Defective IVC Filter Litigation
The inferior vena cava (IVC) is an umbrella-shaped medical device with legs intended to prevent blood clots from relocating from the lower ranges of the body to the heart or lungs. These devices were produced for patients who are at danger for life-threatening blood clots. Those who commonly benefit from the implantation of these devices are patients at danger for deep vein thrombosis (DVT) or individuals who have as of late experienced surgery and maybe have a background marked by blood clusters.
Inferior vena cava filters are frequently utilized as different options for anticoagulant treatment to catch blood clots inside of the body before they reach the lungs and get to be pulmonary embolisms. In one IVC filter study, 94% of the patients had the devices implanted because of a contraindication to, or former failure of blood-thinning prescriptions. An expected 49,000 IVC filters have been placed every year in the United States following 2005, which implies that near a million American individuals have them within their bodies.
The Dangers of IVC Filter Fracture and Migration
Lamentably, IVC filters can at times come up short, breaking apart and sending bits of the gadget into to the heart or lungs. There likewise have been cases in which these medical devices have moved inside of the patient’s body, including into a few zones that are inaccessible by surgery. At the point when any of these things happens, the potential for genuine damage is extraordinary, and these wounds can be lethal. These injuries can lead to an IVC filter lawsuit and eventual settlement.
In the course of recent years, the U.S. Food and Drug Administration (FDA) has gotten more than 1,000 adverse event reports for IVC filters, including those made by Bard, and additionally those fabricated by Cook. Among these occurrences, more than 325 include relocation of the filter within the body and in more than 145 segments of the IVC filter broke off from the body of the device. Furthermore, 70 cases have included perforation of the inferior vena cava itself.
In 2010, the FDA issued a notice to doctors against leaving the devices embedded for long time periods due to the tendency for movement and subsequent health issues. They cautioned that IVC filters are for short-term use for patients at danger for pulmonary embolism, and that doctors who insert them ought to remove them once the danger has died down, so as to avoid further patient complications.
IVC filters continued to face scrutiny over the years. In May of 2014, the FDA issued a safety statement advising doctors that the devices should be removed between 29 and 54 days after implantation, and due to improper warnings and instructions, many physicians were not aware of this important time frame. In 2014 and 2015, the Journal of the American Medical Association published studies finding that IVC filters were not as effective as blood thinners, and that the long term risks of these devices may counteract any health benefits they provide. Most recently, in July 2015, the FDA issued a warning letter to Bard for illegal practices and problems with certain of its devices.
IVC Filter Side Effects
A patient can experience IVC filter fracture and migration symptoms as blood loss, extreme chest pain, breathing issues, or puncturing of veins, organs, or tissues.
Filter Implantation Side Effects Can Include:
- Device-related death
- Device migration
- Filter embolization
- Filter break
- Insertion-site thrombosis
- Perforation of the inferior rate vena cava
- Recurrent deep venous thrombosis (DVT)
- Recurrent pulmonary embolism (PE)
- Surgery to remove the device
- Thrombotic issues
Raizner Slania IVC Filter Attorneys
The first IVC filter defective medical device claims were levied against C.R. Bard in California and Pennsylvania state courts in 2012. In October 2014, the U.S. Judicial Panel on Multidistrict Litigation united Cook IVC filter claims from 11 locales into Multidistrict Litigation No. 2570 in the Southern District of Indiana under the watchful eye of Judge Richard L. Young in IN RE: Cook Medical, Inc., IVC Filters Marketing, Sales Practices and Products Liability Litigation. Subsequently, the JPML again consolidated IVC filter claims, this time for Bard devices, in MDL No. 2641, IN RE: Bard IVC Filters Products Liability Litigation in the District of Arizona under Judge David G. Campbell. Various additional claims for an IVC filter lawsuit remain pending in federal and state courts across the country.
If you or somebody you know had an IVC filter implanted, you may have a legal claim and can potentially reach an IVC filter lawsuit settlement. Contact the experienced defective medical device lawyers of Raizner Slania for a free and confidential consultation about your concerns.