IVC filters are designed to keep blood clots away from vital organs, but some patients are alleging that poor designs have caused filters to break apart. When IVC filters fail, the complications can be life-threatening.
Numerous patients filed lawsuits in 2016 against manufacturers of IVC filters, and more lawsuits are scheduled for 2017.What is the Purpose of an IVC Filter?
The IVC (inferior vena cava) is a vein that transports blood from the lower body to the heart. IVC filters are vascular filters that are implanted into this vein to prevent blood clots from reaching the kidneys, lungs, heart or brain.
The filter, which has a spider-web like design, catches the clot and allows it to break down over time.
IVC filters are often inserted into patients who cannot take anticoagulant medication.
These filters are not permanent and should be removed within six to twelve weeks of insertion. Failure to remove the filter in a timely manner can cause complications and increase the chance of injury.Why Are Patients Filing Lawsuits?
The FDA in 2010 issued a warning to doctors of the risk of retrievable IVC filters. The agency has received at least 900 adverse event reports regarding these filters.
The primary complaint among patients is the filter breaking off, migrating through the body and injuring organs. Some patients also experienced blood clots at the insertion site, something the device was intended to prevent.
Patients have also experienced the following injuries and side effects after having an IVC filter inserted:
- Chest pain
- Heart rhythm irregularities
- Neck pain
- Shortness of breath
In the FDA's 2010 warning, the agency urged doctors to remove the device as soon as the danger of a blood clot had passed.
Patients are filing lawsuits to recover damages caused by injuries from defective IVC filters.Subsequent FDA Warnings and Studies on IVC Filter Effectiveness
In 2015, the FDA issued an updated safety statement indicating that patients are at greater risk of complications if the filters are not removed after the threat of a blood clot has passed.
The agency stated that the ideal time for removal was between 29 and 59 days after implantation.
A study publushed in the April 2015 edition of the Journal of the American Medical Association (JAMA) showed that IVC filters were not as effective as blood thinners in the prevention of pulmonary embolism. Researchers involved in the study found that people with implanted filters were twice as likely to have a blood clot reach their lungs than those on blood thinners.
A warning was also published with the study that stated the long-term risks of IVC filters may offset any health benefits it may offer.
Just a few months after the FDA issued its updated safety statement in 2015, the agency issued a warning letter to Bard for illlegally marketing a device used to remove an IVC filter. The letter also included a warning of complications with the Denali IVC filter.
According to a report from Drug Watch, plaintiffs first filed suit against manufacturers of IVC filters in 2012. The initial suit was filed against Bard in Pennsylvania, but additional suits soon followed in California.