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By: Irvin Jackson | Published: August 15th, 2012
C.R. Bard faces two class action lawsuits over its IVC filters, which allege that the small, spider-like devices implanted into the inferior vena cava to prevent blood clots from traveling to the heart or lungs, are prone to fracture and perforate organs or the heart.
Both of the Bard IVC filter class action lawsuits were filed on August 9; one in the Court of Common Pleas in Philadelphia County (PDF), and the other in Los Angeles County Superior Court (PDF).
Inferior vena cava filters are an alternative treatment for patients at risk for a pulmonary embolism. They are often used when an anticoagulant is contraindicated or if such medications have not been effective. They contain a number of legs or struts that extend out like a spider to catch blood clots that may break free elsewhere in the body, such as the deep veins of the legs.
If there is an IVC filter strut fracture, small pieces of the filter may travel to other parts of the body, such as the heart or lungs.
Allegations raised in each of the complaints indicate that C.R. Bard knew for years that their IVC filters were prone to fracture, which can cause severe complications, including death, but failed to warn doctors and patients.
Lawsuits Seek Coverage of Medical Monitoring for Bard IVC Filters
The complaints seek to force Bard to pay for the medical monitoring that patients will need to ensure that the filters have not fractured in their body as long as they remain in place. An estimated 100,000 of the devices have been implanted in patients in the United States, the lawsuits claim.
As evidence that C.R. Bard has known there is a problems with their IVC filters, the lawsuits point to the company’s latest device, the Eclipse IVC Filter, which is identical to the G2, except that it has undergone electro-polishing to make it stronger and less likely to fracture, according to the complaint.
A number of similar IVC filter lawsuits have been filed on behalf of individuals who received the Bard Recovery or Bard G2 filters and suffered an actual injury after the struts fractured or broke.
Bard recently obtained a defense verdict in the first IVC filter lawsuit to go to trial, after an Arizona state court jury found in June that the devices were not defectively designed. Bard has touted the victory as evidence that the benefits of the filter outweigh the risks, and claim that the failure rate is only about 1.2%. However, outside experts have placed the failure rate closer to 12%.
Flood of Reports Lead to FDA Warnings About IVC Filters
In August 2010, the FDA issued an alert warning about the risk of IVC filter problems, indicating the agency had received more than 900 adverse event reports associated with the products.
The FDA indicated that doctors should remove the filters once the danger of the clot has passed, to reduce the risk of the filters breaking free and traveling through the body.
Of the 921 adverse event reports described in the 2010 FDA warning, the agency indicated that 328 involved the IVC filter breaking free and migrating through the body, 146 involved components breaking loose, 70 involved the inferior vena cava being perforated and 56 involved the filter fracturing.