(June 15, 2019) Matthews & Associates Law Firm and Philadelphia attorney Rosemary Pinto filed an IVC filter lawsuit against Rex Medical L.P. and Argon Medical Devices, Inc. on March 6, 2017 in the Court of Common Pleas in Philadelphia County. A jury trial for the case is set to begin Oct. 2, 2019.
The lawsuit petition states the plaintiff, a woman from Georgia, was implanted with an Option Retrievable Inferior Vena Cava Filter made by Rex Medical, and marketed and distributed by Argon. That IVC filter has caused, and continues to cause, significant injuries.
After the plaintiff reported abdominal pain, she underwent a CT scan in Dec. 2016. That scan showed that her Rex’ Option Retrievable Inferior Vena Cava Filter (IVCF) had perforated through the walls of the vena cava. Two physicians denied repair or removal of the device due to the potential complication levels.
Rex’ Option Retrievable Filter caused Significant Injuries
As a direct result of the IVCF’s intractable position, the plaintiff suffered injuries that include perforation of the Option Retrievable Inferior Vena Cava Filter. The petition says that the struts of the filter have perforated to the fullest extent possible, resulting in severe pain and life-threatening complications. The most medial strut of the filter perforates the woman’s aorta, which could cause death from loss of blood should the aorta perforate further. The most lateral strut of the filter perforates the right renal veins, which leaves the plaintiff at risk of kidney failure. The three anterior struts perforate the small bowel and could cause gastrointestinal problems.
The petition accusing Rex Medical reads, in part:
“(The) perforated filter places the plaintiff at an increased and continual risk of complications, such as the potential for the filter to become embedded and occluded with blood clots, thereby disrupting the normal flow of blood to the heart and lungs. The perforated filter also poses an increased and continual risk of fracturing. Fractured portions could travel to the lungs or heart, possibly causing immediate death or serious injury. The plaintiff needs the perforated filter removed, but doing so could cause severe complications and even death.
The plaintiff is now forced to live with severe pain and complications caused by the filter, as well as the possibility that the filter could, at any moment, cause any of the aforementioned or other complications. That reality has led to severe fear, stress, and anxiety.”
Nature of the Case – General Allegations
The petition further states that prior to the plaintiff’s being implanted with the filter, the defendants knew and should have known that the device was defective and unreasonably dangerous for the following reasons:
- Defendants failed to conduct sufficient clinical testing, such as animal studies, to determine how the device would function once permanently implanted in a human.
- Defendants knew (the) Option filter had a high rate of embedment, fracture, migration, and excessive tilting and perforation of the vena cava wall once implanted in the human body. Defendants (knew) such failures exposed patients to serious injuries, including: death; hemorrhage; cardiac/pericardial tamponade; cardiac arrhythmia; other symptoms similar to myocardial infarction; severe and persistent pain; perforations of tissue, vessels, organs; inability to remove the device.
- Defendants also knew or should have known that certain conditions or post-implant procedures, such as morbid obesity or open abdominal procedures, could affect the safety and integrity of the device.
- The risks for the Option Vena Cava Filter were and are substantially higher than other similar devices.
- The Option filter contained conditions, which Defendants did not intend, that resulted in the device not performing as safely as the ordinary customer would expect.
- Despite being aware of these risks, Defendants misrepresented, omitted, and/or failed to provide adequate warnings of these risks or instructions for safe use.
- Even as Defendants designed, marketed and sold what they alleged to be a device that specifically reduced these risks of the Filter, they nonetheless failed to issue a recall of the Filter or otherwise notify customers that a safer device was available.
Causes of Action Charged
- Strict Products Liability — Failure to warn
- Strict Product Liability — Design Defect
- Strict Product Liability — Manufacturing Defect
- Breach of Implied Warranty of Merchantability
- Negligent misrepresentation
- Punitive damages allegations
IVC Filter case filed against Rex Argon
The jury trial beginning Oct. 2 is expected to last at least three weeks. The case is # 170300241.