A Celect IVC filter lawsuit has been filed by a man who claims injury from the device implanted in May 2014.

The Cook Celect IVC filter is designed as a retrievable filter, implanted in the inferior vena cava vein to prevent blood clots from traveling from the lower part of the body to the heart and lungs. Some people who are prone to blood clots are unable to tolerate blood-thinning medications. For these patients, IVC filters are intended to act as a physical barrier to stop blood clots.

The Celect IVC filter lawsuit alludes to a master consolidated complaint for individual claims that alleges the devices were defectively designed and manufactured, leading to device migration, device breakage, and a high risk of perforation and damage to the vena cava’s wall.

Celect IVC Filter Shows High Rate of Retrieval Issues

Four anchoring struts for fixation and eight independent secondary struts to assist with centering and clot-trapping make up the Cook Celect IVC filter.

In a review of Cook filters retrieved between July 2006 and February 2008, 33 standard retrievals failed out of 130 retrievals. Another review of 73 patients who had Celect IVC filters implanted between August 2007 and June 2008 demonstrated a high incidence of caval filter leg penetration. Four filters had significantly tilted.

According to the Celect IVC filter lawsuit, “the Defendants failed to disclose to physicians, patients and/or Plaintiffs that its Cook filters were subject to breakage, tilt, inability of removal, and migration even though they knew or should have known the same was true.”

Cook filters are made of conichrome, a material that was marketed as one that “reduces the risk of fracture.”

However, “[t]he failure of the Cook filters is attributable, in part, to the fact that the Cook filters suffer from a design defect causing it to be unable to withstand the normal anatomical and physiological loading cycles exerted” within the human body.

Cook also allegedly insufficiently warned of the risks of “tilting, perforation, fracture and migration which are associated with and did cause serious injury and/or death.”

Medical Device Amendment Allowed IVC Filters Quick Market Entry

Cook sought FDA approval for its Celect IVC filter under section 510(k) of the Medical Device Amendments, which allows marketing of a medical device “if the device is substantially equivalent to other legally marketed predicate devices without formal review for the safety or efficacy of the said device.” Critics say the 510(k) process can be used as a loophole to escape the full evaluation process required for FDA approval.

The Celect IVC filter fell under this umbrella of FDA approval status.

Cook stands accused of “unreasonably and carelessly failing to properly warn of the dangers and risks of harm associated with Cook IVC filters.”

The Celect IVC filter lawsuit adds that Cook “knew or should have known of the hazardous and dangerous propensities of the said products, and thereby actively participated in the tortious conduct that resulted in the injuries suffered by the Plaintiffs.”

The Celect IVC Filter Lawsuit is Case No. 1:17-cv-01861-WCG-MPB in the U.S. District Court for the Southern District of Indiana, Indianapolis Division.