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It can take awhile for a drug or medical device to gain approval through the Food and Drug Adminstration. However, there is a fast track that can be utilized. It’s called the 501(k) Clearance Loophole. This fast tracked approval process might have a role in medications and devices that have recently come under scrutiny and face class-action lawsuits. The IVC filter is one such device.
An IVC filter is a device that is designed to fit into the inferior vena cava artery. The purpose of the device is to catch and stop blood clots from the legs from making it to the heart and lungs, causing pulmonary embolism.
Many patients have experienced the filter itself migrating to other parts of their internal organs. Some even make it as far as the heart. Some become so embedded into organ tissue that removal of the filter is impossible.
The FDA recently released an edict giving doctors a time line for removing the devices. For an overwhelming majority of patients, removal has not been an option. They are forced to live with the device remaining within their body.
Various IVC filters have been the target of lawsuits. Two Canadian lawsuits involving Celect and Gunther Tulip filters have been filed. U.S. Lawsuits have been filed against the C.R. Bard IVC filter and the Bard G2 IVC filter. Some of the filters were marketed and manufactured by Cook Medical.
The Canadian lawsuits against Cook Medical maintain that the company failed to warn patients of the potential for fracture and migration of the device.
A study appearing in the April 2013 edition of JAMA suggested that only about 10% of IVC filter retrieval attempts are actually successful.
If you have suffered injury or an adverse health event due to the implantation of an IVC filter, you may be entitled to compensation. Contact the “Strong Arm” attorneys at John Foy & Associates. Our attorneys will work to get you the compensation you deserve. Contact us today.
