The family of a now-deceased Florida man has filed a lawsuit in Pennsylvania over the alleged failure of the Rex Medical Option Inferior Vena Cava (IVC) filter device. The lawsuit was filed in Pennsylvania.
In September 2014, the man was implanted with Rex Medical’s Option IVC filter. The implantation surgery was conducted to prevent a pulmonary embolism (PE). PEs take place when a blood clot that starts in the body’s lower extremities travel to the arteries in the lungs and block blood flow.
The human body’s two largest veins, the vena cavas, carry deoxygenated blood to the heart. The inferior vena cava carries blood from the lower body.
IVC filter devices are usually one-and-a-half-inches in size and constructed of metal. The devices are described as “spider-shaped” or “cage-like” and are inserted into the IVC to trap blood clots that are traveling to the heart, lungs, and brain in patients who are diagnosed with deep vein thrombosis (DVT). Patients are also implanted with IVC filters following significant injury such as those seen in car accidents, gunshots or stab wounds, spinal cord damage, or serious falls. Patients unable to tolerate blood-thinning medications may also be implanted with an IVC filter.
The Option IVC filter is implanted into the inferior vena cava to capture blood clots before they travel into the lungs. The family of the deceased man alleges that, while the man was implanted with the Rex Option IVC filter, one week following implantation he experienced a bilateral PE. He died in October 2015 as a result of the PE and respiratory failure.
IVC filters have been tied with a number of injury reports that include device fracture and migration in patients’ bodies, which may lead to serious, life-threatening injuries that include bleeding; chest pain; confusion; death; further embolus; heart rhythm problems; internal bleeding; lightheadedness; low blood pressure; nausea; perforation of the IVC and other organs, including the heart and lungs; severe pain; and shortness of breath.
The Option IVC filter’s release to the market has sparked controversy. The U.S. Food and Drug Administration (FDA) approved the Rex Medical device through the agency’s 510(k) route, which permits the FDA to approve medical devices without being subject to clinical trials if the device is found to be similar to devices that are on the market. This practice is the subject of ongoing debate.
IVC filter devices that came before the Option and helped enable the 510(k) route for its approval include C.R. Bard’s Recovery and G2 IVC filters, which have both been found to be likely to fail. In 2005, C.R. Bard recalled the Recovery IVC filter over increased failure rates.
Meanwhile, numerous IVC manufacturers are facing mounting lawsuits in the United States and Canada. These include C.R. Bard. Cook Medical, Cordis Corporation, and Boston Scientific. The first Cook Medical lawsuit is scheduled for trial in early 2017.
The FDA has also released two warnings over the safety and efficacy of IVC filters. The agency recommends that IVC filters be removed from patients’ bodies as soon as the concern of PE and blood clots has passed.