The U.S. Food and Drug Administration (FDA) have received hundreds of adverse event reports involving retrievable filters. Types of reports include device migration, filter fracture, embolization (movement of the entire filter or fracture fragments to the heart or lungs), perforation of the IVC, and difficulty removing the device. There are several numbers of lawsuits filed by plaintiffs against the manufacturers of IVC filter alleging that medical devices have design defects and were not properly tested before going to market. The lawsuits allege several claims, including negligence, failure to warn, liability for design defects, breach of implied warranty, failure to recall, fraudulent misrepresentation, and concealing evidence.
A man from Texas who was injured by the Option (retrievable) vena cava filter filed a personal injury and defective product liability lawsuit against the manufacturer of the life threatening device Argon Medical Devices and Rex Medical. In September of 2011, Steven Akin was implanted with an Option IVC filter at Baylor University Medical Center in Dallas, Taxes. After few months from the device implanted, in May Akin discovered severe back pain. In May of 2016, he visited to doctor’s Omar Colon clinic for medical checkup. Dr. Omar prescribed an X-ray, the X-ray report revealed that the Option IVC filter was embedded in his inferior vena cava. Dr. Colon suggested that the IVC filter should not be removed because of its position. It is very risky to remove the device as the device was embedded in his vena cava and it can tear the vein.
The IVC filter is placed in the inferior vena cava, the largest vein in the body, and an IVC filter is a metallic cage like device that traps a blood clot before it can reach the lungs. It is used in those patients who may develop a PE and cannot be treated by using anticoagulant medication. There are basically two types of IVC filters, permanent and retrievable. Retrievable filters provide short-term protection and are temporary. The FDA safety communication recommends removal of the IVC filter between 29 and 54 days after implantation.
The lawsuit was filed on August 4, 2016 in Dallas County Civil Court under the Case No. CC-16-03886-A. Plaintiff is represented by Ben C. Martin, Jacob A. Boyd, and Thomas Wm. Arbon of The Law Offices of Ben C. Martin in Dallas, Texas. According to the lawsuit Akin now requires ongoing monitoring “As long as the Option filter remains embedded in his vena cava, Plaintiff is at risk for future thrombosis, filter fractures, migrations, perforations, and tilting. He faces numerous health risks, including the risk of death,” The lawsuits claim that manufacturers failed to warn the general public about the potential health risks associated with the device.
Most often the five products are involved in the IVC filter litigation: The Bard Recovery filter; The Bard G2 filter; The Bard G2 Express filter; The Cook Gunther Tulip filter; and the Cook Celect filter. However Option IVC filter was approved by the FDA with a 510(k) application, but the adverse events are still occurs because the long-term safety of the Option has never been studied. The devices should be completely tested as well as have clinical trial before selling in market. Many Plaintiffs across the nation have to live with embedded IVC filter throughout their life with the risk of further injury from the device lodged inside their body.