Cook IVC Filter Lawsuits
The Cook IVC (inferior vena cava) filter is one of several medical devices doctors implant in patients to prevent blood clots from reaching the lungs and causing serious damage. The inferior vena cava is a large vein that returns blood from the lower body to the heart.
The U.S. Food and Drug Administration issued safety communications in 2010 and 2014 about the Cook IVC filters because of numerous reports of problems associated with the devices. The problems may be associated with the filter being left in the body for too long. The FDA expressed concern that doctors were implanting the retrievable filters to address the short-term risk of a pulmonary embolism, and then often leaving the device in place after the risk subsides.
In a risk analysis published in 2013 in the Journal of Vascular Surgery, FDA researchers suggested that if the patient’s risk of pulmonary embolism has passed, the risk-and-benefit analysis favored removal of the IVC filters between 29 and 54 days after implantation to avoid complications.
A number of patients have filed lawsuits alleging they were harmed by the IVC filter. Lawsuits against Cook Medical, Inc., pertain to the Cook Celect and the Gunther Tulip IVC filters. Patients claim that the devices fracture, migrate and tilt, and may perforate the inferior vena cava, putting the patient in serious danger. Failure of the implant can lead to internal bleeding, pulmonary embolism and possible death.
If you think you or someone you know has been injured by the Cook IVC filter, you may be able to obtain compensation for the harm it has caused. To speak directly with one of our personal injury attorneys about your case, phone (800) 738-0449 or contact us online.
At Hardison & Cochran, we provide free and confidential reviews of potential clients’ cases. We can thoroughly examine the facts of your case and explore all of the legal options available to you.
FDA Warning About IVC Filters
The use of IVC filters has increased greatly in the last three decades, according to the FDA. In its 2010 safety communication about the Cook IVC filter, the FDA said its concern was that the filters were meant to be temporary but were typically left in a patient for longer than was necessary to guard against pulmonary embolism. This error potentially leads to the devices breaking down and failing.
The FDA said that in the five years that IVC filters were on the market, it had received more than 900 “adverse event” reports. They include complaints that involved:
- Device migration (movement)
- Embolizations (detachment of device components)
- Perforation of the inferior vena cava
- Filter fracture.
What is a Pulmonary Embolism?
In addition to the problem of having a broken medical device in a major vein that can perforate the vein, failure of a Cook IVC filter means the patient is no longer protected from a pulmonary embolism, or PE.
A PE blocks blood flow and can lead to heart attack, stroke and death. The clot that causes a PE typically forms in a vein in the lower leg, where it is known as deep vein thrombosis or DVT. When a DVT breaks free, it can travel to the lungs via the inferior vena cava. According to the U.S. Surgeon General, between 350,000 and 600,000 people are affected by blood clots each year, and between 100,000 and 180,000 die of pulmonary embolism (a blog clot that travels to the lungs).
The Cook IVC filter and similar devices are put in place to catch and break up any potentially migrating DVT if blood thinners haven’t worked or the patient can’t take them for other medical reasons.
If you or someone you know has been implanted with an IVC filter and is having bleeding or cardiovascular problems, you should seek medical attention as soon as possible.
Legal Action Against the Cook IVC Filter Manufacturer
In October, a federal court in Indiana ruled that 27 legal claims against Cook Medical, Inc. that alleged injury from failure of a Cook IVC filter could move forward as a multi-district litigation (MDL). This indicates the viability of these claims and the fact that they will be heard in court if not settled.
You need not be a party to the existing MDL to pursue a claim against Cook Medical. Additional lawsuits may move forward. In many cases like these, the manufacturer seeks to settle all claims at once and establishes a fund for existing and future claims.
The faulty medical device lawyers of Hardison & Cochran are reviewing potential claims pertaining to failure of the Cook Celect and the Gunther Tulip IVC filters. We can assist and advise you on your potential claim if you or a loved one of yours has been injured by implantation of a Cook IVC filter.
Contact Hardison & Cochran Today
If you or a loved one of yours has been injured by an IVC filter, you may be able to seek compensation for medical expenses, pain, suffering and other losses. Our personal injury attorneys are reviewing new cases pertaining to the Cook Celect and the Gunther Tulip IVC filters, and can help you learn whether your IVC filter was made by Cook Medical, Inc.
If you or a loved one has suffered from problems with an IVC filter, contact us as soon as possible at 1-800-738-0449, or online for a free and confidential legal consultation.
- Food and Drug Administration – Inferior Vena Cava (IVC) Filters: Initial Communication: Risk of Adverse Events with Long Term Use
- United States Judicial Panel on Multidistrict Litigation – Transfer Order
- Food and Drug Administration, Safety Communication, May 6, 2014: Removing Retrieval Inferior Vena Cava Filters