Retrievable IVC filters are intended to provide temporary protection to patients by catching clots in the legs before they reach a patient’s lungs or heart. Several studies have found that the prolonged placement of a Retrievable IVC filter can cause serious damage and may even lead to death. Manufacturers Bard and Cook may have knowingly concealed information of the risks for complication.
A manufacturer must submit approval for intent to market through the FDA to be cleared for use. FDA regulators first approved Bard’s retrievable IVC filter in 2002 as a low risk, class II medical device. Bard received speedy approval by the FDA with a 510(k) submission. A 510(k) is a premarket submission made by the manufacturer to the FDA to demonstrate that a device to be marketed is at least as safe and effective as a legally marketed device that is not subject to PMA.
Bard and many other manufacturers’ market share of the IVC filters grew dramatically over the next several years. Due to a lack of clinical and safety testing, Bard and other manufacturer’s IVC filters were eventually found to be defective devices. Reports of injuries due to faulty retrievable IVC filters were being submitted to manufacturers as early as 2004.
Bard failed to investigate these reports and did not notify the FDA of said concerns. On August 9, 2010, a statement was issued by the FDA recommending healthcare providers remove retrievable IVC filters as soon as the risk for a Pulmonary Embolism is no longer evident.
After further studies showed an increased risk of injury to patients, the FDA released another statement. On May 6, 2014, the FDA advised healthcare professionals to remove retrievable IVC filters within 29-54 days. Studies have shown that up to 40% of patients implanted with a retrievable IVC filter have experienced IVC filter fracture, perforation, and migration.
An IVC Filter is a device implanted below the kidneys in the large blood vessel, Inferior Vena Cava, to capture a blood clot and prevent an embolism before it reaches the lungs or heart. The device resembles a small, cone-shaped wire whisk. These devices can be permanent or retrievable. A retrievable IVC filter is often used in patients who are; unable to take blood thinners due to a medical condition, are at an elevated risk of uncontrolled bleeds due to a recent surgical procedure or traumatic injury.
IVC filter devices have been linked to multiple complications. The FDA has received more than 900 reports of injury and defects associated with IVC filters. The FDA released a report of these cases of injury in 2010 (http://www.drugwatch.com/ivc-filters/lawsuits/):
There have been many cases of faulty retrievable filters that cause damage, or are often difficult to retrieve from a patient.
Establishing a Lawsuit against Bard, Cook, and Other Manufacturers
Macaluso & Fafinski will help you determine if you are eligible for a lawsuit against Bard, Cook, and others for the manufacturing of potentially defective IVC filters. Manufacturers and IVC Filter models responsible for most injuries in the U.S. include:
Manufacturer C.R. Bard
For IVC filter models
Manufacturer Cook Medical
For IVC filter models
A lawsuit against manufacturers may claim negligence, failure to warn, design defects, manufacturing defects, misrepresentation of safety, and concealment of data. We will investigate the manufacturer’s design and marketing defects responsible for your loss and damages ensued.
If you or your loved one was implanted with an IVC filter device and suffered injuries, and you were not warned of these severe side effects prior to use, we will review your case at no cost to determine if you or your loved one may be entitled to compensation for injuries, trauma, medical expenses, lost wages due to lengthy recovery, emotional pain and suffering, permanent disability, and funeral expenses.
To arrange a free evaluation of your case and explore your legal options, call Macaluso & Fafinski today at 718.364.4000 (in the Bronx) or 212.480.9000 (from elsewhere in New York), or simply fill out our convenient online form, and we will respond as soon as possible. The offices of Macaluso & Fafinski are conveniently located to serve the five-borough area and its residents.