A Washington woman has filed an IVC filter lawsuit that will be consolidated into multidistrict litigation pending against Cook Medical.
Cook Medical was targeted with numerous lawsuits after allegations from patients argued that the manufacturer was responsible for serious injuries.
According to the IVC filter lawsuit, the products developed by Cook within their IVC filter line are associated with an enhanced risk for critical injury and death as a result of numerous different adverse events reported by users of the product.
Those patients who received an IVC filter and suffered a catastrophic injury in the form of fracture, perforation, tilting, breakage and migration came forward to initiate an IVC filter lawsuit by arguing that the company did not properly warn patients or the medical community about the risks.
Medical devices in general, and IVC filters in particular, have been the subject of serious consumer complaints and injury reports in recent years. Many who have had an IVC filter implanted claim they were never warned about the fracture and migration risk and only realized the problems too late. In some of those cases, removal of all the filter pieces was impossible.
The IVC filter lawsuit says that Cook recklessly, intentionally and negligently failed to act regarding the known failures of the filters, and did not properly inform consumers about the disadvantages of the IVC filters.
In addition to claims from the plaintiffs who had IVC filters implanted, the IVC filter lawsuit says that spousal claims may include loss of companionship and consortium.
In some situations, plaintiffs may represent a deceased individual who suffered fatal injuries as a result of an IVC filter.
FDA Fast Track Program Used to Approve IVC Filter from Cook
The IVC filters created by Cook Medical were originally approved by the Food and Drug Administration under the 510(k) program.
510(k) approval is only allowed for those medical devices that are allegedly substantially equivalent to other legally marketed devices.
This removes the formal review process typically associated with the FDA.
The IVC filter lawsuit argues that use of this 510(k) program eliminated additional safety protocols that might have identified the serious risks associated with the medical device. The Cook IVC filter is designed to capture blood clots that travel from the lower parts of a patient’s body to the lungs and heart, where they become potentially life-threatening.
IVC filters may be implanted permanently or temporarily within the vena cava of the patient.
A patient’s inferior vena cava is a vein that returns blood to the heart out of the lower portion of the body. Cook filters are retrievable in nature. However, a broad variety of patients have come forward to file an IVC filter lawsuit after suffering catastrophic injuries or losing a loved one to problems associated with the implantation of an IVC filter.
If you believe you have grounds to file an IVC filter lawsuit, consult with the attorneys at McDonald Worley today.
Note: McDonald Worley is not representing the plaintiff in this lawsuit.