As IVC Filter Lawsuit Numbers Climb, New FDA Guidance Clarifies Rules For Postmarket Studies

June 22, 2016 – – TheProductLawyers.com reports on the guidelines put forth by the FDA for post-market studies conducted on specific products. According to Lexology, the FDA recently added a new guidance document to clarify when the FDA is authorized to require post-market surveillance on a medical device. The new guidance states that the FDA may require post-market surveillance if failure of the device would be reasonably likely to have a serious adverse health consequence; the device is expected to have significant use in pediatric populations; the device is intended to be implanted in the body for more than one year, or the device is intended to be a life-sustaining or life-supporting device used outside of a user facility.

These clarifications are important given the number of patients who have been implanted with IVC filters and those who have experienced significant complications. The devices are designed to catch blood clots before they reach the lungs and are typically implanted in patients who are at risk of blood clots but unable to take anticoagulants. According to the FDA, 921 adverse event reports were submitted to the administration between 2005 and 2010 regarding IVC filters. Issues including filter fracture, device migration, and embolization were among the problems cited.

In many cases, patients have chosen to file lawsuits against C.R. Bard and Cook Medical, the manufacturers of these devices, after suffering from the alleged complications. These cases additionally allege that the companies knew about the issues and did nothing to prevent the filters from going to market. MDLs have been formed in states including Arizona and Indiana and have now reached hundreds in numbers.

Banville Law is working to ensure that those individuals who believe they have been affected by the use of these filters are given the important opportunity to explore their legal rights.The firm has years of experience fighting large pharmaceutical companies who have marketed dangerous drugs or devices and are currently looking to assist those affected. Qualifying individuals may be entitled to significant financial compensation.

For more information, to ask questions, or to schedule a free consultation, contact Banville Law by calling (888) 997-3792.

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Banville Law
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