held responsible for the damage and serious health complications related to their IVC filters. A lack of information about adverse effects impacted how consumers received treatment. Filing a lawsuit will provide you with compensation for injury and harm, lost wages and medical bills.
Last Edited: October 31, 2017
