Design defects of inferior vena cava (IVC) filters have caused many patients to suffer severe complications and on occasion fatal injuries when the small medical devices fractured or break inside the body.
What are IVC Filters?
IVC filters are umbrella-shaped devices that are implanted in patients at risk of pulmonary embolism or a blood clot to the lung. They are implanted in the IVC to trap blood clots from the leg or deep vein thrombosis, blocking them from traveling to the lungs and causing a pulmonary embolism (PE) which in severe cases can be fatal.
What is the problem with IVC Filters?
The filters were designed to be temporary and according to the FDA, should be removed within 29 and 54 days of implantation. The problem has been that most are not removed in that time frame and the risk of fracture, tilting, and migration increases the longer they remain implanted.
In product liability and personal injury lawsuits filed against C.R. Bard, Cook and Cordis the major manufacturers of retrievable filters, it is claimed that the IVC devices are subject to catastrophic failure, moving out of position, puncturing the vein or fracturing, sending metallic shards into the blood stream.
Cordis Corporation, makers of OptEase and TrapEase IVC filters, currently faces over 140 lawsuits alleging life-threatening injuries after being implanted with their filters.
According to a 2011 study by Japanese researchers found that 10 out of 20 patients implanted with the Cordis TrapEase IVC filters had a fractured strut within 50 months of implantation.
Cordis was also forced to issue a Class 1 recall for almost 33,000 OptEase IVC filters due to a labeling error that could cause the filter to be implanted backwards and result in it migrating towards the heart.
The FDA warns that adverse filter side effects can cause complications such as:
- Filter fracture
- Embolization of broken components
- Migration and tilt
- Organ damage (heart, lungs, kidneys, etc.)
- Perforation of the vena cava
- Internal bleeding
- Deep Vein Thrombosis (DVT)
- Filter is clogged with blood clots
- Filter or Broken pieces can’t be removed
According to the latest JPML court data from August 15, there are more than 800 Bard IVC filter lawsuits filed in the federal court system, centralized for coordinated pretrial proceedings as part of an MDL, or multidistrict litigation in Arizona.
Another 800 Cook IVC filter lawsuits are centralized as part of a separate MDL in Indiana. There over 150 filed claims against Cordis, filed in state court California.
According to experts, over 30,000 IVC filters have been implanted in the last 30 years. However, the exact number of IVC filters currently implanted is unknown as the U.S. does not maintain a nationwide implant registry, unlike many other modern countries.
Patients need to know of the high failure rates associated with these devices. IVC filters being named in lawsuits are Cook Celect Filter, Cook Gunther Tulip Filter, Bard Recovery Filter, Bard G2 Filter and Bard G2 Express Filter.
Shezad Malik is an Internal Medicine and Cardiology specialist, a licensed Texas Medical Doctor and Defective Medical Device and Dangerous Drug Attorney. Dr Shezad Malik Law Firm has offices based in Fort Worth and Dallas and represents people who have suffered catastrophic and serious personal injuries including wrongful death, caused by the negligence or recklessness of others.