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March 21, 2016. Category: Unsafe Medical Devices

Patients File Lawsuits After IVC Filters Cause Injuries

Inferior vena cava (IVC) filters are implanted in patients who have a history of or are at risk of developing blood clots.  Certain IVC filters have been linked to serious complications in some patients.

The FDA first announced the dangers of IVC filters in 2010 and has followed up with a series of safety alerts to warn the public. The FDA has expressed concern about the complications associated with temporary filters such as those produced by C.R. Bard, Peripheral Vascular, Inc. and Cook Incorporated (Cook), three manufacturers that produce the most common IVC filters on the market.

In 2014, the FDA recommended that retrievable IVC filters be removed after 54 days to minimize injury to patients. Based on models, the FDA concluded that removing the devices after the risk of pulmonary embolism has passed was beneficial to patients if removed within 29-54 days. Unfortunately, many patients have IVC filter implants that exceed the FDA’s recommended timelines. 

In response to the growing concerns and injuries, numerous patients have filed lawsuits against certain IVC filter manufacturers. Lawyers for injured patients allege that the IVC filters are poorly designed and subject patients to unreasonable risk of harm.  Hundreds of lawsuits against C.R. Bard and Cook have been consolidated in multi-district litigation proceedings.

While the IVC device manufacturers are facing claims that they unnecessarily endangered patients, some companies may have committed fraud during the FDA approval process. In particular, NBC News reports that C.R. Bard may have forged signatures during the original FDA approval process of their IVC filters.

C.R. Bard IVC Filter Failures Cause 27 Deaths

Doctors have largely viewed the filters as a safe alternative to dangerous blood thinners, such as Xarelto. However, the devices have proved to be potentially dangerous and even fatal in some cases. IVC filters can potentially harm patients by moving within the veins, causing clots, destroying the veins or disintegrating within patients’ veins. NBC News reports that 27 deaths and 300 serious injuries have been linked to the use of C.R. Bard’s Recovery IVC Filter in the last 10 years.

Medical professionals have become so concerned that they have designed a large scale study to assess the safety of IVC filters. The study, Predicting the Safety and Effectiveness of Inferior Vena Cava Filters (PRESERVE), is currently enrolling patients. Over the next five years, more than 2,000 patients are expected to take part in the trials. Until the study’s conclusions are published, it is estimated that more than 250,000 Americans will continue to be implanted with IVC filters each year. 

This is particularly concerning to the who have been helping injured Tampa residents since the devices were identified as dangerous.

Hire an Experienced Tampa Defective Medical Device Attorney Today

If you or a loved one has suffered an injury after the placement of an IVC filter, please contact an IVC filter product liability attorneys at Alley, Clark & Greiwe for a free consultation regarding your legal rights.  Call 813-222-0977 or schedule your consultation online.

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