PHILADELPHIA – A California plaintiff is claiming medical device companies manufactured a defective model of vena cava filter, a device used to prevent pulmonary embolism (a blood clot in the lungs).
Debra Victor of Apple Valley, Calif. filed suit on Feb. 17 in the Philadelphia County Court of Common Pleas, against Rex Medical L.P. of Conshohocken and Argon Medical Devices, Inc. of Plano, Texas.
“An IVC filter is a device that is designed to filter or “catch” blood clots (called thrombi) that travel from the lower portions of the body to the heart and lungs. IVC filters may be designed to be implanted, either permanently or temporarily, in the human body, more specifically, within the inferior vena cava,” the allegations state.
Rex’s Option Vena Cava filter entered the market in June 2009, after receiving clearance from the Food & Drug Administration (FDA).
“Plaintiff, Debra Victor, was implanted with an Option Elite Retrievable Inferior Vena Cava Filter manufactured by Rex Medical and marketed and distributed by Argon on or about Sept. 19, 2014. Subsequently, on April 4, 2016, Dr. Thu Tang attempted surgical retrieval of the filter implanted within plaintiff’s body. Dr. Tang was unable to remove the filter because the retrieval hook at the apex of the filter had become embedded into the wall of the plaintiff’s vena cava. Dr. Tang utilized a retrieval snare in his attempt to extract the filter; however, he could not engage the retrieval hook at the apex of the Option Elite Retrievable Inferior Vena Cava Filter,” Victor’s lawsuit says.
The complaint says the defendants negligently manufactured a defective and unsafe product, did not warn customers of its flaws, and put out a product for sale which may lead a patient to suffer “severe health side effects, including, but not limited to: hemorrhage; cardiac/pericardial tamponade; cardiac arrhythmia and other symptoms similar to myocardial infarction; perforations of tissue, vessels and organs; and other severe personal injuries and diseases.”
For counts of negligence, strict product liability with failure to warn, strict product liability with design defect, strict product liability with manufacturing defect, breach of express warranty, breach of implied warranty of merchantability and negligent misrepresentation plus punitive damages, the plaintiffs are each seeking full, fair, and complete recovery for all claims and causes of action relevant to this action, all appropriate costs, fees, expenses, and pre-judgment and post-judgment interest, punitive damages, plus other relief the court deems just and proper, in addition to demanding a trial by jury.
The plaintiff is represented by James J. McHugh Jr. and Carrie R. Capouellez of Lopez McHugh in Moorestown, N.J., plus Thomas P. Cartmell and David C. DeGreeff of Wagstaff & Cartmell, in Kansas City, Mo.
Philadelphia County Court of Common Pleas case 170204272
From the Pennsylvania Record: Reach Courts Reporter Nicholas Malfitano at nickpennrecord@gmail.com