Rex Medical currently is facing a blood clot filter lawsuit in Philadelphia PA. The case involves alleged injuries that a woman says she suffered after she received an IVC filter implant, which is designed to prevent pulmonary embolisms. PE is the third leading cause of death in the US for patients who are in a hospital.
The complaint, which is the first of its kind against Rex Medical in court in Philadelphia, stated that the firm’s Option retrievable IVC filter was prone to failure when used in patients.
The complaint alleges that the defendants knew or should have known that the blood clot filter had defects and was dangerous. The filter, the suit alleges, had a high rate of fracture, migration, tilting and embedment. Also, many of these devices have peforated the vena cava wall in other patients and led to serious patient injury.
The complain alleges that the woman, Rebecca Joy Caseman, suffered serious injuries after she received the Option Retrievable IVC filter in February 2013. Doctors tried to take out the IVC filter in March 2014 but were not able to do so without presenting serious risk to the patient.
The complaint also states that the filters have been available for more than 40 years, must most of them are not designed to stay in the body for years. The complaint also states that Rex did not do enough clinical testing, including tests on animals to make certain that the medical device would work safely.
The product is similar to six other IVC filters that are made by CR Bard and Boston Scientific, and all have been cleared by FDA for sale.
FDA has advised medical professionals that they need to be vigilant about all of the risks that are associated with longer term use of blood clot filters. Generally, FDA recommends that the devices do not stay in the body beyond 60 days.
The complaint also alleges that the firm did not establish proper quality testing procedures for the medical device, per FDA regulations. The complaint states that if Rex had fully complied with FDA requirements, the blood clot filter would have been made properly and would not have caused injuries in the plaintiff.
Overall, IVC filters are put into the inferior vena cava of patients who suffer from deep vein thrombosis in the legs. This device can prevent clots form breaking off and getting into the lungs, heart and brain. There are both permanent and retrievable filters; the latter are more common today as it is believed to be safer to remove the device after the risk of PE lessens.
Retrievable IVC filters have been associated over time with serious problems that include migration and fracturing of the device. As time passes, pieces of the device can move and become lodged in the lungs or heart, and this can cause serious and life threatening complications.
In 2010, FDA advised the industry that it had received a total of 921 adverse event reports that involved blood clot filters:
- Filter Migration (328 reports)
- Embolization (146 reports)
- IVC Perforations (70 reports)
- Filter Fracture (56 reports)
FDA stated in the alert that the most serious complications arise when the retrievable filter stays in the body for too long, after the chance of PE has subsided. FDA recommends that doctors remove the filter as soon as possible after the risk has been reduced.
FDA also has sent out warning letters to other makers of IVC filters. Most seriously, some medical device manufacturers fail to report device malfunctions regularly that result in injury or death.
About Rex Medical:
Rex Medical L.P. develops, manufactures and markets a variety of minimally invasive medical devices for cardiovascular, venous access and oncology markets to deal with unmet clinical needs and to deliver the best patient care to patients. One of its best sellers in is the Option IVC filter which is a retrievable vena cava filter that should be removed after the risk of embolism has passed.