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.
In a recent NBC Nightly News investigation, it was uncovered that despite having knowledge of the product’s defects, C. R. Bard may have repeatedly pushed the Food and Drug Administration (FDA) to approve their IVC filter with disregard to patient safety.
What is an IVC Filter?
An IVC filter is a small, cone-shaped, cage-like medical device implanted into a patient’s inferior vena cava, the large vein that carries oxygen-depleted blood from the lower body up to the heart. IVC filters are intended to prevent a blood clot from reaching the heart or lungs. About 250,000 Americans are implanted with IVC filters each year, industry statistics show.
It has been noted that the Bard IVC filters 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” includes 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 five and a half years for the Bard IVC blood clot filters to fail after they’ve been implanted.
News Report: Bard Knew of IVC Filter Complications
In a year-long investigation conducted by NBC Nightly News, serious questions were raised about why Bard continued to sell and market its IVC filters even after it became aware of serious IVC filter complications including severe injuries at rates significantly higher than other similar devices, and death.
The NBC News investigation linked 27 deaths and more than 300 injuries to failures associated with the Recovery model IVC filters made by Bard.
Over a five-year period between 2005 and 2010, Bard sold over 160,000 units across the country. NBC News obtained a company memo, dated December 2005, which acknowledged that Bard’s Recovery filter had “an 11.5 times higher reporting rate for filter embolization deaths compared with all other vena cava filters.”
That memo, which compares the Bard product with similar filters from other medical device manufacturers, states that “the Recovery has the least ability to resist migration” (in other words, breaking loose from its moorings and traveling into the heart muscle and cardiovascular system).
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 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.
As part of a later application for FDA approval of the Bard IVC blood clot filter, the company submitted a legal document bearing 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, Fuller claims that her signature was forged by Bard. In fact, 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.
IVC Filter Lawsuits
Inferior Vena Cava (IVC) filters are meant to prevent death by capturing blood clots before they can enter the lungs and cause a pulmonary embolism. IVC filters can also have deadly side effects.
Bard began receiving complaints regarding IVC filter complications as early as 2004. Although the company knew about device failures, it allegedly did not disclose this information.
People who were harmed or whose loved ones were harmed by IVC filters filed lawsuits against manufacturer C.R. Bard. These IVC filter lawsuits accuse the company of manufacturing defective devices, failing to warn of risks and negligently misrepresenting the devices.
In August 2015, courts consolidated IVC filter lawsuits against Bard involving its Recovery, G2, and G2 Express devices to the U.S. District Court District of Arizona.
In general, IVC filter lawsuits are filed individually by each plaintiff and are not class actions.
Do YOU have a legal claim? Fill out the form on this page now for a free, immediate, and confidential case evaluation. The attorneys who work with Top Class Actions will contact you if you qualify to let you know if an individual lawsuit or class action lawsuit is best for you. Hurry — statutes of limitations may apply.
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Join a Free IVC Filter Class Action Lawsuit Investigation
If you or a loved one were injured by IVC filter complications, you may have a legal claim. See if you qualify to pursue compensation and join a free IVC filter class action lawsuit investigation by submitting your information for a free case evaluation.
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ALN Implants Chirurgicaux
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Bard Peripheral Vascular
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B Braun Medical
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Boston Scientific
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Cook Medical
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Cordis
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Rex Medical
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Deep Vein Thrombosis (DVT)
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IVC Thrombosis
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Access Site Thrombosis
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IVC Filter Fracture
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