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.
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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.