A Michigan woman has filed a lawsuit against the maker of the inferior vena cava (IVC) filter that broke apart inside her body.
According to the Daily Hornet, Ruthann W. was implanted with the Option Elite retrievable IVC filter made by Argon Medical Devices and Rex Medical on June 12, 2014. Dr. James Joseph Shields and Dr. Jooman Shim, the doctors who performed the procedure at the University of Michigan Health System in Ann Arbor, trusted that the filter would be Ruthann’s best option to prevent pulmonary embolism.
Pulmonary embolism (PE) is a deadly condition in which a blood clot travels through the bloodstream and enters the heart or lungs. It has a high mortality rate and can leave the patient with major medical conditions that require a lifetime of treatment.
When Ruthann underwent a procedure at Munson Medical Center in Traverse City on Oct. 17, 2014, to have the IVC filter removed after the threat of PE had passed, Dr. Farhaan R. Mir found that the filter had tilted and embedded itself into her vein. He was unable to safely retrieve the filter and abandoned the procedure.
A month later, on Nov. 20, 2014, at the University of Michigan in Ann Arbor, Dr. Minhajuddin Syad Khaja attempted to remove the filter. The device was found to be fractured into pieces, and multiple surgeries were required to retrieve each fragment.
Ruthann’s lawsuit accuses Rex Medical and Argon Medical Devices of negligence, failure to warn of the device’s risks and dangers, selling a device with a defective design, failure to warn of potential life-threatening side effects, and more.
Other IVC filter manufacturers such as Cook Medical, B. Braun, and C.R. Bard are facing thousands of lawsuits nationwide over injuries and deaths linked to the devices.