After a Georgia man died due to blood clots in his lungs, his widow questioned the veracity of claims that the Option ELITE IVC Filter was a safe and effective product. Her questions are well founded. IVC filters, promoted as a safe accompaniment to blood thinners for the treatment of blood clots, have been connected with a number health complications and fatalities. If you think an IVC filter insertion has caused serious health problems for yourself or a loved one, it may be worth your time to contact an experienced local personal injury attorney
What is an IVC Filter?
An inferior vena cava filter, or IVC filter, is a tiny metal device that somewhat resembles an octopus with rigid tentacles. It derives its name from the vein in which is placed, the inferior vena cava, and its function of filtering blood clots that may develop in the legs before they travel to the heart and lungs. Patients at risk for pulmonary embolism, or clots in the lungs, are typically candidates for IVC filters.
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Complications of the IVC Filter
As with any surgical procedure, minor complications such as hematoma and access site bleeding are not uncommon. Infection and arterial punctures may also occur. Most patients agree that these are negligible issues. However, much more serious complications have been linked to these devices.
- Migration of the filter: When a filter moves from its original position to the heart or pulmonary outflow tract, it can result to damage to the heart and lungs. Experts say it must then be removed using snares and other retrieval devices. Unfortunately, removal is not always possible.
- Thrombosis: Deep Vein Thrombosis (DVT) incidents increased in patients who had IVC filters by between 13 and 44 percent according to two different studies. Ironically, this is the condition the filters were inserted to deal with initially. Patients with DVT may go on to suffer post-thrombotic syndrome, and may experience leaky or damaged valves, allowing fluid to pool. This can result in swelling, redness, cramping and pain in the affected leg. Additionally, the patient may experience ulcers.
- Filter Fracture: The struts of the filters have fractured in some instances, potentially impacting its effectiveness. More importantly, pieces of the device may migrate to the heart and lungs.
- IVC Perforation: Up to 95 percent of filter struts penetrate the wall of the inferior vena cava. This is generally insignificant. In some patients, however, ureteral, aortic, or duodenal penetration occurs. Lumbar vessels have been lacerated, causing massive bleeding. Organ damage and other complications have occurred. Surgical removal of the filter may be considered in such cases, but the risk of IVC punctures and perforations is a serious consideration.
- Pulmonary Embolism: One study indicates the rate of pulmonary embolism after implantation to be over five percent, with a fatality rate of nearly four percent.
- Infection: Although sterile techniques are used during filter insertion, bacterial infections are always a concern in surgical procedures.
Removal of devices: Although complications may indicate the removal of these devices is advisable, in some cases that is not possible due to :
- The filter has become embedded;
- The filter has protruded through a vessel;
- The position of the filter has shifted and sits in an abnormal position;
- Migration of the filter has made it impossible to safely retrieve; or
- Blood clots have formed inside filters.
Manufacturers of medical devices have a responsibility to patients. They must warn individuals of potential complications, represent the product truthfully, and create a product without defects that could lead to patient harm. IVC filter lawsuits are cropping up with increasing regularity based on a number of issues.
According the U. S. Food and Drug Administration, (FDA) a number of reports have been filed claiming the filters, or fragments of the filters, have travelled to the heart or lungs, causing serious and sometime fatal consequences. Furthermore, several suits allege companies were aware of the defects in the devices but refused to take them off the market, despite significant risks to patients. Lawsuits claim a number of issues, including:
- Design defects;
- Improper warnings for doctors and patients;
- Manufacturing defects;
- Negligent misrepresentation; and
- Breach of implied warranty.
A number of devices have been named in the lawsuits. Cook Medical is facing litigation based on two of its devices. Court documents assert that design flaws in certain Cook filters make the likelihood of fractures, migrations, tilting and perforations a serious problem. Cases in the suit are quickly approaching 3,000.
C.R. Bard is battling claims based on assertions that its IVC filters have fractured and migrated to the heart and lungs of numerous patients. Bard has settled a number of cases out of court, but faces over 2,000 ongoing claims. Documents reveal that Bard, too, was aware of the problems with its devices. Rather than inform the FDA or patients of concerns, Bard paid an independent consultant to study and report on the rate of fracture and migration of older and newer models of filters. The report noted that Bard filters had higher rates of complications than competing brands. What did Bard do with the report? It was distributed to select employees on a need-to-know basis.
Another company under legal scrutiny is Boston Scientific. Liability and wrongful death lawsuits assert that the placement its Greenfield Vena Cava filter in numerous patients has resulted in serious internal injuries and fatalities.
Impacts on Patients
We know that in individual settlements for undisclosed amounts, claimants have experienced a number of physical complications as a result of IVC filters being placed in their bodies. In addition to the physical trauma, patients have recovered damages for lost wages, anxiety, loss of a normal life, emotional trauma, disability and disfigurement. Furthermore, several class action suits claim that the complications associated with these filters necessitate regular monitoring, and that manufacturers should compensate anyone who has a filter for costs associated with that monitoring.
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Do You Have a Claim?
If you or a loved one has experienced serious injuries or death as a result of the insertion of an IVC filter device, you may be able to collect significant damages. At the Roger Ghai Law Offices, our team understands the medical and emotional trauma you have endured. Negligent companies must be forced to pay for their mistakes. Contact us today for a personalized consultation.