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New Jersey based C. R. Bard, Inc. has recently come under scrutiny for marketing a defective medical device called the “Recovery” IVC Blood Clot filter. Despite having knowledge of the product’s defects, C. R. Bard, Inc., appears to have repeatedly pushed the FDA to approve their blood clot filter in wanton disregard to patient safety. It has been noted that the Bard IVC devices have over a 50% failure rate and that there may be well in excess of 100,000 patients who currently have the Recovery blood clot filter implanted in them.
Among the many ways the Bard device has been known to “fail” has been through a perforation of the vein in which it is implanted, a perforation of the surrounding organs, as well as a breaking apart of the filter where sharp fragments can then become mobilized in the patient’s blood stream and puncture the patient’s lungs or heart. On average, it has taken 5-1/2 years for the Bard IVC blood clot filters to fail after they’ve been implanted.
FDA Initially Rejected Bard’s Application to Sell IVC Blood Clot Filters
The manufacturer of a medical device such as the Bard Recovery filter must first meet certain patient safety standards in order obtain FDA approval before it is allowed to sell its product in the United States. However, an application for FDA approval by C. R. Bard was initially rejected by the FDA. After the FDA declined the earlier application by Bard, the company then decided to hire a regulatory specialist named Kay Fuller to help them push the Bard Recovery blood clot filter to market.
On average, it has taken 5-1/2 years for the Bard IVC blood clot filters to fail after they’ve been implanted. If you have a Bard or Cook IVC blood clot filter, contact us now for a free consultation at (800) 215-1003.
The Bard Recovery IVC Blood Clot Filter
The Recovery IVC filter device is a permanent filter which is inserted into a patients vena cava – the largest vein in a patient’s chest – and is supposed to catch or filter-out any blood clots that form in the blood that is being brought back to the patient’s heart. An alternative to mechanical filters include placing the patient on blood-thinners that can also be used by doctors in order to reduce or eliminate blood clots. But a certain percentage of the population cannot tolerate blood thinners, so an IVC filter such as the Bard Recovery Filter may be used instead.
As part of a later application for FDA approval of the Bard IVC blood clot filter, C. R. Bard submitted a legal document bearing Mrs. Kay Fuller’s signature and what appears to be her endorsement of the Bard Recovery device. Eventually, the Bard Recovery blood clot filter did receive FDA approval. However, in a recent interview with MSNBC, Mrs. Fuller claims that her signature was forged by C. R. Bard.
“That is not my signature.” – stated Kay Fuller on NBC recently.
In fact, Mrs. Fuller said that she had become so concerned about the safety of the Bard Recovery filter that she secretly reported the company to the FDA – and later resigned.
Who’s Telling the Truth?
C. R. Bard – which wrapped up 2014 with total sales in excess of $ 3.3 billion dollars annually – is claiming that Mrs. Fuller isn’t being truthful and that it didn’t forge her signature. So far, it’s unclear who is telling the truth. But what’s far more disturbing than this squabble between Bard and it’s former employee turned whistle-blower, is that an estimated 100,000 human patients might have a defective Bard IVC filter implanted in them and may not even know they are at risk for serious injury or sudden death.
Further, since the sale Bard IVC Recovery Filters were discontinued way back around 2007 – and the news about Bard’s potential fraud is only now becoming known – it is uncertain at this time how many patient deaths their devices have already caused. Due to the inherent dangers associated with Bard blood clot filters, it is recommended that anyone who has the device implanted in them immediately consult with their doctors about having the device evaluated and removed.
Free Legal Consultations for IVC Blood Clot Filter Cases
Our office is currently evaluating cases involving the defective Bard and Cook IVC blood clot filters. If you have a Bard or Cook IVC filter, or know someone who does, then please contact us to discuss the case by using the Free Consultation Helpline window in the bottom right of your screen. Or you can call us toll free at (800) 215-1003.