The Cook IVC Filter Lawsuit
Patients who have been injured after having the Gunther Tulip or the Celect filter implanted to protect against blood clots, have filed claims in the Cook IVC filter lawsuit. The U.S. Food and Drug Administration (FDA) approved the Gunther Tulip filter in 2003, and approved the Celect filter five years later in 2008. These filters, which are implanted into the inferior vena cava (IVC), are intended to prevent a pulmonary embolism in at-risk patients. However, when these filters remain implanted after the risk for a pulmonary embolism has passed, complications can occur, including fracture of the device and migration of the broken pieces to the heart, lungs, and other organs. If you or a loved one has suffered serious complications after the implantation of a Cook IVC filter, please contact our experienced legal team today to discuss your legal options.
Cook IVC Filters
Lawsuits against Cook Medical have focused on two IVC filter products made by the company.
The Gunther Tulip IVC filter was approved for temporary placement in the 1990s. In 2003, the FDA granted additional approval for permanent placement. With permanent placement patients, the filter was prone to fracturing after the risk of blood clots and pulmonary embolism had passed. Once the device has fractured and broken pieces began to migrate, it becomes extremely difficult to remove.
The Celect IVC filter was approved in 2008 through the FDA’s controversial 510(k) application, which is a fast-track approval process for companies trying to release products that are similar to devices that are already on the market. This application and approval process requires only minimal testing because the newer products are thought to be just as safe as the existing devices. With the Celect IVC filter, in addition to the potential for fracture and migration of the device, there is also a risk of the filter embedding itself in the vena cava, making them difficult to remove.
Both of Cook Medical’s filters can cause numerous complications, including:
- Fracture of the legs of the device
- Migration of broken pieces to other organs, most frequently the heart and the lungs, resulting in perforation
- Pulmonary embolism
- Deep vein thrombosis
- Organ damage
- Cardiac tamponade
In a 2012 study published in the CardioVascular and Interventional Radiology, it was found that both Cook IVC filters resulted in some amount of perforation after just 71 days. Out of those observed in the study, 86 percent suffered full perforation.
Symptoms of a fractured or migrated IVC filter are similar to those of a heart attack. A patient may experience shortness of breath and chest pain, and typically requires emergency treatment. In many cases, it can even be difficult to determine whether it is a heart attack or not. These complications are often severe and life threatening.
If you have been injured by a defective medical device, Speak with an Attorney
Current IVC Filter Lawsuits
As of July 2015, nearly 100 lawsuits have been filed against Cook Medical for their defective IVC filters. In October 2014, 27 cases were consolidated for multidistrict litigation (MDL) in the Southern District of Indiana. Claims against Cook Medical include negligence; a failure to provide adequate warning of the risks associated with the IVC filters to physicians and their patients; and misrepresentation of the filters as being safe for both temporary and extended use.
Multidistrict litigation is often employed to consolidate a group of similar cases against a common defendant, in this case, IVC filter cases against Cook Medical. This consolidation into MDL allows a single judge to preside over the cases, streamlining the processes of evidence and discovery for more efficient legal proceedings. A benefit of MDL is that each case is still tried and settled separately, which can result in larger settlements for individual plaintiffs, as the amounts are based on the plaintiff’s specific injuries, medical expenses incurred, and pain and suffering.
Class Action Lawsuits
While there have been class action suits filed against C. R. Bard, another IVC filter manufacturer, a class action suit has not yet been filed against Cook Medical. Unlike MDL, class actions seek one large settlement to be divided equally among the plaintiffs.
Speak With an Experienced IVC Filter Attorney
The injuries resulting from a defective IVC filter are severe, complex, and often require additional surgeries and treatments, which can increase the total medical expenses. If you or a loved one has suffered such an injury, please contact our skilled legal team today to schedule a complimentary consultation and to discuss the legal options available to you.