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March 03 2018

Drugwatcher

Bard Medical Among Companies Facing Lawsuits for Inferior Vena Cava Filters

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More than 1,500 lawsuits are in progress regarding the failure of IVCs that led to injuries. There are multiple companies involved, the one with the most involvement being Bard Medical. The devices remain available for use, so read through the list below and determine if anyone you know is at risk from the failure of these devices. 

Boston Scientific

This company offers a single type of filter, introduced in 1989. The Greenfield Vena Cava Filter is designed to be implanted for both the long and short-term. While there are a significant number of lawsuits naming this company and filter, the device is currently available for sale. 

C. R. Bard

This company markets a variety of filters, including: the Eclipse Vena Cava Filter, the Denali Vena Cava Filter, the Recovery Filter System, the G2 Vena Cava Filter, the G2 Express Vena Cava Filter, the Meridian Vena Cava Filter and Simon Nitinol VC Filter. 

Bard is located in the state of New Jersey and has introduced six different filter models since 1990. Of those, five remain available for sale. Some cases against this company have been settled, but a number of cases are still open in California, Pennsylvania and Florida. 

The transgressions of this company are widespread and include the decision to forge employee signatures for an application to the FDA toward the ultimate goal of getting a device approved. The process under which the FDA granted approval is the streamlined Pre-Market Notification Process that negates the need to undergo clinical study when the device is proven to be similar to another model on the market. 

Braun Interventional Systems

With offices located in Pennsylvania, this company introduced their first model of IVC filter prior to 1990. However, that model had issues with “Incomplete Deployment” and was replaced quickly. Successive models have also shown similar issues, leading to lawsuits that were filed starting in the summer of 2017. 

The models included in lawsuit documentation are all sold under the “VenaTech” name and include: The LP Vena Cava Filter, the Convertible Vena Cava Filter, and the LGM Vena Cava Filter. 

Cook Medical

Cook Medical has offices in Bloomington, Ind., and introduced their first long-term implantation device in 1989. The manufacturer claims to produce medical devices designed for procedures that reduce the level of invasiveness. The products that are included in current lawsuits include: The Gunther Tulip Vena Cava Filter, Gianturco-Roehm Bird’s Nest Bena Cava filter, and the Celect Vena Cava Filter. The Gunther Tulip Vena Cava filter is designed for both lengths of implantation. 

Cordis Corporation

This corporation belongs to Johnson & Johnson. The company offers two models of filter, and the TRAPEASE Permanent is the initial model, which has been found to fracture often when studied by Japanese research labs. The second model, the OPTEASE Retrievable was recalled in 2013, due to incorrect labeling. The device was implanted incorrectly as a result of the labeling issue. 

Rex Medical

This company is located in Pennsylvania. The OptionELITE Filter was approved in 2013 through the FDA Clearance rather than clinical testing. The filter model was sold to Argon Medical Devices in 2016, and the company continues to manufacture and sell the filter. Issues with this filter include fracturing and also the chance for migration.  A recent lawsuit names both companies and was filed by a woman who had her filter migrate and become embedded in veins. This issue required surgery for the patient. 

A French company, ALN Implants Chirurgicaux offers a filter that was cleared through the FDA Clearance process for US sale. The product is connected to five adverse incidents since the sales began in 2008. 

Latest IVC Filter News


Use of the IVC Filter in the US Declines

Drugwatcher/the-bodys-pathways-the-superior-and-inferior-vena-cava-eb1cd6cf436">The Body’s Pathways: The Superior and Inferior Vena Cava
IVC Filter Use in Spinal Cord Injuries Next To Nil

IVC Filter Resources 


December 09 2014

Drugwatcher
Just posted a very long and informative article on the Zoloft lawsuit: http://www.drugwatcher.org/zoloft/
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