A troubled consumer recently filed a lawsuit against Cook, claiming that he sustained damages after undergoing IVC filter insertion with one of the company’s intravenous blood clot filters.

Plaintiff David B. recently filed a lawsuit against Cook Incorporated, Cook Medical LLC, and William Cook Europe ApS, alleging that the company’s IVC filters are defective and dangerous. David says he underwent IVC filter insertion in September 2012 and was implanted with the Gunther Tulip IVC filter. After this, he allegedly experienced numerous complications associated with the IVC filter insertion.

In certain at risk individuals, clots can form in the deep veins of the legs. When these clots pass up the vena cava and into the lungs, they can cause pulmonary embolisms. This clotting of blood vessels in the lungs can be life threatening as it diminishes lung capacity.

To manage clotting and avoid pulmonary embolisms, some individuals undergo IVC filter insertion. During the process of IVC filter insertion, the filter is positioned in the inferior vena cava and anchored by struts. Once in the vena cava, IVC filters catch clots and break them up before they reach the lungs.

The Gunther Tulip filter is a small device with four anchoring struts. On each of these struts, there is a “flower” formation made of wire pieces designed to break up clots passing through the vena cava.

The Gunther Tulip IVC filter was approved by the U.S. Food and Drug Administration (FDA) through the 510(k) process. This process allows the approval of certain devices by proving that they are sufficiently similar to a pre-existing approved device. Although this process increases the amount of life saving devices that can be distributed to benefit consumers, it also increases the potential that dangerous devices will be sold without any prior testing.

David claims that this was the case with the Gunther Tulip IVC filter and other IVC filters sold by Cook.

According to David’s IVC filter insertion lawsuit, the Gunther Tulip IVC filter is incapable of withstanding the normal force associated with blood flow cycles. This lack of stability can allegedly lead to tilt and vena caval perforation.

A review of outcomes associated with Cook Filters showed that these complications are alarmingly common. In a study of 73 patients, around 7% showed significant tilt immediately after IVC filter insertion. Follow-up CT scans showed that 39% of patients experienced filter problems including tilt, perforation, filter fracture, and migration of the device.

David claims that Cook knew or should have known that their products were dangerous, and failed to warn consumers of the high risks associated with IVC filter insertion.

He accuses the defendants of failure to warn, design defect, negligence, breach of warranties, and violation of consumer protection laws. The IVC filter insertion lawsuit seeks compensatory damages, punitive damages, disgorgement, restitution, court costs, and attorneys’ fees.

The IVC Filter Lawsuit is Case No. 1:18-cv-02697-WTL-MPB and is part of the IVC Filter 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.