The Bard Inferior Vena Cava Filter is a medical device meant to prevent potentially life-threatening recurrent pulmonary embolism. The inferior vena cava is one of two large blood veins returning deoxygenated blood to the right atrium of the heart. The Bard IVC Filter is a retrievable filter, meant only for short term placement. It has been the subject of multiple FDA warnings and lawsuits across the country.
FDA IVC Filter Warnings
The FDA has issued to official Bard IVC Filter warnings, reporting serious injury and death in patients with a Bard IVC Filter implanted as well as sending multiple warning letters to the maker of the device, C.R. Bard, Inc., regarding the company's handling of various aspects of the device.
2010 FDA Bard IVC Filter Warning
Although C.R. Bard, Inc. became of complications in some patients and problems with the device in 2004, the FDA did not receive enough information to realize the Bard IVC Filter posed a risk to patients until 2010, at which time the FDA announced that it had "received reports of adverse events and product problems associated with IVC filters. Problems included:
The FDA's 2010 IVC Filter Warning reported morbidity - death associated with the device, recurrent deep vein thrombosis, recurrent pulmonary embolism, vena cava thrombosis and thrombotic complications.
In 2014, the FDA issued a second, updated Bard IVC Filter Warning. The 2014 Warning spoke directly to the length of time the device could remain implanted before problems were likely to occur. At this time, research indicated that the device should be removed from 29 - 54 days after implantation in order to prevent problems with the device resulting in serious injury or death.
The FDA is concerned that retrievable filters are frequently not removed when the risk of pulmonary embolism subsides.Â Retrievable IVC filters were first approved by the FDA in 2002, when the first Bard retrievable IVC filter was approved under a fast-track process that did not require clinical trials or safety studies. C.R. Bard, Inc. went from a 12% market share in 2002 to 42% in 2012, during which time the company's annual revenue went from $1.27 billion to $2.96 billion. C.R. Bard, Inc. had $3.3 billion in annual sales in 2014.
The Onder Law Firm is offering free consultation to persons, and their family members, who have had a Bard IVC Filter implanted, regardless of whether complications have yet occurred. We are deeply concerned about the safety of this device and that the company behind it was aware of the increased risks it posed and sought to minimize those dangers to the medical community, prospective patients and federal regulators. C.R. Bard has a history of conducting business without the level of integrity we expect, and should demand, from companies engaged in the public health industry, such as the settlement it reached over allegations of submitting fraudulent Medicare claims and paying kickbacks to both health care professionals and consumers. It recently announced a $200 million settlement for complications arising from surgical mesh the company manufactured and sold to treat pelvic organ prolapse. We believe that companies such as C.R. Bard, Inc. must be held accountable. All Bard IVC Filter attorney consultations are completely confidential, free of charge and without any further obligation. Bard IVC Filter claims and lawsuits are handled on a contingency basis, without any up-front fees and we only receive compensation if and when we are able to secure a settlement on your behalf.
More information on Bard IVC Filters can be found at The Onder Law Firm's Bard IVC Filter website at www.bardivcfilterlawsuits.com.