A consumer’s lawsuit against Cook argues that their IVC Gunther Tulip filter is defective and can cause serious health complications.

Plaintiff Paul A. recently filed a lawsuit against Cook Medical Inc. and its subsidiaries, claiming that the company’s IVC Gunther Tulip filter was defective, causing health complications. He says he was implanted with the Gunther Tulip filter in April 2003 and later experienced complications.

The Gunther Tulip filter is a cardiac filter device placed in the inferior vena cava. The vena cava returns blood to the heart from the lower portion of the body. In some patients, clots travel up the vena cava into the lungs, causing pulmonary embolism.

These lung clots can cause many symptoms including chest pain, shortness of breath, cough, high heart rate and anxiety. If not treated, pulmonary embolisms can be life threatening.

The Gunther Tulip filter is intended to sit in the blood vessel and catch clots that would cause recurrent pulmonary embolism. The filter is placed in the vena cava via a sheath system and anchored with hooks and struts to the blood vessel. Flower shaped wires and fixtures on the Gunther Tulip filter are supposed to break up clots before they reach the lungs, limiting the risks of blockages.

However, Paul claims that the device is defective and causes serious problems. The lawsuit alleges that the Gunther Tulip filter is associated with tilting, perforation, fracture, breakage and migration.

“The failure of the [Gunther Tulip filter] is attributable, in part, to the fact that the [Gunther Tulip filters] suffer from a design defect causing it to be unable to withstand the normal anatomical and physiological loading cycles exerted in vivo,” the complaint states.

The lawsuit claims that the device cannot withstand the anatomical force of blood flow, meaning it can become unattached. This can lead to perforation of the vena cava wall caused by tilting or migration.

A study referenced in the lawsuit allegedly found that 20 out of 50 (40%) of tilted Gunther Tulip filter devices also demonstrated vena caval perforation. “Defendants knew or should have known that their IVC filters were more likely than not tilt and to perforate,” the lawsuit states.

“Defendants’ misrepresentations included knowingly withholding material information from the medical community and the public, including Plaintiffs’ physicians, concerning the safety of their [Gunther Tulip filter devices],” the lawsuit states.

“The Defendants’ conduct was willful, wanton, and undertaken with a conscious indifference to the consequences that consumers of their product faced, including Plaintiffs.”

Paul accuses Cook of strict products liability – failure to warn, strict products liability – design defect, negligence, negligence per se, breach of warranty and violations of consumer protection laws. The lawsuit seeks compensatory damages, punitive damages, disgorgement, restitution, court costs and attorneys’ fees.

The Gunther Tulip Filter Lawsuit is Case No. 1:18-cv-01405-RLY-TAB and is part of the Cook IVC MDL, In re: Cook Medical, Inc, IVC Filters Marketing, Sales Practices And Products Liability Litigation, Case No. 1:14-ml-2570-RLY-TAB, in the United States District Court for the Southern District of Indiana.