Joanna Szabo  |  August 31, 2015

Category: Legal News

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The internal adrenal Organs. 3D rendered anatomical illustration.The Food and Drug Administration (FDA) recently indicated that C.R. Bard has failed to properly report complications with its blood clot filters, and has thus been illegally marketing its retrievable IVC device.

These blood clot filters, which are also known as inferior vena cava (IVC) filters, are meant to prevent blood clots from traveling to and damaging the lungs.

The IVC was first used in 1979, and has been used considerably more since then. By 2012, doctors had inserted IVC filters into more than 250,000 patients.

The IVC filter is placed inside the inferior vena cava, the largest vein in the human body. The inferior vena cava returns blood back into the heart and then onto the lungs.

Blood clots in this vein are extremely dangerous. Blood clots which travel to the lungs can become a pulmonary embolism (PE) which cuts off blood flow to the lungs. Pulmonary embolisms cause about 300,000 deaths every year, though they are preventable with the right measures.

The FDA sent C.R. Bard, the manufacturer of Bard IVC filters and other medical devices, a warning letter in July. The letter referred to recent FDA inspections of two of C.R. Bard’s manufacturing facilities, which made the Denali IVC Filter and the Recovery Cone Removal Kit, among other blood clot filter products.

Various Bard IVC filter products have been linked with reports of serious medical problems, where an IVC filter may puncture the vena cava or move out of position. These kinds of problems can result in the patient suffering serious injury or, in some cases, death.

Despite these reports associated with its IVC filter products, federal investigators report that the company failed to submit adverse event reports about Denali IVC filter malfunctions. On top of this, the company failed to explain why it believed the problems associated with its product would not reoccur with other individuals who used the same product, also resulting in severe injury or death.

Federal investigators also report that Bard allegedly marketed and sold the Recovery Cone Removal Kit without FDA approval. The Recovery Cone Removal Kit is used to remove blood clot filters after their job is done.

The FDA reports that this product was marketed without approval from the FDA, and that the company did not file for an exemption. So the product has not been tested by the FDA for either safety or effectiveness.

The FDA found that the company not only failed to file reports in a timely manner, but also failed to include vital information in those reports that it did submit.

The FDA’s warning letter follows a growing number of Bard IVC filter lawsuits regarding individuals who have experienced serious injury while using its retrievable blood clot filters.

The FDA has previously warned about the risks associated with these products. In 2010, the agency reported receiving hundreds of adverse events reports in which IVC filters either broke free of their intended placement, punctured the body, or caused another type of injury.

Recent studies have even questioned the effectiveness of blood clot filters such as Bard’s products, indicating that very few IVC filters can be successfully removed. Up to eight percent of patients with similar IVC filters suffered a pulmonary embolism, the condition these devices are supposed to prevent.

So many IVC filter lawsuits against Bard IVC filters have been filed in recent months that these cases may be centralized and consolidated before one judge in a multi district litigation.

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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