March 3, 2017 – A California woman whose doctor was allegedly unable to retrieve an Option ELITE IVC filter from her body has filed a products liability lawsuit against Argon Medical Devices and Rex Medical in the Philadelphia County Court of Common Pleas. Plaintiff Debra Victor claims the filter couldn’t be removed because it had become embedded in her vena cava, and is suing the companies for manufacturing a defective medical device.
What is the OptionELITE?
The OptionELITE IVC Filter is a spider-like medical device that is inserted in the inferior vena cava — a large vein that transports blood from the lower body to the heart — just below the kidneys. The filter is used to prevent blood clots from reaching the lungs (pulmonary embolism) in patients who are unable to take anticoagulant medications. The OptionELITE is manufactured by Argon Medical, and was approved by the FDA in January 2014.
What’s the Problem?
Reports first started surfacing in 2005 that the radial arms and struts of IVC filters made by Bard Medical were breaking off inside some patients’ bodies. Since then, the FDA has received nearly 1000 adverse reports involving IVC filters, primarily regarding the devices fragmenting and embolizing inside the body.
As a result of these problems, FDA urged physicians to consider the risks before recommending IVC filter placement in patients who are ineligible for anticoagulation therapy. The agency also recommends that the filters be removed as soon as the blood clot risk has passed.
IVC Filter Complications
- Deep Vein Thrombosis (DVT)
- Chest pain
- Filter fracture
- Filter migration
- Embolization of filter fragments
- IVC perforation
- Perforation of the heart
- Organ damage
- Cardiac tamponade
- Hemorrhagic pericardial effusion
- Pulmonary embolism
- Emergency surgery
- Parts of IVC filter permanently embedded in body
FDA Warning on Risks of Long-Term IVC Filter Use
On May 6, 2014, the FDA issued a Drug Safety Alert warning that IVC filters should be removed immediately after the risk of pulmonary embolism has subsided. The agency concluded that the risk of injury outweighs any potential benefit of IVC filter placement.
“The FDA has received reports of adverse events and product problems associated with IVC 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. Some of these events led to adverse clinical outcomes.”
The first IVC filter lawsuits were filed against Bard Medical in California and Pennsylvania state courts in 2012. In October 2014, the U.S. Judicial Panel on Multidistrict Litigation (JPML) consolidated Cook IVC filter claims from 11 jurisdictions into MDL 2570 in the Southern District of Indiana. The JPML later consolidated claims against Bard IVC filters into MDL 2641 in the District of Arizona. Various additional claims for an IVC filter lawsuit remain pending in state and federal courts around the country.
Do I Have an OptionELITE IVC Filter Class Action Lawsuit?
The Medical Device Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in OptionELITE IVC filter lawsuits. We are handling individual litigation nationwide and currently accepting new injury and death cases in all 50 states.
Free Confidential Lawsuit Evaluation: If you or a loved one has had an IVC filter implanted, you should contact our law firm immediately. Our lawyers are evaluating every individual case regardless of whether you have been injured or not. So, if you have received an IVC filter implant, we would like to speak with you. You may be entitled to compensation by filing a suit against the manufacturer and our lawyers can help.