Lawsuit Against Rex Medical IVC Filter. A wrongful death lawsuit has been filed against Rex Medical over its Option Inferior VenaCava (IVC) filter, alleging that the defective device led to Pulmonary Embolism Deathmonary embolism and death. The suit was filed on behalf of the family of a Florida man who died in October 2014.
The IVC filter was placed in order to prevent blood clots from reaching the heart and lungs. The lawsuit alleges that Rex Medical was aware of the risks but failed to inform the patient or his physician.
IVC filters are implanted in patients who cannot take traditional oral blood thinners. They are intended to catch blood clots before they can reach the heart and lungs, a life-threatening condition known as pulmonary embolism.
According to the lawsuit, the Option IVC filter caused a pulmonary embolism and subsequent death. IVC filters have raised safety concerns in recent years following reports of serious complications.
In some patients, IVC filters have migrated from their intended location or fractured within the blood vessel. This can lead to fatal injuries if filter pieces move into the heart and lungs (embolization). The U.S. Food and Drug Administration (FDA) warned of these complications in 2014, reporting that adverse events had been submitted to the agency.
There were also cases where the IVC filter punctured the wall of the inferior vena cava, which is the major vein carrying deoxygenated blood from the lower part of the body back to the heart and lungs.
FDA advised Health Care Professionals to retrieve IVC
The FDA noted that in some cases, the IVC filters were difficult to remove. IVC filters can be retrievable, meaning they are temporary, or permanent. In light of the adverse event reports, the FDA advised health care professionals to retrieve IVC filters as soon as the risk of pulmonary embolism subsides.
Regulators in Canada have also addressed IVC filter complications. Health Canada issued a recent safety alert noting cases of caval perforation, caval thrombosis, filter fracture and fragment embolization, intracardiac migration, cardiac perforation, cardiac tamponade and death associated with retrievable IVC filters. The agency stated that these injuries occurred more often when left for 30 days or longer.
The Option IVC filter was approved and implanted in patients without extensive testing for safety or efficacy, the lawsuit states. This is because Rex Medical was able to approve the device through 510(k), a regulatory route that circumvents clinical testing if manufacturers can show that the product is “substantially equivalent” to an older device.
The lawsuit states that older devices such as C.R. Bard’s Recovery and G2 IVC filter paved the way for Option. Lawsuits have also been filed over these devices.
IVC filter lawsuits have been filed against Cook Medical, Cordis Corporation and Boston Scientific.