A new Cook IVC filter lawsuit has been filed in a federal court in Indiana, joining a consolidated group of product liability lawsuits pending against medical device manufacturer Cook Medical Inc.

Plaintiff Rita F. is a citizen and resident of New Hampshire and brings her Cook IVC filter lawsuit against named defendants Cook Inc., Cook Medical LLC, and William Cook Europe. She claims that she sustained injury as a direct consequence of her implantation with the Gunther Tulip Vena Cava Filter on Aug. 7, 2006.

In her Cook IVC filter lawsuit, Rita has chosen to bring the following counts against the defendants:

Count One: Strict Products Liability – Failure to Warn; Count Two: Strict Products Liability – Design Defect, Count Three: Negligence; Count Four: Negligence Per Se; Count Five: Breach of Express Warranty; Count Six: Breach of Implied Warranty; Count Seven: Violations of Applicable New Hampshire Law Prohibiting Consumer Fraud and Unfair and Deceptive Trade Practices; Count Eleven: Punitive Damages.

Through her retained counsel, Rita, in her Cook IVC filter lawsuit is asking for compensatory damages based on past and future medical expenses, pain and suffering, loss of enjoyment of life, lost wages and earning capacity.

She is also asking for a return of all court and attorney fees and assessment of punitive damages against the defendant.

The History of the Gunther Tulip Vena Cava Filter

The Gunther Tulip vena cava filter is a medical device designed to be temporarily or permanently placed in the major vein that returns deoxygenated blood to the heart from the lower part of the body—the vena cava.

Its purpose is to filter out blood clots known as thrombi—often produced in the deep veins of the legs—to prevent them from traveling to the heart and lung region. These traveling blood clots have been known to cause respiratory or cardiac arrest if allowed to move unimpeded up to this region.

The Gunther Tulip was approved for the commercial market in April 2005 under the U.S. Food and Drug Administration’s 510(k) process. As opposed to a pre-market approval process requiring extensive safety testing amounting to at least 1200 hours, the 510(k) process can be completed in an average of 20 hours, according to Rita’s IVC filter lawsuit.

With this expedited process, a proposed device relies upon the performance of a like product already market-available known as a ‘predicate device’. The Gunther Tulip in question relied upon the Gunther Tulip MReye Vena Cava Filter Set as its proposed predicate.

Lacking the extensive safety testing it did, litigants such as Rita allege that ensuing difficulties with the filter could and should have been known by the manufacturers prior to advertising.

The Gunther Tulip has a hook and four struts that give it a flower-like appearance. While it was designed to be removeable, the lawsuit narrative indicates a post-market review over a year and a half period discovered retrieval problems in roughly a quarter of studied patients.

Similarly, implantation records reviewed over two years allegedly found that almost all patients had some perforation of the vena cava by the device by two months after device introduction.

The Cook IVC Filter Lawsuit is Case No. 1:18-cv-00489-SEB-MJD, in the U.S. District Court, Southern District of Indiana, Indianapolis Division.