IVC Filter Lawsuit | Fractures, Migration, Tilt and Perforation
Have you had an IVC filter implanted to prevent blood clots from reaching your lungs? If you have experienced a fracture, migration, or tilt of the filter or IVC wall perforation, you may have a claim. Zoll & Kranz, LLC offers a free case evaluation if you have questions about this ongoing litigation. To speak to a defective device attorney, please fill out the form on this page or call toll-free at 888-841-9623.
What is an IVC Filter?
This device is a small, cage-like implant that is inserted into the inferior vena cava,
the main vessel that returns blood from the lower half of the body to the heart. Generally, IVC filters are used when a patient is at risk for a blood clot in the lungs called a pulmonary embolism (PE).
IVC filters were originally designed to be permanent implants although some of these devices are now designed to have the option to be removed. A retrievable Inferior Vena Cava Filter is used for the prevention of recurrent pulmonary embolism in patients under specific situations. The device is implanted into the inferior vena cava and is designed to be retrieved when the patient no longer requires a filter
What is the Risk/Warning?
Recently, you may have seen U.S. Food and Drug Administration safety warnings on the IVC filter device.
- August 9, 2010 FDA Safety Communication: At this time, the FDA was receiving an alarming number of adverse events, over 900 in 5 years. These adverse events included reports of filter migration, filter fractures, perforation, and even embolizations (detachment of device components). The concern for retrievable IVC filters is that they were not always removed once the risk for PE subsides. The FDA ultimately recommended that implanting physicians and clinicians responsible for the ongoing care of patients with retrievable IVC filters consider removing the filter as soon as protection from the PE is no longer needed. The FDA expressed concerns of long-term risks of possible lower limb deep vein thrombosis (DVT), filter fracture, filter migration, filter embolization, and IVC perforation.
- May 6, 2014 FDA Safety Communication: The FDA developed a quantitative decision analysis that was published in the Journal of Vascular Surgery in October 2013. According to the FDA, that mathematical model suggests that if the patient’s transient risk for PE has passed, the risk/benefit profile begins to favor removal of the IVC filter between 29 and 54 days after implantation. Additional requirements of clinical data collection are now ongoing for currently marketed IVC filters in the U.S. All manufacturers were given two options to collect the data:
- PRESERVE (Predicting the Safety and Effectiveness of Inferior Vena Cava Filters)
- Postmarket Surveillance (522 studies)
- July 13, 2015 FDA Warning Letter to C.R. Bard, Inc.: A letter was sent to manufacturer, C.R. Bard, Inc., detailing the multiple noted violations including, but not limited to, adulteration and misbranding, along with quality system violations. The letter primarily involved the Recovery Cone Removal System (pictured to the right) and how C.R. Bard, Inc. never received the required approval or clearance from the FDA to market this product. The FDA determined that the Recovery Cone Removal System is a regulated device and is intended to percutaneously remove the IVC filter. The FDA requested that Bard Peripheral Vascular immediately cease activities that result in the misbranding or adulteration of the Recovery Cone System, Models RC-15 and FBRC.
IVC Filter Litigation Updates
IVC filters are provided by multiple manufacturers, including Cook Medical and C.R. Bard, Inc. (Bard Peripheral Vascular). As the FDA report and letters indicate, concerns regarding the use of these products continue to develop. There is an ongoing multidistrict litigation (MDL) for injuries caused by Cook Medical IVC filters (Cook MDL NO. 2570). There is also a pending hearing on the potential MDL consolidation of claims related to the Bard IVC filters in Bard MDL NO. 2641 in San Francisco, California on July 30, 2015.
As a plaintiff product liability Firm that focuses our practice on Mass Torts known as Multidistrict Litigations (MDLs), we invite you to contact us through the form provided, our live chat services, or simply calling us toll-free at 888-841-9623. The defective device attorneys at Zoll & Kranz are happy to provide a complimentary case evaluation or to answer questions that may have surfaced after reading this information. Some injuries may be asymptomatic at first so if you or a loved one is concerned they may want to consult with their physician.