Bard IVC Filter Failure Allegations Warning: Resource4thePeople Outlines Problems Being Investigated

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National network of attorneys offers complimentary consultations over several concerns raised in FDA IVC health advisory about allegations of migrations, perforation, filter fracture and other problems linked by FDA to life-threatening health problems.

http://www.resource4thepeople.com/defectivemedicaldevices/bard-ivc.html

Resource4thePeople today detailed several serious health problems that its national network of attorneys is investigating in connection with concerns raised by the Food and Drug Administration* involving interior vena cava (IVC) filters.

“As the FDA warns,* these problems can have devastating, long-term consequences that adversely affect the health of individuals from whom IVC filters were not removed in a timely manner," said Resource4thePeople.

"We have received a continual increase in the number of consumers seeking information about their legal rights over this issue and we will continue our policy of offering free consultations about health problems identified by the FDA in connection with IVC filters."

Resource3thePeople said that the most common inquiries about serious problems with IVC filters center on the following allegations:

  •     Shortness of breath
  •     Persistent chest pain
  •     Fracture or migration of the IVC filter
  •      Perforation of the heart
  •     Perforation of the lungs
  •     Perforation of the vena cava
  •     Perforation of other tissues
  •     Cardiac or pericardial tamponade
  •     Ventrical tachycardia

"Any consumer who has suffered the above conditions may be eligible to seek compensation for medical costs, treatment, pain and suffering and other expenses attributable to concerns raised by the FDA in its health warning about IVC filters," said Resource4thePeople.

The FDA issued the health advisory* about IVC filters on Aug. 9, 2010 and updated it in 2013 after agency officials said that they had received numerous reports of adverse events in connection with the device.

IVC filters are medical devices designed to prevent blood clots in patients at risk for a pulmonary embolism in cases in which an anticoagulant is contraindicated or proven ineffective.

Resource4thePeople is also announcing that in addition to accepting inquiries from consumers about C.R. Bard filters, inquiries about allegations involving other manufacturers also are being reviewed.

The IVCs being added to the list of devices eligible for review by Resource4thePeople attorneys are the Cook Celect, the Cordis OptEase and the ALN IVC filters.

Earlier models identified for review are the C.R. Bard Recovery IVC Filter and G2 IVC Filter, the Braun Tempofilter, the Cook Gunther Tulip and Select and the Rex Medical Option.

Here is a key part of the IVC filters health advisory* issued by the FDA:

“Since 2005, the FDA has received 921 device adverse event reports involving IVC filters, of which 328 involved device migration, 146 involved embolizations (detachment of device components), 70 involved perforation of the IVC, and 56 involved filter fracture. Some of these events led to adverse clinical outcomes in patients. These types of events may be related to a retrievable filter remaining in the body for long periods of time, beyond the time when the risk of pulmonary embolism (PE) has subsided.

“The FDA is concerned that these retrievable IVC filters, intended for short-term placement, are not always removed once a patient’s risk for PE subsides. Known long term risks associated with IVC filters include but are not limited to lower limb deep vein thrombosis (DVT), filter fracture, filter migration, filter embolization and IVC perforation.”

Since that warning Resource4thePeople reports that IVC lawsuits have been filed across the country.

Among the latest IVC filter lawsuits was one** filed in U.S. District Court for the Western District of Texas by a woman who had a G2 filter implanted into her inferior vena cava to protect her from contraindications to anticoagulants.

"This allegations contained in the court file in this case** claim that the Bard IVC filter was defectively designed and simply not strong enough to perform the task for which it was designed," said Resource4thePeople.

The court file shows the Texas woman claims that the Bard G2 filter failed after it was implanted in her and 2007 and alleges that the filter's arms have penetrated her inferior vena cava walls and cannot be safely removed unless she undergoes major invasive surgery.

Another Texas case*** was filed by another woman who claims a Bard IVC was defectively designed, failed after being implanted in her body and migrated to her heart, according to the court file.

The woman claims in her court documents that a Bard G2 filter was implanted in her in 2009 to prevent blood clots but failed and caused her to suffer serious health problems and expenses.

She is seeking a jury trial and damages for medical expenses, pain and suffering, mental anguish, physical impairment, disfigurement, economic losses and other expenses, according to the court file.

Another recent filing of a Bard IVC filter lawsuit was made on behalf of a New York woman who is claiming in her lawsuit that the device was defectively designed, broke and caused her to suffer significant internal injuries.****

The woman is alleging in her court documents that the filter was implanted to prevent blood clots but broke apart with particles migrating through her body and damaging her internal organs.

The FDA's health warning* reports that serious health problems can occur on these spider-like devices when the legs that extend from it to block clots break off.

What can then occur, according to the FDA, is that these broken parts from the filter may travel to other parts of the body and cause serious problems such as lower limb deep vein thrombosis (DVT), filter fracture, filter migration, filter embolization and IVC perforation.

Sources:
*http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm221707.htm
**Arnold et al v C.R. Bard, Case #5:13cv00609, US. District Court for the Western District of Texas
*** Case #1:13cv00633 U.S. District Eastern District of Texas, Beaumont Division, Judge Thad Heartfield
****Case # 2:13-cv-2281, U.S. District Court, Eastern District of New York

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Bill Callahan
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