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Cook Celect IVC Filters Approved Through FDA Fast Track Approval Process


. By Gordon Gibb

One of the manufacturers of inferior vena cava filters facing lawsuits is Cook Medical, the enterprise behind the Cook Celect line of IVC filters. The devices are placed into the inferior vena cava, the primary artery returning deoxygenated blood from the lower extremities up to the heart and lungs. The devices by Cook and other manufacturers have been known to fracture, or become dislodged and drift towards vital organs. Designed to be removed, they often can’t. One Cook Celect IVC filter lawsuit filed last April alleges negligence and a defective design.

The plaintiff, identified only as Michael P., underwent a procedure to have a Cook Celect IVC filter implanted in his inferior vena cava August 25 of 2015 in an effort to mitigate problems stemming from blood clots. IVC filters are spider-like devices designed to entrap a migrating blood clot before the clot can migrate up to the lungs, risking a pulmonary embolism and placing a patient in certain jeopardy.

The plaintiff in the Cook Celect IVC filter lawsuit alleges injury as a result of the failure of the Celect filter, an update to the original Cook Gunther Tulip filter. The updated filter – the Cook Celect – was deemed substantially equivalent to the Gunther Tulip filter and thus granted a 510(k) Clearance by the US Food and Drug Administration (FDA). The latter is a fast-track approval process that spares the manufacturer the need for more thorough pre-market testing, provided the device is substantially equivalent to an approved device already on the market. The devices were approved as ‘Cook Celect and Gunther Tulip Vena Cava Filter Sets,’ and assigned a 510(k) Clearance No. K121057. A cardiovascular panel reviewed the 510(k) Clearance application. There was no third party review identified.

The Cook Celect inferior vena cava filter lawsuit is Case No. 1:17-cv-01225-SEB-DKL in US District Court for the Southern District of Indiana, Indianapolis Division.

Meanwhile, Cook Medical Inc. caught a break through the partial dismissal of a bellwether lawsuit when the US District Court for the Southern District of Indiana, the court assigned to the Cook Celect multidistrict litigation, ruled that a federal statute cannot support private negligence claims.

Law360 (05/17/17) reports that an IVC filter lawsuit brought by plaintiff Elizabeth Hill (Hill v. Cook Medical Inc. et al., Case No. 1:14-cv-06016, US District Court for the Southern District of Indiana) alleges Cook Medical failed to disclose that physicians may be unable to remove Celect Vena Cava filters once the treatment window had closed, or that the devices can fracture, migrate or damage the vena cava or adjacent organs.

IVC filters, originally envisioned as a permanent hedge against blood clots, are now primarily held as a temporary measure against heightened risk for blood clot. The FDA advocates a tight window for removal of the IVC filter once the danger of blood clot has passed.

For many patients, however, IVC filters cannot be removed. Hill, in her IVC filter lawsuit, asserted that IVC filters that remain in place indefinitely require the patient to remain on blood thinners indefinitely, which also increases the risk of hemorrhage and makes other medical treatment difficult, Hill claims.

Cook Medical sought dismissal of Hill’s claims of breach of express and implied warranty and negligence per se. Hill contested the dismissal of the negligence claim.

US District Judge Richard L. Young dismissed negligence claims based on the federal Food, Drug and Cosmetic Act (FDCA), saying the wording of the law provides that all enforcement actions under it, or associated [with] FDA rules must be made by, and in the name of the federal government.

“Accordingly, plaintiff’s negligence per se claim based on violations of the FDCA or the FDA’s implementing regulations may not go forward,” he wrote.

The MDL is In re: Cook Medical Inc., Case No. 1:14-ml-02570, US District Court for the Southern District of Indiana.

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