The plaintiff was implanted with the Cook Gunther Tulip IVC filter April 19, 2016, according to his lawsuit petition. Just three days later, on April 22, the implanting surgeon attempted to remove the temporary filter. The surgeon attempted removal through the jugular vein and also the right common femoral vein.
IVC Filter stuck in Patient
The surgeon, who is named a party in the lawsuit, was unable to remove the Cook Gunther Tulip filter. In his first attempts, he noted that it had migrated from the inferior vena cava and was lodged in the right ventricle of the man’s heart.
The petition reads: “During the numerous attempts to retrieve (the filter), Plaintiff’s heart rate slowed on a number of occasions and Plaintiff suffered from severe episodes of bradycardia, pericardial effusion, and symptomatic pericardial tamponade requiring urgent pericardiocentesis and pericardial catheter placement.”
The filter could not be retrieved intravascularly; it was stuck . This situation led to emergency bypass surgery. There was no other way to remove the filter from the right ventricle of the man’s heart, according to the petition. The surgery required the opening of his sternum and pericardium and led to his cardiopulmonary bypass. Surgeons found the filter in the right ventricle of the heart “with the tip pointed toward the right ventricular apex and the legs of the filter entwined with the chordae tendinae of the tricuspid valve preventing the closure of the tricuspid leaflets.”
Cook IVC Filter Lawsuit Petition
The plaintiff’s lawyers allege in the petition that because of the open heart surgery caused by the filter’s migration and embedment in his heart ventricle, the man “suffered injury and pain and suffering, and currently suffers from and will continue to suffer from numerous health risks for the remainder of his lifetime, including increase risk of heart failure, kidney damage, and increased risk of death.” They also allege that he will also require ongoing medical care and monitoring for the rest of his life and may ultimately require additional surgeries.
The petition further charges that the surgeon knew or should have known that only certain patients were proper candidates for an IVC Filter, that the Cook Gunther Tulip had a high rate of device migration and failure, that it is not effective to prevent clots and/or increases the risks of clots, that safer alternatives existed, that IVC filters such as the Cook Gunther Tulip frequently tilt, migrate, perforate or fracture, and thus involve an increasing degree of risk to a patient implanted with one.
The plaintiff’s petition also charges that the Cook Defendants knew or should have known that the device was defective and unreasonably dangerous for six reasons. Cook defendants::
* failed to conduct any clinical testing, such as animal studies
* knew or should have known that the Gunther Tulip had a high rate of fracture, migration, excessive tilting, perforation of the vena cava. Such failures exposed patients to serious injuries including death, hemorrhage, cardiac/pericardial tamponade, cardiac arrhythmia, severe and persistent pain, perforations of tissue, vessels, organs such as the heart, inability to remove the device, and/or extensive surgeries to remove it.
* knew or should have known these risks were substantially higher than other similar devices
* knew or should have known that the Gunther Tulip contained conditions that resulted in the device not performing as safely as the customer would expect
* misprepresented , omitted, and/or failed to provide adequate warnings of these risks or instructions for safe use
* failed to issue a recall or otherwise notify people that a safer device was available
IVC Filter Lawsuit filed in Dallas
The case has been filed in Dallas County. The plaintiff has requested a trial by jury and submitted the appropriate fee.