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Bard IVC Filters Class Action Lawsuits Allege Manufacturer Hid Risks

  • Written by: Irvin Jackson
  • 3 Comments

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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 class action lawsuits seek to represent individuals who have been implanted with a Bard Recovery IVC Filter, or Bard G2 or G2 Express IVC filter, but who have not been injured.

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.

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Image via Lissandra Melo / Shutterstock.com

3 comments

  1. ruth Reply

    Cant find that Arizona lawsuit where Bard got a defense result. I can’t believe it really happened like that. Does anyone have more information on which area of Arizona this lawsuit took place in and/or case number? I want to read up on it.

  2. Shelly Reply

    I am one of the unlucky people with one of those death traps and it in fact punctured my vena cava. I almost died as a result of their product. It is more risk than good….I would highly advise against this product based on my own medical injuries. I am living with the aftermath of this device. Horrible!

  3. Rose Reply

    Sadly I woke up to a preacher reading me my last rites and they gave me like two seconds to say yes to surgery to have this dam thing put in my body as have small children and my life has been a nightmare since with pain that feels like hundreds of knives slicing me apart. my body right after surgery blew up like balloon and can’t get rid of the issue as tried water pills and so on as its my belly area. I get sharp pains that race through my heart and lungs where I end up clutching my chest trying to catch my breath. horrible pain in thigh area where they put it through where it burns, stabbing pain where can’t move leg sometimes and unexplained bruising. This is a night mare . I would never ever wish anyone else to ever have to go through this . All I wonder is are they going to explain to the children and families of those of us that die that you FUCKING knew and looked away. Shit if I had known I would have taken chances and not done it. The pain is hell when your kids beg you please play and such or your trying to get into a new relationship , but feel a bit guilty to as don’t want them to have to deal with it. Plus when I look at my beautiful babies and fear did I really do wrong and this really will be my doom. yes all of this crap goes through my head at night as does the pain so lack of sleep also .SO I SAY FOR MY CHILDREN ,MYSELF AND THOSE LIKE ME FOR NOT CARING FOR OUR LIVES ,BUT YOUR POCKETBOOKS

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