Blood clots that develop in the legs, called deep vein thrombosis (DVT), can cause serious complications. Typically, doctors treat DVTs with anticoagulant medications (sometimes called blood thinners). However, some patients continue to experience blood clots while taking blood thinners, and others are not able to tolerate those drugs at all. In those cases, doctors may place a device called an inferior vena cava (IVC) filter. IVC filters are small, metal devices that resemble the top of a bird cage. They are inserted into the inferior vena cava – the main vessel that carries blood from the lower half of the body back to the heart – to trap blood clots that form in the legs and prevent them from traveling to the heart or lungs.
IVC filters have been in use for more than 30 years. The use of these filters has increased dramatically over the years. Currently, an estimated 250,000 IVC filters are implanted each year. In recent years, doctors have begun to question whether IVC filters do more harm than good. The FDA has received hundreds of adverse event reports involving IVC filters. Pieces of the filter can break off and cause damage to the heart, or a large clot can push the entire filter into a person’s heart, causing serious injury or death.
More troubling is the fact that at least one of the manufacturers knew about these risks more than 10 years ago. C.R. Bard commissioned a medical researcher in 2004 to study the risks of its Recovery IVC filter compared to its competitors. That study found that Recovery was associated with a significantly higher risk of death, filter fracture, perforation, and filter embolization than all other IVC filters. Bard continued to market and sell the Recovery devices. In September 2005, Bard made modifications to the Recovery design and released the G2 IVC filter as its replacement. Even though the new design was engineered to reduce device fractures, further studies found that the G2 still has a high risk of fracture.
According to an NBC Nightly News report, Bard may have known about these safety risks even before the Recovery IVC filter was approved. In 2002, the FDA rejected Bard’s initial application for approval of its Recovery device. Bard then hired regulatory specialist Kay Fuller to assist with a subsequent application. In NBC’s report, Fuller says that she expressed serious concerns about the safety of Recovery. Fuller says that she told her boss that she would not sign the application until her concerns were addressed. Bard later submitted its application to the FDA with what appears to be Fuller’s signature. However, Fuller says that the signature on the application isn’t hers.
Device manufacturers are now facing lawsuits brought by people who have been injured by IVC filters. More than 100 lawsuits have been filed against Cook Medical, Inc. by people injured by its IVC filters. Those cases have been centralized in a Federal Multidistrict Litigation (MDL) in the U.S. District Court for the Southern District of Indiana. On Aug. 18, 2015, the Judicial Panel on Multidistrict Litigation transferred 22 lawsuits alleging injuries from Bard’s IVC filters into an MDL in Arizona. If you would like more information about IVC filters, contact Melissa Prickett, a lawyer in our Mass Torts Section, at 800-898-2034 or by email at Melissa.Prickett@beasleyallen.com.
Sources: NBC News, MSNBC,
William Nicholson, MD, et.al, Prevalence of Fracture and Fragment Embolization of Bard Retrievable Vena Cava Filters and Clinical Implications Including Cardiac Perforation and Tamponade, Arch. Intern Med Vol. 170, No. 20. Nov. 8, 2010.
FDA Safety Communication: Removing Retrievable Inferior Vena Cava Filters, August 9, 2010 and May 6, 2014
In re: Bard IVC Filters Products Liability Litigation, MDL No. 2641, Transfer Order, Document 63
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