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W&L Evaluating Injuries from Cook Medical and Bard Retrievable IVC FiltersOct. 7, 2015
Weitz & Luxenberg, P.C., is now taking cases involving patients fatally or seriously injured by either a C.R. Bard, Inc. or Cook Medical, Inc., retrievable inferior vena cava (IVC) filter.
IVC filters, also known as vena cava filters, are sometimes placed in patients in an attempt to prevent blood clots from reaching the lungs, heart or brain. These devices are approved for use when blood thinners prove ineffective or are contraindicated, according to device approval documents.
The Bard retrievable filter cases the firm is accepting for evaluation are the Murray Hill, New Jersey-based company’s Recovery, G2, G2 Express (G2X), Eclipse, Meridian and Denali models. Also being accepted for evaluation are two retrievable IVC filters from Cook Medical of Bloomington, Indiana. They are the Celect and Günther Tulip models.
The U.S Food and Drug Administration (FDA) has not at this time ordered a recall of any of these IVC retrievable filters. The companies have also not issued recalls.
However, the FDA has issued two Safety Communications within the last five years regarding retrievable IVC filters. It has received hundreds of reports of retrievable IVC filter patients suffering fatal or serious adverse events including device migration, fracture, embolization and IVC perforation, as well as other adverse symptoms.
Retrievable IVC Filters Can Fracture or Migrate
Retrievable IVC filters resemble a cage and are designed to intercept clots traversing the main vessel, the inferior vena cava, that carries blood from the legs and pelvis back up to the heart. Some retrievable filters can be implanted in other parts of the vena cava than the inferior portion, as well.
The primary problem with the Bard and Cook Medical retrievable IVC filters is that it appears they are particularly vulnerable to fracturing or migrating.
Fracturing can permit the device or its fragments to dislodge and migrate. Should that occur, the IVC or other blood vessels and organs may be perforated. Life-threatening blood clots can then form inside those anatomic structures. Even without fracture, these filters may migrate, embolize, or perforate vessels or organs. Also, if the retrievable IVC filter or a fragment migrates, it may even become impossible to remove.
In July of this year, Bard was cited by the FDA for adulterating and misbranding some of its IVC filter products, including the IVC Denali Filter Delivery System, which was found to be misbranded.
The FDA also faulted Bard for quality system regulation violations due to failure to “establish and maintain procedures for receiving, reviewing, and evaluating complaints.”
For example, the FDA said the death of one patient who had been implanted with a Bard G2 Filter was incorrectly filed by the company as simply a “malfunction” in its medical device report. The FDA insists the event should have been filed as a death.
The FDA also cited Bard for listing as malfunctions other events that should have been listed as serious injuries involving the Eclipse, G2 Express, G2, and Denali IVC filters, such as “embolization of a detached filter arm with associated areas of hemorrhage and necrosis” resulting in death, “detached filter limb resulting in pericardial effusion and cardiac catheterization,” and “IVC perforation and aneurysm,” among other issues.
The FDA also noted at least 10 patients whose IVC filter retrieval was unsuccessful, but for which there was not “sufficient information to allow for adequate complaint investigation and disposition…”
Injured Retrievable IVC Filter Patients Should Seek Legal Help
Weitz & Luxenberg’s pursuit of cases involving retrievable IVC filters is presently focused on exploring the legal rights of injured patients.
Injured patients – including the family of those who have died may be entitled to compensation from Bard or Cook Medical.
The compensation would help injured patients or their estates recover the costs of additional surgeries and hospitalizations made necessary by a defective retrievable IVC filter.
Compensation might also include recovery of lost wages stemming from health problems caused by a defective retrievable IVC filter.
Injured retrievable IVC filter patients may contact the firm by calling (844) 787-8721 or using the online form for more information to arrange a no-cost, no-obligation evaluation of their legal rights against either Bard or Cook Medical.